NCT01714505

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (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. 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.

Detailed description

The overall objective of this project is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system for optimal blood glucose (BG) regulation in people with type 1 diabetes. The CTR system is comprised of two algorithmic layers: a Safety Supervision Module (SSM) and Insulin on Board Tracking and Safety Module (ITSM), and an automated Range Correction Module (RCM). Both modules will receive continuous glucose monitoring (CGM) and insulin delivery data. The SSM and ITSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia. The RCM will be responsible for optimizing BG control and mitigating postprandial hyperglycemic excursions through series of insulin boluses. To run CTR, we will use our wearable artificial pancreas platform, known as DiAs (Diabetes Assistant), which consists of a smart phone running CTR and connected to standard insulin delivery and CGM devices.

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: 2012-10-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-10-26
• Last updated: 2014-09-09
• Results posted: 2014-09-09

Locations

2 sites across 1 country: United States