Personalized Nutrition for Type 2 Diabetes

University of Minnesota (UMN)

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Blinded CGM/Nutrition Therapy; Behavioral: Unblinded CGM/No Nutrition Therapy; Behavioral: Blinded CGM/No Nutrition Therapy; Behavioral: Unblinded CGM/Nutrition Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06784375

MED-2024-31907

Details and patient eligibility

About

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).

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

Unblinded CGM/Nutrition Therapy

Experimental group

Treatment:

Behavioral: Unblinded CGM/Nutrition Therapy

Blinded CGM/Nutrition Therapy

Experimental group

Treatment:

Behavioral: Blinded CGM/Nutrition Therapy

Unblinded CGM/No Nutrition Therapy

Experimental group

Treatment:

Behavioral: Unblinded CGM/No Nutrition Therapy

Blinded CGM/No Nutrition Therapy

Experimental group

Treatment:

Behavioral: Blinded CGM/No Nutrition Therapy