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

Part of paid clinical trials in Middletown, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT06487962
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 28, 2024
Status verified
Aug 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.
  • 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.

Primary Outcome Measure

Number of days CGM worn [ Time Frame: 3 months and 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Community Health Center, Inc.MiddletownConnecticut06457-
Treasure Coast Community HealthVero BeachFlorida32960-

Find similar trials in Middletown, CT

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Community Health Center, Inc.· Middletown, CTTreasure Coast Community Health· Vero Beach, FL

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