Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to see if an automated insulin management system ("study
      system") can safely be used at home to manage blood sugar. The study system includes (1) a
      CGM that measures glucose levels, (2) a computer program on a smartphone that determines how
      much insulin is needed and allows the study participant user to control the whole system, and
      (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be
      from Roche. The CGM and pump are similar to the devices that are currently available for
      people to purchase and use. However, the smartphone device, the CGM sensor type used with it,
      and the overall study system can only be used for research at this time.

      The study will be completed by about 24 individuals at 6 centers in the United States and
      Europe. This study has several phases and will take about 11-14 weeks to complete depending
      on whether the study participant is a CGM user or not.

      At selected sites (based on subject eligibility and availability), approximately 10-20
      subjects who exhibit safe and competent use of the system at home will be given the option to
      continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.
    

Detailed description: 
      The study phases are as follows:

        -  Screening visit to see if you are eligible for the study and to determine how long you
           will need to use the study CGM (visit 1)

        -  Up to 3 weeks using the study CGM (depends on your current CGM use), followed by an
           office visit (visit 2)

        -  2 weeks using the study insulin pump and study CGM together

        -  Full day visit in clinic or hotel for training using the system (visit 3)

        -  1 week using the system without automated insulin delivery or suspension

        -  2-day hotel or clinic visit for closed-loop training (visit 4),

        -  16-19 days using the system in the evening and overnight only followed by an office
           visit (visit 5)

        -  16-19 days using the system for the full 24 hours

        -  Final study clinic visit (visit 6)

        -  Option 5 month extension phase of day-and-night closed-loop home use
    

Intervention name(s): Closed-Loop Control System; Sensor-Augmented Pump (SAP)
Intervention type(s): Device; Device
Intervention description(s): This investigational device system included the following components:
DiAs - a smart-phone medical platform;
Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class; This commercial device system included the following components:
Dexcom G4 Platinum CGM system;
Roche Accu-Chek insulin pump
Other intervention name(s): Diabetes Assistant (DiAs)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas