Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— PREPARE4CGM  

Official title:

PRimary Care Education and Practice Adoption Resource Evaluation for Continuous Glucose Monitoring

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05336214
• Other study ID #: 21-4269
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Continuous Glucose Monitoring
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Other:
• Virtual CGM initiation service
Primary care practices will refer patients to an external virtual initiation service staffed by clinical pharmacists, diabetes care and education specialists, and physicians. The initiation service will communicate with eligible patients (referred to the virtual initiation service by their provider) to review device options and provide patient education and support on device use for up to 12 months to help initiate use of the device. The initiation service will communicate with a patient's provider about treatment and follow up, but will not make treatment recommendations directly to patients.
• Online educational module on CGM
Primary care practices will complete online educational modules, the American Academy of Family Physicians Transformation in Practice Series on CGM. This series includes education on diabetes; glucose monitoring; evidence behind CGM; CGM implementation tools, strategies, and workflows; billing, reimbursement, and insurance authorization of CGM; and tools and strategies to use CGM for quality improvement in diabetes care.
• Practice facilitation
A practice facilitator will support primary care practices in training team members using the American Academy of Family Physicians Transformation in Practice Series on CGM and in implementation of strategies to support CGM use for patients with diabetes in primary care.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

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