Recruiting

CGM & Medical Nutrition Therapy

Sponsor:

University of Minnesota

Code:

NCT06784375

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Unblinded CGM/Nutrition Therapy

Blinded CGM/Nutrition Therapy

Unblinded CGM/No Nutrition Therapy

Blinded CGM/No Nutrition Therapy

Study Details

Brief summary:

This project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes

Study ID

NCT06784375

Start date

Jul 14, 2025

Status verified date

Jul, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • at least 18 years of age
  • previous diagnosis of T2DM
  • HbA1c of 6.8-8.5%

Exclusion Criteria:

  • type 1 diabetes mellitus
  • treatment with insulin, sulfonylurea, or meglitinide
  • use of nondiabetic medications that affect blood glucose control (such as corticosteroids)
  • BMI <25 kg/m2 or <23 kg/m2 for participants who self-identify as Asian
  • weight change >5 pounds in the 3 months prior to study enrollment
  • estimated glomerular filtration rate <60 ml/minute/1.73 m2
  • pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of HbA1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Unblinded CGM/Nutrition Therapy

experimental: Blinded CGM/Nutrition Therapy

experimental: Unblinded CGM/No Nutrition Therapy

experimental: Blinded CGM/No Nutrition Therapy

Interventions

Unblinded CGM/Nutrition Therapy

Personalized nutrition counseling based on CGM data

Blinded CGM/Nutrition Therapy

Standard nutrition education which does not incorporate CGM data

Unblinded CGM/No Nutrition Therapy

CGM and general diabetes education (no nutrition education)

Blinded CGM/No Nutrition Therapy

General diabetes education (no nutrition education)

Primary outcome measure

  • Hemoglobin A1c [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Anne Bantle

612-625-8673bant0015@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Type 2 Diabetes
  • Nutrition
  • CGM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-16.