Pediatric Boot Camp Program | NCT05066893

Studies
Pediatric Boot Camp Program

NCT05066893

Sponsor

Georgetown University

Status

Unknown status

Last Update Posted

Oct 4, 2021Actual

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Type 1 Diabetes
Children, Only

Interventions

telehealth visits

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2020Actual

Primary Completion Date

Nov 5, 2023Estimated

Completion Date

Nov 5, 2024Estimated

First Submitted Date

Sep 23, 2021

First Submission Date that Met QC Criteria

Sep 23, 2021

First Posted Date

Oct 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2021

Last Update Posted Date

Oct 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard of care	Active Comparator	standard of care will be given as per usual care	Other: telehealth visits
intensive monitoring	Experimental	intensive monitoring every week will be given to participants	Other: telehealth visits

Interventions

Name	Type	Description	Arm Group Labels	Other Names
telehealth visits	Other	intensive visits with doctor	intensive monitoring standard of care

Measure	Description	Time Frame
Change in HbA1c		3 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medstar Pediatrics	Recruiting	Washington D.C.	District of Columbia	20007	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided