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临床试验/NCT00362193
NCT00362193已完成4 期

Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)0 个研究点目标入组 165 人开始时间: 2002年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
165
主要终点
Glycemic relapse: increase in HbA1c by 1% over baseline and >8%

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Glycemic relapse: increase in HbA1c by 1% over baseline and >8%

次要结局

  • Systolic/Diastolic BP
  • Demographic variables
  • Waist/Hip Circumference
  • Height/Weight
  • 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

研究者

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