Clinical Decision Support With Continuous Glucose Monitoring Data for Managing Type 2 Diabetes (TRACTION-PC)

April 14, 2026 updated by: HealthPartners Institute

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55440
        • HealthPartners Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults age 18-75 being seen at primary care clinics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in % glucose management indicator (GMI%)
Time Frame: Baseline and 6 months
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in % time in range (TIR%)
Time Frame: Baseline and 6 months
Baseline and 6 months
Change in % time below range (TBR%)
Time Frame: Baseline and 6 months
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Thomas Martens, MD, HealthPartners Institute, International Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-011
  • 7-25-ICTSPC-413 (Other Grant/Funding Number: American Diabetes Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Local: Investigators work closely with the clinical and administrative leaders at HealthPartners Medical Group and Park Nicollet Clinic and also primary care clinicians, adult endocrinologists, nephrologists and the diabetes education team, to ensure that the results of this study will be shared.

Regional: Investigators and the research team are influential regional and national opinion leaders in caring for people with diabetes, with the ability to ensure statewide availability and dissemination of results. In addition, findings of this research will be presented at regional conferences.

Consistent with ADA policy, the study team will share data generated by the study. Study data will be archived in an approved, secure an open data repository such as the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository (NIDDK-CR). Data will be shared by 6-months after the first publication date or 18-months after the award end date, whichever comes first.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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