E10
Conditions
Interventions
Group 1: The project is planned as a one-arm study with a total of 40 study participants. Families with female and male children with type 1 diabetes aged 3 to 12 years will be included in the study.
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Range (percentage of CGM sensor glucose levels between 70 and 180 mg/dl per day) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of hypoglycaemic events (% of sensor glucose 180 and >250 mg/dl. • Incidence and cause of diabetic ketoacidosis (DKA). • Impact on treatment costs (A&E treatment, hospital admissions due to T1D. • Impact on long-term complication risk, evaluation the change in baseline HbA1c in mmol/mol from baseline to post-assessment. • Change in health-related Quality of Life (QoL) from baseline to post-assessment according to PedsQL. • Feasibility of the study system for the patient population by the percentage of eligible subjects who enrol in the study and the percentage of enrolled patients who complete the study protocol. • Acceptability of the study system by change in patient satisfaction from baseline to post-assessment. • Change in Health Care Professional (HCP) satisfaction from baseline to post-assessment. | — |
Countries
Germany
Contacts
Public ContactKatarina Braune
Charité - Universitätsmedizin Berlin
Outcome results
None listed