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Recruiting NCT07742306

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

— Observational Type 1 Diabetes (T1D)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intermittent CGM.
Who it may be relevant to
Registry conditions: Type 1 Diabetes (T1D). Basic parameters: 10 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Dominican Republic
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change in HbA1c [Time frame: Baseline, 3 months, 6 months, 9 months and 12 months]
  • Change in % CGM Time in Range [Time frame: Baseline, Month 1 and Month 4]
Secondary outcome measures (10)
  • Mean sensor glucose [Time frame: Month 1 and Month 4]
  • % CGM Time in tight range [Time frame: Month 1 and Month 4]
  • % CGM time spent above range [Time frame: Month 1 and Month 4]
  • % CGM time below range [Time frame: Month 1 and Month 4]
  • CGM glycemic variability [Time frame: Month 1 and Month 4]
  • Episodes of diabetic ketoacidosis [Time frame: Throughout study follow-up duration of 12 months]
  • Episodes of severe hypoglycemia [Time frame: Throughout study follow-up duration of 12 months]
  • Change in Fear of Hypoglycemia [Time frame: Baseline and Month 3]
  • Change in Diabetes-Related Distress [Time frame: Baseline and Month 3]
  • Satisfaction With Glucose Monitoring [Time frame: Month 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Dominican Republic · 3 centers
  • Hospital Infantil Regional Universitario Dr. Arturo Grullón — Santiago de los Caballeros
  • Fundación Aprendiendo a Vivir — Santo Domingo
  • Hospital Infantil Robert Reid Cabral — Santo Domingo

Identifiers

NCT: NCT07742306 · 0114112023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