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

July 24, 2025 updated by: University of Minnesota
Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

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 Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

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
  • Have a previous diagnosis of type 2 diabetes
  • HbA1c of 7.0 - 9.5%
  • Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.

Exclusion Criteria:

  • Type 1 diabetes
  • Treatment with insulin, sulfonylurea, or meglitinide
  • Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
  • BMI <25 kg/m2
  • Weight change >5 pounds in the 3 months prior to enrollment
  • Estimated glomerular filtration rate <60 ml/minute/1.73 m2
  • Pregnant or breastfeeding
  • Anemia (which affects HbA1c)
  • 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1
After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy
Device: Unblinded CGM plus nutrition therapy

will receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose.

will receive Dexcom G6 Pro CGMs to wear throughout the study. The CGM will be unblinded so that the glucose data will be available in real time to the participant and investigators. The dietitian and participant will review CGM data together
Active Comparator: Group 2
After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only
Behavioral: Nutrition therapy only
will receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HgbA1c
Time Frame: week 12
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose variability/coefficient of variation
Time Frame: week 12
using CGM data
week 12
mean glucose
Time Frame: week 12
using CGM data
week 12
time in range (glucose 70-180 mg/dl)
Time Frame: week 12
using CGM data
week 12
time above range (glucose 70-180 mg/dl)
Time Frame: week 12
using CGM data
week 12
Weight
Time Frame: week 12
week 12
Fasting plasma glucose
Time Frame: week 12
week 12
Fasting serum insulin
Time Frame: week 12
week 12
Serum lipid panel
Time Frame: week 12
week 12
Intervention Acceptability Questionnaire
Time Frame: week 12
week 12
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time Frame: week 12
week 12
Diet Satisfaction Questionnaire (DSat-28)
Time Frame: week 12
week 12
Diabetes Management Self-Efficacy Scale (DMSES)
Time Frame: week 12
week 12
Medication Effect Score
Time Frame: week 12
week 12

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, MD,MS, 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)

May 1, 2024

Primary Completion (Actual)

July 14, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2023-32168

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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