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Glucose Clamp Study to Prove Hypo- and Hyperglycemic Episodes Using a Non-invasive Glucose Monitoring Device

2014-08-27 03:16:14 | BioPortfolio

Summary

Continuous monitoring of the skin tissue glucose concentration on two different study days using glucose sensors that work on the principle of impedance spectroscopy, with systematic alteration of the blood glucose concentration using the glucose clamp technique in healthy subjects and subjects with type 1 diabetes. Simultaneous determination of electrolyte concentrations in the blood by taking frequent blood samples.

Description

A completely non-invasive continuous glucose monitoring device is considered as a major target of glucose sensor development. The aim of this study is to evaluate the performance of a non-invasive glucose sensor (wristwatch) under controlled conditions (glucose clamp) at hyperglycemia (study day 1) and at hypoglycemia (study day 2). Measurements of the non-invasive glucose monitoring device are compared to those obtained from a minimally invasive glucose monitoring device (GlucoDay, microdialysis principle). In addition, changes in blood electrolyte concentrations as well as their impact on the measurements of the non-invasive glucose sensor are evaluated.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Mellitus

Intervention

Non-invasive CGMS (continuous glucose monitoring system), Hyperglycemic and hypoglycemic glucose clamp, Non-invasive CGMS (GlucoDay)

Location

Profil Institut für Stoffwechselforschung GmbH
Neuss
Germany
41460

Status

Completed

Source

Profil Institut für Stoffwechselforschung GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:14-0400

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