Glycemic Relapse Prevention: Maintenance Dose Assessment

Phase 4

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00362193
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-06
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-07
• Study First Posted: 2006-08-09
• Study Completion: 2007-02
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-12
• Last Update Posted: 2010-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

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

Exclusion Criteria

• pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic relapse: increase in HbA1c by 1% over baseline and >8%

Secondary Outcome Measures

Name	Time	Method
Systolic/Diastolic BP
Demographic variables
Height/Weight
Waist/Hip Circumference
Duration of Diabetes (years)
Hypoglycemia
3-day food record
SF-36
Medication Adherence
Exercise
Self Efficacy
Medication
Self-monitoring blood glucose (obtained from DIP records)
Fasting Lipid Panel