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

NCT06465693 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-07-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

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.

Sponsors & Collaborators

Principal Investigators

  • Anne Bantle, MD,MS · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-07-14
Completion
2026-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06465693 on ClinicalTrials.gov