NCT07394075

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Jul 2028

First Submitted

Initial submission to the registry

February 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

February 2, 2026

Last Update Submit

April 14, 2026

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesContinuous Glucose MonitoringClinical Decision SupportGlucose Management Indicator

Outcome Measures

Primary Outcomes (1)

  • Change in % glucose management indicator (GMI%)

    Baseline and 6 months

Secondary Outcomes (2)

  • Change in % time in range (TIR%)

    Baseline and 6 months

  • Change in % time below range (TBR%)

    Baseline and 6 months

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Medical Group

Minneapolis, Minnesota, 55440, United States

Location

Related Publications (8)

  • 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.

    PMID: 40094500BACKGROUND

  • 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.

    PMID: 39353661BACKGROUND

  • 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.

    PMID: 37982066BACKGROUND

  • 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.

    PMID: 34077499BACKGROUND

  • 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.

    PMID: 28828487BACKGROUND

  • 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.

    PMID: 38272993BACKGROUND

  • 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.

    PMID: 30374807BACKGROUND

  • 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.

    PMID: 34107181BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thomas Martens, MD

    HealthPartners Institute, International Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 6, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL

Locations

US(1)