CGM Initiation Approach for Type 2 Diabetes
Trial Summary
What is the purpose of this trial?
This study includes two phases. The purpose of Phase 1 of this study is to understand if there is a difference between two ways of introducing a continuous glucose monitor (CGM) to people with type 2 diabetes (T2D). The study will evaluate the effect of using a nutrition-focused approach (NFA) versus a self-directed approach (SDA) during CGM initiation on time in range (TIR) glucose. TIR is the percent of time that someone's glucose is between 70 and 180 mg/dL. It is possible that the approach used to introduce the CGM could impact TIR and other outcomes.The purpose of Phase 2 of the study is to evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention on CGM-derived metrics, dietary intake assessment, and patient reported outcomes.
Research Team
Holly Willis, PhD
Principal Investigator
HealthPartners Institute, International Diabetes Center
Eligibility Criteria
Adults over 18 with type 2 diabetes who haven't used a personal CGM in the last 90 days. They must have a compatible smartphone, be willing to wear CGM, make diet changes based on its data, and attend study visits. Their HbA1c levels should be between 7.0%-10.0%. People using certain diabetes medications or with allergies to medical adhesives cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Blinded baseline CGM data assessment over approximately 10 days
Phase 1 Treatment
Participants receive CGM initiation with either a Nutrition-Focused Approach (NFA) or a Self-Directed Approach (SDA) for 50 days
Phase 2 Follow-up
Evaluation of the impact of discontinuing CGM for 4 months on CGM-derived metrics and patient-reported outcomes
Post-intervention Assessment
Participants undergo post-intervention assessments including CGM data evaluation and dietary intake assessment
Treatment Details
Interventions
- CGM initiation approach
Find a Clinic Near You
Who Is Running the Clinical Trial?
Holly Willis
Lead Sponsor