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Pediatric Boot Camp Program

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ClinicalTrials.gov Identifier: NCT05066893
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Georgetown University

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Children, Only Other: telehealth visits Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Type 1 Diabetes Boot Camp Program: An Intensive Program to Improve Glycemic Control in Adolescents With Type 1 Diabetes
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : November 5, 2023
Estimated Study Completion Date : November 5, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05066893


Locations
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United States, District of Columbia
Medstar Pediatrics Recruiting
Washington, District of Columbia, United States, 20007
Contact: Barbara Runner    202-243-3560 ext 5    diabetes@georgetown.edu   
Principal Investigator: Evgenia Gourgari, MD         
Sponsors and Collaborators
Georgetown University
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT05066893    
Other Study ID Numbers: 2604
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases