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

Diabetes Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes

• NCT number: NCT01093833
• Study type: Interventional
• Source: Becton, Dickinson and Company
• Status: Completed
• Phase: Phase 1
• Start date: January 2009
• Completion date: April 2009