Last updated March 15, 2022

Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

Recommendations

1: What glucose metrics should be used in clinical practice to assess glycemic status?

Q1.1 What are the priority metrics for clinical decision-making regarding the use of diabetes technology?

Established clinical targets should be used to individualize glycemic targets and adjust therapy based on each individual’s overall health status, concomitant medical condition (eg, pregnancy, frailty), and risk for hypoglycemia:
All Persons with Diabetes
  • Number of days of active CGM use: 14 days preferred
  • Percentage of data available from active CGM use: >70% of data from 14 days
  • Mean glucose: Individualized to targets
  • Glucose management indicator (GMI): Individualized to targets
  • Glycemic variability, percent coefficient of variation (%CV [coefficient of variation]): 36%
Type 1 Diabetes (T1D)/Type 2 Diabetes (T2D)
  • Percentage of time in range (%TIR) 70 to 180 mg/dL: >70%
  • Percentage of time below range (%TBR) <70 mg/dl: <4%
  • %TBR <54 mg/dL: <1%
  • Percentage of time above range (%TAR) >180 mg/dL: <25%
  • %TAR >250 mg/dL: <5%
Older/High Risk T1D/T2D
  • %TIR 70 to 180 mg/dL: >50%
  • %TBR 250 mg/dL: 70%: <1%
  • %TBR <54 mg/dL: ~0%
  • %TAR >140 mg/dL: <25%
Pregnancy: T1D
  • %TIR 63 to 140 mg/dL: >70%
  • %TBR <63 mg/dL: <4%
  • %TBR <54 mg/dL: <1%
  • %TBR >140 mg/dL: <25%
(CL-I2)
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Two metrics, %TIR and %TBR, should be used as a starting point for the assessment of quality of glycemic control and as the basis for therapy adjustment, with emphasis on reducing %TBR when the percentages of CGM values falling below 54 mg/dL or 70 mg/dL are close to or exceed targets. (BL-I1)
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2: Who would benefit from diabetes technologies?

Glucose Monitoring Technologies

Who would benefit from routine use of continuous glucose monitoring?
1. CGM is strongly recommended for all persons with diabetes treated with intensive insulin therapy, defined as 3 or more injections of insulin per day or the use of an insulin pump. (AH1)
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2. Structured SMBG is recommended for individuals on insulin therapy who have limited success with or are unable or unwilling to use CGM. (AH1)
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3. CGM is recommended for all individuals with problematic hypoglycemia (frequent/severe hypoglycemia, nocturnal hypoglycemia, hypoglycemia unawareness). (AI-H1)
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4. CGM is recommended for children/adolescents with T1D. (AI-H1)
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5. CGM is recommended for pregnant women with T1D and T2D treated with intensive insulin therapy. (AI-H1)
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6. CGM is recommended for women with gestational diabetes mellitus (GDM) on insulin therapy. (AI1)
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7. CGM may be recommended for women with GDM who are not on insulin therapy. (BI1)
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8. CGM may be recommended for individuals with T2D who are treated with less intensive insulin therapy. (BI1)
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What is an efficient approach to interpreting continuous glucose monitoring data?

1. The AGP may be utilized to assess glycemic status in persons with diabetes. (BL1)
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2. When using the AGP, a systematic approach to interpret CGM data is recommended:
(1. Review overall glycemic status (eg, GMI, average glucose)
(2. Check TBR, TIR, and TAR statistics, focusing on hypoglycemia (TBR) first. If the TBR statistics are above the cut-point for the clinical scenario (ie, for most with T1D >4% 1% <54 mg/dL), the visit should focus on this issue. Otherwise, move on to the TIR and TAR statistics.
(3. Review the 24-hour glucose profile to identify the time(s) and magnitude(s) of the problem identified.
(4. Review treatment regimen and adjust as needed.
(BL1)
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When is one method of continuous glucose monitoring (real-time continuous glucose monitoring versus intermittently scanned continuous glucose monitoring) preferred over the other?

