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: 
      A single arm, single treatment study is proposed to assess the feasibility of the AP Platform
      (cell phone + Control to Range system) outside of a hospital based clinical research center.
    

Detailed description: 
      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). This
      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, 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 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
      subjects will be responsible for operating the CTR system with nursing and technicians
      available for additional support. A study physician and senior engineer will be on call.

      Five subjects each will be enrolled at University of Virginia and the University of
      California, Santa Barbara.
    

Intervention name(s): Outpatient Control-to-Range
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Ambulatory Artificial Pancreas
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas; Type 1 Diabetes Mellitus; Control-to-Range; Closed-Loop Control; Continuous Glucose Monitor