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

University of Colorado Denver (CU Denver)

Status: Completed

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

Treatments: Other: Online educational module on CGM; Other: Virtual CGM initiation service; Other: Practice facilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05336214

21-4269

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 3 patient groups

Refer

Experimental group

Description:

Practice referral of patients to a virtual CGM initiation service

Treatment:

Other: Virtual CGM initiation service

Learn

Experimental group

Description:

Practice completion of online educational module, American Academy of Family Physicians (AAFP) Transformation in Practice Series (TIPS) on continuous glucose monitoring in primary care

Treatment:

Other: Online educational module on CGM

Learn + Practice Facilitation

Experimental group

Description:

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

Treatment:

Other: Practice facilitation

Other: Online educational module on CGM