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临床试验/NCT07394075
NCT07394075Enrolling By Invitation不适用

Translating Continuous Glucose Monitoring (CGM) Data Into Action to Improve Management of Insulin-Treated T2D in Primary Care

HealthPartners Institute1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
150
试验地点
1
主要终点
Change in % glucose management indicator (GMI%)

研究概览

简要总结

The goal of this project is to see if an electronic health record (EHR)-based smart order set with continuous glucose monitoring data to provide decision support can improve blood sugar management in people with type 2 diabetes (T2D) using insulin.

详细描述

Develop and test an electronic health record (EHR)-based smart order set to provide decision support by combining retrospective CGM data and a novel tool called Clinician CGM Guided Management (CCGM) that incorporates elements of the American Diabetes Association/European Association for the Study of Diabetes (ADA/EASD) Algorithm and established principles of insulin titration in T2D to improve glycemic management in people with T2D using insulin who are managed in primary care.

A current quality improvement (QI) project within the care system will improve CGM data access to primary care providers (PCPs) through cloud-based and EHR resources, to enhance data availability at the time of clinical interactions. This care system integration QI project will generate an order set to help clinicians order CGM devices, consolidate clinic cloud access portals, create care pathways to optimize availability of CGM data at the time of clinical interactions. While this quality improvement project will improve the ease of initiating CGM devices and obtaining CGM data organizationally, for this research project an enhanced, smart order set (CGM-SOS) will be created to supplement the existing order set and will be available to study clinics to help with decision support regarding management of non-insulin and insulin therapies for individuals managed at the clinics involved in this research project. By integrating CGM-based decision support directly into the EHR setting, the hope is to dramatically improve the accessibility of guidance regarding medication in insulin management for PCPs involved in this project.

The availability of CGM data allows for rapid evaluation and adjustment of therapies, which provides an opportunity for improvement in "cycle time" in titration of medications. Based on a cadence of clinical visits every 2-4 weeks for individuals not meeting glycemic goals, a six-month study timeframe should allow adequate time for optimization of glycemic therapies in T2D. Additionally, significant glycemic improvement in this timeframe would improve upon current practices in primary care settings, in which intensification and advancement of therapies can often be delayed for months or years because of issues related to care delivery in primary care settings.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • A1c greater than 7.5%
  • On insulin therapy
  • Use CGM for glycemic monitoring

排除标准

  • Pregnancy
  • Use of insulin pump or automated insulin delivery system
  • Active cancer (other than nonmelanoma skin cancer or low-grade prostate cancer being followed with observation)
  • Cognitive barriers requiring assistance of a surrogate or caregiver for insulin management

结局指标

主要结局

Change in % glucose management indicator (GMI%)

时间窗: From baseline to 6 months

Change in % glucose management indicator (GMI%)

时间窗: Baseline and 6 months

次要结局

  • Change in % time in range (TIR%)(From baseline to 6 months)
  • Change in % time below range (TBR%)(From baseline to 6 months)
  • Change in % time in range (TIR%)(Baseline and 6 months)
  • Change in % time below range (TBR%)(Baseline and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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