Diabetes Mellitus Type 1 / Diabetes
Conditions
Interventions
The intervention includes 2 weeks of closed-loop control with the artificial
pancreas (AP) of Inreda Diabetic. The device uses 2 subcutaneous glucose
sensors, 2 subcutaneous infusion sets, and incor
Sponsors
Inreda Diabetic B.V.
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: - Diagnosed with Type 1 Diabetes - 12-18 years old - Treated with insulin therapy for at least 6 months
Exclusion criteria
Exclusion criteria: - Impaired awareness of hypoglycaemia (score >= 4) according to Gold and/or Clarke questionnaire - BMI >= 35 kg/m2 - Pregnancy and/or breastfeeding - HbA1c > 97 mmol/mol (11.0%) - Use of acetaminophen (paracetamol) during the open loop or closed-loop period - Limited ability to see, hear or feel the alarm signals of the closed-loop system - Unwillingness to act in response to the alarm signals - Living alone during the night during the closed-loop period - Expected poor internet connectivity regarding 24/7 tele monitoring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter is the percentage of time spent in the target range (3.9-10.0 mmol/L), which will be compared between the open and closed-loop periods for each patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety parameters are: • The proportion of time spent in the following categories: o Hypoglycaemia ( 10.0 mmol/L); o Hyperglycaemia (> 13.9 mmol/L). Secondary performance parameters are: • Mean or median sensor glucose concentration; • Glycaemic variability; • Day and night mean or median sensor glucose concentration; • Day and night time spent in hypo-, hyper- and euglycaemia. • Percentage of time that the closed-loop algorithm is active (closed-loop period only). • Expectations of the closed-loop system and treatment satisfaction scores in patients and their parents (expectations for closed-loop only). | — |
Countries
Netherlands
Outcome results
None listed