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

This study has been completed.
Sponsor:
Collaborator:
Pendragon Medical AG Switzerland
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT01060917
First received: February 1, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Device: Non-invasive CGMS (continuous glucose monitoring system)
Procedure: Hyperglycemic and hypoglycemic glucose clamp
Device: Non-invasive CGMS (GlucoDay)
Phase 1
Phase 2

Study Type: Interventional
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 in Order to Prove Hypo- and Hyperglycaemic Episodes Using a Non-invasive Glucose Measuring Method in Healthy Volunteers and in Type 1 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • skin tissue glucose concentration [ Time Frame: continuously during the glucose clamp ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: January 2003
Study Completion Date: May 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060917

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Pendragon Medical AG Switzerland
Investigators
Principal Investigator: Tim Heise, MD Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
  More Information

No publications provided by Profil Institut für Stoffwechselforschung GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tim Heise, MD, Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01060917     History of Changes
Other Study ID Numbers: 06/0097-Study 4
Study First Received: February 1, 2010
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014