Pediatric Boot Camp Program

NCT ID: NCT05066893

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2024-11-05

Brief Summary

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An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes.

Detailed Description

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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

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Type 1 Diabetes Children, Only

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard of care

standard of care will be given as per usual care

Group Type ACTIVE_COMPARATOR

telehealth visits

Intervention Type OTHER

intensive visits with doctor

intensive monitoring

intensive monitoring every week will be given to participants

Group Type EXPERIMENTAL

telehealth visits

Intervention Type OTHER

intensive visits with doctor

Interventions

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telehealth visits

intensive visits with doctor

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medstar Pediatrics

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Barbara Runner

Role: primary

202-243-3560 ext. 5

Other Identifiers

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2604

Identifier Type: -

Identifier Source: org_study_id

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