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Type 2 DiabetesTRACTION-PCNCT07394075

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

An observational study of Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Continuous Glucose Monitoring Clinical Decision Support
How many people
150 participants
Where
1 siteUnited States
Study dates
4 Mar 2026to Jul 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • HealthPartners Medical Group

    Minneapolis, Minnesota, 55440

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Type 2 Diabetes
Being tested
Continuous Glucose Monitoring Clinical Decision Support
Keywords
Type 2 Diabetes, Continuous Glucose Monitoring, Clinical Decision Support, Glucose Management Indicator
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose Monitoring Clinical Decision SupportOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From baseline to 6 months

Secondary outcomes (2)

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

    Measured: From baseline to 6 months

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

    Measured: From baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start4 Mar 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394075
Sponsor's protocol ID
25-011
Other IDs
7-25-ICTSPC-413
Acronym
TRACTION-PC
Status last verified
Jul 2026
First submitted
2 Feb 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Simonson GD, Martens TW, Carlson AL, Bergenstal RM. Primary Care and Diabetes Technologies and Treatments. Diabetes Technol Ther. 2025 Mar;27(S1):S141-S156. doi: 10.1089/dia.2025.8810.gds. No abstract available.

    PubMed 40094500

  • Martens TW, Simonson GD, Bergenstal RM. Using continuous glucose monitoring data in daily clinical practice. Cleve Clin J Med. 2024 Oct 1;91(10):611-620. doi: 10.3949/ccjm.91a.23090.

    PubMed 39353661

  • Martens TW. Roadmap to the Effective Use of Continuous Glucose Monitoring in Primary Care. Diabetes Spectr. 2023 Fall;36(4):306-314. doi: 10.2337/dsi23-0001. Epub 2023 Nov 15.

    PubMed 37982066

  • Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, Bergenstal RM; MOBILE Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444.

    PubMed 34077499

  • Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R; DIAMOND Study Group. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017 Sep 19;167(6):365-374. doi: 10.7326/M16-2855. Epub 2017 Aug 22.

    PubMed 28828487

  • Rodriguez P, San Martin VT, Pantalone KM. Therapeutic Inertia in the Management of Type 2 Diabetes: A Narrative Review. Diabetes Ther. 2024 Mar;15(3):567-583. doi: 10.1007/s13300-024-01530-9. Epub 2024 Jan 25.

    PubMed 38272993

  • Okemah J, Peng J, Quinones M. Addressing Clinical Inertia in Type 2 Diabetes Mellitus: A Review. Adv Ther. 2018 Nov;35(11):1735-1745. doi: 10.1007/s12325-018-0819-5. Epub 2018 Oct 29.

    PubMed 30374807

  • Fang M, Wang D, Coresh J, Selvin E. Trends in Diabetes Treatment and Control in U.S. Adults, 1999-2018. N Engl J Med. 2021 Jun 10;384(23):2219-2228. doi: 10.1056/NEJMsa2032271.

    PubMed 34107181

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in % glucose management indicator (GMI%) (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07394075, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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