Clinical trial NCT00362193: Glycemic Relapse Prevention: Maintenance Dose Assessment
Official title: Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Diabetes
Chronic disease management
Relapse
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Vanderbilt University
First posted: 2006-08-09
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnant

Primary outcomes:
measure: Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
Secondary outcomes:
measure: Height/Weight
measure: Waist/Hip Circumference
measure: Systolic/Diastolic BP
measure: Demographic variables
measure: Duration of Diabetes (years)
measure: Hypoglycemia
measure: 3-day food record
measure: SF-36
measure: Self Efficacy
measure: Medication
measure: Medication Adherence
measure: Exercise
measure: Self-monitoring blood glucose (obtained from DIP records)
measure: Fasting Lipid Panel
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Tom A Elasy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huizinga MM, Gebretsadik T, Garcia Ulen C, Shintani AK, Michon SR, Shackleford LO, Wolff KL, Brown AW, Rothman RL, Elasy TA. Preventing glycaemic relapse in recently controlled type 2 diabetes patients: a randomised controlled trial. Diabetologia. 2010 May;53(5):832-9. doi: 10.1007/s00125-010-1658-3. Epub 2010 Jan 19.