Diabetes Technology—Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults

Last updated April 8, 2022

Key Points

Advances in the pharmacokinetics and pharmacodynamics of insulin products and in the methods of insulin delivery and glucose monitoring are geared toward improving glucose control, minimizing hypoglycemia, and improving quality of life. Two such advances are continuous subcutaneous insulin infusion (CSII) and real-time continuous glucose monitoring (RT-CGM).

Success of these devices and technologies is directly linked to the level to which people are educated, capable, and willing to use them.

This guideline attempts to assess all available data on existing and emerging technologies and procedures for improving glucose control for patients with diabetes.

Treatment

Insulin Pump Therapy Without Sensor Augmentation

Endocrine Society (ES) recommends CSII over analog-based basal-bolus multiple daily injections (MDI) in patients with type 1 diabetes mellitus (T1DM) who have not achieved their A1C goal, as long as the patient and caregivers are willing and able to use the device. (1-M)

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ES recommends CSII over analog-based basal-bolus MDI in patients with T1DM who have achieved their A1C goal but continue to experience severe hypoglycemia or high glucose variability, as long as the patient and caregivers are willing and able to use the device. ( 1-L )

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ES suggests CSII in patients with T1DM who require increased insulin delivery flexibility or improved satisfaction and are capable of using the device. (2-L)

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Insulin Pump Therapy in Type 2 Diabetes Mellitus

ES suggests CSII with good adherence to monitoring and dosing in patients with type 2 diabetes mellitus (T2DM) who have poor glycemic control despite intensive insulin therapy, oral agents, other injectable therapy, and lifestyle modifications. (2-L)

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Insulin Pump Use in the Hospital

ES suggests that clinicians continue CSII in patients admitted to the hospital with either type of diabetes if the institution has clear protocols for evaluating patients as suitable candidates and appropriate monitoring and safety procedures. (2-L)

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Selection of Candidates for Insulin Pump Therapy

ES recommends that before prescribing CSII, clinicians perform a structured assessment of a patient’s mental and psychological status, prior adherence to diabetes self-care measures, willingness and interest in trying the device, and availability for the required follow-up visits. ( 1-L )

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Use of Bolus Calculators in Insulin Pump Therapy

ES suggests encouraging patients to use appropriately adjusted embedded bolus calculators in CSII and have appropriate education regarding their use and limitations. (2-L)

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Real-Time Continuous Glucose Monitors in Adult Outpatients

ES recommends RT-CGM devices for adult patients with T1DM who have A1C levels above target and who are willing and able to use these devices on a nearly daily basis. ( 1-H )

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ES recommends RT-CGM devices for adult patients with well-controlled T1DM who are willing and able to use these devices on a nearly daily basis. ( 1-H )

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Use of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Mellitus

ES suggests short-term, intermittent RT-CGM use in adult patients with T2DM (not on prandial insulin) who have A1C levels ≥7% and are willing and able to use the device. ( 2-L )

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Education and Training on the Use of Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring

ES suggests that adults with T1DM and T2DM who use CSII and continuous glucose monitoring (CGM) receive education, training, and ongoing support to help achieve and maintain individualized glycemic goals. (UGPS)

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Table 1. CSII—Considerations for Education and Training

Patient
Collaborate with health care professional (HCP) overseeing CSII use and/or the multidisciplinary diabetes team by returning for follow-up. Participate in using data management resources to make adjustments to therapy and evaluate self-care behaviors.
Provider
Provide education as indicated to address deficiencies or when upgrading to new technology.
Assess CSII use and evaluate for the loss of ability to operate insulin pump due to cognitive, physical, or age-related changes; changes in insurance coverage; or changes in the healthcare provider managing CSII use.
Time periods to assess patient self-care behaviors and knowledge before initiating CSII, assess:
Glucose monitoring via self-monitoring blood glucose (SMBG) frequency, and/or CGM use defined by HCP to meet individualized glycemic goals.
Carbohydrate counting or another method of mealtime bolus determination.
Ability to operate CSII and make setting changes due to factors such as dexterity, vision impairment, mental health, or cognition—independently or with assistance from a designated care provider.
Infusion site health and selection.
DKA prevention and treatment.
Hypoglycemia—prevention, detection, and treatment.
Emergency supplies.
If using bolus calculator, assess these settings: insulin-to-carbohydrate ratio, insulin sensitivity factor, glucose targets, and active insulin time.
Annually and/or when upgrading to a new CSII device, re-assess:
Glucose monitoring via SMBG frequency and/or CGM use defined by HCP to meet individualized glycemic goals.
Basal settings via basal rate testing across different time periods, adjust as indicated.
Bolus calculator settings, if using feature, adjust as indicated.
Infusion sites and type of infusion set, adjust as indicated.
Ability to troubleshoot insulin pump malfunction.
DKA prevention and treatment.
Hypoglycemia prevention, detection, and treatment.
Emergency supplies.
Back-up plan for use of injected insulin should pump fail.
When discontinuing CSII or transitioning to MDI, re-assess:
Glucose monitoring via SMBG frequency and/or CGM use defined by HCP to meet individualized glycemic goals. New insulin plan for MDI.

Table 2. RT-CGM Technology—Considerations for Education and Training for Personal Use

Patient
Collaborate with HCP overseeing RT-CGM use and/or the multidisciplinary diabetes team by returning for follow-up.
Participate in use of data management resources to make adjustments to therapy and evaluate self-care behaviors.
Provider
Provide education as indicated to address deficiencies or when upgrading to new CGM technology.
On an ongoing basis, assess CGM use and evaluate for the loss of ability to operate CGM system due to: cognitive, physical, or age-related changes; changes in insurance coverage; or changes in the healthcare provider managing CGM use.
Time periods to assess patient self-care behaviors and knowledge
Before initiating RT-CGM, assess:
Patient understanding that CGM does not replace SMBG.
Factors and self-care behaviors that may influence success with CGM.
When initiating RT-CGM, assess:
Knowledge of CGM system components—receiver, sensor, and transmitter.
Understanding of how CGM data differ from SMBG data.
Use of trend information based on changing glucose levels to adjust insulin doses.
Use of SMBG to calibrate CGM system.
Site selection and care.
Alarms (Check that alarms are set in a fashion to optimize patient benefit and minimize alarm fatigue. The initial focus is often on low alerts and falling blood glucose alarms. High alerts can be turned off or set well above target at first if patient is consistently high and doesn’t benefit from high alerts.)
Annually and/or when upgrading technology (for ongoing RT-CGM use), re-assess:
Ability to make insulin adjustment based on trend information.
Use of SMBG to calibrate.
Sensor site health and care.

