Outpatient Control-to-Range: System and Monitoring Testing

Type 1 Diabetes Mellitus Clinical Trial

Official title: Systems Approach to Closed-Loop Control of Type 1 Diabetes at Home

Status Completed

Clinical Trial 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

Clinical Trial Description

I.A. PURPOSE/OBJECTIVES

1. Primary objective The purpose of this pilot study is to test a closed-loop Control-to-Range (CTR) system in a semi-controlled environment and especially to evaluate if the system can accurately collect data coming from patient inputs, insulin pump, and continuous glucose monitoring (CGM) device with more than 80% of time of use.

2. Secondary objectives

This pilot study will use a Artificial Pancreas Platform (AP Platform) cell phone/phone-based system to test an outpatient controller and remote monitoring as follows:

• test that the CTR system can be remotely monitored by nurses/physicians/ technicians to confirm appropriate functioning outside of the hospital setting

• test that the CTR system can be deployed, with appropriate subject response, outside of the hospital setting

I.B. STUDY DESIGN

This study is an early feasibility pilot trial with the principal goal is to validate an initial outpatient ready CTR system and its remote-monitoring capability. Therefore, this is an unblinded pilot study and no control group will be used. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT01697150
• Study type: Interventional
• Source: William Sansum Diabetes Center
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Completion date: December 2015