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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: CGM Intervention; Other: SMBG Control Condition

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • Community Health Center, Inc.
  • Florida
    • Vero Beach, Florida, United States, 32960
      • Treasure Coast Community Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitoring (CGM) Intervention Arm; 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.	Device: CGM Intervention; The intervention has 4 components with CGM uptake and maintenance as a primary focus. (1) Participants will visit their primary care provider (PCP) at baseline and 3- and 6-months post-baseline (or more frequently as needed) for review of CGM data and insulin therapy adjustments as indicated. Intervention providers received rigorous training in T1D management and CGM via Project ECHO (Extension for Community Healthcare Outcomes). (2) After each PCP visit, the CDCES will follow-up with participants to ensure participant understanding of the education/instructions provided at the PCP visit. (3) Next, participants will receive 4-weekly sessions of culturally sensitive, intensive CGM education and training led by a CDCES with accompaniment of a supportive family member or friend. (4) Virtual group support sessions, led by a peer educator, will follow over 5 months. During this period, the peer-led sessions will take place every two weeks and then move to every three weeks.
Other: Self-Monitoring of Blood Glucose (SMBG) Arm; 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.	Other: SMBG Control Condition; The SMBG control condition consists of 3 components delivered over 6 months. (1) Participants will visit their PCP at baseline and 3- and 6-months post-baseline (or more frequently as needed) for review of SMBG data and insulin therapy adjustments as indicated. Control providers received rigorous training in T1D management via Project ECHO. (2) Commencing after the first PCP visit, participants will have 4-weekly telehealth visits for knowledge and skills reinforcement for SMBG. (3) CDCES support phone calls will follow over 5 months. During this period, the support phone calls will take place every two weeks and then move to every three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days CGM worn	The total number of days CGM worn. Data will be collected from Ambulatory Glucose Profile Reports.	3 months and 6 months
Percentage of time the CGM is active	The percentage of time the CGM is active. Data will be collected from Ambulatory Glucose Profile Reports.	3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1C	Measure of glycemic control over the past 3 months	Baseline, 3 months, and 6 months
CGM time in range (TIR)	TIR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports.	3 months and 6 months
CGM time below range (TBR)	TBR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports.	3 months and 6 months
CGM time above range (TAR)	TAR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports.	3 months and 6 months
Number of hypoglycemic-related emergency department (ED) visits over past 3 months	1-item measure	Baseline, 3 months, and 6 months
Number of hypoglycemic-related hospitalizations	1-item measure	Baseline, 3 months, and 6 months
Number of hyperglycemic-related ED visits	1-item measure	Baseline, 3 months, and 6 months
Number of hyperglycemic-related hospitalizations	1-item measure	Baseline, 3 months, and 6 months
Medical Outcomes Survey Short Form-36	Quality of Life	Baseline, 3 months, and 6 months
Multidimensional Scale of Perceived Social Support	Social Support	Baseline, 3 months, and 6 months
Interpersonal Processes of Care Survey: Short Form	Disparities in Interpersonal Care (communication, decision-making, and interpersonal style)	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Family; Continuous Glucose Monitor; Social Ecological Model; Hispanic Adult
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 24-08-011-910

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes