Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes

NCT05336214 | Completed

• 1 other identifier: 21-4269
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Glycemic control (a)

  Baseline to 12 months after enrollment

• Glycemic control (b)

  Baseline, 3, 6, and 12 months from baseline

• Glycemic control (c)

  Baseline, 3, 6, and 12 months from baseline

• Glycemic control (d)

  Baseline, 3, 6, and 12 months from baseline

• Glycemic control (e)

  Baseline, 3, 6, and 12 months from baseline

Study Arms (3)

Refer

EXPERIMENTAL

Practice referral of patients to a virtual CGM initiation service

Other: Virtual CGM initiation service

Learn

EXPERIMENTAL

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

Learn + Practice Facilitation

EXPERIMENTAL

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; Other: Practice facilitation

Interventions

Virtual CGM initiation service 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.

Refer

Online educational module on CGM 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; Learn + Practice Facilitation

Practice facilitation 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.

Learn + Practice Facilitation

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 40490741 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tamara Oser, MD

  University of Colorado Denver | Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

• Sean Oser, MD, MPH

  University of Colorado Denver | Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 20, 2022
• Study Start: June 7, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)