Outpatient Control-to-Range: System and Monitoring Testing
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can
      have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The
      investigators inter-institutional and international research team has been on the forefront
      of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006.
      Thus far, the investigators have conducted three closed-loop control clinical trials
      (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable
      "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during
      CLC compared to open loop. The investigators overall objective is to sequentially test,
      validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range
      (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a
      Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's
      continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also
      monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations
      or loss of sensitivity. The HMM will be responsible for the optimal regulation of
      postprandial hyperglycemic excursions through correction boluses.

      This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and
      (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who
      are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local
      hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for
      validation that remote system monitoring can successfully occur. During the study, study
      subject will be responsible for. operating the CTR system with nursing and technicians
      available
    

Detailed description: 
      I.A. PURPOSE/OBJECTIVES

        1. Primary objective The purpose of this pilot study is to test a closed-loop
           Control-to-Range (CTR) system in a semi-controlled environment and especially to
           evaluate if the system can accurately collect data coming from patient inputs, insulin
           pump, and continuous glucose monitoring (CGM) device with more than 80% of time of use.

        2. Secondary objectives

      This pilot study will use a Artificial Pancreas Platform (AP Platform) cell phone/phone-based
      system to test an outpatient controller and remote monitoring as follows:

        -  test that the CTR system can be remotely monitored by nurses/physicians/ technicians to
           confirm appropriate functioning outside of the hospital setting

        -  test that the CTR system can be deployed, with appropriate subject response, outside of
           the hospital setting

      I.B. STUDY DESIGN

      This study is an early feasibility pilot trial with the principal goal is to validate an
      initial outpatient ready CTR system and its remote-monitoring capability. Therefore, this is
      an unblinded pilot study and no control group will be used.
    

Intervention name(s): DiAs Diabetes Assistant Wearable Artificial Pancreas Platform
Intervention type(s): Device
Intervention description(s): Subjects will spend two nights in a non hospital setting while the Artificial Pancreas Device System is remotely monitored from an adjacent room. Artificial Pancreas Device System is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes mellitus; closed loop artificial pancreas