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Individualized Diabetes Education Assisted by CGM (IDEA-CGM)

Status: Recruiting

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).

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• At least 18 years of age
• Diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c of 6.8 – 8.5 %
• Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period
Exclusion Criteria:

• Type 1 diabetes mellitus
• Treatment with insulin, sulfonylurea, or meglitinide
• Use of a non-diabetes medication affecting blood glucose (e.g. corticosteroid)
• 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
• Pregnant or breastfeeding
• Anemia
• Changes to diabetes medications, including change in dose, in the 3 months prior to enrollment
• Presence of any disease that would make adherence to the protocol difficult
Interventions:

Behavioral: Blinded CGM/No Nutrition Therapy, Behavioral: Blinded CGM/Nutrition Therapy, Behavioral: Unblinded CGM/No Nutrition Therapy, Behavioral: Unblinded CGM/Nutrition Therapy

Conditions:

Diabetes & Endocrine

Keywords:

blood glucose, blood sugar, continuous glucose monitor (CGM), Diet, nutrition

Study Contact: IDEA-CGM Study - d-study@umn.edu
Principal Investigator: Anne Bantle
Phase: NA
IRB Number: STUDY00022947
See this study on ClinicalTrials.gov

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