Increasing CGM Use Among Patients With T2D

Part of paid clinical trials in El Centro, California.

Sponsor
San Diego State University
Study ID
NCT06638099
Status
Recruiting

Conditions

  • Diabetes
  • Diabetes Mellitus
  • Diabetes Mellitus Type 2
  • Diabetes Mellitus Type 2 (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CGM Toolkit Prescriber Training — BEHAVIORAL
    A CGM prescription toolkit was created for prescribing clinicians and staff that includes written guidance on CGM eligibility criteria, instructions for screening patients for eligibility using EHR records and during healthcare visits, recommended provider documentation templates to address all required eligibility criteria for insurance coverage of CGM device and supplies (e.g., Medicare, Medicaid), sample scripts for communicating with patients about the purpose and use of CGM, and patient-level frequently asked questions (FAQs), including free resources available to learn more about CGM benefits, where/how to acquire CGM, and determining out-of-pocket costs. The toolkit will be introduced during a 20 minute initial training session and reinforced during a 10 minute booster training approximately one month after initial training

Study Details

Study Overview: This interventional study aims to assess whether training healthcare professionals (HCPs) increases the number of continuous glucose monitor (CGM) prescriptions for patients with Type 2 Diabetes in a Federally Qualified Health Center serving a predominantly Hispanic/Latino population. Research Questions: Does HCP training enhance CGM prescription rates in a primary care setting? Does receiving a CGM prescription lead to improved Type 2 Diabetes control, as measured by Hemoglobin A1c levels? What barriers do patients face when prescribed and using CGMs? Given the significant impact of CGMs on diabetes management, this project seeks to improve CGM utilization among eligible patients through a focused intervention for HCPs and evaluate diabetes outcomes for those who do and do not receive a CGM. Methodology: HCPs and staff from three clinics within the same healthcare system will undergo a brief, in-person training on current clinical guidelines and insurance eligibility for CGMs. A booster session will follow about one month later to reinforce learning and address any prescribing challenges. Training efficacy will be evaluated by comparing CGM prescription rates before and after training using electronic health records. HCPs will complete pre- and post-training surveys to assess changes in knowledge, beliefs, and prescribing practices related to CGMs. Additionally, a small subset of prescribers will participate in interviews about their experiences with CGM prescriptions four months post-training. Patient Recruitment and Surveys: Patients with Type 2 Diabetes will be recruited for surveys at baseline, and at 3 and 6 months. These surveys will gather information on their diabetes management experience, levels of diabetes distress, and whether CGM discussions occurred with their primary care provider. Participants who received CGM prescriptions will share their experiences and any barriers encountered. A subset will also be invited for interviews to further explore their CGM experiences. Conclusion: This study seeks to fill a crucial gap in understanding how HCP training influences CGM prescription rates and the associated diabetes management outcomes, ultimately aiming to enhance diabetes care for a vulnerable population.

Key Dates

Start date
Nov 4, 2024
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
318 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Healthcare Prescribers Exposed to CGM Prescriber Toolkit Training
    Participants in this arm will include qualified healthcare prescribers (MDs, DOs, PAs, NPs, etc.) and staff who treat patients with Type 2 diabetes in primary care settings who will receive in depth training using a study-developed prescriber toolkit. The toolkit covers important information including current clinical practice guidelines, eligibility criteria, provider documentation requirements and scripts for discussing CGM use with their patient population. The impact of the training will be evaluated by examining changes in CGM prescription rates for patients with Type 2 diabetes seen in primary care before and after the training is delivered. Secondarily, Participants will be surveyed pre- and post-training to elicit prescribing knowledge and attitudes towards CGM use.
  • No Intervention: Healthcare Prescribers Not Exposed to CGM Prescriber Toolkit Training
    Participants in this arm are prescribers (MDs, DOs, PAs, NPs, etc.) and staff who will NOT receive in depth training using a study-developed prescriber toolkit.

Primary Outcome Measure

CGM prescription rates [ Time Frame: From training until month 6 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Innercare IncEl CentroCalifornia92243-
Innercare, IncEl CentroCalifornia92243
Sara Sanders
760-344-9951

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