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

NCT01060917 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2010-02-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Non-invasive CGMS (continuous glucose monitoring system)

A non-invasive continuous glucose monitoring device measure was applied at the wrist and measure skin glucose as an indirect measure of blood glucose every 10 min.

PROCEDURE

Hyperglycemic and hypoglycemic glucose clamp

The automated glucose clamp technique was used to control glucose levels at baseline glycemia for 1h, hyperglycemia (300 mg/dL) for 1.5 h, and euglycemia (100 mg/dL) for another 1.5 h. A continuous somatostatin infusion was initiated after the 2 h run-in period to suppress endogenous insulin secretion. A glucose solution was infused to increase blood glucose towards the hyperglycemic target level. At the end of the hyperglycemic level the somatostatin infusion was stopped and blood glucose was controlled at the euglycemic target level. On a second study day a hypoglycemic clamp took place, where blood glucose after the run-in period of 2 h was lowered by means of intravenous insulin administration over a period of appr. 30 min to a hypoglycemic level of 45 mg/dL, where it was kept constant for appr. 30 min, after which blood glucose was raised to euglycemia (100 mg/dL) again by means of an intravenous glucose infusion and was kept there for 1.5 hours. .

DEVICE

Non-invasive CGMS (GlucoDay)

The minimally-invasive glucose sensor GlucoDay, was used as a control measure

Sponsors & Collaborators

  • Pendragon Medical AG Switzerland

    collaborator UNKNOWN

  • Profil Institut für Stoffwechselforschung GmbH

    lead INDUSTRY

Principal Investigators

  • Tim Heise, MD · Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2003-03-31
Completion
2003-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060917 on ClinicalTrials.gov