NCT01552603

Artificial Pancreas Control System in an Inpatient Setting

Sensor-controlled Insulin- and Glucagon Delivery in Subjects With Type 1 Diabetes: Testing of an Automated System in a Supervised Inpatient Setting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Legacy Health System · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The objective of the current human study is to verify the components of the Artificial Pancreas Control system during an inpatient study. This master controller software is designed to be used in conjunction with two subcutaneous continuous glucose monitoring systems to regulate blood glucose levels as well as two Omnipod pumps, one for administering insulin and one for administering glucagon. The sensors communicate wirelessly with two sensor receivers which will be interfaced with the APC by wireless USB connection. The insulin and glucagon pumps will be controlled by the APC through a wireless USB connection. The algorithm included in the APC is an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm, which was previously studied as an investigational device. The APD has been studied in vivo (in 28 experiments, each 33 hr in length, with manual adjustment of pumps) and no serious adverse effects were noted. Manual input of the glucose sensor data and insulin/glucagon infusion rates will no longer be necessary. The APC will be tested in vivo during 28 hour experiments in an inpatient setting in preparation for outpatient testing.

Conditions

• Type I Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-03-13
• Last updated: 2016-06-03
• Results posted: 2014-09-17

Locations

2 sites across 1 country: United States