Table 3. Suggested Health Care Provider Resources to Support the Safe and Effective Use of CSII and RT-CGM

Clinicians should implement a formalized educational plan for the initiation and long-term support of CSII and RT-CGM that is established by the practice setting. Clinicians should communicate education plans to potential candidates and individuals new to the practice setting.

Clinics should have a designated multidisciplinary diabetes team to evaluate potential candidates, initiate therapy and education, and to support long-term CSII and RT-CGM use that is part of the practice setting. Alternatively, a sole practitioner may also provide medical care and CSII education supported by other healthcare professionals or industry consultants as indicated. CSII and RT-CGM diabetes care team members could include the following health care providers: endocrinologist, advanced practice registered nurse, physician’s assistant, primary care provider, certified diabetes educator, registered dietitian with expertise in diabetes medical nutrition therapy, and mental health/behavioral therapists.

The clinical support staff or patient should know how to download data from glucose meters, insulin pumps, and RT-CGMs, and they should download data before an appointment in order to review data via print format, online secure patient pump portal, or the patient’s electronic health record.

Designated staff members (diabetes educators, medical assistants, or patient service representatives) should be available to help clinics obtain prior authorizations, schedule peer-to-peer reviews, submit supporting documents for determining coverage, answer insurance and distributor/third party vendor queries for additional documentation, and issue letters of support and/or appeal if therapy is declined.

Toolkit Resource Section

Additional Guidance from Professional Societies and Organizations

Excerpts from 2021 American Association of Clinical Endocrinology (AACE) Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

(Click to View Guideline)

Insulin Delivery Technologies

Q2.6 Who would benefit from the use of connected pens?

R2.6.1 Connected pens may be recommended for all persons with diabetes who are treated with intensive insulin management, with 3 or more injections per day and who are not on insulin pump therapy, in whom an assessment of insulin dosing may help the person with diabetes and the clinician to further optimize the insulin regimen and avoid the stacking of rapid-acting insulin doses that could lead to hypoglycemia. Grade C; Intermediate SEO/EOTF; BEL 2 ()

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Q2.7 Who would benefit from the use of an insulin pump without continuous glucose monitoring?

R2.7.1 The use of an insulin pump without CGM could be used to manage persons with diabetes who are achieving glycemic targets with minimal TBR, who report infrequent episodes of symptomatic hypoglycemia, and who are using SMBG on a regular basis (at least 4 times per day for persons with T1D). Grade B; Intermediate-High SEO; BEL 1 ()

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Q2.8 Who would benefit from the use of an insulin pump with continuous glucose monitoring (separate devices or sensor-augmented pump)?

R2.8.1 Insulin pump with CGM or SAP is recommended to manage all persons with diabetes treated with intensive insulin management who prefer not to use automated insulin suspension/dosing systems or have no access to them. Grade A; Intermediate-High SEO; BEL 1 ()

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Q2.9 Who would benefit from the use of more advanced insulin pump technologies: low-glucose suspend, predictive low-glucose suspend, and hybrid closed loop?

R2.9.1 Low-glucose suspend (LGS) is strongly recommended for all persons with T1D to reduce the severity and duration of hypoglycemia, whereas predictive low glucose suspend (PLGS) is strongly recommended for all persons with T1D to mitigate hypoglycemia. Both systems do not lead to a rise in mean glucose, and lead to increased confidence and trust in the technology, more flexibility around mealtimes, and reduced diabetes distress for both persons with diabetes and caregivers. Therefore, anyone with frequent hypoglycemia, impaired hypoglycemia awareness, and those who fear hypoglycemia leading to permissive hyperglycemia should be considered for this method of insulin delivery. Grade A; High SEO; BEL 1 ()

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R2.9.2 AID systems are strongly recommended for all persons with T1D, since their use has been shown to increase TIR, especially in the overnight period, without causing an increased risk of hypoglycemia. Given the improvement in TIR and the reduction in hyperglycemia with AID, this method of insulin delivery is preferred above other modalities. For persons with diabetes with suboptimal glycemia, significant glycemic variability, impaired hypoglycemia awareness, or who allow for permissive hyperglycemia due to the fear of hypoglycemia, such AID systems should be considered. Grade A; High SEO; BEL 1 ()

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ADA 2022 Standards of Care - Highlight of New Recommendations:

Diabetes Technology Introduction

The type(s) and selection of devices should be individualized based on a person’s specific needs, desires, skill level, and availability of devices. In the setting of an individual whose diabetes is partially or wholly managed by someone else (e.g., a young child or a person with cognitive impairment), the caregiver’s skills and desires are integral to the decision-making process. E
When prescribing a device, ensure that people with diabetes/caregivers receive initial and ongoing education and training, either in-person or remotely, and regular evaluation of technique, results, and their ability to use data, including uploading/sharing data (if applicable), to adjust therapy. C
People who have been using continuous glucose monitoring, continuous subcutaneous insulin infusion, and/or automated insulin delivery for diabetes management should have continued access across third-party payers. E
Students must be supported at school in the use of diabetes technology including continuous subcutaneous insulin infusion, connected insulin pens, and automated insulin delivery systems as prescribed by their diabetes care team. E
Initiation of continuous glucose monitoring, continuous subcutaneous insulin infusion, and/or automated insulin delivery early in the treatment of diabetes can be beneficial depending on a person’s/caregiver’s needs and preferences. C

Insulin Pumps and Automated Insulin Delivery Systems

Automated insulin delivery systems should be offered or diabetes management to youth and adults with type 1 diabetes A and other types of insulin-deficient diabetes E who are capable of using the device safely (either by themselves or with a caregiver). The choice of device should be made based on patient circumstances, desires, and needs.
Insulin pump therapy alone with or without sensor-augmented low glucose suspend should be offered for diabetes management to youth and adults on multiple daily injections with type 1 diabetes A or other types of insulin-deficient diabetes E who are capable of using the device safely (either by themselves or with a caregiver) and are not able to use/interested in an automated insulin delivery system. The choice of device should be made based on patient circumstances, desires, and needs. A
Insulin pump therapy can be offered for diabetes management to youth and adults on multiple daily injections with type 2 diabetes who are capable of using the device safely (either by themselves or with a caregiver). The choice of device should be made based on patient circumstances, desires, and needs. A
Individuals with diabetes who have been successfully using continuous subcutaneous insulin infusion should have continued access across third-party payers. E

ADA evidence-grading system for “Standards of Medical Care in Diabetes”

