NCT01501032

Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes

Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise.

Detailed description

The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic artificial pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise. During the the visits, meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. Between-meal insulin dosing will be fully automated. Bolus confirmation by the physician/nurse will be requested by the closed loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.

Conditions

• Diabetes Type 1

Interventions

Type	Name	Description
DEVICE	MD-logic artificial pancreas system	The MD-logic artificial pancreas system is a closed loop control system using continuous glucose monitoring (CGM)and subcutaneous insulin pump infusion to mange glucose control in individuals with type 1 diabetes

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-12-29
• Last updated: 2015-03-19

Locations

1 site across 1 country: Israel