AzTrials
AzTrials

Diabetes Mellitus, Type 1PREPARE4CGMNCT05336214

Implementing Continuous Glucose Monitoring in Primary Care for Patients With Diabetes

A study testing Virtual CGM initiation service, Online educational module on CGM and Practice facilitation in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
What is being tested?
Virtual CGM initiation service, Online educational module on CGM and Practice facilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteUnited States
Study dates
7 Jun 2022to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: PRimary Care Education and Practice Adoption Resource Evaluation for Continuous Glucose Monitoring

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.

Being tested
Virtual CGM initiation service, Online educational module on CGM, Practice facilitation
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual CGM initiation serviceOther

    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.

  • Online educational module on CGMOther

    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.

  • Practice facilitationOther

    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.

Study groups in NCT05336214
Study groupRoleWhat they receive
ReferExperimentalPractice referral of patients to a virtual CGM initiation service
Receives: Other: Virtual CGM initiation service
LearnExperimentalPractice completion of online educational module, American Academy of Family Physicians (AAFP) Transformation in Practice Series (TIPS) on continuous glucose monitoring in primary care
Receives: Other: Online educational module on CGM
Learn + Practice FacilitationExperimentalPractice 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
Receives: Other: Online educational module on CGM; Other: Practice facilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 6, and 12 months from baseline

Secondary outcomes (9)

  1. Glycemic control (a)

    Change in HbA1c over time by study arm.

    Measured: Baseline to 12 months after enrollment

  2. Glycemic control (b)

    Change in Time in Range for each participant based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm

    Measured: Baseline, 3, 6, and 12 months from baseline

  3. Glycemic control (c)

    Change in Time above range for each participant with various glycemic ranges based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm

    Measured: Baseline, 3, 6, and 12 months from baseline

  4. Glycemic control (d)

    Change in Time below range for each participant with various glycemic ranges based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm

    Measured: Baseline, 3, 6, and 12 months from baseline

  5. Glycemic control (e)

    Change in GMI (glucose management indicator) for each participant based on Continuous Glucose Monitor recordings (past 10-14 days), by study arm

    Measured: Baseline, 3, 6, and 12 months from baseline

  6. Diabetes-related distress

    Change in diabetes-related distress over time by study arm, as measured by the Diabetes Distress Screening Scale (DSS). This is a patient-level indicator measuring dimensions of emotional burden and regimen-related distress; changes in distress metrics are expected as an outcome of increased Continuous Glucose Monitor prescriptions. Ratings are averaged across the 17 scale items for a DSS score ranging between 1 and 6. Higher scores indicate greater distress (worse outcome), with a score of 3 or greater indicating "moderate distress."

    Measured: Baseline, 3, and 6 months from baseline

  7. Glucose Monitoring Satisfaction Survey

    Change in Patient device satisfaction over time by study arm, as measured by the Glucose Monitoring System Satisfaction Survey (GMSS). This is a patient-level indicator measuring dimensions of emotional burden and regimen-related distress; changes in distress metrics are expected as an outcome of increased CGM prescriptions. Ratings are averaged across scale items for a GMSS score ranging between 1 and 5. Higher scores indicate greater satisfaction (positive outcome).

    Measured: Baseline, 3, and 6 months from baseline

  8. Cost Analysis and Economic Sustainability

    Counts of Current Procedural Terminology (CPT)/Healthcare Common procedure Coding System (HCPCS) codes collected for all visits with Continuous Glucose Monitor patients and calculated using the Medicare Reimbursement Rate

    Measured: 6 months from baseline

  9. Implementation and Maintenance

    The Implementation Milestones Checklist will allow the investigators to identify differences between study arms' ability to meet and/or maintain various steps in the intervention timelines. This is a practice-level indicator of ability to sustain the intervention and any positive effects. Items are averaged for an overall measure of practice implementation, with ratings ranging from 0 (Don't plan to use) to 4 (completed). Higher scores indicate greater implementation (better outcome).

    Measured: 6 and 12 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start7 Jun 2022
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336214
Sponsor's protocol ID
21-4269
Acronym
PREPARE4CGM
Status last verified
Mar 2025
First submitted
23 Mar 2022
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40490741

Questions about this trial

What is this clinical trial studying?

A study testing Virtual CGM initiation service, Online educational module on CGM and Practice facilitation in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in practice-reported prescriptions of Continuous Glucose Monitors (time frame: Baseline, 6, and 12 months from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05336214, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in