NCT01874392

Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp

Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) and Technosphere® Insulin Inhalation System From MannnKind Corp.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin (Technosphere® Insulin Inhalation System by MannKind Corporation). The goal of this proposed study is to explore the feasibility of using multiple insulin delivery routes in order to mimic the physiology of both first- and second-phase insulin secretion. The intent is to exploit the rapid action achieved by inhaled insulin to compensate for part of the meals and utilize the conventional subcutaneous route for management of basal insulin and as second-phase meal-related insulin.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Investigational inhaled insulin (Technosphere)	by MannKind Corp. IND 61,729
DEVICE	Artificial Pancreas (AP) device (APS©)	Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-06-11
• Last updated: 2021-11-11
• Results posted: 2021-11-11

Locations

1 site across 1 country: United States