RecruitingRecruiting
Individualized Diabetes Education Assisted by CGM (IDEA-CGM)
NCT06784375 · University of Minnesota
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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).
Eligibility criteria
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
Enrollment target: 72 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-14
Estimated completion: 2027-09-15
Last updated: 2026-07-16
Interventions
Behavioral: Unblinded CGM/Nutrition TherapyBehavioral: Blinded CGM/Nutrition TherapyBehavioral: Unblinded CGM/No Nutrition TherapyBehavioral: Blinded CGM/No Nutrition Therapy
Primary outcomes
- • Hemoglobin A1c (12 weeks)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactAnne Bantle · contact · bant0015@umn.edu · 612-625-8673
InvestigatorAnne Bantle · principal_investigator, University of Minnesota
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States