Glycemic Relapse Prevention: Maintenance Dose Assessment

This study has been completed.
Sponsor:
Collaborator:
Vanderbilt University
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00362193
First received: August 7, 2006
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Behavioral: Telephonic diabetes care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

Estimated Enrollment: 165
Study Start Date: June 2002
Study Completion Date: February 2007
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362193

Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Tom A Elasy, MD, MPH Vanderbilt University
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00362193     History of Changes
Other Study ID Numbers: DK62258 (completed), P60 DK 020593
Study First Received: August 7, 2006
Last Updated: February 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Diabetes
Chronic disease management
Relapse

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014