Pilot RCT: FQHC Intervention for Uptake of CGM in Low-Income Adults With T1D

University of Connecticut

Status: Invitation-only

Conditions: Type 1 Diabetes

Treatments: Device: CGM Intervention; Other: SMBG Control Condition

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06487962

24-08-011-910

Details and patient eligibility

About

Low-income adults with type 1 diabetes (T1D), despite their disproportionate burden of acute complications (hypoglycemia and diabetes ketoacidosis) and related emergency department visits, hospitalizations, and death, remain largely disenfranchised from continuous glucose monitoring (CGM), an efficacious technology to mitigate these inequities. To increase CGM uptake in low-income, adults with T1D receiving diabetes management in federally qualified health centers (FQHCs), this pilot randomized control trial (RCT), will assess the feasibility of our study protocol, including our multi-level intervention informed by the Socio-Ecological Model.

Full description

Low-income adults with T1D experience a disproportionate burden of life-threatening, acute complications with high rates of related emergency department visits, hospitalizations, and death. Use of CGM may mitigate these inequities. Yet, low-income adults with T1D have exceptionally low levels of CGM use. This reflects social determinants of health (SODH), as framed by the multiple levels of the Socio-Ecological Model (SEM). The SEM's healthcare provider level is a main driver in Hispanic disenfranchisement from CGM. With a severe shortage of endocrinologists, primary care providers are increasingly managing T1D although many report inadequate confidence in titrating insulin and using CGM. With limited access to endocrinology, low-income, Hispanic adults with T1D thus often receive diabetes management in FQHCs with scant or no access to CGM. Hence, to foster equitable uptake of CGM in the most vulnerable adults with T1D, a 4-year, mixed-methods, feasibility study with a pilot randomized controlled trial (RCT) is underway to primarily assess the feasibility of the SEM-guided, 6-month intervention (targeting the individual, family/social networks, and healthcare provider levels). The SEM-guided intervention was refined by our Community Advisory Board. Refinements were informed by qualitative research exploring SDOH barriers to CGM uptake in low-income adults with T1D from the perspectives of four stakeholder groups.

The individual level of the intervention, guided by the Information-Motivation-Behavioral-Skills Model, fosters essential acquisition of information, motivation, and behavioral skills for CGM uptake through two principal approaches: (1) 4-week, personalized, CGM sessions with a RN/ certified diabetes care and education specialist (CDCES); and (2) subsequent virtual peer educator-led support groups, integrating CGM education, through study month six. The family/social networks level leverages social support to promote critical support in CGM uptake with a family member co-attending the 4-week sessions and participant engagement in peer-led support group sessions, respectively. The provider level of the intervention is designed to promote enhanced cultural competency in intervention delivery and provide clinical support for CGM informed by rigorous training in T1D management and CGM via Project ECHO (Extension for Community Healthcare Outcomes).

A total of 11 FQHC sites were randomized to deliver the intervention (n=6) or control (n=5) conditions with a total enrollment goal of 30 low-income adults with T1D (sites having roughly equivalent enrollment rates). The feasibility of the study protocol (e.g., recruitment and retention yields, data collection procedures, intervention implementation, and intervention acceptability, among others) will be routinely assessed. Significant intervention signals in terms of physiological (e.g., A1C and time within, above, and below range glucose range), psychosocial (e.g., quality of life and family support), and behavioral (CGM adherence) outcomes from baseline to 3- and 6-months post-baseline will be assessed. The long-term goal of this study is to inform a large, multi-site RCT, and with successful results, provide a model for CGM uptake in low-income adults with T1D for FQHCs nationally

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low-income status
• Documented diagnosis of T1D
• 18 years of age or older
• Federally Qualified Health Center (FQHC) primary care provider
• English or Spanish-speaking And at intervention sites
• Willingness to wear a CGM sensor
• Adult family member or friend, who will give consent to participate in the study and co-attend the 4-week intervention sessions
• Reported difficulty in using CGM if current or past use of CGM

Exclusion criteria

• Pregnancy or planning to become pregnant
• Lactation
• Serious illness that may prevent study participation (e.g., severe depression)
• Less than 6 months life expectancy
• Alcohol abuse or dependence
• Uncorrected hearing or vision impairment

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Continuous Glucose Monitoring (CGM) Intervention Arm

Experimental group

Description:

The intervention arm comprises participants receiving care from FQHC sites randomized to deliver the intervention. This arm will receive the 6-month, SEM-informed intervention to promote CGM uptake and maintenance.

Treatment:

Device: CGM Intervention

Self-Monitoring of Blood Glucose (SMBG) Arm

Other group

Description:

The SMBG control arm comprises participants receiving care from FQHC sites randomized to deliver the control condition. This arm will receive the 6-month control condition.

Treatment:

Other: SMBG Control Condition