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

Profil Institut für Stoffwechselforschung

Status and phase

Completed

Phase 2

Phase 1

Conditions

Diabetes Mellitus

Treatments

Device: Non-invasive CGMS (GlucoDay)

Device: Non-invasive CGMS (continuous glucose monitoring system)

Procedure: Hyperglycemic and hypoglycemic glucose clamp

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01060917

06/0097-Study 4

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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