Guideline:
Clinical guideline for pharmacological management of type 2 diabetes
Bibliographic Source(s)
- Joslin Diabetes Center. Clinical guideline for pharmacological management of type 2 diabetes. Boston (MA): Joslin Diabetes Center; 2007 Jan 12. 9 p. [91 references]
Guideline Status
This is the current release of the guideline.
This guideline will be reviewed periodically and modified to reflect changes in clinical practice and available pharmacological information.
Guideline Category
Diagnosis
Management
Treatment
Intended Users
Advanced Practice Nurses
Physician Assistants
Physicians
Guideline Objective(s)
To support clinical practice and influence clinical behavior to improve outcomes and assure quality of care according to accepted standards for the pharmacological management of type 2 diabetes
Target Population
Non-pregnant adults with type 2 diabetes mellitus
Interventions and Practices Considered
- Diagnosis
- Casual plasma glucose
- Fasting plasma glucose
- Oral glucose tolerance test
- Treatment
- Glycemic control goals
- Initial treatment
- Mild presentation
- Moderate presentation
- Severe presentation
- Oral antihyperglycemic therapy:
- Metformin
- Thiazolidinediones
- Insulin secretagogue
- Alpha–glucosidase inhibitor
- Combination therapy
- Insulin
- Rapid-acting
- Short-acting
- Intermediate-acting
- Long-acting
- Pre-meal insulin mixture
- Exenatide
Major Outcomes Considered
Glycemic control: fasting plasma glucose 2-hour postprandial glucose and bedtime glucose levels percent hemoglobin
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Review of all new papers on selected topics in PubMed MEDLINE OUID Cochrane databases
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
| Grade of Recommendation | Clarity of Risk/Benefit | Quality of Supporting Evidence |
|---|---|---|
| 1A Strong recommendation High quality of evidence | Benefits clearly outweigh risk and vice versa. | Consistent evidence from well performed randomized controlled trials or overwhelming evidence of some other form. Further research is unlikely to change our confidence in the estimate of benefit and risk. |
| 1B Strong recommendation Moderate quality of evidence | Benefits clearly outweigh risk and burdens or vice versa. | Evidence from randomized controlled trials with important limitations (inconsistent results methodological flaws indirect or imprecise) or very strong evidence of some other research design. Further research is likely to have an impact on our confidence in the estimate of the benefit and risk and may change the estimate. |
| 1C Strong recommendation Low quality of evidence | Benefits outweigh risk and burdens or vice versa. | Evidence from observational studies unsystematic clinical experience or from randomized controlled trials with serious flaws. Any estimate of effect is uncertain. |
| 2A Weak recommendation High quality of evidence | Benefits closely balanced with risks and burdens. | Consistent evidence from well performed randomized controlled trials or overwhelming evidence of some other form. Further research is unlikely to change our confidence in the estimate of benefit and risk. |
| 2B Weak recommendation Moderate quality of evidence | Benefits closely balanced with risks and burdens; some uncertainty in the estimates of benefits risks and burdens. | Evidence from randomized controlled trials with important limitations (inconsistent results methodological flaws indirect or imprecise) or very strong evidence of some other research design. Further research is unlikely to have an impact on our confidence in the estimate of the benefit and risk and may change the estimate. |
| 2C Weak recommendation Low quality of evidence | Uncertainty in the estimates of benefits risks and burdens; benefits may be closely balanced with risks and burdens. | Evidence from observational studies unsystematic clinical experience or from randomized controlled trials with serious flaws. Any estimate of effect is uncertain. |
Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Not stated
Rating Scheme for the Strength of the Recommendations
| Grade of Recommendation | Clarity of Risk/Benefit | Quality of Supporting Evidence |
|---|---|---|
| 1A Strong recommendation High quality of evidence | Benefits clearly outweigh risk and vice versa. | Consistent evidence from well performed randomized controlled trials or overwhelming evidence of some other form. Further research is unlikely to change our confidence in the estimate of benefit and risk. |
| 1B Strong recommendation Moderate quality of evidence | Benefits clearly outweigh risk and burdens or vice versa. | Evidence from randomized controlled trials with important limitations (inconsistent results methodological flaws indirect or imprecise) or very strong evidence of some other research design. Further research is likely to have an impact on our confidence in the estimate of the benefit and risk and may change the estimate. |
| 1C Strong recommendation Low quality of evidence | Benefits outweigh risk and burdens or vice versa. | Evidence from observational studies unsystematic clinical experience or from randomized controlled trials with serious flaws. Any estimate of effect is uncertain. |
| 2A Weak recommendation High quality of evidence | Benefits closely balanced with risks and burdens. | Consistent evidence from well performed randomized controlled trials or overwhelming evidence of some other form. Further research is unlikely to change our confidence in the estimate of benefit and risk. |
| 2B Weak recommendation Moderate quality of evidence | Benefits closely balanced with risks and burdens; some uncertainty in the estimates of benefits risks and burdens. | Evidence from randomized controlled trials with important limitations (inconsistent results methodological flaws indirect or imprecise) or very strong evidence of some other research design. Further research is unlikely to have an impact on our confidence in the estimate of the benefit and risk and may change the estimate. |
| 2C Weak recommendation Low quality of evidence | Uncertainty in the estimates of benefits risks and burdens; benefits may be closely balanced with risks and burdens. | Evidence from observational studies unsystematic clinical experience or from randomized controlled trials with serious flaws. Any estimate of effect is uncertain. |
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation
The guideline was approved by the Joslin Clinical Oversight Committee on 1/12/07.
