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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05066893
Other study ID # 2604
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 5, 2020
Est. completion date November 5, 2024

Study information

Verified date September 2021
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date November 5, 2024
Est. primary completion date November 5, 2023
Accepts healthy volunteers No
Gender All
Age group 11 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
telehealth visits
intensive visits with doctor

Locations

Country Name City State
United States Medstar Pediatrics Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c 3 months
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