1. Real-time continuous glucose monitoring (rtCGM) should be recommended over intermittently scanned continuous glucose monitoring (isCGM) to persons with diabetes with problematic hypoglycemia (frequent/severe hypoglycemia, nocturnal hypoglycemia, hypoglycemia unawareness) who require predictive alarms/ alerts; however, the lifestyle of persons with diabetes and other factors should also be considered. (BL-I1)
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2. isCGM should be considered for persons with diabetes who meet 1 or more of the following criteria:
  • Newly diagnosed with T2D
  • Treated with nonhypoglycemic therapies
  • Motivated to scan device several times per day
  • At low risk for hypoglycemia, but desire more data than SMBG provides.
(DL-E4)
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When should diagnostic/professional continuous glucose monitoring be considered?

Diagnostic/professional CGM should be used in the management of persons with diabetes who meet 1 or more of the following criteria:
  • Newly diagnosed with diabetes mellitus
  • Not using CGM
  • May have problematic hypoglycemia, but no access to personal CGM
  • Persons with T2D treated with non-insulin therapies who would benefit from episodic use of CGM as an educational tool
  • Persons who would like to learn more about CGM before committing to daily use.
Importantly, in those using “masked” or “blinded” diagnostic/professional CGM, they must have and continue using adjunctive SMBG to assist in daily diabetes self-care (BI1)
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When should intermittent/occasional use of continuous glucose monitoring be considered?

1. 1 Intermittent/occasional CGM may be recommended for the management of persons with diabetes who are reluctant or unable to commit to routine CGM use. (CI1)
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Insulin Delivery Technologies

Who would benefit from the use of connected pens?
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. (CL-E2)
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Who would benefit from the use of an insulin pump without continuous glucose monitoring?
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). (BI-H1)
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Who would benefit from the use of an insulin pump with continuous glucose monitoring (separate devices or sensor-augmented pump)?
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. (AI-H1)
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Who would benefit from the use of more advanced insulin pump technologies: low-glucose suspend, predictive low-glucose suspend, and hybrid closed loop?
1. Low-glucose suspend (LGS) is strongly recommended for all persons with T1D to reduce the severity and duration of hypoglycemia, whereas predictive lowglucose 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. (AH1)
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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. (AH1)
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In what settings or special situations is the use of diabetes technologies beneficial?
1. The continuation of CGM and/or CSII (insulin pump, SAP, LGS/PLGS) should be considered in hospitalized persons with diabetes without cognitive impairment and ideally with the presence of a family member who is knowledgeable and educated in the use of these devices or with a specialized inpatient diabetes team available for advice and support. (AI1)
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2. rtCGM is recommended for persons 65 years old with insulin-requiring diabetes to achieve improved glycemic control, reduce episodes of severe hypoglycemia, and improve QoL; however, glycemic goals should be individualized due to increased comorbidities and reduced capacity to detect and counter-regulate against severe hypoglycemia in this population. (BI-H1)
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3. Clinicians should prescribe CGM as a tool to track glucose before, during, and after exercise in persons with diabetes; monitor the glycemic response to exercise; and help direct insulin and carbohydrate consumption to avoid hypoglycemia and hyperglycemia. When this technology is utilized as part of AID systems, it can reduce glycemic excursions during exercise. (AI1)
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What is the role of telemedicine in the implementation and ongoing use of diabetes technology?
1. Telemedicine, including periodic phone calls, smartphone-web interactions, and periodic supervision by health care professional interactions, is strongly recommended to treat persons with diabetes, provide diabetes education, remotely monitor glucose and/or insulin data to indicate the need for therapy adjustments, and improve diabetes-related outcomes/control with better engagement. (AI-H1)
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Do smartphone applications have utility in the management of diabetes?
1. Clinically validated smartphone applications should be recommended to persons with diabetes to teach/reinforce diabetes self-management skills, encourage engagement (eg, coaching), and support/encourage desired health behaviors (healthy eating instruction, physical exercise tracking). (BI-H1)
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3: What are safety considerations for the use of diabetes technologies?

What are safety considerations for the use of continuous glucose monitoring?

