NCT01093833

A Comparison Study of Prototype Continuous Glucose Sensors in the Intradermal and Subcutaneous Spaces

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare two continuous glucose sensors, one placed subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours.

Detailed description

This was a single site, non-randomized study. The study consisted of a screening visit (Visit 1), during which the subject was consented and the inclusion and exclusion criteria confirmed, an experimental intervention (Visit 2) and a follow-up visit (Visit 3). The experimental intervention was based on an initial glucose clamp involving a basal intravenous (IV) insulin infusion and IV insulin boluses plus IV glucose infusion / IV glucose boluses as required to maintain euglycemic, hypoglycemic and hyperglycemic plateaus respectively in 41 subjects with Type 1 or Type 2 Diabetes. At the end of hour five of the study the glucose clamp was discontinued and subjects given a standardized meal to stimulate a hyperglycemic excursion Each subject participated in one experimental intervention. During the glucose clamp intervention, the subject's blood glucose was continuously monitored either by means of the Biostator or by frequent venous blood glucose measurements based on a standard lab method (YSI STAT2300 analyzer), and measured by means of the BD Technologies test devices, and the Medtronic Guardian CGM. Once the clamp was discontinued the Biostator was discontinued as well. During the unclamped period and meal the subjects BG was monitored via the YSI Glucose Analyzer, the BD CGM sensor and the Medtronic Guardian CGM.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	BD Continuous glucose monitor (BD CGM)	Continuous glucose monitoring for 12-14 hours
DEVICE	YSI Glucose Analyzer	Continuous glucose monitoring for 12-14 hours
DEVICE	Medtronic Guardian CGM	Continuous glucose monitoring for 12-14 hours

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2010-03-26
• Last updated: 2016-05-06

Locations

1 site across 1 country: United States