Artificial Pancreas Control System in an Inpatient Setting
Condition: Type I Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Artificial Pancreas Control Software
Intervention type(s): Device
Intervention description(s): 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.
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucose sensors; artificial pancreas; Diabetes Mellitus