Type 1 diabetes Type 1 diabetes mellitus
Conditions
Interventions
Bi-hormonale volledige closed loop (Inreda AP®)
Sponsors
Inreda Diabetic BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Clinically planning to and be able to start with the AP of Inreda Diabetic; - Treatment with continuous glucose monitoring (CGM) or flash glucose monitoring (FGM) for at least 3 months prior to AP treatment; - Receive treatment in one of the participating centers; - Willing and able to sign informed consent.
Exclusion criteria
Exclusion criteria: - Planning to become pregnant during the follow-up period; - Any condition that the local investigator feels would interfere with trial participation or the evaluation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of time spent in the target range (3.9-10 mmol/l) after 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance parameters: - Mean and median glucose concentration - Mean and median glucose concentration during the night (from 00:00 to 06:00) - Mean and median glucose concentration during the day (from 06:00 to 00:00) - Glycemic variability, various parameters: - Coefficient of Variation (CV) - Interquartile range (IQR) Safety parameters: - Percentage of time spent above range (hyperglycemia, level 1; 10.1-13.9 mmol/l) - Percentage of time spent in hyperglycemia, level 2 (>13.9 mmol/l) - Percentage of time spent below range (hypoglycemia, level 1; 3.0-3.8 mmol/l) - Percentage of time spent in hypoglycemia, level 2 (<3.0 mmol/l) - Incidence of (severe) adverse events Adherence parameters: - Adherence; expressed as the percentage of days during the study period that participants use the AP for the full day. - Continuation rate; expressed as the percentage of participants that continue AP treatment after 1 year of use Patient reported outcome measures (PROMs): - World Health Organization- Five Well-Being Index (WHO-5) score - Problem Areas in Diabetes (PAID) score - PAID score for each of the four sub dimensions - Score for PAID question concerning hypoglycemia worry - Insulin delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) score - Trust in the device score: score from a shortened version of the Technology Acceptance Scale (TAS) - Sleep quality score: score from a shortened version of the Pittsburgh Sleep Quality Index (PSQI) - Gold score (hypoglycemia awareness) - Usability questionnaire – 12 questions regarding the usability of the AP AP related parameters: - Daily insulin use - Daily glucagon use - Mean number of blood glucose measurements per day - Mean number of sensor calibrations per day - Mean number of sensor inactivity per day (as determined by the AP) - Mean number of sensor changes per 3 months - Mean number of infusion set changes per 3 months - Number of insulin and glucagon occlusions (as determined by the AP) - Perce | — |
Contacts
Public ContactTom Jansen
Inreda Diabetic
Outcome results
None listed