Level of evidence	Description
A	Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered, including
	Evidence from a well-conducted multicenter trial
	Evidence from a meta-analysis that incorporated quality ratings in the analysis
	Compelling nonexperimental evidence, i.e., “all or none” rule developed by the Centre for Evidence-Based Medicine at the University of Oxford
	Supportive evidence from well-conducted randomized controlled trials that are adequately powered, including
	Evidence from a well-conducted trial at one or more institutions
	Evidence from a meta-analysis that incorporated quality ratings in the analysis
B	Supportive evidence from well-conducted cohort studies
	Evidence from a well-conducted prospective cohort study or registry
	Evidence from a well-conducted meta-analysis of cohort studies
	Supportive evidence from a well-conducted case-control study
C	Supportive evidence from poorly controlled or uncontrolled studies
	Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results
	Evidence from observational studies with high potential for bias (such as case series with comparison with historical controls)
	Evidence from case series or case reports
	Conflicting evidence with the weight of evidence supporting the recommendation
E	Expert consensus or clinical experience

Consensus Statement by the American Association of Endocrinologists / American College of Endocrinology - Insulin Pump Management Task Force

Based on currently available data, CSII is justified for basal-bolus insulin therapy in patients with type 1 diabetes mellitus (T1DM)
Only providers whose practice can assume full responsibility for a comprehensive pump management program should offer this technology
Appropriate patient selection is necessary and must include a thorough assessment of the patient’s knowledge of diabetes management principles
The ideal CSII candidate is:
- A patient with T1DM or intensively managed insulin-dependent T2DM
- Currently performing ≥4 insulin injections and ≥4 self-monitored blood glucose (SMBG) measurements daily
- Motivated to achieve optimal blood glucose control
- Willing and able to carry out the tasks that are required to use this complex and time-consuming therapy safely and effectivel
- Willing to maintain frequent contact with their health care team
Adult patients
- At CSII initiation, the patient should have daily contact with the pump trainer
- A return visit with the endocrinologist/diabetologists/advanced practice nurse is advised within 3 to 7 days of initiation
- Educational consults should be scheduled weekly or biweekly at first, then periodically as needed
- Specialist follow-up visits should be scheduled at least monthly until the pump regimen is stabilized, then at least once every 3 months
Pediatric patients
- An international consensus conference of leading pediatric diabetes specialists agreed that CSII was indicated for pediatric patients with:
  - Elevated hemoglobin A1c (HbA1c) levels on injection therapy
  - Frequent, severe hypoglycemia
  - Widely fluctuating glucose levels
  - A treatment regimen that compromises lifestyle
  - Microvascular complications and/or risk factors for macrovascular complications
- Ideal pediatric candidates are those with motivated families who are committed to monitoring blood glucose ≥4 times/day and have a working understanding of basic diabetes management
- Patient age and duration of diabetes should not be factors in determining the transition from injections to CSII
Patient diabetes education and pump training should be implemented by a multidisciplinary team under the direction of an experienced endocrinologist/ diabetologist
- Patients must be educated on the meaning of pump alarms, particularly those that may signal a potential interruption to insulin delivery
- Patients must be taught to keep backup supplies on hand in the event of a pump or infusion set failure
- Patients/families should undergo periodic retesting of skills to maximize the effectiveness of pump therapy and maintain patient safety
  - Patients should have the knowledge and technical ability to make recommended pump setting changes at home
  - Patients/families should be trained to handle emergency situations
  - Patients should be retrained when switching to a new pump model
- All patients should have periodic re-education and retraining to address knowledge gaps, as well as to troubleshoot any issues with the pump system and glycemic control
- The health care team should periodically re-evaluate whether pump therapy is appropriate for the patient
- Schools and hospitals should be provided with manufacturers’ information describing insulin pump use, along with a contact to answer questions and provide further training
- Providers should have on-call systems available 24 hours/day to handle patient questions; patients should also be periodically reminded of the pump manufacturer’s emergency number

Shared Decision-Making Tool

Recent guidelines recommend that continuous subcutaneous insulin infusion (CSII) may be an appropriate option for many patients with both type 1 and type 2 diabetes. However, before prescribing CSII, clinicians and patients should discuss a number of factors, including: the patient’s prior adherence to diabetes self-care measures, willingness and interest in trying the device, and availability for the required follow-up visits. This resource is a guide for HCPs to have a dialogue with their patients, and will help guide that discussion and offer additional tips and insights into a shared decision-making process.

Factors to Consider When Prescribing CSII:

Willingness to try device(s) and participate in follow ups
Adherence
Activity levels
Access (Price and Insurance Coverage)
Ease of use
Feelings about needles (e.g. needle phobia)
Comfort with technology
Trial periods
Discretion
And more

Are you willing and able to try an insulin pump?

This is the most important question on this list. Some patients prefer shots/needles, others are open to exploring both traditional and automated insulin delivery devices. There is no right or wrong answer - only right or wrong for each patient. On that note, in the last decade there have been a number of new breakthroughs to help patients with diabetes manage their glucose levels in the simplest, most effective ways possible. If patients are willing and able to try, and willing to participate in follow up visits, then exploring these new devices may be a good option.

Have you struggled with engagement with your therapy in the past?

It’s nothing to be ashamed of, and no secret that some people may have issues remembering to follow through with a routine. If engagement with the therapy has been a problem in the past, or if you foresee potential issues with therapy engagement in the future, it is a good idea take this into account when determining the right system.

How active is your lifestyle? And is a waterproof device important to you?

If you are an active individual? Do you swim regularly? If either answer is “yes”, there will be benefits from an automated insulin delivery system that doesn’t need to be disconnected like tubed pumps often are. Even better, look for a device that is waterproof to avoid needing to remove prior to taking a swim. Also, some devices come with temporary setting support, like an exercise mode or another mode which reduces insulin delivery during times of decreased insulin needs.

Are you able to obtain access to your desired device? (Price and Insurance Coverage):

Talk with your insurance company about what they will cover. It’s important to understand that, even if your particular insurance doesn’t cover the desired device(s), you can check the device manufacturer’s website for patient assistance options. Also take note that, depending on the device(s) chosen and the insurance offered, coverage may be in the form of either durable medical equipment (DME) benefits or pharmacy benefits.

How important is it to you that the therapy is simple to use?

When considering insulin delivery options, it’s important to take ease of use into account. Some devices are tubeless, making it simpler to go about everyday life. Touch screen devices are also a nice feature to support ease of use.

How do you feel about needles and frequent injections?

For someone with “needle phobia”, or someone who wants to avoid needles as much as possible, a pump system to help minimize the frequency of injections might be the best choice. Also, look for pumps with auto cannula insertions so you do not need to see the needle upon insertion.

How comfortable are you with technology, and is it important for your healthcare team to be able to monitor your numbers regularly?

For those who want to manage glucose trends and insulin delivery on the go, and/or easily share numbers with healthcare providers, it’s important to look for a system that can connect to other devices such as computers and smartphones for wireless data upload and sharing capabilities.

How important is it to you to have some sort of money back guarantee or trial period?

