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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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Diabetes, Chronic disease management, Relapse

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 7, 2006
    Last Updated
    February 12, 2010
    Sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Collaborators
    Vanderbilt University
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    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

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    Glycemic Relapse Prevention: Maintenance Dose Assessment

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