Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes (PREPARE4CGM)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Continuous Glucose Monitoring
• Intervention / Treatment: Other: Virtual CGM initiation service; Other: Online educational module on CGM; Other: Practice facilitation

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Refer; Practice referral of patients to a virtual CGM initiation service	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.
Experimental: Learn; Practice completion of online educational module, American Academy of Family Physicians (AAFP) Transformation in Practice Series (TIPS) on continuous glucose monitoring in primary care	Other: 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.
Experimental: Learn + Practice Facilitation; Practice completion of online educational module, American Academy of Family Physicians (AAFP) Transformation in Practice Series (TIPS) on continuous glucose monitoring in primary care plus practice facilitation	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control (a)	Change in HbA1c over time by study arm.	Baseline to 12 months after enrollment
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
• Investigators: Principal Investigator: Tamara Oser, MD, University of Colorado Denver | Anschutz Medical Campus; Principal Investigator: Sean Oser, MD, MPH, University of Colorado Denver | Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 21-4269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No