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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Device: Unblinded CGM plus nutrition therapy; Behavioral: Nutrition therapy only

• Registration Number: NCT06465693
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1	Unblinded CGM plus nutrition therapy	After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy
Group 2	Nutrition therapy only	After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only

Primary Outcome Measures

Name	Time	Method
HgbA1c	week 12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States