Practice facilitation for Diabetes, Autoimmune

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Colorado Anschutz Medical Campus, Aurora, CO
Diabetes, Autoimmune+3 More
Practice facilitation - Other
Eligibility
18+
All Sexes
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Study 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.

Eligible Conditions

  • Diabetes, Autoimmune
  • Diabetes Mellitus, Type 2
  • Continuous Glucose Monitoring

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline, 3, 6, and 12 months from baseline

Month 12
Implementation and Maintenance
6 months from baseline
Cost Analysis and Economic Sustainability
Month 12
Glycemic control (a)
Month 12
Glycemic control (b)
Glycemic control (c)
Glycemic control (d)
Glycemic control (e)
Month 6
Diabetes-related distress
Glucose Monitoring Satisfaction Survey
Month 12
Change in practice-reported prescriptions of Continuous Glucose Monitors

Trial Safety

Trial Design

3 Treatment Groups

Refer
1 of 3
Learn + Practice Facilitation
1 of 3
Learn
1 of 3
Experimental Treatment

500 Total Participants · 3 Treatment Groups

Primary Treatment: Practice facilitation · No Placebo Group · N/A

Refer
Other
Experimental Group · 1 Intervention: Virtual CGM initiation service · Intervention Types: Other
Learn + Practice FacilitationExperimental Group · 2 Interventions: Practice facilitation, Online educational module on CGM · Intervention Types: Other, Other
Learn
Other
Experimental Group · 1 Intervention: Online educational module on CGM · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3, 6, and 12 months from baseline
Closest Location: University of Colorado Anschutz Medical Campus · Aurora, CO
Photo of aurora  1Photo of aurora  2Photo of aurora  3
2015First Recorded Clinical Trial
1 TrialsResearching Diabetes, Autoimmune
86 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged between 18 and 89 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.