← Back to Search

CGM Implementation for Diabetes (PREPARE4CGM Trial)

N/A

Waitlist Available

Led By Tamara Oser, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has diagnosis of type 1 diabetes or type 2 diabetes

Between ages of 18 and 89 years

Must not have

Younger than 18 years of age

Older than 89 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, and 12 months from baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will help to understand how to best implement and use continuous glucose monitors in primary care practices so that more patients have access to this technology.

Who is the study for?

This trial is for adults aged 18-89 with type 1 or type 2 diabetes, who are recommended by their primary care doctor to use continuous glucose monitoring (CGM). Participants must be able to read or speak English or Spanish. Pregnant women and those outside the age range cannot join.

What is being tested?

The study tests three ways of implementing CGM in primary care: an educational module only, the module plus practice facilitation support, and a virtual CGM initiation clinic. Up to 500 patients across up to 90 practices will compare these methods over three years.

What are the potential side effects?

Since this trial focuses on implementation strategies rather than medication, traditional side effects are not a concern. However, participants may experience discomfort from wearing the CGM device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with diabetes.

Select...

I am between 18 and 89 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I am 90 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, and 12 months from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, and 12 months from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, and 12 months from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in practice-reported prescriptions of Continuous Glucose Monitors

Secondary study objectives

Cost Analysis and Economic Sustainability

Diabetes-related distress

Glucose

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ReferExperimental Treatment1 Intervention

Practice referral of patients to a virtual CGM initiation service

Group II: Learn + Practice FacilitationExperimental Treatment2 Interventions

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 III: LearnExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met