NCT01727817

Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (Italy)

Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control to Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical research center.

Detailed description

The principal goal is to validate a smart phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger home-based trials of CTR.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Diabetes Assistant (DiAs)	A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-11-16
• Last updated: 2014-09-30

Locations

1 site across 1 country: Italy