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临床试验/NCT05711108
NCT05711108已完成不适用

Continuous Glucose Monitoring (CGM) to Assess Hypoglycemia in Older Adults With Diabetes in Long Term Care (LTC) Facilities

Joslin Diabetes Center1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年1月19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
86
试验地点
1
主要终点
Biochemical hypoglycemia

研究概览

简要总结

To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications).

This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Adults >64 years with diagnosis of type 1 or type 2 diabetes
  • Using glucose-lowering medication or insulin

排除标准

  • Currently taking or planning to take hydroxyurea
  • Patient or Health care proxy refuses to sign consent form

结局指标

主要结局

Biochemical hypoglycemia

时间窗: Baseline

minutes per day sensor glucose \<70 mg/dL

次要结局

  • Time-in-range(Baseline)
  • Clinically significant hypoglycemia(Baseline)
  • Severe hypoglycemia(Baseline)
  • Falls, hospitalization(Baseline)
  • A1C(Baseline)
  • Symptoms of hypoglycemia reported to the staff by the resident in between or at the time of fingerstick glucose monitoring (information derived from nursing notes)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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