NCT01770561

Feasibility Study of an Integrated Sensor and Infusion Set

Feasibility Study to Assess Performance of an Integrated Sensor and Infusion Set. TRIAL II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Medtronic Diabetes R&D Denmark · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect performance data on the integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the Integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy.

Detailed description

Sensor clinical accuracy will be evaluated based on the following parameters: Mean ARD (absolute relative difference), median ARD, Clarke Grid Analysis. Meter BG values will be used as reference. Descriptive statistics will be used to assess non-inferiority of the Integrated sensor and infusion sets sensors compare to control Enlite sensors. Insulin delivery functionality will be evaluated based on BG profiles obtained during peri-prandial periods during which BG measurements will be performed at 15, 20, 30 min intervals according to a SMBG schedule. Post-prandial pharmacodynamic profiles will be analyzed to demonstrate the effect of insulin delivered using the Integrated sensor and infusion set. Specifically, rise in glucose levels followed by their fall will be used as an indication that insulin was delivered and absorbed. Post-prandial BG areas under the curve (AUC), Tmax (time to maximum rise of BG), and Cmax (maximum post-prandial BG) values will be calculated for each meal (breakfast, lunch, and dinner) consumed during both inpatient days and compared. Intra - and inter-subject mean values and standard deviations will be calculated. Paired and unpaired T-tests will be used to evaluate statistical significance. Longevity of device performance will be assessed by comparing the listed parameters obtained during two inpatient days.

Conditions

• Diabetes Type 1

Interventions

Type	Name	Description
DEVICE	Integrated sensor and infusion set.	Change patients from current devices to the Integrated sensor and infusion set.

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-01-18
• Last updated: 2013-02-05

Locations

1 site across 1 country: Denmark