Major Recommendations
Definitions of the recommendation and evidence level grades (1A to 2C) are provided at the end of the "Major Recommendations" field.
| Diabetes Mellitus – Diagnostic Criteria (Non-Pregnant Adult) |
|---|
|
| Goals of Glycemic Control for People with Diabetes1 | ||
|---|---|---|
| Biochemical Index | Normal | Goal |
| Average Fasting Plasma Glucose or Preprandial Glucose (mg/dl) | <100< td> | 90 – 130 |
| Average Postprandial 2 hours (mg/dl) | <140< td> | <160< td> |
| Average Bedtime Glucose (mg/dl) | <120< td> | 110 – 150 |
| A1C (%) - sustained | <6%< td> | <7%2 |
1Laboratory methods measure plasma glucose. Most glucose monitors approved for home use calibrate whole blood glucose readings to plasma values. Plasma glucose values are 10-15% higher than whole blood glucose values. It is important for people with diabetes to know whether their meters and strips record whole blood or plasma results.
2The true goal of care is to bring A1C as close to normal as safely possible. [1C] A goal of <7% is chosen as practical level for most patients using medications that may cause hypoglycemia to avoid the risk of that complication. achieving normal blood glucose is recommended if it can be done practically and safely. [1B]
The guideline recommendations are presented in a series of algorithms on the following topics:
- Initial Treatment Strategy
- Considerations for Selecting Initial Oral Antihyperglycemic Therapy
Refer to the original guideline document for more information.
Definitions:
| Grade of Recommendation | Clarity of Risk/Benefit | Quality of Supporting Evidence |
|---|---|---|
| 1A Strong recommendation High quality of evidence | Benefits clearly outweigh risk and vice versa. | Consistent evidence from well performed randomized controlled trials or overwhelming evidence of some other form. Further research is unlikely to change our confidence in the estimate of benefit and risk. |
| 1B Strong recommendation Moderate quality of evidence | Benefits clearly outweigh risk and burdens or vice versa. | Evidence from randomized controlled trials with important limitations (inconsistent results methodological flaws indirect or imprecise) or very strong evidence of some other research design. Further research is likely to have an impact on our confidence in the estimate of the benefit and risk and may change the estimate. |
| 1C Strong recommendation Low quality of evidence | Benefits outweigh risk and burdens or vice versa. | Evidence from observational studies unsystematic clinical experience or from randomized controlled trials with serious flaws. Any estimate of effect is uncertain. |
| 2A Weak recommendation High quality of evidence | Benefits closely balanced with risks and burdens. | Consistent evidence from well performed randomized controlled trials or overwhelming evidence of some other form. Further research is unlikely to change our confidence in the estimate of benefit and risk. |
| 2B Weak recommendation Moderate quality of evidence | Benefits closely balanced with risks and burdens; some uncertainty in the estimates of benefits risks and burdens. | Evidence from randomized controlled trials with important limitations (inconsistent results methodological flaws indirect or imprecise) or very strong evidence of some other research design. Further research is unlikely to have an impact on our confidence in the estimate of the benefit and risk and may change the estimate. |
| 2C Weak recommendation Low quality of evidence | Uncertainty in the estimates of benefits risks and burdens; benefits may be closely balanced with risks and burdens. | Evidence from observational studies unsystematic clinical experience or from randomized controlled trials with serious flaws. Any estimate of effect is uncertain. |
Clinical Algorithm(s)
The original guideline document contains clinical algorithms for:
- Initial Treatment Strategy
- Considerations for Selecting Initial Oral Antihyperglycemic Therapy
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation.
