Personalized Nutrition for Type 2 Diabetes

July 14, 2025 updated by: University of Minnesota

Personalized Nutrition Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Anne Bantle

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

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unblinded CGM/Nutrition Therapy
Behavioral: Unblinded CGM/Nutrition Therapy
Personalized nutrition counseling based on CGM data
Experimental: Blinded CGM/Nutrition Therapy
Behavioral: Blinded CGM/Nutrition Therapy
Standard nutrition education which does not incorporate CGM data
Experimental: Unblinded CGM/No Nutrition Therapy
Behavioral: Unblinded CGM/No Nutrition Therapy
CGM and general diabetes education (no nutrition education)
Experimental: Blinded CGM/No Nutrition Therapy
Behavioral: Blinded CGM/No Nutrition Therapy
General diabetes education (no nutrition education)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 12 weeks
Measure of blood glucose control
12 weeks

Collaborators and Investigators

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

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Anne Bantle, University of Minnesota

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)

July 14, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2024-31907

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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