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

Life for a Child Program, Diabetes Australia40 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes (T1D)

Interventions

Eligibility

Sex: ALLMin age: 10 YearsMax age: 19 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

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