NCT06784375RecruitingNot Applicable
Individualized Diabetes Education Assisted by CGM (IDEA-CGM)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Minnesota
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1c
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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."
Arms & Interventions
Blinded CGM/No Nutrition Therapy
Experimental
Intervention: Blinded CGM/No Nutrition Therapy (Behavioral)
Unblinded CGM/No Nutrition Therapy
Experimental
Intervention: Unblinded CGM/No Nutrition Therapy (Behavioral)
Unblinded CGM/Nutrition Therapy
Experimental
Intervention: Unblinded CGM/Nutrition Therapy (Behavioral)
Blinded CGM/Nutrition Therapy
Experimental
Intervention: Blinded CGM/Nutrition Therapy (Behavioral)
Outcomes
Primary Outcomes
Hemoglobin A1c
Time Frame: 12 weeks
Measure of blood glucose control
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Use of CGM in Kidney Transplant RecipientsDiabetes Mellitus, Type 2Kidney Transplant ComplicationsInsulin Dependent DiabetesNCT04783441University of California, Davis80
Completed
Phase 1
Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)Type 2 Diabetes MellitusNCT01537120Merck Sharp & Dohme LLC25
Recruiting
Not Applicable
Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes: A Prospective Community-based (Workplace) Cohort StudyPreDiabetesDiabetes Mellitus, Type 2NCT06542627Kangbuk Samsung Hospital420
Completed
Not Applicable
Continuous Glucose Monitoring and Behavioral Change Intervention for People With Type 2 Diabetes and Diabetes DistressType 2 DiabetesNCT05941000Northwell Health3
Completed
Not Applicable
Continuous Glucose Monitoring (CGM) in Subjects With Type 2 DiabetesType 2 Diabetes MellitusNCT01341067Rocky Mountain Diabetes and Osteoporosis Center30