Clinical trial NCT05336214: Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes
Official title: PRimary Care Education and Practice Adoption Resource Evaluation for Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Continuous Glucose Monitoring
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2022-04-20
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Change in practice-reported prescriptions of Continuous Glucose Monitors
timeFrame: Baseline, 6, and 12 months from baseline
Secondary outcomes:
measure: Glycemic control (a)
timeFrame: Baseline to 12 months after enrollment
measure: Glycemic control (b)
timeFrame: Baseline, 3, 6, and 12 months from baseline
measure: Glycemic control (c)
timeFrame: Baseline, 3, 6, and 12 months from baseline
measure: Glycemic control (d)
timeFrame: Baseline, 3, 6, and 12 months from baseline
measure: Glycemic control (e)
timeFrame: Baseline, 3, 6, and 12 months from baseline
measure: Diabetes-related distress
timeFrame: Baseline, 3, and 6 months from baseline
measure: Glucose Monitoring Satisfaction Survey
timeFrame: Baseline, 3, and 6 months from baseline
measure: Cost Analysis and Economic Sustainability
timeFrame: 6 months from baseline
measure: Implementation and Maintenance
timeFrame: 6 and 12 months from baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz Medical Campus
name: Tamara Oser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Denver | Anschutz Medical Campus
name: Sean Oser, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: