Mean Percent of Time in Target Blood Glucose Range
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Artificial Pancreas Control | 62.4 | 7.0 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataThis trial does not test a peptide that PepBank tracks.
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 purpose of this study is to verify an automated system of blood glucose control in Type I Diabetics. The automated system consists of the investigational Artificial Pancreas Control software (APC), two blood glucose sensors, and two hormone pumps, one for delivering insulin to lower blood sugar, and the second for delivering glucagon to raise blood sugar. The blood glucose sensors relays information to the Artificial Pancreas software, which uses the Adaptive Proportional Device algorithm to determine the rate of insulin and glucagon infusion by the hormone pumps. In prior studies, the Adaptive Proportional Device algorithm has been verified, but required manual input into the computer and hormone pumps. This study differs in that it uses a fully automated system under the control of the Artificial Pancreas Control software. The importance of this change is that it is the next step to enable outpatient use of automated, closed loop blood glucose control.
Experimental
Artificial Pancreas Control
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Outcomes the sponsor listed as primary.
Mean Percent of Time in Target Blood Glucose Range
Time frame · all 28 hour studies
Mean percent of time venous blood glucose was sampled between 70-180 mg/dl
Mean Deviation From Target Blood Glucose
Time frame · all 28 hour studies
Mean difference of venous blood glucose from glucose target. Daytime venous blood glucose values (7am-11pm) subtracted from daytime target of 115 mg/dl. Nighttime venous blood glucose values (11pm-7am) subtracted from nighttime target of 140 mg/dl. This is a metric of how successful the closed loop algorithm was at controlling glucose.
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 |
|---|---|---|
| Artificial Pancreas Control | 62.4 | 7.0 |
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Artificial Pancreas Control | 59.9 | 51.6 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Artificial Pancreas ControlType 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose. Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm. | – | 0 / 14 | 1 / 14 |
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