Managing diabetes is a lifelong journey, and along the way it is very normal to undergo a bit of trial and error to find the solution(s) that works best. For that reason, it’s important to look for options that include some sort of trial period.

Is discretion important to you?

If discretion is important, look at options that are tubeless. In addition to being discrete, tubeless pumps may also be less intrusive during times of physical activity or intimacy.

Other factors to consider: Is customization important to you? Are good reviews and customer feedback a major factor? Are you looking for a device that is “future proof” with things like software updates? Are you interested in sharing data with other connected devices and receiving personalized insights? Are you looking for something that can help simplify your life?

If the answer to any of the above is a “yes”, automated insulin delivery systems may be a great option!

Comparison Table

	Multiple Daily Injections	Tubed Insulin Pump Therapy ¹	Tubeless Insulin Pump Therapy ¹
What will you need to carry?	Insulin pen Alcohol swabs Continuous Glucose Monitor (CGM) or/and blood glucose meter with test strips and lancing device/lancets	Insulin pump (connected to infusion set by tubing) Continuous Glucose Monitor (CGM) or/and blood glucose meter with test strips and lancing device/lancets	Tubeless pump is attached to body directly Handheld controller (Personal Diabetes Manager)* Continuous Glucose Monitor (CGM) or/and blood glucose meter with test strips and lancing device/lancets
Where to carry it?	Supplies are commonly carried in pockets or in a carry case.	Insulin pump is commonly clipped to a belt or pocket. Insulin pump is connected to infusion set by tubing. All other supplies are carried in a separate carry case.	Tubeless pump is worn on the body with no attachment to PDM.* Tubeless pump will deliver basal insulin regardless of PDM location once programmed.* PDM is commonly carried in a separate carry case with all other supplies.*
Considerations	No bolus calculator No ability to adjust basal throughout the day No mechanical device to maintain No wardrobe considerations Nothing to remove for water or intense activity 4-6+ injections required per day Must plan when/where to inject insulin Cost/insurance coverage	Bolus calculator Ability to adjust basal insulin to match your body’s needs Must manage tubing Need to disconnect for certain occasions Insulin pump required to be near infusion site Possible mechanical issues Cost/insurance coverage	Bolus calculator Ability to adjust basal insulin to match your body’s needs No tubing to manage No need to disconnect until site change Tubeless pump is concealed under clothing Possible mechanical issues Cost/insurance coverage
ILLNESS Most common: BGs rise and sometimes BGs go low	Basal insulin is hard to adjust for short term illness, but it may be adjusted for extended illness. Bolus insulin may be adjusted with more frequent injections.	Use the temporary basal feature to temporarily increase or decrease basal insulin. Bolus insulin may be adjusted without extra injections.
STRESS Most common: BGs rise ¹	Basal insulin is hard to adjust for short term stress, but it can be adjusted for extended stress. Bolus insulin may be adjusted with more frequent injections.	Use the temporary basal feature to temporarily increase your basal insulin. Bolus insulin may be adjusted without extra injections.
ACTIVITY Most common: BGs rise ¹	Basal insulin is hard to adjust for activity. Snacks or adjustment of bolus doses may be required to help prevent hypoglycemia.	Disconnect during activity may be required, resulting in disruption in insulin delivery. If not disconnected, the temporary basal feature can be used to decrease basal insulin for a given time period.	Tubeless pump does not need to be disconnected. The temporary basal feature can be used to decrease the basal rate while active.
VARIABLE SCHEDULES Variable schedules make it a challenge to manage BGs	Bolusing more often may be necessary, which will mean more injections. Unable to track insulin that is still working in your body from a previous bolus.	Allows for option to bolus more often without extra injections. Use advanced bolus features to help with high fat meals and/or extended eating at holidays or parties. Can track active insulin from a previous bolus to help prevent insulin stacking, which can lead to hypoglycemia.

* For Omnipod® Products

1. Bolderman, K. Putting your patients on the pump. 2nd ed. American Diabetes Association. 2013.

Critical Success Factors with Insulin Pump Use

While almost anyone is capable of using insulin pumps, the most important requirement is that the patient and/or the patient’s caregivers are ready and willing to do what it takes to use the pump safely.

A successful user is:

Responsible
Knowledgeable about diabetes selfcare
Desiring for better glycemic control
Willing to monitor blood sugars as required
Willing to undergo insulin pump training to safely use the technology
Understanding that success of insulin pump therapy is reliant on knowledgeable users and interaction with you care team

A successful user will have the opportunity to take advantage of a number of advantages that come with insulin pump therapy, including

Increased flexibility in lifestyle
Predictable and precise insulin delivery
Blood glucose improvements, while reducing the risk of hypoglycemia
Reducing episodes of severe hypoglycemia
And more

Additional Information

Automated Insulin Delivery Systems

Automated insulin delivery systems increase and decrease insulin delivery based on sensor-derived glucose level to begin to approximate physiologic insulin delivery.
These systems consist of three components: an insulin pump, a continuous glucose sensor, and an algorithm that determines insulin delivery.
With these systems, insulin delivery can not only be suspended but also increased or decreased based on sensor glucose values.
While eventually insulin delivery in closed-loop systems may be truly automated, currently meals must be announced.
A so-called hybrid approach, hybrid closed-loop, has been adopted in first-generation closed-loop systems and requires users to bolus for meals and snacks.
Multiple studies, using a variety of systems with varying algorithms, pump, and sensors, have been performed in adults and children.
Evidence suggests such systems may reduce A1C levels and improve time in range. They may lower the risk of exercise-related hypoglycemia and may have psychosocial benefits.
Use of these systems depends on patient preference and selection of patients (and/or caregivers) who are capable of safely and effectively using the devices.

Clinical benefits of Tubeless Insulin Pump

Tubeless Automated Insulin Delivery System

In the single-arm, multicenter, prospective study of 240 participants [112 children (age 6–13.9 years) and 128 adults and adolescents (age 14–70 years)] with type 1 diabetes who initiated the Omnipod® 5 AID System demonstrated a reduction in HbA1c after 3 months in children by -0.71% (p < 0.0001) and in adults by -0.38% (p < 0.0001) compared to standard therapy. Time in range improved by 15.6% (3.7 h/day) in children and 9.3 (2.2 h/day) in adults and adolescents (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults: 2.00% to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events and one diabetic ketoacidosis event. These cases were not related to automated insulin delivery malfunction.[5]

Tubeless Insulin pump

Type 1 Diabetes

HbA1c change:

