Continuous Glucose Monitoring in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic

NCT07742306 | Recruiting FDA Device

• 1 other identifier: 0114112023
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this pilot longitudinal study is to investigate whether intermittent use of the Dexcom G7 continuous glucose monitor, together with pediatric endocrinology follow-up, diabetes education, and psychological support, can improve glucose control in children and adolescents with high-risk type 1 diabetes in the Dominican Republic. The study will include 40 participants, 10 to 19 years of age, from two pediatric diabetes care centers. Participants will use the Dexcom G7 during two short monitoring periods in the early part of the study. Each participant will use six sensors in total. Between and after these monitoring periods, participants will return to their usual finger-stick glucose monitoring with a glucometer. Participants and their families will also attend scheduled medical visits, diabetes education sessions, and psychological support sessions. Study information will be collected from medical records, laboratory results, Dexcom Clarity reports, participant glucose logs, study forms, and questionnaires. The study will assess changes in HbA1c, time in range, average glucose, glucose variability, low and high blood glucose episodes, adverse events, diabetes-related distress, fear of hypoglycemia, and satisfaction with glucose monitoring.

Conditions

Type 1 Diabetes (T1D)

Keywords

Continous glucose monitoring (CGM); Youth; Dominican Republic; Intermittent CGM

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c

  Baseline, 3 months, 6 months, 9 months and 12 months

• Change in % CGM Time in Range

  Baseline, Month 1 and Month 4

Secondary Outcomes (10)

• Mean sensor glucose

  Month 1 and Month 4

• % CGM Time in tight range

  Month 1 and Month 4

• % CGM time spent above range

  Month 1 and Month 4

• % CGM time below range

  Month 1 and Month 4

• CGM glycemic variability

  Month 1 and Month 4

Interventions

Intermittent CGM DEVICE

Intermittent CGM + pediatric endocrinology follow-up, diabetes education and psychological support

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with T1D aged between 10-19 years of age with an HbA1c \>9.0% that are managed at two pediatric endocrinology health-centers in the Dominican Republic. These include the Pediatric Hospital Regional Universitario Dr. Arturo Grullon en Santiago de Caballeros (STI) and Pediatric Hospital Robert Reid Cabral with assistance provided by the foundation Aprendiendo a Vivir in the city of Santo Domingo (SD).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Life for a Child Program, Diabetes Australia: lead
• Hospital Infantil Regional Universitario Dr. Arturo Grullón, Santiago de los Caballeros, Republica Dominican: collaborator
• Pontificia Universidad Catolica Madre y Maestra (PUCMM), Santiago de Caballeros, Dominican Republic: collaborator
• Instituto Tecnologico de Santo Domingo (INTEC) Santo Domingo, Dominican Republic: collaborator
• Hospital Infantil Robert Reid Cabral, Santo Domingo, Dominican Republic: collaborator
• Fundación Aprendiendo A Vivir, Santo Domingo, Dominican Republic: collaborator
• Warren Alpert Medical School of Brown University, United States of America: collaborator

Study Sites (3)

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Liv A Torres

CONTACT

1 829-592-5946; livtbueno@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 3, 2026
• Study Start: November 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

DO (3)