Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Virtual CGM initiation service
* Other: Online educational module on CGM
* Other: Practice facilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refer<br>Practice referral of patients to a virtual CGM initiation service | Other: Virtual CGM initiation service<br>* 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.<br>|
| Experimental: Learn<br>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<br>* 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.<br>|
| Experimental: Learn + Practice Facilitation<br>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<br>* 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.<br>Other: Practice facilitation<br>* 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.<br>|

What is the study measuring?
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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 |