Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Use of Zone-Model Predictive Control (MPC) Controller on the Diabetes Assistant (DiAs) Platform With Fault Detection in Adolescents With Type 1 Diabetes in the Outpatient Setting (UCSB Study)
This clinical trial is designed to test the feasibility of a portable closed-loop artificial pancreas (AP) system using the Zone-Model Predictive Control (MPC) algorithm on the Diabetes Assistant (DiAs) platform in adolescents with type 1 diabetes. The system will also have additional fault detection algorithms designed to detect sensor failure as well as infusion set failure. The fault detection algorithms will be implemented via the remote monitoring software and clinical staff will be alerted to potential failures to assist with clinical care.
This clinical trial is designed to test the feasibility of a portable closed-loop artificial
pancreas (AP) system using the Zone-Model Predictive Control (MPC) algorithm on the Diabetes
Assistant (DiAs) platform. The system will also have additional fault detection algorithms
designed to detect sensor failure as well as infusion set failure. The fault detection
algorithms will be implemented via the remote monitoring software and clinical staff will be
alerted to potential failures to assist with clinical care. This information will not be
directly communicated to subjects to influence diabetes management in real-time.
The study is a safety and feasibility study to assess the performance of the AP device in a
fully supervised study of adolescents with type 1 diabetes over 72 hours. The study will
recruit up to 10 subjects, with up to 5 subjects at both Stanford University and University
of Colorado. Subjects will reside in a hotel setting where they will sleep overnight and
engage in mild to moderate intensity exercise at least twice daily, with clinical staff in
attendance at all times. Exercise will include activities such as soccer, basketball,
football or gym sessions. Subjects will choose the size, content and timing of their meals
to emulate free-living conditions. The primary objective is to ensure that the system is
feasible in glucose control in this cohort. Subjects will also wear a Dexcom G4P sensor at
home for 72h prior to the start of the hotel admission and this will serve as a control
period. This will generate up to 30 days of closed-loop data. Prior to proceeding to the
second phase, there will be a DSMB review of the data generated from this initial phase.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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