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

NCT06465693 | Active Not Recruiting FDA Device

• 1 other identifier: MED-2023-32168
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• HgbA1c

  week 12

Secondary Outcomes (13)

• Glucose variability/coefficient of variation

  week 12

• mean glucose

  week 12

• time in range (glucose 70-180 mg/dl)

  week 12

• time above range (glucose 70-180 mg/dl)

  week 12

• Weight

  week 12

Study Arms (2)

Group1

EXPERIMENTAL

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

Group 2

ACTIVE COMPARATOR

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

Behavioral: Nutrition therapy only

Interventions

Unblinded CGM plus nutrition therapy 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

Group1

Nutrition therapy only 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.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Anne Bantle, MD,MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: will compare CGM plus nutrition therapy to nutrition therapy only in participants with type 2 diabetes

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: May 1, 2024
• Primary Completion: July 14, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (1)