Type 1 Diabetes (T1D)NCT07742306
Continuous Glucose Monitoring in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic
An observational study of Type 1 Diabetes (T1D), run by Life for a Child Program, Diabetes Australia at 3 sites in Dominican Republic.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Intermittent CGM
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 3 sitesDominican Republic
- Study dates
- 14 Nov 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dominican Republic3 sites, 3 recruiting
- Recruiting
Hospital Infantil Regional Universitario Dr. Arturo Grullón
Santiago de los Caballeros
Angela Matos, +1-809-854-3397, am.matos@ce.pu
- Recruiting
Fundación Aprendiendo a Vivir
Santo Domingo
Claudia Matos, +1-849-919-7005, matosclaudia545@gmail.com
- Recruiting
Hospital Infantil Robert Reid Cabral
Santo Domingo
Dr. Rosario Almanzar, +1-829-592-5946, rosarioalmanzar@gmail.com
About this study
Official title: The Effects of Continuous Glucose Monitoring Interventions in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic
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.
Read more
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.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Intermittent CGM
- Keywords
- Continous glucose monitoring (CGM), Youth, Dominican Republic, Intermittent CGM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent CGMDevice
Intermittent CGM + pediatric endocrinology follow-up, diabetes education and psychological support
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Change in % CGM Time in Range
Measured: Baseline, Month 1 and Month 4
Secondary outcomes (10)
Mean sensor glucose
Measured: Month 1 and Month 4
% CGM Time in tight range
Measured: Month 1 and Month 4
% CGM time spent above range
Measured: Month 1 and Month 4
% CGM time below range
Measured: Month 1 and Month 4
CGM glycemic variability
Measured as SD sensor glucose and coefficient of variation
Measured: Month 1 and Month 4
Episodes of diabetic ketoacidosis
Measured: Throughout study follow-up duration of 12 months
Episodes of severe hypoglycemia
Measured: Throughout study follow-up duration of 12 months
Change in Fear of Hypoglycemia
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.
Measured: Baseline and Month 3
Change in Diabetes-Related Distress
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.
Measured: Baseline and Month 3
Satisfaction With Glucose Monitoring
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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start14 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life for a Child Program, Diabetes Australia
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742306
- Sponsor's protocol ID
- 0114112023
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Continuous Glucose Monitoring Interventions in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic
- ClinicalTrials.gov ID
- NCT07742306
- Acronym / sponsor ID
- 0114112023
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Continous glucose monitoring (CGM), Youth, Dominican Republic, Intermittent CGM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Life for a Child Program, Diabetes AustraliaUniversity, hospital or other
- Collaborators
- 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 start
- 14 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent CGMIntermittent CGM + pediatric endocrinology follow-up, diabetes education and psychological support | Device | – |
Primary outcome
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D), run by Life for a Child Program, Diabetes Australia at 3 sites in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liv A Torres (+1-829-592-5946, livtbueno@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Baseline, 3 months, 6 months, 9 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.