Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Continuous Glucose Monitoring
• Interventions: Other: Virtual CGM initiation service; Other: Online educational module on CGM; Other: Practice facilitation

• Registration Number: NCT05336214
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-20
• Study Start: 2022-06-07
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

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Exclusion Criteria

• Pregnant women
• Younger than 18 years of age
• Older than 89 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Learn + Practice Facilitation	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
Refer	Virtual CGM initiation service	Practice referral of patients to a virtual CGM initiation service
Learn + Practice Facilitation	Online educational module on CGM	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
Learn	Online educational module on CGM	Practice completion of online educational module, American Academy of Family Physicians (AAFP) Transformation in Practice Series (TIPS) on continuous glucose monitoring in primary care

Primary Outcome Measures

Name	Time	Method
Change in practice-reported prescriptions of Continuous Glucose Monitors	Baseline, 6, and 12 months from baseline	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.

Secondary Outcome Measures

Name	Time	Method
Glycemic control (a)	Baseline to 12 months after enrollment	Change in HbA1c over time by study arm.
Glycemic control (c)	Baseline, 3, 6, and 12 months from baseline	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
Glycemic control (b)	Baseline, 3, 6, and 12 months from baseline	Change in Time in Range for each participant based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm
Diabetes-related distress	Baseline, 3, and 6 months from baseline	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."
Cost Analysis and Economic Sustainability	6 months from baseline	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
Glycemic control (e)	Baseline, 3, 6, and 12 months from baseline	Change in GMI (glucose management indicator) for each participant based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm
Implementation and Maintenance	6 and 12 months from baseline	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).
Glycemic control (d)	Baseline, 3, 6, and 12 months from baseline	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
Glucose Monitoring Satisfaction Survey	Baseline, 3, and 6 months from baseline	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).

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States