Multisite, retrospective study of 873 pediatric, adolescent, and adult patients with type 1 diabetes on multiple daily injections (MDI) and tubed pumps by Layne et al. After 3 months of tubeless insulin pump use, an overall reduction in HbA1c of 0.6% was seen compared to baseline. For MDI patients, HbA1c improved from 8.4% to 7.8%. For previous tubed pump users, HbA1c improved from 8.3% to 7.8% These improvements were seen across all age groups independent of prior treatment. [6]
Multicenter, retrospective electronic health record–based clinical investigation. 156 adult patients with T1D who had been using either tubed CSII or multiple daily injections (MDI) for diabetes maintenance. Overall, HbA1c reduction was -0.3% following the switch to tubeless CSII, from 8.1% to 7.8% Among patients switching from MDI, the drop was -0.4% (from 8.2 to 7.8). The change was most notable for patients whose baseline A1C reading was 9% or higher. Those patients had a decrease of −1.2%.[7]

Total daily dose change:

Another important finding in the Layne et al. type 1 diabetes study was the reduction in the total daily dose (TDD) of insulin with tubeless insulin pump use reported for both previous MDI and tubed pump users. There was a 16.4% decrease in TDD of insulin at 3 months for the total population. [6]

Hypoglycemia:

Layne et al. data showed that the frequency and severity of self-reported hypoglycemia decreased significantly in participants with type 1 diabetes (2.6/ week to 1.6/week). Improvements in hypoglycemia frequency and severity were significant across all age groups independent of prior treatment modality.[6]

Type 2 Diabetes [8]:

3,592 Adults with Type 2 diabetes experienced a significant reduction in HbA1c (-1.3%, p<0.0001), Total Daily Dose (-33U, p<0.0001) & self-reported Hypoglycemic Events (-0.5/week, p<0.0001) after only 3 months of Omnipod® use in a retrospective study.

Quality of Life [9]:

In a survey study by Polonsky and colleagues of more than 1200 adults with type 1 diabetes using the tubeless insulin management system, there were QOL and clinical benefits associated with use of this system. The majority of patients reported positive changes in overall well-being (53.5%), perceived control over diabetes (72.5%), hypoglycemic safety (50.6%), and diabetes distress (69.6%). Improvement in glycemic control was also reported by the majority (64.2%) of respondents with 35.2% reporting a decrease in episodes of severe hypoglycemia. These data are particularly compelling as 44% of respondents had previously used a tubed pump.

References:

https://www.endocrine.org/clinical-practice-guidelines/diabetes-technology
https://marlin-prod.literatumonline.com/pb-assets/Health%20Advance/journals/eprac/EPRAC180.pdf
https://diabetesjournals.org/care/article/45/Supplement_1/S97/138911/7-Diabetes-Technology-Standards-of-Medical-Care-in
https://www.endocrinepractice.org/article/S1530-891X(20)42190-1/fulltext
Brown S. et al. Diabetes Care. 2021;44:1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6 - 70 yrs [adults/adolescents (n= 128; aged 14-70 yrs) children (n=112; aged 6-13.9 yrs)]. Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod 5 hybrid closed-loop phase. HbA1c was significantly reduced in children by 0.71% (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63%, P < 0.0001) and in adults by 0.38% (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001).Mean time 70-180mg/dL as measured by CGM in adults/adolescents and children, ST vs. Omnipod 5: 64.7% vs. 73.9%, P<0.0001; 52.5% vs. 68.0%, P<0.0001, respectively. Median time <70 mg/dL in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 2.0% vs. 1.1%, P<0.0001; 1.4% vs. 1.5%, P=0.8153, respectively. Results measured by CGM
J. Layne et al. Journal of Diabetes Science and Technology 2016, Vol. 10(5) 1130–1135. Note that A1C and TDD results could be self-reported or taken from medical records.
Mehta S, Tinsley L, Kruger D, et al. Improved glycemic control following the transition to tubeless insulin pump therapy in adults with type 1 diabetes. Published by Clinical Diabetes Journal, December 2020. It was a multicenter, retrospective electronic medical record study in the US. 156 adults with type 1 diabetes (≥18 years of age) initiated therapy with Omnipod® System after either MDI (n=99) or CSII with a tubed insulin pump (n=57). The primary endpoint was a change in A1C from the time of transition (baseline) to 12 months following initiation of the tubeless insulin pump. In HbA1c analysis, baseline vs. 12-month follow-up HbA1c values were 8.1% vs 7.8% respectively, p<0.01.
Carlson, AL et al. Improved Glycemic Control in 3,592 Adults with Type 2 Diabetes Mellitus Initiating a Tubeless Insulin Management System. Diabetes Res Clin Pr; 2021;174,108745: https://doi.org/10.1016/j.diabres.2021.108735 3,592 patients with Type 2 diabetes aged ≥18 years were included in a multisite, retrospective study based in the US. The study evaluated glycemic control and insulin use after three months of Omnipod System and Omnipod DASHR System use, compared to prior treatment with MDI (74%), tubed insulin pumps (15%), and unknown (11%). HbA1c and TDD outcomes were from medical records or self-reported if medical records were not available. HbA1c decreased from (mean ± SD) 9.2 ± 2.0% to 7.9% ± 1.3% overall, p<0.0001; TDD decreased from 103 ± 70U to 71 ± 41U overall, p<0.0001; the self-reported number of HE (<70 mg/dL) per week decreased significantly from 1.2 ± 2.0 to 0.7 ± 1.1 per week , p<0.0001.
Polonsky WH, et al. Diabetes Technol Ther. 2016 Oct;18(10):664–670

Recommendation Grading

Abbreviations

CGM: Continuous Glucose Monitoring
CSII: Continuous Subcutaneous Insulin Infusion
DKA: Diabetes Ketoacidosis
HCP: Health Care Professional
MDI: Multiple Daily Injections
RT-CGM: Real-time CGM
SMBG: Self-monitoring Blood Glucose
T1DM: Type 1 Diabetes Mellitus
T2DM: Type 2 Diabetes Mellitus

Source Citation

Anne L. Peters, Andrew J. Ahmann, Tadej Battelino, Alison Evert, Irl B. Hirsch, M. Hassan Murad, William E. Winter, Howard Wolpert, Diabetes Technology—Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline, The Journal of Clinical Endocrinology & Metabolism, Volume 101, Issue 11, 1 November 2016, Pages 3922–3937, https://doi.org/10.1210/jc.2016-2534

Disclaimer

This pocket guide attempts to define principles of practice that should produce high-quality patient care. It is applicable to specialists, primary care, and providers at all levels. This pocket guide should not be considered exclusive of other methods of care reasonably directed at obtaining the same results. The ultimate judgment concerning the propriety of any course of conduct must be made by the clinician after consideration of each individual patient situation. Neither IGC, the medical associations, nor the authors endorse any product or service associated with the distributor of this clinical reference tool.

