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临床试验/NCT04806685
NCT04806685已完成不适用

Diabetes Education and A1c Study

Michigan State University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Hemoglobin A1c

研究概览

简要总结

Sleep problems are associated with poor blood glucose control, but current diabetes self-management programs do not include sleep education. This study will randomize participants into two groups: one that receives sleep education and one that does not. The researchers expect both groups to experience reductions in blood glucose. The researchers hypothesize that individuals who receive sleep education as part of their diabetes self-management training will experience greater improvements in blood glucose control, as measured by hemoglobin A1c, compared to the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Individuals with a diagnosis of type 2 diabetes who are patients at the Michigan State University (MSU) Endocrinology clinic,
  • a diagnosis of overweight or obesity (Body Mass Index greater than or equal to 25.0 kg/m2),
  • the most recent hemoglobin A1c value greater than or equal to 7.5%, and
  • the ability to attend online program sessions.

排除标准

  • significant psychiatric disorders,
  • advanced medical conditions that require alterations to the MNT for DM2, e.g., advanced chronic kidney disease, and
  • an inability to follow recommendations due to cognitive deficits.

结局指标

主要结局

Hemoglobin A1c

时间窗: 12 weeks

Lab value

次要结局

  • Body mass index(12 weeks)
  • Sleep duration(12 weeks)
  • Sleep quality(12 weeks)
  • Epworth Sleepiness Scale(12 weeks)
  • Diabetes self-care(12 weeks)
  • Insomnia Severity Index(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robin Tucker

Assistant Professor

Michigan State University

研究点 (2)

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