Individualized Diabetes Education Assisted by CGM (IDEA-CGM)
Recruiting · NCT06784375 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Minnesota
View the official record on ClinicalTrials.gov →Interventions studied
Blinded CGM/No Nutrition TherapyBlinded CGM/Nutrition TherapyUnblinded CGM/No Nutrition TherapyUnblinded CGM/Nutrition Therapy
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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."
Where it is running
1 location listed across 1 US state.
- University of Minnesota - Minneapolis, Minnesota, United States