1. With the use of CGM, clinicians should make a reasonable effort to ascertain that a person with diabetes is not inadvertently ingesting a substance or medication that will cause the CGM to deliver false or misleading information. Furthermore, clinicians should make a reasonable effort to make persons with diabetes aware of the theoretical risk of radiation exposure to diabetes technologies. (CL-E3)
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2. Persons with diabetes who have a care provider, such as a spouse, adult child of a geriatric person with diabetes, or parent of a child with diabetes, who remotely monitors glucose data, should be cautioned that remote glucose monitoring is dependent upon server functionality and that data interruption can result. Back-up plans of having persons with diabetes revert to SMBG or methods to communicate CGM data to those who remotely follow will be needed until functionality can be restored. (DL-E4)
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What are safety issues for the use of insulin delivery devices?

1. All persons with diabetes using an insulin delivery technology should receive comprehensive training in its proper use and care. (AL-E2)
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2. The use of United States (U.S.) Food and Drug Administration (FDA) ‒ cleared and clinically validated smartphone bolus calculators, in the absence of pump therapy, is strongly recommended to decrease the frequency of hypoglycemia or severe postprandial hyperglycemia. (AH1)
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3. Clinicians should ensure that persons with diabetes using an insulin delivery technology are aware of the frequency and relative risk of pump malfunction, receive instruction for identifying signs of pump malfunction, know who to contact in the event of a pump malfunction, and have a defined plan for emergency measures (eg, back-up insulin pen, remediation). (AL-E2)
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What are safety issues for the use of integrated devices to manage persons with diabetes?

1. Persons with diabetes using integrated devices should receive requisite training in the use of their device(s) and that the devices are being safely and properly used according to manufacturer instructions. (AL-I2)
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Are open-source automatic insulin-dosing systems, which currently are not approved by the U.S. Food and Drug Administration, safe and effective in the management of persons with diabetes mellitus?

1. Clinicians should caution persons with diabetes who are using do-it-yourself systems that these devices have not undergone rigorous review by the FDA for safety and efficacy. (BL-E4)
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What are the criteria for discontinuing the use of insulin pumps in persons with diabetes?

1. Clinicians should strongly consider the discontinuation of insulin pump therapy based on an individual’s ability to use it effectively and safely or based on the personal preference of a person with diabetes to discontinue this insulin delivery modality. (AI1)
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4: How should the use of diabetes technologies be implemented in clinical practice?

Who should prescribe/direct/supervise the implementation of diabetes technologies?

1. Initiation and use of diabetes technology should be implemented by health care professionals who are trained, committed, and experienced to prescribe and direct the use of these tools. Clinicians should have the infrastructure to support the needs of persons with diabetes using the technology. (BL-E1)
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How should patient education programs be structured?

1. Training of persons with diabetes should utilize a structured, comprehensive training program that covers all aspects of safe and effective use of diabetes technologies. (CL-E2)
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2. Diabetes self-management education and support program specialists should assess knowledge base, review data with the person with diabetes, and provide individualized feedback for initiating therapy, adjustments, and/or behavioral modifications as needed to support the attainment of individualized glycemic goals. (BL-E1)
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Recommendation Grading

Overview

Title

Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

Authoring Organization

Publication Month/Year

May 1, 2021

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Inclusion Criteria

Female, Male, Adult, Older adult

Health Care Settings

Ambulatory, Hospital, Long term care

Intended Users

Physician, nurse practitioner, nurse, diabetes educator, physician assistant

Scope

Management

Diseases/Conditions (MeSH)

D003920 - Diabetes Mellitus

Keywords

diabetes mellitus, Continuous Glucose Monitoring, Clinical Practice Guideline, automated insulin dosing, continuous subcutaneous insulin infusion diabetes, diabetes technology, glucose sensors, hybrid closed loop, insulin pumps, sensor-augmented pump, low-glucose suspend, predictive low-glucose suspend

Methodology

Number of Source Documents
357
Literature Search Start Date
January 1, 2012
Literature Search End Date
February 1, 2021