NCT02137512

Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time. The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not. At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.

Detailed description

The study phases are as follows: * Screening visit to see if you are eligible for the study and to determine how long you will need to use the study CGM (visit 1) * Up to 3 weeks using the study CGM (depends on your current CGM use), followed by an office visit (visit 2) * 2 weeks using the study insulin pump and study CGM together * Full day visit in clinic or hotel for training using the system (visit 3) * 1 week using the system without automated insulin delivery or suspension * 2-day hotel or clinic visit for closed-loop training (visit 4), * 16-19 days using the system in the evening and overnight only followed by an office visit (visit 5) * 16-19 days using the system for the full 24 hours * Final study clinic visit (visit 6) * Option 5 month extension phase of day-and-night closed-loop home use

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Closed-Loop Control System	This investigational device system included the following components: * DiAs - a smart-phone medical platform; * Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; * Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; * Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network * Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
DEVICE	Sensor-Augmented Pump (SAP)	This commercial device system included the following components: * Dexcom G4 Platinum CGM system; * Roche Accu-Chek insulin pump

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-05-13
• Last updated: 2018-10-29
• Results posted: 2016-10-19

Locations

6 sites across 4 countries: United States, France, Israel, Italy