Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02705053 | At Home Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAs) System and Run-to-Run Adaptation | PHASE3 | COMPLETED | 32 | — | — | Feb 1, 2016 | Aug 1, 2016 | Oct 14, 2016 | 3 | United States |
The primary endpoint is change in HbA1c from baseline (end of week 2) to end of week 15 (end of study). HbA1c will be measured at weeks 7 and 11 as well following each adaptation period, so the overall design of the study includes 4 repeated measures and a baseline-end of study contrast.
| Arm | Type | Description |
|---|---|---|
| Sensor-Augmented Pump Open-Loop Care (Week 2) | ACTIVE_COMPARATOR | The subjects' Sensor-Augmented Pump Open-Loop Care for the second week of the study before any adjustments to pump settings, using a CGM and Insulin Pump. |
| Closed-Loop Control System with Zone MPC and HMS | EXPERIMENTAL | The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on CGM glucose levels. The Health Monitoring System algorithm uses the same CGM data as the MPC control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values. Using a redundant and independent algorithm is an important safety feature of the overall AP device. Algorithmic adjustment of carbohydrate ratios prior to closed-loop initiation, and continued basal rate and carbohydrate ratio algorithmic optimization during closed-loop use will occur. |
| Name | Type | Description |
|---|---|---|
| CGM and Insulin Pump | DEVICE | Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump. |
| Closed-Loop Control System | DEVICE | The devices that will be used in the Closed-Loop Control System include the following components: DiAs - a smart-phone medical platform; Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS) |
Inclusion Criteria: * Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year and an insulin pump for at least 6 months * Willing to wear the study CGM device for the duration of the study * Age ≥21 to \<65 years * HbA1c \...