Codes

CPT Codes

Code	Descriptor
96170	Health behavior intervention, family (without the patient present), face-to-face; initial 30 minutes
96167	Health behavior intervention, family (with the patient present), face-to-face; initial 30 minutes
96156	Health behavior assessment, or re-assessment (ie, health-focused clinical interview, behavioral observations, clinical decision making)
98962	Education and training for patient self-management by a qualified
98961	Education and training for patient self-management by a qualified
96158	Health behavior intervention, individual, face-to-face; initial 30 minutes
99078	Physician or other qualified health care professional qualified by education
96159	Health behavior intervention, individual, face-to-face; each additional 15 minutes (List separately in addition to code for primary service)
98960	Education and training for patient self-management by a qualified
0592T	Health and well-being coaching face-to-face; individual
96164	Health behavior intervention, group (2 or more patients), face-to-face; initial 30 minutes
96168	Health behavior intervention, family (with the patient present), face-to-face; each additional 15 minutes (List separately in addition to code for primary service)
0593T	Health and well-being coaching face-to-face; group (2 or more individuals)
96165	Health behavior intervention, group (2 or more patients), face-to-face; each additional 15 minutes (List separately in addition to code for primary service)
0591T	Health and well-being coaching face-to-face; individual

ICD-10 Codes

Code	Descriptor	Documentation Concepts	Quality/Performance
E10.9	Type 1 diabetes mellitus without complications	Type, caused by due to, complications or manifestations, laterality
E09.3522	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye	Type, caused by due to, complications or manifestations, laterality
E10.3492	Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E11.59	Type 2 diabetes mellitus with other circulatory complications	Type, caused by due to, complications or manifestations, laterality
E09.39	Drug or chemical induced diabetes mellitus with other diabetic ophthalmic complication	Type, caused by due to, complications or manifestations, laterality
E13.621	Other specified diabetes mellitus with foot ulcer	Type, caused by due to, complications or manifestations, laterality
E10.3312	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E10.628	Type 1 diabetes mellitus with other skin complications	Type, caused by due to, complications or manifestations, laterality
E11.628	Type 2 diabetes mellitus with other skin complications	Type, caused by due to, complications or manifestations, laterality
E11.3532	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye	Type, caused by due to, complications or manifestations, laterality
E08.43	Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy	Type, caused by due to, complications or manifestations, laterality
E11.3549	Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E10.311	Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema	Type, caused by due to, complications or manifestations, laterality
E11.311	Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema	Type, caused by due to, complications or manifestations, laterality
E13.3412	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E08.3553	Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, bilateral	Type, caused by due to, complications or manifestations, laterality
E08.3292	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E11.22	Type 2 diabetes mellitus with diabetic chronic kidney disease	Type, caused by due to, complications or manifestations, laterality
E09.42	Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy	Type, caused by due to, complications or manifestations, laterality
E13.37X2	Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, left eye	Type, caused by due to, complications or manifestations, laterality
E09.3559	Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.3512	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E10.3543	Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral	Type, caused by due to, complications or manifestations, laterality
E13.3392	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E13.3541	Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye	Type, caused by due to, complications or manifestations, laterality
E08.59	Diabetes mellitus due to underlying condition with other circulatory complications	Type, caused by due to, complications or manifestations, laterality
E10.39	Type 1 diabetes mellitus with other diabetic ophthalmic complication	Type, caused by due to, complications or manifestations, laterality
E08.3532	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye	Type, caused by due to, complications or manifestations, laterality
E13.29	Other specified diabetes mellitus with other diabetic kidney complication	Type, caused by due to, complications or manifestations, laterality
E09.3312	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E11.43	Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy	Type, caused by due to, complications or manifestations, laterality
E10.3522	Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye	Type, caused by due to, complications or manifestations, laterality
E09.3492	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E13.44	Other specified diabetes mellitus with diabetic amyotrophy	Type, caused by due to, complications or manifestations, laterality
E10.3559	Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.3512	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E09.3543	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral	Type, caused by due to, complications or manifestations, laterality
E11.3292	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E13.0	Other specified diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)	Type, complications/manifestations, due to/caused by, temporal factors	RXHCC30, HCC17
E10.649	Type 1 diabetes mellitus with hypoglycemia without coma	Type, caused by due to, complications or manifestations, laterality
E11.649	Type 2 diabetes mellitus with hypoglycemia without coma	Type, caused by due to, complications or manifestations, laterality
E08.3549	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.22	Diabetes mellitus due to underlying condition with diabetic chronic kidney disease	Type, caused by due to, complications or manifestations, laterality
E10.42	Type 1 diabetes mellitus with diabetic polyneuropathy	Type, caused by due to, complications or manifestations, laterality
E11.3553	Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral	Type, caused by due to, complications or manifestations, laterality
E13.52	Other specified diabetes mellitus with diabetic peripheral angiopathy with gangrene	Type, caused by due to, complications or manifestations, laterality
E11.3552	Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eye	Type, caused by due to, complications or manifestations, laterality
E09.37X1	Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, right eye	Type, caused by due to, complications or manifestations, laterality
E10.3519	Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E10.43	Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy	Type, caused by due to, complications or manifestations, laterality
E09.3411	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E11.39	Type 2 diabetes mellitus with other diabetic ophthalmic complication	Type, caused by due to, complications or manifestations, laterality
E09.59	Drug or chemical induced diabetes mellitus with other circulatory complications	Type, caused by due to, complications or manifestations, laterality
E13.641	Other specified diabetes mellitus with hypoglycemia with coma	Type, caused by due to, complications or manifestations, laterality
E08.610	Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy	Type, caused by due to, complications or manifestations, laterality
E09.610	Drug or chemical induced diabetes mellitus with diabetic neuropathic arthropathy	Type, caused by due to, complications or manifestations, laterality
E11.3293	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E13.1	Other specified diabetes mellitus with hyperosmolarity with coma	Type, complications/manifestations, due to/caused by, temporal factors	RXHCC30, HCC17
E11.3513	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E09.3542	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye	Type, caused by due to, complications or manifestations, laterality
E09.3391	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E10.3299	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.3319	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E13.3521	Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye	Type, caused by due to, complications or manifestations, laterality
E13.69	Other specified diabetes mellitus with other specified complication	Type, caused by due to, complications or manifestations, laterality
E09.3539	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E09.3493	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E10.3523	Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral	Type, caused by due to, complications or manifestations, laterality
E11.3211	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E13.3599	Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.42	Type 2 diabetes mellitus with diabetic polyneuropathy	Type, caused by due to, complications or manifestations, laterality
E09.22	Drug or chemical induced diabetes mellitus with diabetic chronic kidney disease	Type, caused by due to, complications or manifestations, laterality
E11.3591	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E13.3219	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E09.3313	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E11.3529	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.3499	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.3533	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral	Type, caused by due to, complications or manifestations, laterality
E09.3299	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E13.3393	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E08.3513	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E10.3542	Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye	Type, caused by due to, complications or manifestations, laterality
E10.3391	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E10.3411	Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E13.37X3	Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral	Type, caused by due to, complications or manifestations, laterality
E08.3293	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E09.43	Drug or chemical induced diabetes mellitus with neurological complications with diabetic autonomic (poly)neuropathy	Type, caused by due to, complications or manifestations, laterality
E13.3413	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E08.3552	Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, left eye	Type, caused by due to, complications or manifestations, laterality
E08.39	Diabetes mellitus due to underlying condition with other diabetic ophthalmic complication	Type, caused by due to, complications or manifestations, laterality
E10.59	Type 1 diabetes mellitus with other circulatory complications	Type, caused by due to, complications or manifestations, laterality
E10.37X1	Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye	Type, caused by due to, complications or manifestations, laterality
E13.319	Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema	Type, caused by due to, complications or manifestations, laterality
E13.49	Other specified diabetes mellitus with other diabetic neurological complication	Type, caused by due to, complications or manifestations, laterality
E09.3519	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.42	Diabetes mellitus due to underlying condition with diabetic polyneuropathy	Type, caused by due to, complications or manifestations, laterality
E10.22	Type 1 diabetes mellitus with diabetic chronic kidney disease	Type, caused by due to, complications or manifestations, laterality
E08.3529	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E13.3311	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E11.3499	Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.3533	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral	Type, caused by due to, complications or manifestations, laterality
E08.3591	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E13.65	Other specified diabetes mellitus with hyperglycemia	Type, caused by due to, complications or manifestations, laterality
E10.3313	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E13.620	Other specified diabetes mellitus with diabetic dermatitis	Type, caused by due to, complications or manifestations, laterality
E10.3539	Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E10.3493	Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E09.3523	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral	Type, caused by due to, complications or manifestations, laterality
