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临床试验/NCT06192940
NCT06192940招募中不适用

Impact of Smart Connected Insulin Pens on Quality of Life in Dependent Patients with Diabetes Using Continuous Glucose Measurement

Centre Hospitalier Sud Francilien1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Insulin Injection

研究概览

简要总结

Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. The purpose of this tudy is to know how smart connected insulin pens and continuous glucose measurement can improve insulin therapy practice in dependent and/or institutionalized patients?

详细描述

Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. Current practice and my experience in diabetes show a misuse of insulin therapy by caregivers at home and in institutions. Studies on the elderly insulin-treated person living in institutions show, through continuous glucose measurement, frequent nocturnal hypoglycemia at 79%. The continuous measurement of glucose has also shown its interest in reducing hospitalizations for acute event and, permanently.

A norwegian study shows that hypoglycemic treatments are too frequently prescribed in nursing homes. Hospitalizations for severe hypoglycemia are often due to dose errors or unsupervised recommendations in people over 65 years.

Smart connected insulin pens have shown a benefit in the management of insulin therapy in patients living with type 1 diabetes, improving glycemic balance.

Study focuses on the identification of misuses of insulin therapy in dependent and/or institutionalized patients. A study of everyday life, we expect a decrease in dysfunctions in patients equipped with a continuous glucose measurement system and connected pens after advice given to their caregivers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Older than 18 years patient with type 1 or 2 diabetes
  • Treated with multiple insulin injections
  • Equipped with a continuous glucose measurement system and smart connected insulin pens at least one month before
  • Dependent on a health professional for treatment management.
  • Subject informed of the study and not objecting to data collection.

排除标准

  • Patient refusing study.

结局指标

主要结局

Insulin Injection

时间窗: at day 0

Percentage of insulin injections not as prescribed

次要结局

  • number of injections(at day 0)
  • Acute Diabetes Events(at day 30)
  • number of missed injections(at day 0)
  • Continuous glucose measurement parameters(at day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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