Digital Diabetes Clinic - DDC

Charité - Universitätsmedizin Berlin0 sites52 target enrollmentOctober 7, 2019

Overview

No summary available.

Registry

who.int

Start Date

October 7, 2019

End Date

December 31, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Female and male children aged 3 to 12 years who have been diagnosed with T1D (type 1 diabetes mellitus; Global International Diabetes Federation/International Society for Pediatric and Adolescent Diabetes, IDF\-ISPAD 2011; IDF Criteria) will be included.
•The treatment of T1D at the time of randomization has to include:
•o Use of daily insulin therapy (MDI, multiple daily injections; or CSII, continuous subcutaneous insulin infusion) for \>6 months
•o Use of a Dexcom G6 glucose monitoring sensor measuring interstitial glucose levels (CGM, continuous glucose monitoring) for \>1 month and the intention to continuously use a Dexcom sensor for the duration of the study
•The subject has to live with a parent/caregiver as a care partner operating the DDC study system.
•The subject and parent/caregiver are willing to allow the respective diabetes team to receive and view therapy data transmitted by upload therapy data regularly via their client during the intervention phase.
•The subject and parent/carer are willing to keep a digital diabetes logbook during the intervention phase.
•Since 2020, children and adolescents aged 12 years and above and adults can enroll in the study as well.

•The subject is excluded if subject or parent/caregiver operating with the study system are diagnosed with a medical and/or psychiatric condition considered to interfere with ability to complete the study protocol.
•The subject and parent/caregiver have a known cellular and/or WiFi connectivity problem at their home considered to interfere with the ability to complete the study protocol.