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

NCT06487962 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-12

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Connecticut

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2026-08-01
Completion
2026-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06487962 on ClinicalTrials.gov