Type 1 Diabetes (T1D)
Conditions
Keywords
Continous glucose monitoring (CGM), Youth, Dominican Republic, Intermittent CGM
Brief 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.
Interventions
DEVICEIntermittent CGM
Intermittent CGM + pediatric endocrinology follow-up, diabetes education and psychological support
Sponsors
Life for a Child Program, Diabetes Australia
Hospital Infantil Regional Universitario Dr. Arturo Grullón, Santiago de los Caballeros, Republica Dominican
Pontificia Universidad Catolica Madre y Maestra (PUCMM), Santiago de Caballeros, Dominican Republic
Instituto Tecnologico de Santo Domingo (INTEC) Santo Domingo, Dominican Republic
Hospital Infantil Robert Reid Cabral, Santo Domingo, Dominican Republic
Fundación Aprendiendo A Vivir, Santo Domingo, Dominican Republic
Warren Alpert Medical School of Brown University, United States of America
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change in % CGM Time in Range | Baseline, Month 1 and Month 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean sensor glucose | Month 1 and Month 4 | — |
| % CGM Time in tight range | Month 1 and Month 4 | — |
| % CGM time spent above range | Month 1 and Month 4 | — |
| % CGM time below range | Month 1 and Month 4 | — |
| CGM glycemic variability | Month 1 and Month 4 | Measured as SD sensor glucose and coefficient of variation |
| Episodes of diabetic ketoacidosis | Throughout study follow-up duration of 12 months | — |
| Episodes of severe hypoglycemia | Throughout study follow-up duration of 12 months | — |
| Change in Fear of Hypoglycemia | 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. |
| Change in Diabetes-Related Distress | 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. |
| Satisfaction With Glucose Monitoring | 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. |
Countries
Dominican Republic
Contacts
CONTACTLiv A Torres
CONTACTDr. Victor Ramirez
Outcome results
None listed