Glycemic Relapse Prevention: Maintenance Dose Assessment
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telephonic diabetes care
Sponsored by

About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring Diabetes, Chronic disease management, Relapse
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
Sites / Locations
Outcomes
Primary Outcome Measures
Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
Secondary Outcome Measures
Height/Weight
Waist/Hip Circumference
Systolic/Diastolic BP
Demographic variables
Duration of Diabetes (years)
Hypoglycemia
3-day food record
SF-36
Self Efficacy
Medication
Medication Adherence
Exercise
Self-monitoring blood glucose (obtained from DIP records)
Fasting Lipid Panel
Full Information
NCT ID
NCT00362193
First Posted
August 7, 2006
Last Updated
February 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT00362193
Brief Title
Glycemic Relapse Prevention: Maintenance Dose Assessment
Official Title
Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Vanderbilt University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Chronic disease management, Relapse
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Telephonic diabetes care
Primary Outcome Measure Information:
Title
Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
Secondary Outcome Measure Information:
Title
Height/Weight
Title
Waist/Hip Circumference
Title
Systolic/Diastolic BP
Title
Demographic variables
Title
Duration of Diabetes (years)
Title
Hypoglycemia
Title
3-day food record
Title
SF-36
Title
Self Efficacy
Title
Medication
Title
Medication Adherence
Title
Exercise
Title
Self-monitoring blood glucose (obtained from DIP records)
Title
Fasting Lipid Panel
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom A Elasy, MD, MPH
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20084363
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.
Results Reference
derived
Learn more about this trial
Glycemic Relapse Prevention: Maintenance Dose Assessment
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