Glycemic Relapse Prevention: Maintenance Dose Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362193
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : February 15, 2010
Vanderbilt University
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
This purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Telephonic diabetes care Phase 4

Detailed Description:

Recent large randomized controlled trials have proven that tight glycemic control reduces the microvascular and macrovascular complications of diabetes. Reduction of these complications also leads to a great cost savings to healthcare and society. However, it has been difficult to translate the success of these large randomized control trials to everyday practice. A recent cross-sectional analysis of 95 clinicians revealed only 40.5% of type 2 diabetes patients had a glycated hemoglobin (HbA1c) less than 7%. The disparity of care between the large trials and a primary care office is largely due to the difference in resources available in the typical medical office. Practical, sustainable ways of maintaining tight glycemic control are needed in everyday practice.

While diabetes improvement programs are successful in acutely lowering HbA1c the long-term effectiveness of these programs is disappointing. Approximately 40% of those who return to routine care after completing an intensive diabetes improvement program experience a relapse in their glycemic control within one year. Some proportion of the relapse is likely due to a patient's inability to maintain adherence to key self-care behaviors - diet, exercise, self-monitoring of blood glucose and medication regimen.

The purpose of this study is to better understand prevention of glycemic relapse. The primary aim of this study is to assess the relative effectiveness of three management approaches, varying in frequency, for preventing glycemic relapse after glycemic control has been achieved through participation in an intensive diabetes improvement program. This study will determine the optimal frequency of intervention needed to prevent glycemic relapse in patients with type 2 diabetes. The authors hypothesize that high intensity intervention will lead to a decrease in glycemic relapse in a dose dependent fashion.

Study Type : Interventional  (Clinical Trial)
Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse
Study Start Date : June 2002
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Glycemic relapse: increase in HbA1c by 1% over baseline and >8%

Secondary Outcome Measures :
  1. Height/Weight
  2. Waist/Hip Circumference
  3. Systolic/Diastolic BP
  4. Demographic variables
  5. Duration of Diabetes (years)
  6. Hypoglycemia
  7. 3-day food record
  8. SF-36
  9. Self Efficacy
  10. Medication
  11. Medication Adherence
  12. Exercise
  13. Self-monitoring blood glucose (obtained from DIP records)
  14. Fasting Lipid Panel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes
  • Recent control obtain (HbA1c<8%) after diabetes improvement program
  • Receives care in primary care clinic

Exclusion Criteria:

  • pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362193

Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University
Principal Investigator: Tom A Elasy, MD, MPH Vanderbilt University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00362193     History of Changes
Other Study ID Numbers: DK62258 (completed)
P60DK020593 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Chronic disease management

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes