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NCT Number: NCT07742306

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

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Infantil Regional Universitario Dr. Arturo Grullón, Santiago de los Caballeros, Dominican Republic

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent CGM

Device

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

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline, 3 months, 6 months, 9 months and 12 months

  2. Change in % CGM Time in Range

    Time frame: Baseline, Month 1 and Month 4

Secondary outcomes

  1. Mean sensor glucose

    Time frame: Month 1 and Month 4

  2. % CGM Time in tight range

    Time frame: Month 1 and Month 4

  3. % CGM time spent above range

    Time frame: Month 1 and Month 4

  4. % CGM time below range

    Time frame: Month 1 and Month 4

  5. CGM glycemic variability

    Time frame: Month 1 and Month 4

    Measured as SD sensor glucose and coefficient of variation

  6. Episodes of diabetic ketoacidosis

    Time frame: Throughout study follow-up duration of 12 months

  7. Episodes of severe hypoglycemia

    Time frame: Throughout study follow-up duration of 12 months

  8. Change in Fear of Hypoglycemia

    Time frame: Baseline and Month 3

    Evaluated using the Children/youth version of the Hypoglycemia Fear Survey (CHFS with Part II (Child/Teen)). A low score indicates lower fear of hypoglycemia.

  9. Change in Diabetes-Related Distress

    Time frame: Baseline and Month 3

    Diabetes-related distress will be assessed using the Problem Areas In Diabetes questionnaires for children (PAID-C), adolescents (PAID-T), and parents (P-PAID-C or P-PAID-T) according to the participant's age. A low PAID score indicates that the individual is experiencing low levels of diabetes-related distress.

  10. Satisfaction With Glucose Monitoring

    Time frame: Month 6

    Satisfaction with glucose monitoring will be assessed using the Glucose Monitoring Satisfaction Survey (GMSS). A higher total score indicates greater satisfaction with the monitoring tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Liv A Torres

CONTACT

[email protected]

1 829-592-5946

Sponsors and collaborators

Lead sponsor

Life for a Child Program, Diabetes Australia

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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