Type 1 DiabetesNCT05066893
Pediatric Boot Camp Program
A study testing telehealth visits in people with Type 1 Diabetes and Children, Only, run by Georgetown University at 1 site in United States.
Trial summary
An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Children, Only
- What is being tested?
- telehealth visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 11-18 years old
- HbA1c > 8.5%
- Duration of type 1 diabetes >1 year
- Child uses Dexcom and has a phone that is compatible with the InPen app and Dexcom Clarity app.
Who cannot join
- Not able to attend telehealth visits
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medstar Pediatrics
Washington D.C., District of Columbia, 20007
Barbara Runner, 202-243-3560 ext. 5, diabetes@georgetown.edu
Evgenia Gourgari, MD
About this study
Official title: Type 1 Diabetes Boot Camp Program: An Intensive Program to Improve Glycemic Control in Adolescents With Type 1 Diabetes
An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes.
Read the detailed description
Our new PeDi-BoCa Program aims to help children with type 1 diabetes achieve better diabetes control by interacting weekly with their doctor/nurse practitioner (NP) and also by using a "smart pen" that can facilitate the burden of daily calculations with the use of an app on the phone.
Your child's doctor/NP will be able to remotely monitor your child's glucose every week (Dexcom) and make recommendations for changes, discuss solutions to possible obstacles and offer intensive diabetes education.
- Conditions
- Type 1 Diabetes, Children, Only
- Being tested
- telehealth visits
- 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.
telehealth visitsOther
intensive visits with doctor
| Study group | Role | What they receive |
|---|---|---|
| standard of care | Active comparator | standard of care will be given as per usual care Receives: Other: telehealth visits |
| intensive monitoring | Experimental | intensive monitoring every week will be given to participants Receives: Other: telehealth visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start5 Nov 2020
- Primary completion5 Nov 2023 (estimated)
- Study completion5 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066893
- Sponsor's protocol ID
- 2604
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Boot Camp Program: An Intensive Program to Improve Glycemic Control in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05066893
- Acronym / sponsor ID
- 2604
- Conditions
- Type 1 Diabetes, Children, Only
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 5 Nov 2023 (estimated)
- Study completion
- 5 Nov 2024 (estimated)
- First posted
- 4 Oct 2021 (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.
An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes.
Detailed description
Our new PeDi-BoCa Program aims to help children with type 1 diabetes achieve better diabetes control by interacting weekly with their doctor/nurse practitioner (NP) and also by using a "smart pen" that can facilitate the burden of daily calculations with the use of an app on the phone.
Your child's doctor/NP will be able to remotely monitor your child's glucose every week (Dexcom) and make recommendations for changes, discuss solutions to possible obstacles and offer intensive diabetes education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | Active comparator | Other: telehealth visitsstandard of care will be given as per usual care |
| intensive monitoring | Experimental | Other: telehealth visitsintensive monitoring every week will be given to participants |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 11-18 years old
- HbA1c > 8.5%
- Duration of type 1 diabetes >1 year
- Child uses Dexcom and has a phone that is compatible with the InPen app and Dexcom Clarity app.
Key exclusion criteria (1 listed)
- Not able to attend telehealth visits
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 |
|---|---|---|
| telehealth visitsintensive visits with doctor | Other | intensive monitoring, standard of care |
Primary outcome
Change in HbA1c
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telehealth visits in people with Type 1 Diabetes and Children, Only, run by Georgetown University at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 3 months). 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 4 Oct 2021.