Pediatric Boot Camp Program
Primary Purpose
Type 1 Diabetes, Children, Only
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telehealth visits
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
Not able to attend telehealth visits
Sites / Locations
- Medstar PediatricsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard of care
intensive monitoring
Arm Description
standard of care will be given as per usual care
intensive monitoring every week will be given to participants
Outcomes
Primary Outcome Measures
Change in HbA1c
Secondary Outcome Measures
Full Information
NCT ID
NCT05066893
First Posted
September 23, 2021
Last Updated
September 23, 2021
Sponsor
Georgetown University
1. Study Identification
Unique Protocol Identification Number
NCT05066893
Brief Title
Pediatric Boot Camp Program
Official Title
Type 1 Diabetes Boot Camp Program: An Intensive Program to Improve Glycemic Control in Adolescents With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
November 5, 2023 (Anticipated)
Study Completion Date
November 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Children, Only
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard of care
Arm Type
Active Comparator
Arm Description
standard of care will be given as per usual care
Arm Title
intensive monitoring
Arm Type
Experimental
Arm Description
intensive monitoring every week will be given to participants
Intervention Type
Other
Intervention Name(s)
telehealth visits
Intervention Description
intensive visits with doctor
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Not able to attend telehealth visits
Facility Information:
Facility Name
Medstar Pediatrics
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Runner
Phone
202-243-3560
Ext
5
Email
diabetes@georgetown.edu
First Name & Middle Initial & Last Name & Degree
Evgenia Gourgari, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pediatric Boot Camp Program
We'll reach out to this number within 24 hrs