Artificial Pancreas Control System in an Inpatient Setting
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.
Type I Diabetes Mellitus
Device: Artificial Pancreas Control Software
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sensor-controlled Insulin- and Glucagon Delivery in Subjects With Type 1 Diabetes: Testing of an Automated System in a Supervised Inpatient Setting|
- Verification of the Automation and Telemetry Components [ Time Frame: all 28 hour studies ] [ Designated as safety issue: Yes ]This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. This will be accomplished by assigning each lapse a grade from 0-6 based on: 1) the type of lapse (insulin or glucagon), and 2) the amount of time of the lapse.
- Deviation from Target Blood Glucose [ Time Frame: all 28 hour studies ] [ Designated as safety issue: Yes ]Assessment of how accurately the algorithm controls glycemia in the subjects will be carried out using mean BG (mg/dL). Metric will be compared for awake vs sleep hours.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552603
|United States, Oregon|
|Legacy Good Samaritan Hospital|
|Portland, Oregon, United States, 97210|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||W K Ward, MD||Legacy Health Research|