ENROLLING_BY_INVITATION

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-28
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06487962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Low-income status
  2. * Documented diagnosis of T1D
  3. * 18 years of age or older
  4. * Federally Qualified Health Center (FQHC) primary care provider
  5. * English or Spanish-speaking And at intervention sites
  6. * Willingness to wear a CGM sensor
  7. * Adult family member or friend, who will give consent to participate in the study and co-attend the 4-week intervention sessions
  8. * Reported difficulty in using CGM if current or past use of CGM
  1. * Pregnancy or planning to become pregnant
  2. * Lactation
  3. * Serious illness that may prevent study participation (e.g., severe depression)
  4. * Less than 6 months life expectancy
  5. * Alcohol abuse or dependence
  6. * Uncorrected hearing or vision impairment

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Connecticut

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-28
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Type 1 Diabetes