Intermittent CGM Use in high-risk children and teens with Type 1 Diabetes in the Dominican Republic

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, pilot longitudinal study enrolling 40 participants aged 10–19 with poorly controlled Type 1 Diabetes. Participants will wear the Dexcom G7 during two short monitoring periods, totaling six sensors, while continuing standard finger-stick monitoring in between and after. Regular follow-up visits, diabetes education, and psychological support are provided; data will come from medical records, labs, Dexcom Clarity, and glucose logs to assess changes in glycemic control over 12 months. The intervention is intermittent CGM use in conjunction with ongoing clinical care. The study will identify feasibility, adherence, and potential signals of improved glucose management in this setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* HbA1c \>9.0%
* Age range: 10-19 years
* Disposition and availability for patients and families to attend scheduled provider meetings, as well as general diabetic educational and psychological support meetings throughout the whole study. Namely, meeting every 2 weeks for the first 3 months and then every 4 weeks until completion of study for next 12 months.
* Willingness and ability to provide signed voluntary consent form. Date and signature is requested however based on literacy levels a patient can provide consent verbally as long as there is a witness who is 18 years or older and demonstration of acknowledgement of information provided.

Exclusion Criteria:

* Diagnosis of T1D within the past 12 months
* Previous or current use of CGM like FreeStyle Libre 2, Dexcom (G6, G7), or similar devices from other companies not mentioned
* Current use of continuous insulin pump in combination with CGM use at present or prior to study
* Residence location with greater than 3 hours of travel time distance from each health center in setting of cost and feasibility for families to travel on frequent necessary basis
* Current steroid therapy orally or intravenously.
* Medical comorbidities including chronic renal disease, hemoglobinopathies, leukemia, hematologic or oncologic conditions that can affect glycemia
* Pregnancy

Where it's running

• Hospital Infantil Regional Universitario Dr. Arturo Grullón
  Santiago de los Caballeros, Dominican Republic Recruiting
• Fundación Aprendiendo a Vivir
  Santo Domingo, Dominican Republic Recruiting
• Hospital Infantil Robert Reid Cabral
  Santo Domingo, Dominican Republic Recruiting

Study contacts

• Study coordinator: Liv A Torres
• Email: livtbueno@gmail.com
• Phone: +1-829-592-5946

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.