NCT01291719

Insulin Balanced Infusion System

Insulin Balanced Infusion System Control of Glucose

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Admetsys Corporation · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery

Detailed description

The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm

Conditions

• Hyperglycemia
• Diabetes

Interventions

Type	Name	Description
DEVICE	glucose and insulin infusions	combined algorithm directed glucose and insulin infusion with 5 minute blood glucose measurements to direct glucose control; regular insulin and glucose are infused intravenously as adjusted by the algorithm without manual intervention in the group of diabetic individuals under study to adjust the glucose level to a target range of 80-180 mg/dl

Timeline

• Start date: 2008-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2011-02-08
• Last updated: 2024-07-30

Locations

1 site across 1 country: United States