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
Conditions
Type 2 Diabetes
Locations
University of Minnesota
Minneapolis, Minnesota 55455
United States