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.
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.
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
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).
Cohort
Prospective
Intermittent CGM
DeviceIntermittent CGM + pediatric endocrinology follow-up, diabetes education and psychological support
Change in HbA1c
Change in % CGM Time in Range
Mean sensor glucose
% CGM Time in tight range
% CGM time spent above range
% CGM time below range
Click on the lead sponsor to view all of their trials.
Life for a Child Program, Diabetes Australia
Lead sponsor
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