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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Dominican Republic
Hospital Infantil Regional Universitario Dr. Arturo Grullón
RECRUITING
Santiago De Los Caballeros
Fundación Aprendiendo a Vivir
RECRUITING
Santo Domingo
Hospital Infantil Robert Reid Cabral
RECRUITING
Santo Domingo
Contact Information
Primary
Liv A Torres
livtbueno@gmail.com
+1-829-592-5946
Backup
Dr. Victor Ramirez
vramirezq1992@gmail.com
+1-401-563-0380
Time Frame
Start Date: 2025-11-14
Estimated Completion Date: 2027-12
Participants
Target number of participants: 40
Related Therapeutic Areas
Sponsors
Collaborators: Fundación Aprendiendo A Vivir, Santo Domingo, Dominican Republic, Warren Alpert Medical School of Brown University, United States of America, Pontificia Universidad Catolica Madre y Maestra (PUCMM), Santiago de Caballeros, Dominican Republic, Instituto Tecnologico de Santo Domingo (INTEC) 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
Leads: Life for a Child Program, Diabetes Australia

This content was sourced from clinicaltrials.gov