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

Summary: 
      The objectives of this outpatient research study are (1) to assess the ability of this
      automated system to be operated by a subject with limited professional oversight; (2) to
      assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump
      controller) will reduce the frequency of hardware and data communication lapses seen in the
      previous system; and (3) to measure the degree of glucose control achievable with this
      automated system. The system will adjust blood glucose by administering insulin and glucagon.
      Insulin is a hormone that lowers blood glucose and will be given nearly continuously during
      this study. Glucagon raises blood glucose and will be automatically administered during
      hypoglycemia. Both are natural hormones made by people without diabetes. Each subject will
      have four devices placed on his abdomen: two Omnipod insulin pumps, one for delivering
      insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors for measuring
      glucose. The two sensors will feed glucose data into Motorola smart phone master controller,
      which will calculate the correct amount of insulin or glucagon to deliver. The system will
      then send the command to the correct Omnipod through the iDex pod controller.

      In this new system, the research subject will be able to monitor the progress of the study by
      use of the smart phone graphical user interface. The subject will have a companion with
      him/her during the entire study for safety purposes. Both the subject and companion will
      complete a training course on how to treat diabetic emergencies and how to operate the
      system. A study physician and technician will be in the hotel during each study and will be
      monitoring the study via a cloud-based data communication system. These studies will be
      carried out in a hotel setting.
    

Detailed description: 
      The objective of the current human study is to verify the components of the Artificial
      Pancreas Control Software during an outpatient 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 Automated APD has been studied in vivo (in 13 experiments, each
      28 hr in length, with automated adjustment of pumps) and no serious adverse effects were
      noted. The APC will be tested in vivo during 28 hour experiments in an outpatient setting in
      preparation for home 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 outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment