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 efficacy 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 efficacy 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 designed to test efficacy of the AP device in adolescents with type 1 diabetes
under outpatient conditions. For this phase, we will recruit up to 20 subjects, 10 at
Stanford and 10 at Denver. At each site, 5 subjects will be randomized to closed-loop
control and 5 subjects will be randomized to sensor-augmented pump therapy. Subjects in both
groups will be studied for 5 days/5 nights. Subjects will reside in a hotel/camp setting
where they will sleep overnight and engage in mild to moderate intensity exercise during the
day. Subjects will be fully supervised with clinical staff in attendance at all times. There
will be at least twice daily exercise. Subjects will choose their own meals and perform
their own carbohydrate counting for pre-meal insulin delivery. This second phase will
generate 50 days of closed-loop data to compare with 50 days of sensor-augmented pump
therapy.
The primary outcome for the second phase of the study will be to determine the efficacy of
the system, as assessed by the percentage of time spent in range for sensor glucose values
between 70-180 mg/dL, for closed-loop control compared to sensor-augmented pump therapy.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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