CGM Initiation Approach for Type 2 Diabetes
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
Holly Willis, PhD
Principal Investigator
HealthPartners Institute, International Diabetes Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- CGM initiation approach
Find a Clinic Near You
Who Is Running the Clinical Trial?
Holly Willis
Lead Sponsor