Clinical trial NCT06487962: Pilot RCT: FQHC Intervention for Uptake of CGM in Hispanic Adults with T1D
Official title: Pilot RCT: FQHC Intervention for Uptake of CGM in Hispanic Adults with T1D
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Continuous Glucose Monitor
Hispanic Adult
Family
Social Ecological Model
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a mixed-methods, pragmatic pilot RCT design. Mixed-methods will be used to assess study feasibility and acceptability while quantitative methods will be used to assess RCT outcomes. As a pragmatic trial, the intervention (except peer-led support sessions) and control conditions are embedded in routine FQHC diabetes care in the participating sites.
Primary purpose: OTHER

Brief summary: Hispanics 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, Hispanic 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.

Detailed description: Low-income Hispanic 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, Hispanics 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 Hispanic 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 Hispanic 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 the core Hispanic values of familismo and collectivismo 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 4 FQHC sites were randomized to deliver the intervention (n=2) or control (n=2) conditions with a total enrollment goal of 30 Hispanics 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 Hispanic adults with T1D for FQHCs nationally

Eligibility criteria: Inclusion Criteria:

* Hispanic ethnicity
* Documented diagnosis of T1D
* Greater than 24 years of age
* 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:

* Currently receiving diabetes care outside of the FQHC (e.g., endocrinologist)
* 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

Primary outcomes:
measure: Number of days CGM worn
timeFrame: 3 months and 6 months
measure: Percentage of time the CGM is active
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: A1C
timeFrame: Baseline, 3 months, and 6 months
measure: CGM time in range (TIR)
timeFrame: 3 months and 6 months
measure: CGM time below range (TBR)
timeFrame: 3 months and 6 months
measure: CGM time above range (TAR)
timeFrame: 3 months and 6 months
measure: Number of hypoglycemic-related emergency department (ED) visits over past 3 months
timeFrame: Baseline, 3 months, and 6 months
measure: Number of hypoglycemic-related hospitalizations
timeFrame: Baseline, 3 months, and 6 months
measure: Number of hyperglycemic-related ED visits
timeFrame: Baseline, 3 months, and 6 months
measure: Number of hyperglycemic-related hospitalizations
timeFrame: Baseline, 3 months, and 6 months
measure: Medical Outcomes Survey Short Form-36
timeFrame: Baseline, 3 months, and 6 months
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Baseline, 3 months, and 6 months
measure: Interpersonal Processes of Care Survey: Short Form
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Community Health Center, Inc.
state: Connecticut
Study officials:
References: