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

February 1, 2010 updated by: Profil Institut für Stoffwechselforschung GmbH

A Single Center, Open Study in Order to Prove Hypo- and Hyperglycaemic Episodes Using a Non-invasive Glucose Measuring Method in Healthy Volunteers and in Type 1 Diabetic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy male and female volunteers:

  • Written informed consent
  • Aged between 18 and 40 years
  • Body mass index between 18 and 28 kg/m²
  • Haemoglobin > 13 g%

Male and female patients with type 1 diabetes:

  • Known type 1 diabetes, first manifestation 6 months to 15 years before the start of the study
  • HbA1c <= 9%
  • Written informed consent
  • Aged between 18 and 40 years
  • Body mass index between 18 and 28 kg/m²
  • Haemoglobin > 13 g%

Exclusion Criteria:

  • Uncontrolled arterial hypertension (diastolic blood pressure >100 mmHg and/or systolic blood pressure > 180 mmHg)
  • For women, pregnancy or breast-feeding or, for sexually active women of child-bearing age, the use of contraceptive methods considered to be safe (oral contraceptives, IUD, implanted or injected contraceptives, diaphragms, or surgical sterilisation of the patient or her partner)
  • Deviations in the lab values (excluding HbA1c), as judged by the investigator to be clinically significant, in particular an increase in transaminases to a level that is two and a half times higher than the upper normal value and a creatinine value that is above the normal range
  • Severe acute diseases, as judged by the investigator
  • Severe chronic disease, as judged by the investigator
  • History of macrovascular illnesses such as pAVK, myocardial infarction
  • Known microvascular (diabetic) complications (other than diabetic background retinopathy)
  • Positive serology for hepatitis B, hepatitis C or HIV
  • Blood donation within 3 months prior to the start of the study and intention of donating blood within 3 months after the end of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
skin tissue glucose concentration
Time Frame: continuously during the glucose clamp
continuously during the glucose clamp

Secondary Outcome Measures

Outcome Measure
Time Frame
serum and urine electrolyte concentrations (sodium, potassium, chloride, calcium, magnesium, urea, osmolarity, pH, lactate, p(O2), standard bicarbonate, p(CO2), blood glucose concentration
Time Frame: at 5 min intervals between the individual plateau phases, at 10 min intervals during the plateau phases (of the blood glucose concentration)
at 5 min intervals between the individual plateau phases, at 10 min intervals during the plateau phases (of the blood glucose concentration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Collaborators

Pendragon Medical AG Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/0097-Study 4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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