Personalized Nutrition for Type 2 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06784375
• Lead Sponsor: University of Minnesota

Brief Summary

This project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type 2 diabetes mellitus (T2DM).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-15
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• at least 18 years of age
• previous diagnosis of T2DM
• HbA1c of 6.8-8.5%

Exclusion Criteria

• type 1 diabetes mellitus
• treatment with insulin, sulfonylurea, or meglitinide
• use of nondiabetic medications that affect blood glucose control (such as corticosteroids)
• BMI <25 kg/m2 or <23 kg/m2 for participants who self-identify as Asian
• weight change >5 pounds in the 3 months prior to study enrollment
• estimated glomerular filtration rate <60 ml/minute/1.73 m2
• pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of HbA1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	12 weeks	Measure of blood glucose control