Improving continuous glucose monitoring use in Hispanic adults with type 1 diabetes
Pilot RCT: FQHC Intervention for Uptake of CGM in Hispanic Adults with T1D
This study is trying to see if a new program can help low-income Hispanic adults with type 1 diabetes use continuous glucose monitors better to manage their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | University of Connecticut Academic / other |
| Locations | 1 site (Middletown, Connecticut) |
| Trial ID | NCT06487962 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to increase the uptake of continuous glucose monitoring (CGM) among low-income Hispanic adults with type 1 diabetes (T1D) who are often underserved in healthcare settings. The study employs a multi-level intervention based on the Socio-Ecological Model, targeting individuals, families, and healthcare providers to address barriers to CGM use. Participants will receive a 6-month intervention designed to enhance their ability to manage diabetes effectively. The feasibility of this approach will be assessed over a 4-year period, with insights gathered from community stakeholders to refine the intervention.
Who should consider this trial
Good fit: Ideal candidates include Hispanic adults over 24 years old with a documented diagnosis of T1D who receive care at federally qualified health centers.
Not a fit: Patients currently receiving diabetes care from endocrinologists or those with serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve diabetes management and reduce acute complications in Hispanic adults with T1D.
How similar studies have performed: While similar approaches have been explored, this specific intervention targeting Hispanic adults with T1D is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hispanic ethnicity * Documented diagnosis of T1D * Greater than 24 years of age * 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: * Currently receiving diabetes care outside of the FQHC (e.g., endocrinologist) * 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
Where this trial is running
Middletown, Connecticut
- Community Health Center, Inc. — Middletown, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Idiana Vaquez, BS
- Email: velezi@mwhs1.com
- Phone: (860) 347-6971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.