Outpatient Control-to-Range: System and Monitoring Testing

Summary

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). The investigators inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the 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 investigators 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 subject will be responsible for. operating the CTR system with nursing and technicians available

Conditions

• Type 1 Diabetes Mellitus

Interventions

DEVICE

DiAs Diabetes Assistant Wearable Artificial Pancreas Platform

Subjects will spend two nights in a non hospital setting while the Artificial Pancreas Device System is remotely monitored from an adjacent room. Artificial Pancreas Device System is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.

Sponsors & Collaborators

• University of California, Santa Barbara

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Sansum Diabetes Research Institute

  lead OTHER

Principal Investigators

• Howard Zisser, MD · Sansum Diabetes Research Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United States

Study Locations