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

NCT ID: NCT06465693

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-07-01

Brief 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

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group1

After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy

Group Type: EXPERIMENTAL

Unblinded CGM plus nutrition therapy

Intervention Type: DEVICE

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

Group 2

After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only

Group Type: ACTIVE_COMPARATOR

Nutrition therapy only

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 &gt;5 pounds in the 3 months prior to enrollment
• Estimated glomerular filtration rate &lt;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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Bantle, MD,MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

MED-2023-32168

Identifier Type: -

Identifier Source: org_study_id