E08.3211	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E13.3491	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E08.630	Diabetes mellitus due to underlying condition with periodontal disease	Type, caused by due to, complications or manifestations, laterality
E11.3319	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E09.630	Drug or chemical induced diabetes mellitus with periodontal disease	Type, caused by due to, complications or manifestations, laterality
E10.8	Type 1 diabetes mellitus with unspecified complications	Type, caused by due to, complications or manifestations, laterality
E11.3312	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E10.3532	Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye	Type, caused by due to, complications or manifestations, laterality
E10.622	Type 1 diabetes mellitus with other skin ulcer	Type, caused by due to, complications or manifestations, laterality
E11.622	Type 2 diabetes mellitus with other skin ulcer	Type, caused by due to, complications or manifestations, laterality
E08.49	Diabetes mellitus due to underlying condition with other diabetic neurological complication	Type, caused by due to, complications or manifestations, laterality
E10.29	Type 1 diabetes mellitus with other diabetic kidney complication	Type, caused by due to, complications or manifestations, laterality
E08.3522	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye	Type, caused by due to, complications or manifestations, laterality
E13.39	Other specified diabetes mellitus with other diabetic ophthalmic complication	Type, caused by due to, complications or manifestations, laterality
E11.3492	Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E08.3559	Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E10.52	Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene	Type, caused by due to, complications or manifestations, laterality
E11.3543	Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral	Type, caused by due to, complications or manifestations, laterality
E13.42	Other specified diabetes mellitus with diabetic polyneuropathy	Type, caused by due to, complications or manifestations, laterality
E09.3512	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E10.3549	Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E09.3553	Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, bilateral	Type, caused by due to, complications or manifestations, laterality
E10.44	Type 1 diabetes mellitus with diabetic amyotrophy	Type, caused by due to, complications or manifestations, laterality
E09.3292	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E10.618	Type 1 diabetes mellitus with other diabetic arthropathy	Type, caused by due to, complications or manifestations, laterality
E11.618	Type 2 diabetes mellitus with other diabetic arthropathy	Type, caused by due to, complications or manifestations, laterality
E11.69	Type 2 diabetes mellitus with other specified complication	Type, caused by due to, complications or manifestations, laterality
E11.3522	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye	Type, caused by due to, complications or manifestations, laterality
E08.3492	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E11.49	Type 2 diabetes mellitus with other diabetic neurological complication	Type, caused by due to, complications or manifestations, laterality
E09.29	Drug or chemical induced diabetes mellitus with other diabetic kidney complication	Type, caused by due to, complications or manifestations, laterality
E13.3212	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E10.638	Type 1 diabetes mellitus with other oral complications	Type, caused by due to, complications or manifestations, laterality
E11.638	Type 2 diabetes mellitus with other oral complications	Type, caused by due to, complications or manifestations, laterality
E09.3532	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye	Type, caused by due to, complications or manifestations, laterality
E13.3592	Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E08.3312	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E08.621	Diabetes mellitus due to underlying condition with foot ulcer	Type, caused by due to, complications or manifestations, laterality
E09.621	Drug or chemical induced diabetes mellitus with foot ulcer	Type, caused by due to, complications or manifestations, laterality
E10.3292	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E13.3551	Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eye	Type, caused by due to, complications or manifestations, laterality
E08.9	Diabetes mellitus due to underlying condition without complications	Type, caused by due to, complications or manifestations, laterality
E09.44	Drug or chemical induced diabetes mellitus with neurological complications with diabetic amyotrophy	Type, caused by due to, complications or manifestations, laterality
E09.3549	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.69	Diabetes mellitus due to underlying condition with other specified complication	Type, caused by due to, complications or manifestations, laterality
E10.3553	Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral	Type, caused by due to, complications or manifestations, laterality
E09.52	Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy with gangrene	Type, caused by due to, complications or manifestations, laterality
E11.3559	Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.65	Type 2 diabetes mellitus with hyperglycemia	Type, caused by due to, complications or manifestations, laterality
E08.3543	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral	Type, caused by due to, complications or manifestations, laterality
E10.3512	Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye	Type, caused by due to, complications or manifestations, laterality
E08.3542	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye	Type, caused by due to, complications or manifestations, laterality
E08.29	Diabetes mellitus due to underlying condition with other diabetic kidney complication	Type, caused by due to, complications or manifestations, laterality
E10.49	Type 1 diabetes mellitus with other diabetic neurological complication	Type, caused by due to, complications or manifestations, laterality
E10.3513	Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E13.59	Other specified diabetes mellitus with other circulatory complications	Type, caused by due to, complications or manifestations, laterality
E08.3391	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E11.3299	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E13.3511	Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E08.37X1	Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, right eye	Type, caused by due to, complications or manifestations, laterality
E08.319	Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema	Type, caused by due to, complications or manifestations, laterality
E09.319	Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy without macular edema	Type, caused by due to, complications or manifestations, laterality
E10.3552	Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye	Type, caused by due to, complications or manifestations, laterality
E11.3519	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E13.3291	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E08.3411	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E08.8	Diabetes mellitus due to underlying condition with unspecified complications	Type, caused by due to, complications or manifestations, laterality
E10.3293	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E11.101	Type 2 diabetes mellitus with hyperosmolarity with coma	Type, complications/manifestations, due to/caused by, temporal factors	RXHCC30, HCC17
E08.44	Diabetes mellitus due to underlying condition with diabetic amyotrophy	Type, caused by due to, complications or manifestations, laterality
E08.620	Diabetes mellitus due to underlying condition with diabetic dermatitis	Type, caused by due to, complications or manifestations, laterality
E10.3591	Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E09.620	Drug or chemical induced diabetes mellitus with diabetic dermatitis	Type, caused by due to, complications or manifestations, laterality
E09.69	Drug or chemical induced diabetes mellitus with other specified complication	Type, caused by due to, complications or manifestations, laterality
E08.3313	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E10.3529	Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E13.3593	Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E09.3499	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E09.3533	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral	Type, caused by due to, complications or manifestations, laterality
E10.65	Type 1 diabetes mellitus with hyperglycemia	Type, caused by due to, complications or manifestations, laterality
E09.3319	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E13.630	Other specified diabetes mellitus with periodontal disease	Type, caused by due to, complications or manifestations, laterality
E13.3213	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E08.52	Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy with gangrene	Type, caused by due to, complications or manifestations, laterality
E08.3539	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.3493	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E13.22	Other specified diabetes mellitus with diabetic chronic kidney disease	Type, caused by due to, complications or manifestations, laterality
E11.3523	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral	Type, caused by due to, complications or manifestations, laterality
E10.3211	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E13.3399	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E13.610	Other specified diabetes mellitus with diabetic neuropathic arthropathy	Type, caused by due to, complications or manifestations, laterality
E11.3411	Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E08.641	Diabetes mellitus due to underlying condition with hypoglycemia with coma	Type, caused by due to, complications or manifestations, laterality
E09.641	Drug or chemical induced diabetes mellitus with hypoglycemia with coma	Type, caused by due to, complications or manifestations, laterality
E09.3293	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E11.37X1	Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye	Type, caused by due to, complications or manifestations, laterality
E09.3552	Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, left eye	Type, caused by due to, complications or manifestations, laterality
E08.3519	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E08.3299	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.29	Type 2 diabetes mellitus with other diabetic kidney complication	Type, caused by due to, complications or manifestations, laterality
E09.49	Drug or chemical induced diabetes mellitus with neurological complications with other diabetic neurological complication	Type, caused by due to, complications or manifestations, laterality
E13.37X9	Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.3542	Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye	Type, caused by due to, complications or manifestations, laterality
E13.43	Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy	Type, caused by due to, complications or manifestations, laterality
E09.3513	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E13.3419	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.3391	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E09.65	Drug or chemical induced diabetes mellitus with hyperglycemia	Type, caused by due to, complications or manifestations, laterality
E11.3539	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.3493	Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral	Type, caused by due to, complications or manifestations, laterality
E08.3523	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral	Type, caused by due to, complications or manifestations, laterality
E09.3211	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye	Type, caused by due to, complications or manifestations, laterality
E11.52	Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene	Type, caused by due to, complications or manifestations, laterality
E10.3319	Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E11.44	Type 2 diabetes mellitus with diabetic amyotrophy	Type, caused by due to, complications or manifestations, laterality
E09.3529	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E10.3499	Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye	Type, caused by due to, complications or manifestations, laterality
E10.69	Type 1 diabetes mellitus with other specified complication	Type, caused by due to, complications or manifestations, laterality
E10.3533	Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral	Type, caused by due to, complications or manifestations, laterality

