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

NCT06487962 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 24-08-011-910
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Continuous Glucose Monitor; Hispanic Adult; Family; Social Ecological Model

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• A1C

  Baseline, 3 months, and 6 months

• CGM time in range (TIR)

  3 months and 6 months

• CGM time below range (TBR)

  3 months and 6 months

• CGM time above range (TAR)

  3 months and 6 months

• Number of hypoglycemic-related emergency department (ED) visits over past 3 months

  Baseline, 3 months, and 6 months

Study Arms (2)

Continuous Glucose Monitoring (CGM) Intervention Arm

EXPERIMENTAL

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

Self-Monitoring of Blood Glucose (SMBG) Arm

OTHER

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

Interventions

CGM Intervention DEVICE

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.

Continuous Glucose Monitoring (CGM) Intervention Arm

SMBG Control Condition OTHER

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.

Self-Monitoring of Blood Glucose (SMBG) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low-income status
• Documented diagnosis of T1D
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Community Health Center, Inc.

Middletown, Connecticut, 06457, United States

Location

Treasure Coast Community Health

Vero Beach, Florida, 32960, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 5, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (2)