Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Bihormonal iLet Bionic Pancreas | 89.2 | 6.4 |
| Insulin-Only iLet Bionic Pancreas | 91.0 | 6.4 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.
Experimental
Bihormonal iLet first, then Insulin-Only iLet
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.
Experimental
Insulin-Only iLet first, then Bihormonal iLet
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.
Outcomes the sponsor listed as primary.
Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas
Time frame · Days 1-7
Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.
Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available
Time frame · Days 1-7
Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.
The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon
Time frame · Days 1-7
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.
Proportion of Time With CGM Glucose < 54 mg/dl
Time frame · Days 2-7
Mean Continuous Glucose Monitor Glucose Concentration
Time frame · Days 2-7
Mean continuous glucose monitor glucose concentration measured days 2-7
Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl
Time frame · Days 2-7
Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)
Time frame · Days 1-7
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Bihormonal iLet Bionic Pancreas | 89.2 | 6.4 |
| Insulin-Only iLet Bionic Pancreas | 91.0 | 6.4 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Bihormonal iLet Bionic Pancreas | 99.1 | 1.3 |
| Insulin-Only iLet Bionic Pancreas | 99.7 | 0.20 |
| Group | Value (ratio of dose delivered:dose attempted) | Spread |
|---|---|---|
| Bihormonal iLet Bionic Pancreas | 0.999 | 0.006 |
| Insulin-Only iLet Bionic Pancreas | 1.002 | 0.004 |
| Group | Value (proportion of time) |
|---|---|
| Bihormonal iLet Bionic Pancreas | 0.2 |
| Insulin-Only iLet Bionic Pancreas | 0.6 |
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Bihormonal iLet Bionic Pancreas | 139 | 11 |
| Insulin-Only iLet Bionic Pancreas | 149 | 13 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Bihormonal iLet Bionic Pancreas | 79 | 9 |
| Insulin-Only iLet Bionic Pancreas | 71 | 8 |
| Group | Value (grams of carbs per day) | Spread |
|---|---|---|
| Bihormonal iLet Bionic Pancreas | 18 | 21 |
| Insulin-Only iLet Bionic Pancreas | 16 | 13 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Bihormonal iLet Bionic PancreasEach arm 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 glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas. Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas | 0 / 10 | 0 / 10 | 4 / 10 |
| Insulin-Only iLet Bionic PancreasEach arm 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 glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas. Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin | 0 / 10 | 0 / 10 | 3 / 10 |
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