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Diabetes Technology—Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults

Key Points

Key Points

Treatment

Treatment

Insulin Pump Therapy Without Sensor Augmentation

Insulin Pump Therapy in Type 2 Diabetes Mellitus

Insulin Pump Use in the Hospital

Selection of Candidates for Insulin Pump Therapy

Use of Bolus Calculators in Insulin Pump Therapy

Real-Time Continuous Glucose Monitors in Adult Outpatients

Use of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Mellitus

Education and Training on the Use of Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring

Table 1. CSII—Considerations for Education and Training

Table 2. RT-CGM Technology—Considerations for Education and Training for Personal Use

Table 3. Suggested Health Care Provider Resources to Support the Safe and Effective Use of CSII and RT-CGM

Toolkit Resource Section

Toolkit Resource Section

Additional Guidance from Professional Societies and Organizations

Excerpts from 2021 American Association of Clinical Endocrinology (AACE) Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

Insulin Delivery Technologies

Q2.6 Who would benefit from the use of connected pens?

Q2.7 Who would benefit from the use of an insulin pump without continuous glucose monitoring?

Q2.8 Who would benefit from the use of an insulin pump with continuous glucose monitoring (separate devices or sensor-augmented pump)?

Q2.9 Who would benefit from the use of more advanced insulin pump technologies: low-glucose suspend, predictive low-glucose suspend, and hybrid closed loop?

ADA 2022 Standards of Care - Highlight of New Recommendations:

Diabetes Technology Introduction

Insulin Pumps and Automated Insulin Delivery Systems

ADA evidence-grading system for “Standards of Medical Care in Diabetes”

Consensus Statement by the American Association of Endocrinologists / American College of Endocrinology - Insulin Pump Management Task Force

Shared Decision-Making Tool

Are you willing and able to try an insulin pump?

Have you struggled with engagement with your therapy in the past?

How active is your lifestyle? And is a waterproof device important to you?

Are you able to obtain access to your desired device? (Price and Insurance Coverage):

How important is it to you that the therapy is simple to use?

How do you feel about needles and frequent injections?

How comfortable are you with technology, and is it important for your healthcare team to be able to monitor your numbers regularly?

How important is it to you to have some sort of money back guarantee or trial period?

Is discretion important to you?

Comparison Table

Critical Success Factors with Insulin Pump Use

Additional Information

Automated Insulin Delivery Systems

Clinical benefits of Tubeless Insulin Pump

Tubeless Automated Insulin Delivery System

Tubeless Insulin pump

Type 1 Diabetes

HbA1c change:

Total daily dose change:

Hypoglycemia:

Type 2 Diabetes [8]:

Quality of Life [9]:

References:

Recommendation Grading

Abbreviations

Source Citation

Disclaimer

Codes

CPT Codes

ICD-10 Codes

TOOLS

FILTERS

Inclusion Criteria

Recommendation Scope