Potential Benefits
Appropriate pharmacological management of type 2 diabetes
Potential Harms
- Hypoglycemia
- Thiazolidinediones can be used in renal impairment but may increase fluid retention
Contraindications
- Metformin is contraindicated in the following conditions:
- Creatinine > 1.4 (women)
- Creatinine > 1.5 (men)
- Intravenous (IV) contrast
- Congestive heart failure (CHF)
- Dehydration
- Alcohol excess
- > 80 years of age (unless creatinine clearance is normal)
- Thiazolidinediones are contraindicated in the following conditions:
- Class III or IV CHF
- Liver function tests > 2.5 times upper limit of normal
- Insulin secretagogues (sulfonylurea or short-acting secretagogue) are contraindicated in the following conditions:
- Sulfonylureas in severe liver or renal disease
- Alpha-glucosidase inhibitors are contraindicated in the following conditions:
- Chronic intestinal disorders
- Acarbose in cirrhosis
- Acarbose and miglitol in renal impairment (creatinine > 2.0)
- Exenatide is contraindicated in gastroparesis requiring treatment with metoclopramide
- Inhaled insulin is contraindicated in smokers recent smokers and patients with underlying lung disease
Qualifying Statements
This Clinical Guideline is not intended to serve as a mandatory standard but rather provides a set of recommendations for patient care management. These recommendations are not a substitute for sound and reasonable clinical judgment or decision-making and do not exclude other options. Clinical care must be individualized to the specific needs of each patient and interventions must be tailored accordingly. The guideline has been created to address initial presentation and treatment strategies in the adult non-pregnant patient population.
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Living with Illness
IOM Domain
Effectiveness
Bibliographic Source(s)
- Joslin Diabetes Center. Clinical guideline for pharmacological management of type 2 diabetes. Boston (MA): Joslin Diabetes Center; 2007 Jan 12. 9 p. [91 references]
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
Joslin Diabetes Center
Guideline Committee
Joslin Clinical Oversight Committee
Composition of Group that Authored the Guideline
Committee Members: James Rosenzweig MD (Chairperson); Richard Beaser MD; Elizabeth Blair MS CS-ANP CDE; Patty Bonsignore MS RN CDE; Amy Campbell MS RD CDE; Cathy Carver ANP CDE; Jerry Cavallerano OD PhD; Om Ganda MD; John W. Hare MD; Lori Laffel MD MPH; Melinda Maryniuk MEd RD; William Petit MD; Kristi Silver MD; Susan Sjostrom JD; Kenneth Snow MD; Robert Stanton MD; William Sullivan MD; Howard Wolpert MD; Martin J. Abrahamson MD (ex officio)
Financial Disclosures/Conflicts of Interest
Not stated
Guideline Status
This is the current release of the guideline.
This guideline will be reviewed periodically and modified to reflect changes in clinical practice and available pharmacological information.
Guideline Availability
Electronic copies: Available in Portable Document Format (PDF) from the Joslin Diabetes Center.
Print copies: Available from the Joslin Diabetes Center One Joslin Place Boston MA 02215
Availability of Companion Documents
None available
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI Institute on April 19 2007. The information was verified by the guideline developer on May 10 2007. This summary was updated by ECRI Institute on September 5 2007 following the U.S. Food and Drug Administration advisory on the Thiazolidinedione class of antidiabetic drugs. This summary was updated by ECRI Institute on November 6 2007 following the U.S. Food and Drug Administration advisory on Byetta (exenatide). This summary was updated by ECRI Institute on November 28 2007 following the U.S. Food and Drug Administration advisory on the Avandia (rosiglitazone maleate) Tablets. This summary was updated by ECRI Institute on March 10 2008 following the U.S. Food and Drug Administration advisory on Avandia (rosiglitazone maleate). This summary was updated by ECRI Institute on April 21 2008 following the U.S. Food and Drug Administration advisory on Exubera (insulin human rDNA origin) Inhalation Powder.
COPYRIGHT STATEMENT
This NGC summary is based on the original guideline which is subject to the guideline developer's copyright restrictions.
NGC Disclaimer
The National Guideline Clearinghouse™ (NGC) does not develop produce approve or endorse the guidelines represented on this site.
All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies relevant professional associations public or private organizations other government agencies health care organizations or plans and similar entities.
Guidelines represented on the NGC Web site are submitted by guideline developers and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .
NGC AHRQ and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC AHRQ or its contractor ECRI Institute and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.
Readers with questions regarding guideline content are directed to contact the guideline developer.