Feasibility Study of a Portable Artificial Pancreas System in Type 1 Diabetes Mellitus (T1DM) - Padova
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A single arm, single treatment study is proposed to assess the feasibility of a portable
      artificial pancreas system outside of a hospital based clinical research center.

      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous
      insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions
      (hotel).
    

Detailed description: 
      Automated closed-loop control (CLC), known as "artificial pancreas" (AP) can have tremendous
      impact on the health and lives of people with type 1 diabetes (T1D). Our inter-institutional
      and international research team has been on the forefront of CLC developments since the
      beginning of the Juvenile Diabetes Research Foundation (JDRF) Artificial Pancreas initiative
      in 2006. Thus far, we have conducted three closed-loop control clinical trials (totaling 60
      subjects with T1D), 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. Our 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 an automated
      Range Correction Module (RCM). 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 RCM will be responsible for the optimal regulation of postprandial
      hyperglycemic excursions through correction boluses.

      The first phase to address our overall objective is a pilot study that will test the ability
      of a cell-phone-based system to (1) run CTR in an outpatient setting, and (2) be remotely
      monitored. Specifically, this pilot study entails a hybrid hotel/hospital design targeting
      adults with T1D that are experienced insulin pump users. Subjects will spend one night in a
      local hotel, during which the phone-based system will be remotely monitored in an adjacent
      hotel room for validation that remote system monitoring can successfully occur. Subjects will
      spend the following day in the hospital, where CTR will be activated, and challenged with
      meals and a CGM sensor replacement . Subjects will then spend a second night in the hotel for
      continued evaluation of remote system monitoring, along with outpatient testing of the CTR
      system run on the phone-based system. This series of admissions will address the first major
      hurdles that need to be overcome for home deployment of a closed loop CTR system:

      Specific Aim 1: The phone-based CTR system can be remotely monitored by
      nurses/physicians/technicians to confirm appropriate functioning outside of the hospital
      setting.

      Specific Aim 2: The CTR can be deployed outside of the hospital setting.
    

Intervention name(s): Portable artificial pancreas system with Control-To-Range
Intervention type(s): Device
Intervention description(s): We will test the new portable Control-To-Range system in clinical research center conditions for 10 hours followed by 18 hours of Control-To-Range in a hotel.
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas; Insulin Pump; Continuous Glucose Monitor; Closed Loop