Changes in Serum Electrolytes at Different Glucose Concentrations + Impact on a Non-invasive Glucose Monitoring Method
In healthy subjects: Continuous monitoring of the glucose concentration in the skin by means of a non-invasive glucose sensor during a glucose clamp when systematically changing the blood glucose concentration (e.g. to hyperglycemia). Simultaneous frequent determinations of serum electrolytes.
Device: Non-invasive CGMS
Procedure: Hyperglycemic glucose clamp
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Center, Open Study to Evaluate Changes in Serum Electrolytes at Different Glucose Concentrations and Their Impact on a Non-invasive Glucose Monitoring Method|
- plasma ion concentrations (sodium, potassium, chloride, calcium, magnesium) and osmolarity [ Time Frame: blood samples every 10 min during baseline, plateau hyperglycemic and final euglycemic phase, every 5 min during increase and decrease of blood glucose ] [ Designated as safety issue: No ]
- blood glucose concentration [ Time Frame: continuously during glucose clamp ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2001|
|Study Completion Date:||August 2002|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
Device: Non-invasive CGMS
Non-invasive continuous glucose monitoring is a promising approach in diabetes therapy. It is known that changes in glucose concentration in the skin can be registered by means of optical, spectroscopic measures in subjects with diabetes. The precision of such measures, however, so far has been unsatisfactory.
This study evaluates the changes in skin glucose concentration by means of a non-invasive glucose sensor and compares these to blood glucose concentrations during a glucose clamp. It is also known that with hyperglycemic blood glucose concentrations there is a consecutive hyponatraemia. This study shall evaluate to which extent and how fast serum electrolyte parameters change when establishing a hyperglycaemic blood glucose level. This shall help estimate which impact these changes in electrolytes have on the non-invasive glucose sensor.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058577
|Profil Institut für Stoffwechselforschung GmbH|
|Neuss, Germany, 41460|
|Principal Investigator:||Christoph Kapitza, MD||Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany|