Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This clinical trial is a feasibility study to assess the performance of an Artificial
      Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with
      type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San
      Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System
      (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is
      controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety
      algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20
      adults subjects aged 21 to 65 years old.
    

Detailed description: 
      The study consists of an evaluation of the Artificial Pancreas device during a 24-hour
      closed-loop in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA).
      The 24-hour period includes:

        -  2 unannounced meals (evening dinner and breakfast);

        -  1 period of 30 minutes of exercise at 50% of the predicted heart rate reserve (HRR)
           preceded with a snack and followed by a snack 3 hours later (on Day 2);

        -  complete night from 12:00 am to 7:00 am; The subject will arrive at approximately 4:00
           pm to the CRC (clinical research center), the closed-loop will be initiated at
           approximately 4:30 pm that same day and continued until 4:30 pm the next day. A
           physician will be monitoring the patient with the artificial Pancreas (AP) device at all
           time.

      The proposed study will evaluate the performance of the AP device in predicting the fall and
      rise of glucose values and in regulating insulin delivery to mitigate extreme blood glucose
      variations during the following challenges:

        -  following unannounced meals,

        -  during a nocturnal period, and

        -  during a period of active exercise.

      The goal is to demonstrate that the AP device is able to maintain the subject blood glucose
      within a safe range at all times. One of the objectives of the study will be to measure the
      percent of time spent in the following zones:

        -  [80-140] mg/dL at all times unless described otherwise

        -  [80-140] mg/dL during the nocturnal period

        -  [70-180] mg/dL postprandial, for 5 hours following the unannounced meals

        -  [70-150] mg/dL during and for 3 hours following exercise It is anticipated that
           following the planned challenges, glucose value might increase temporarily beyond those
           ranges. These excursions will be reviewed and analyzed (value and duration) and the
           study will determine how the AP device mitigates those excursions and maintains glucose
           levels within a safe and acceptable range. The clinical study will also review any event
           that occur during the course of the 24-hour closed-loop: hypoglycemic events,
           hyperglycemic events, outside intervention, other Adverse Event, Serious Adverse Events,
           Unanticipated Adverse Device Effect, and device complaints for the commercial devices
           used. The safety of the patient will remain the primary goal. The goal of the AP device
           is to operate without outside intervention even when challenged by meals or exercise
           unless the outside intervention is requested by the Health Monitoring System (HMS).
    

Intervention name(s): Sansum Closed-Loop Artificial Pancreas; Insulin infusion pump; Continuous Glucose Monitor; zone-Model Predictive Control algorithm; Safety Health Monitoring System
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): The Sansum Closed-loop Artificial Pancreas Device is the infrastructure that allows communication between the insulin pump, the CGM, the zone-MPC, and the HMS.; The insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set.; The CGM, which is an approved device (P050012), measures interstitial glucose.; The zone-MPC predicts future glucose values, based on CGM data, to regulate blood glucose level by increasing, decreasing, or stopping insulin infusion via an insulin infusion pump.; The HMS predicts future glucose values, based on CGM data, to warn the Sansum Closed-loop Artificial Pancreas Device of values below 70 mg/dL.
Other intervention name(s): Sansum AP; CGM; zone-MPC; HMS
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: type 1 diabetes mellitus; closed-loop artificial pancreas