Digital Diabetes Clinic

Not Applicable

• Conditions: E10; Type 1 diabetes mellitus

• Registration Number: DRKS00016170
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-07
• Results First Posted: 2021-04-05
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in Range (percentage of CGM sensor glucose levels between 70 and 180 mg/dl per day)