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OpenTrials
Enrolling by Invitation

NCT Number: NCT07394075

Clinical Decision Support With Continuous Glucose Monitoring Data for Managing Type 2 Diabetes

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.

Enrolling by Invitation

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthPartners Medical Group

Minneapolis, Minnesota, 55440, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Continuous Glucose Monitoring Clinical Decision Support

Other

Retrospective CGM data is combined with a readily available EHR-based smart order set tool to assist with guidance and decision support for participants with type 2 diabetes on insulin.

Primary outcomes

  1. Change in % glucose management indicator (GMI%)

    Time frame: From baseline to 6 months

Secondary outcomes

  1. Change in % time in range (TIR%)

    Time frame: From baseline to 6 months

  2. Change in % time below range (TBR%)

    Time frame: From baseline to 6 months

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

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

Acronym: TRACTION-PC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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