Clinical trial NCT06638099: Increasing CGM Use Among Patients With T2D
Official title: Increasing Use of Continuous Glucose Monitors Among Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Diabetes Mellitus
Diabetes Mellitus Type 2
Diabetes Mellitus Type 2 (T2DM)
Keywords: Diabetes Mellitus Type 2
Continuous Glucose Monitor
FQHC Intervention
health care providers
CGM Education
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of California, Berkeley
First posted: 2024-10-15
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Background \& Significance: Approximately 30 million adults in the U.S. suffer from diabetes, a chronic condition with serious long-term health and social consequences. Diabetes is a leading cause of death and disability across the country that disproportionately burdens minoritized ethnoracial, low-income, and rural populations-such as in the border-area region of Imperial County, CA where diabetes rates far exceed state and national averages.Continuous glucose monitoring (CGM) is increasingly recognized as a valuable tool for patients with Type 1 and Type 2 Diabetes (T1D and T2D, respectively), with use of the technology associated with improved disease management, reduced diabetes distress, and healthcare costs. Unfortunately, while clinical practice guidelines recommend use of CGM in diabetes care, inequities in CGM use threaten to exacerbate existing diabetes disparities. For instance, patients from minoritized ethnoracial groups, particularly Hispanic and Black patients, are less likely to use CGM than non-Hispanic white patients.

Disparities in CGM use may be attributed to a variety of factors; However, the most common barrier reported by both patients and providers is limited uptake due to perceived cost. Research has shown that providers may not prescribe CGM due to concerns about costs and their lack of knowledge about insurance eligibility requirements. Fortunately, recent expansions in insurance coverage mean costs may no longer prohibit access to CGM for low-income patients who meet clinical eligibility criteria. Notwithstanding, many providers may not prescribe CGM even to those who qualify for coverage. This may be particularly true among primary care providers who increasingly serve as the primary point of care for patients with diabetes living in rural and medically underserved areas without access to an endocrinologist. A study of over 600 HCPs showed that only 38.6% had ever prescribed CGM, but nearly two-thirds said they would be likely to do so with increased education on CGM or consultation on insurance requirements. Thus, educating HCP on current CGM clinical practice recommendations and insurance coverage eligibility requirements could greatly improve CGM prescriptions in clinics serving low-income and ethnoracially diverse patients.

While increasing CGM prescriptions is an important step to providing more equitable access to CGM, additional intervention may be needed to ensure patients from historically marginalized communities can access and use the devices. More specifically, once prescribed, CGM effectiveness is contingent on patients' acquiring, applying and using the device. Research has shown that patients may share their providers' uncertainty over coverage eligibility requirements and out-of-pocket costs associated with CGM use; a study of over 1,500 patients with T1D found the most reported concerns about using CGM were insurance coverage and costs. If not addressed, cost concerns could impede patients from acquiring CGMs even if prescribed by their healthcare provider (HCP).

Given the potential impact of CGM on diabetes management, efforts to increase CGM uptake are critically needed, especially in historically marginalized and under-resourced regions without access to diabetes specialty care. Strategies such as educating HCP on current CGM eligibility criteria and insurance costs and improving patient education on costs may be effective in increasing initial CGM uptake and ultimately improving patient outcomes. However, no prior studies have evaluated the impact of these strategies in low-resource, primary care settings, or with Hispanic/Latino patients. Existing studies have also primarily focused on CGM use and impact in patients with T1D rather than T2D. The proposed project will fill this gap by evaluating the impact of a system-level, provider-focused intervention on CGM prescription rates and diabetes outcomes for eligible patients with T2D of a large Federally-Qualified Health Center in Imperial County, California.

The project will be guided by the following aims:

1.Determine whether the proportion of T2D patients who are prescribed CGM significantly increases following a system-level CGM intervention that is implemented sequentially in three different clinics. HCPs and staff will participate in a training and receive a CGM prescription toolkit, including procedures for determining clinical eligibility, insurance documentation templates, scripts for communication with patients, and patient education materials with information about CGM benefits, how and where to acquire the device, and any anticipated out-of-pocket costs. CGM prescription rates will be extracted from electronic health records (EHR) to determine changes over time. H1: CGM prescription rate for T2D patients will increase significantly after the intervention.

