Pediatric Boot Camp Program

September 23, 2021 updated by: Georgetown University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Medstar Pediatrics
        • Principal Investigator:
          • Evgenia Gourgari, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard of care
standard of care will be given as per usual care
Other: telehealth visits
intensive visits with doctor
Experimental: intensive monitoring
intensive monitoring every week will be given to participants
Other: telehealth visits
intensive visits with doctor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Anticipated)

November 5, 2023

Study Completion (Anticipated)

November 5, 2024

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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