"The main objective of this trial is to assess long-term performance and obtain real-world experience with the bi-hormonal fully closed loop system (Inreda AP®)"
ID
Source
Brief title
Condition
- Endocrine and glandular disorders NEC
Synonym
Health condition
Type 1 diabetes
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of time spent in the target range (3.9-10 mmol/l) after 1 year.
Secondary outcome
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) - Percentage of time that the AP algorithm is active Other secondary endpoints: - HbA1c - Weight - Concomitant medication - Reasons for discontinuation of the AP treatment
Background summary
The safety and performance of a bi-hormonal closed loop system for automated glucose control in patients with type 1 diabetes (Inreda AP®); Inreda® Diabetic B.V.) has been demonstrated in previous clinical studies (APPEL 4 and 5). In these studies time in range (TIR; 3.9–10.0 mmol/l) improved during closed loop treatment compared to insulin pump therapy. The clinical data from these studies facilitated CE-marking of the Inreda® AP. However, real-world data with regard to the performance, safety and the use of the system for a longer period of time have not been obtained yet. The main objective of this investigation is to assess long-term performance and obtain real-world experience with the Inreda AP® in 75 individuals with type 1 diabetes over 1 year. The secondary objectives are to examine long-term safety of the Inreda AP® system, treatment adherence, to asses person-reported outcome measures, and to explore Inreda AP® related outcomes.
Study objective
"The main objective of this trial is to assess long-term performance and obtain real-world experience with the bi-hormonal fully closed loop system (Inreda AP®)"
Study design
Multicenter, prospective, single-arm intervention trial
Intervention
Bi-hormonal fully closed loop (Inreda AP®)
Study burden and risks
Participants and their diabetes treatment team have decided to switch to the Inreda AP® as their regular care. There are no specific risks in this investigation and the extent of the burden will be minimal. No study visits will be scheduled solely for study purposes, but will be combined with standard of care visits.
Age
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
- 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
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9578 |
| Other | DCRF (adviescommissie nWMO Martini ziekenhuis Groningen) : METC 2021-046 |