Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes

NCT ID: NCT05336214

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2024-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Refer

Practice referral of patients to a virtual CGM initiation service

Group Type: EXPERIMENTAL

Virtual CGM initiation service

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Online educational module on CGM

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Online educational module on CGM

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamara Oser, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver | Anschutz Medical Campus

Sean Oser, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver | Anschutz Medical Campus

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

References

Wiggins KT, Hall TL, Jortberg B, Dickinson WP, Dickinson LM, Parascando JA, Fernald DH, Sobczak C, Oser SM, Oser TK. Primary care practices' choice of implementation strategy for continuous glucose monitoring for patients with diabetes: a multiple methods study within a larger hybrid type-3 effectiveness-implementation study. BMC Prim Care. 2025 Jun 9;26(1):195. doi: 10.1186/s12875-025-02903-0.

Reference Type: DERIVED

PMID: 40490741 (View on PubMed)

Other Identifiers

21-4269

Identifier Type: -

Identifier Source: org_study_id