1a: Evaluate impact of toolkit training on knowledge and attitudes towards CGM among HCP/Staff. H2: Knowledge and attitudes towards CGM will significantly improve following completion of the toolkit training.

2. Compare changes in A1C values over time between T2D patients who do and do not receive a CGM. A1C values will be extracted from the EHR to compare changes over time among patients with T2D who received and filled a new CGM prescription vs. never received or did not fill their prescription. H0: Patients who use CGM will show significantly greater improvement in A1C values over 6 months compared to those who did not use CGM.

2a. Determine whether the impact of CGM use on A1C is mediated by changes in diabetes distress. H2: Reductions in diabetes distress will mediate the relationship between CGM use and A1C among patients.

3.Identify factors that influence CGM uptake among healthcare providers, staff, and patients. Providers, staff, and patients will complete interviews about their experiences with CGM post-intervention. H3: NA.

Research Design \& Methods:

The study aims will be achieved in a three-phase, three-year project. This study will be conducted in collaboration with Innercare, which is a federally-qualified health center in Imperial County, CA, and participants will include healthcare professionals (HCPsl including prescribing clinicians and their staff) and patients recruited from the three largest Innercare clinics in Imperial County: Brawley, El Centro, Calexico. In Phase 1, the investigators will evaluate a systems-level intervention (CGM prescription toolkit and associated training for HCPs and staff) designed to improve CGM prescription rates among patients with T2D in primary care clinics (Aim 1, 1a, 3). In Phase 2, the impact of CGM use on diabetes management among patients with T2D will be evaluated through an examination of A1C laboratory values extracted from the electronic health records (EHR) of patients who were prescribed and received a CGM during the study period (Aim 2). Additionally, the mechanisms of action for CGM will be explored by examining diabetes distress as a mediator between CGM use and A1C values among a subset of patients who complete a self-report survey that will be linked to their EHR data (Aim 2a). In Phase 3, patients will participate in one-on-one interviews about their experiences with CGM, including challenges and facilitators to accessing and using the technology (Aim 3).

Eligibility criteria: Participant Eligibility:

Inclusion:

* adults 18 years or older,
* have been diagnosed with T2D at least one year prior to recruitment,
* are a current patient of one of the three participating Innercare Clinics with no -
* plans to discontinue their care at Innercare within the next 6 months,
* can understand and speak in English or Spanish,
* have telephone access,
* do not plan to move out of the area within the next 6 months.

Exclusion:

* Plans to move out of the area in the next 6 months
* Patients with newly diagnose diabetes mellitus (less than one year), diabetes insipidus, diabetes type 1 or gestational diabetes.

Provider/Staff Eligibility:

Inclusion

* 18 years or older,
* able to read and write in English,
* currently employed at one of the participating Innercare clinics (Brawley, El Centro, Calexico),
* currently be treating at least one adult patient for T2D, scheduled to complete the CGM toolkit training. Exclusion
* Personnel without experience providing care to adult patients with T2D in primary care settings.

Primary outcomes:
measure: CGM prescription rates
timeFrame: From training until month 6
Secondary outcomes:
measure: HCP/Staff Knowledge and Attitudes Towards CGM Use & Prescribing Behavior in Target Population
timeFrame: Pre-training to Month 3
measure: Effect of CGM Prescription on HgbA1C
timeFrame: Receipt of CGM Prescription to Month 6
measure: Effect of CGM on Individual Diabetes Distress Among Patients with T2D
timeFrame: Receipt of CGM Prescription to month 6
measure: Challenges and Facilitators to CGM Uptake in Patients with T2D
timeFrame: Receipt of CGM to Month 6
Other outcomes:
measure: Participant Experience with Prescribing, Acquiring and/or Using a CGM.
timeFrame: Clinic Implementation to Month 9
measure: HCP/Staff Experiences with Prescribing & Monitoring CGM use in Target Population
timeFrame: Toolkit Training to Month 6
Locations:
city: El Centro
country: United States
facility: Innercare Inc
state: California
city: El Centro
country: United States
facility: Innercare, Inc
state: California
Study officials:
affiliation: San Diego State University
name: Emily Schmied,, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Shiloh Williams, PhD RN
role: PRINCIPAL_INVESTIGATOR
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