Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05653518 - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes N/A
Enrolling by invitation NCT05515939 - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed NCT05109520 - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting NCT04016987 - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes N/A
Active, not recruiting NCT04190368 - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes N/A
Active, not recruiting NCT05413005 - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus Early Phase 1
Active, not recruiting NCT04668612 - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes N/A
Recruiting NCT05414409 - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action Phase 2
Completed NCT02837094 - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 Phase 1
Recruiting NCT05418699 - Real-life Data From Diabetic Patients on Closed-loop Pumps
Recruiting NCT05670366 - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes N/A
Completed NCT04084171 - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 N/A
Recruiting NCT06144554 - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting NCT05281614 - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D Early Phase 1
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Recruiting NCT05153070 - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Phase 2
Withdrawn NCT04259775 - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes N/A
Active, not recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02750527 - Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Completed NCT02914886 - Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Phase 4