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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03840278 | The Bihormonal iLet Bionic Pancreas Feasibility Study | PHASE2 | COMPLETED | 12 | — | — | May 15, 2019 | Jul 3, 2019 | Dec 16, 2019 | 1 | United States |
Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.
Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.
Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.
| Arm | Type | Description |
|---|---|---|
| Bihormonal iLet first, then Insulin-Only iLet | EXPERIMENTAL | Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week. |
| Insulin-Only iLet first, then Bihormonal iLet | EXPERIMENTAL | Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week. |
| Name | Type | Description |
|---|---|---|
| Bihormonal iLet Bionic Pancreas | DEVICE | Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon |
| Insulin-only Bionic Pancreas | DEVICE | Insulin-only iLet Bionic Pancreas using just insulin |
| Dasiglucagon | DRUG | Experimental stable glucagon for use in the iLet Bionic Pancreas |
Inclusion Criteria: 1. Age ≥ 18 years and have had clinical type 1 diabetes for at least one year 2. Diabetes managed using an insulin pump for ≥ 3 months 3. Prescription medication regimen stable for \> 1 month (except for medications that will not affect the safety of the participant and are not ...