Recruiting

Individualized Diabetes Education Assisted by CGM (IDEA-CGM)

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).

ClinicalTrials.gov IDNCT06784375

PhaseNA

Enrollment72

SponsorUniversity of Minnesota

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes

About this study

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).

Interventions

Behavioral: Unblinded CGM/Nutrition Therapy — Personalized nutrition counseling based on CGM data
Behavioral: Blinded CGM/Nutrition Therapy — Standard nutrition education which does not incorporate CGM data
Behavioral: Unblinded CGM/No Nutrition Therapy — CGM and general diabetes education (no nutrition education)
Behavioral: Blinded CGM/No Nutrition Therapy — General diabetes education (no nutrition education)

Primary outcomes

Hemoglobin A1c (12 weeks)

Eligibility information

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 locations

University of Minnesota, Minneapolis, Minnesota 55455 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.