Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Bionic Pancreas With Automated Meal-priming Bolus | 132 | 3 |
| Bionic Pancreas Without Automated Meal-priming Bolus | 146 | 9 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataShort name CL2
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.
Experimental
Bi-hormonal with meal-priming bolus
The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal
Experimental
Bi-hormonal without meal-priming bolus
The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
Outcomes the sponsor listed as primary.
Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)
Time frame · 48 hours
Percentage of Time Spent With Blood Glucose < 60 mg/dl
Time frame · 48 hours
Percentage of Time Spent With Blood Glucose <70 mg/dl
Time frame · 48 hours
Percentage of Time Spent With Blood Glucose 70-180 mg/dl
Time frame · 48 hours
Insulin Total Daily Dose
Time frame · 48 hours
Number of Carbohydrate Interventions for Hypoglycemia
Time frame · 48 hours
Number of Blood Glucose Events < 70 mg/dl
Time frame · 48 hours
Nadir Blood Glucose in Each Arm
Time frame · 48 hours
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Bionic Pancreas With Automated Meal-priming Bolus | 132 | 3 |
| Bionic Pancreas Without Automated Meal-priming Bolus | 146 | 9 |
| Group | Value (percentage of total time) | Spread |
|---|---|---|
| Bionic Pancreas With Automated Meal-priming Bolus | 2.3 | 3.9 |
| Bionic Pancreas Without Automated Meal-priming Bolus | 1.4 | 2.7 |
| Group | Value (percentage of total time) | Spread |
|---|---|---|
| Bionic Pancreas With Automated Meal-priming Bolus | 5.1 | 6.7 |
| Bionic Pancreas Without Automated Meal-priming Bolus | 3.6 | 4.5 |
| Group | Value (percentage of total time) | Spread |
|---|---|---|
| Bionic Pancreas With Automated Meal-priming Bolus | 80 | 6 |
| Bionic Pancreas Without Automated Meal-priming Bolus | 70 | 9 |
| Group | Value (u/kg/day) | Spread |
|---|---|---|
| Bionic Pancreas With Automated Meal-priming Bolus | 0.6 | 0.2 |
| Bionic Pancreas Without Automated Meal-priming Bolus | 0.7 | 0.2 |
| Group | Value (Carbohydrate Interventions) |
|---|---|
| Bi-hormonal With Meal Priming Bolus | 12 |
| Bi-hormonal Without Meal Priming Bolus | 10 |
| Group | Value (Number of events) |
|---|---|
| Bi-hormonal With Meal Priming Bolus | 59 |
| Bi-hormonal Without Meal Priming Bolus | 48 |
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Bionic Pancreas With Automated Meal-priming Bolus | 65.9 | 17.4 |
| Bionic Pancreas Without Automated Meal-priming Bolus | 66.4 | 17.8 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Bi-hormonal With Meal Priming BolusBi-hormonal with adaptive meal priming bolus | 0 / 12 | 0 / 12 | 1 / 12 |
| Bi-hormonal Without Meal Priming BolusBi-hormonal with no meal announcements or meal priming boluses | 0 / 12 | 0 / 12 | 1 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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