NCT Number: NCT00362193
Glycemic Relapse Prevention: Maintenance Dose Assessment
This purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse.
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Type 2 diabetes
- Recent control obtain (HbA1c<8%) after diabetes improvement program
- Receives care in primary care clinic
Exclusion criteria
- pregnant
Treatment and study plan
Primary outcomes
-
Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Nih
Collaborators
- Vanderbilt University
Registry information
Official study title
Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse
Important dates
- Study start
- 2002
- Study completion
- 2007
- First posted
- Aug 9, 2006
- Registry last updated
- Feb 15, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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