University of Minnesota
Minneapolis, Minnesota, 55455, United States
Location status: Recruiting
Location contact
Anne Bantle
CONTACT
Recruiting
NCT Number: NCT06784375
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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."
Treatment and study plan
Unblinded CGM/Nutrition Therapy
BehavioralPersonalized nutrition counseling based on CGM data
Blinded CGM/Nutrition Therapy
BehavioralStandard nutrition education which does not incorporate CGM data
Unblinded CGM/No Nutrition Therapy
BehavioralCGM and general diabetes education (no nutrition education)
Blinded CGM/No Nutrition Therapy
BehavioralGeneral diabetes education (no nutrition education)
Primary outcomes
-
Hemoglobin A1c
Time frame: 12 weeks
Measure of blood glucose control
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Minnesota
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 20, 2025
- Registry last updated
- Jul 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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