E10
Conditions
Interventions
Group 1: Each participant will complete two in-clinic sessions, separated by a washout and system reconfiguration period of approximately 4 weeks to ensure complete metabolic recovery, review of inter
Sponsors
OneTwenty AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Adults aged =18 years with a confirmed diagnosis of Type 1 Diabetes (T1D) for =12 months prior to enrolment. - Current use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) as part of a hybrid closed-loop (HCL) system. - Pump: YpsoPump - Controller: CamAPS FX (=3 months of continuous use) - CGM: Libre 3 (=48 hours active sensor before enrolment) - HbA1c between 6.5 and 7.5 % at screening. - Time in Range (TIR 70-180 mg/dL) between 70 % and 85 % during the preceding 3 months (based on donated CGM data). - Time Below Range (TBR <70 mg/dL / 3.9 mmol/L) = 4 % over the same period. - Body-mass index (BMI) between 18 and 30 kg/m². - Equal gender distribution target: Approximately 50 % male and 50 % female participants. -Ability to understand and communicate in German or English. - Willingness and ability to provide written informed consent and comply with all study procedures
Exclusion criteria
Exclusion criteria: Any of the following will exclude a participant: - Initiation of current CGM system 30 kg/m². - Any psychiatric, cognitive, or behavioral condition that may interfere with safe study participation or adherence to protocol procedures. - Participation in another interventional clinical study within the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoint: % Time Below Range (TBR, <70 mg/dL / 3.9 mmol/L) – evaluated as the primary measure of system safety. - Performance target: Median =4% TBR across participants, with no individual exceeding 10%. - Level 2 hypoglycemia (<54 mg/dL / 3.0 mmol/L) and severe hypoglycemia (requiring assistance) will be monitored as critical safety sub-endpoints. - The definition and acceptance threshold are aligned with FDA statements on safe automated insulin therapy and current consensus guidelines for AID systems. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic Control Metrics: - % Time In Range (TIR, 70–180 mg/dL / 3.9–10.0 mmol/L) - % Time In Tight Range (TiTR, 70–140 mg/dL / 3.9–7.8 mmol/L) - % Time Above Range (TAR, >180 mg/dL / >10.0 mmol/L) - % Time in Hypoglycemia (Level 2, 250 mg/dL / 15 mmol/L sustained for =15 minutes, confirmed by venous draw - Number of Critical Events: Any excursion beyond range sustained for >30 minutes - Participants with Recurrent Events: >2 adverse or >1 critical event per session - Glucose Rate of Change (RoC): During each challenge (mg/dL/min, 5-min moving average window) - Time to Recovery to TIR: Interval from start of deviation (non-euglycemic event) to first sustained TIR =30 minutes - Number of Algorithm Overrides or Alarms: Capturing safety-rail activations, system pauses, or manual interventions. Exploratory Outcomes - Event Detection and Prediction Accuracy: Accuracy, latency, and specificity of neoAP’s automated detection of unannounced meals and exercise events compared with timestamped ground truth. - Algorithmic Adaptation Metrics: Correlation between dosing deviations and baseline basal delivery, quantifying algorithm responsiveness and learning stability. | — |
Countries
Austria
Contacts
Public ContactJulia Mader
Medizinische Universität Graz
Outcome results
None listed