NCT02127827

Multiday Fully Closed Loop Insulin Delivery in Monitored Outpatient Conditions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can approximate the insulin release patterns of the normal pancreas. Timely and accurate knowledge of ambient glucose levels is important for insulin dose adjustments. Typically, glucose values are measured volitionally, several times a day, using capillary "fingerstick" samples. In addition, glucose in the interstitial fluid can be measured automatically and continuously using implantable glucose oxidase-based sensors. Recent study showed that this continuous measurement of glucose levels allows for a fully automated "closed-loop" insulin replacement therapy which requires an algorithm that receives glucose data, calculates an appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for development of a closed-loop insulin replacement system that integrates insulin delivery, glucose measurement, and control subsystems will present several challenges to biomedical engineers.

Conditions

• To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days.
• To Assess Effectiveness in Maintaining Patients' Glucose Levels in the Target Range of 70 to 180 mg/dl, Measured by Blood Glucose Sensor.
• To Evaluate the User Experience With a Closed Loop System

Interventions

Type	Name	Description
DEVICE	Automated Ambulatory Glycemic Controller (AAGC)

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• First posted: 2014-05-01
• Last updated: 2014-05-01

Locations

1 site across 1 country: Israel