Glycemic Relapse Prevention: Maintenance Dose Assessment

Type 2 Diabetes Clinical Trial

Official title:

Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362193
• Other study ID #: DK62258 (completed)
• Secondary ID: P60DK020593
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2006
• Last updated: February 12, 2010
• Start date: June 2002
• Est. completion date: February 2007

Study information

• Verified date: February 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Telephonic diabetes care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
Secondary	Height/Weight
Secondary	Waist/Hip Circumference
Secondary	Systolic/Diastolic BP
Secondary	Demographic variables
Secondary	Duration of Diabetes (years)
Secondary	Hypoglycemia
Secondary	3-day food record
Secondary	SF-36
Secondary	Self Efficacy
Secondary	Medication
Secondary	Medication Adherence
Secondary	Exercise
Secondary	Self-monitoring blood glucose (obtained from DIP records)
Secondary	Fasting Lipid Panel