跳至主要内容
临床试验/NCT06921902
NCT06921902招募中不适用

Observation and Identification of Glycemic Metrics and Patterns in People With and Without Prediabetes (PREMAP)

Abbott Diabetes Care2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2025年2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
2,000
试验地点
2
主要终点
Characterize the glycemic profiles of people with and without a prediabetes diagnosis.

研究概览

简要总结

The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.

详细描述

This is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. Up to 2000 subjects will be enrolled in up to 20 sites. Approximately 50% of evaluable subjects will have a prediabetes diagnosis.

研究设计

研究类型
Observational
观察模型
Other
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

  • Subject must be at least 18 years of age.
  • Subject must be willing and able to provide written signed and dated informed consent.

排除标准

  • Subject has a diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes.
  • Subject is known to be currently practicing a low-carbohydrate or ketogenic diet at the time of enrollment.
  • Subject is known to be pregnant at the time of enrollment.
  • Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
  • Subject is currently on any form of treatment indicated for the treatment of diabetes.
  • Subject is currently on any form of medication indicated for weight loss.

结局指标

主要结局

Characterize the glycemic profiles of people with and without a prediabetes diagnosis.

时间窗: up to 50 days

This is a data collection study.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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