Diabetes Mellitus, Type 2 Clinical Trial
— PREPARE4CGMOfficial title:
PRimary Care Education and Practice Adoption Resource Evaluation for Continuous Glucose Monitoring
Verified date | May 2024 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overarching goal of this study is to decrease disparities and increase access to continuous glucose monitoring (CGM) for patients with diabetes, regardless of where people receive their diabetes care. This study aims to evaluate the effectiveness of three implementation strategies for CGM in primary care practices in an efficient, sustainable, and scalable fashion. The investigators will also perform economic analysis of the implementation strategies. This 3-year study will compare practices that implement CGM with (a) an evidence-based educational module only, (b) an educational module plus practice facilitation support, or (c) a virtual CGM initiation clinic for patients. There will be up to 30 practices in each group for a possible total of 90 primary care practices. The investigators expect to enroll up to 500 patient participants across these 90 practices and to compare outcomes among patients from each study arm. This comparison will help investigators to understand the different implementation strategies and their ability to help primary care practice adopt, implement, and maintain CGM for their patients. The information the investigators collect will also help to understand how patients in these primary care practices experience initiation and use of CGM. The results will help to develop strategies and tools to train more primary care practices to offer CGM more widely to patients for whom it is recommended, especially for those where access to specialty care is limited.
Status | Active, not recruiting |
Enrollment | 190 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - Between ages of 18 and 89 years - Has diagnosis of type 1 diabetes or type 2 diabetes - Recommended by primary care clinician to use continuous glucose monitoring to manage diabetes - Ability to read or speak English or Spanish Exclusion Criteria: - Pregnant women - Younger than 18 years of age - Older than 89 years of age |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | The Leona M. and Harry B. Helmsley Charitable Trust |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in practice-reported prescriptions of Continuous Glucose Monitors | Change in number of patients over time by study arm with diabetes prescribed a Continuous Glucose Monitoring Device. This is a practice-level indicator of patient reach in primary care settings. | Baseline, 6, and 12 months from baseline | |
Secondary | Glycemic control (a) | Change in HbA1c over time by study arm. | Baseline to 12 months after enrollment | |
Secondary | Glycemic control (b) | Change in Time in Range for each participant based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm | Baseline, 3, 6, and 12 months from baseline | |
Secondary | Glycemic control (c) | Change in Time above range for each participant with various glycemic ranges based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm | Baseline, 3, 6, and 12 months from baseline | |
Secondary | Glycemic control (d) | Change in Time below range for each participant with various glycemic ranges based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm | Baseline, 3, 6, and 12 months from baseline | |
Secondary | Glycemic control (e) | Change in GMI (glucose management indicator) for each participant based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm | Baseline, 3, 6, and 12 months from baseline | |
Secondary | Diabetes-related distress | Change in diabetes-related distress over time by study arm, as measured by the Diabetes Distress Screening Scale (DSS). This is a patient-level indicator measuring dimensions of emotional burden and regimen-related distress; changes in distress metrics are expected as an outcome of increased Continuous Glucose Monitor prescriptions. Ratings are averaged across the 17 scale items for a DSS score ranging between 1 and 6. Higher scores indicate greater distress (worse outcome), with a score of 3 or greater indicating "moderate distress." | Baseline, 3, and 6 months from baseline | |
Secondary | Glucose Monitoring Satisfaction Survey | Change in Patient device satisfaction over time by study arm, as measured by the Glucose Monitoring System Satisfaction Survey (GMSS). This is a patient-level indicator measuring dimensions of emotional burden and regimen-related distress; changes in distress metrics are expected as an outcome of increased CGM prescriptions. Ratings are averaged across scale items for a GMSS score ranging between 1 and 5. Higher scores indicate greater satisfaction (positive outcome). | Baseline, 3, and 6 months from baseline | |
Secondary | Cost Analysis and Economic Sustainability | Counts of Current Procedural Terminology (CPT)/Healthcare Common procedure Coding System (HCPCS) codes collected for all visits with Continuous Glucose Monitor patients and calculated using the Medicare Reimbursement Rate | 6 months from baseline | |
Secondary | Implementation and Maintenance | The Implementation Milestones Checklist will allow the investigators to identify differences between study arms' ability to meet and/or maintain various steps in the intervention timelines. This is a practice-level indicator of ability to sustain the intervention and any positive effects. Items are averaged for an overall measure of practice implementation, with ratings ranging from 0 (Don't plan to use) to 4 (completed). Higher scores indicate greater implementation (better outcome). | 6 and 12 months from baseline |
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