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NCT06784375NARecruiting

Individualized Diabetes Education Assisted by CGM (IDEA-CGM)

University of Minnesota

Start Date

7/14/2025

Completion Date

9/15/2027

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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."

Interventions

BEHAVIORAL

Unblinded CGM/Nutrition Therapy

BEHAVIORAL

Blinded CGM/Nutrition Therapy

BEHAVIORAL

Unblinded CGM/No Nutrition Therapy

BEHAVIORAL

Blinded CGM/No Nutrition Therapy

Interested in This Trial?

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Conditions

Type 2 Diabetes

Locations

University of Minnesota

Minneapolis, Minnesota 55455

United States