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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
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 11-18 years old
  2. HbA1c > 8.5%
  3. Duration of type 1 diabetes >1 year
  4. 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

First Posted
September 23, 2021
Last Updated
September 23, 2021
Sponsor
Georgetown University
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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

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Pediatric Boot Camp Program

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