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

NCT01060917 | Completed Phase 1

• 1 other identifier: 06/0097-Study 4
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

• skin tissue glucose concentration

  continuously during the glucose clamp

Secondary Outcomes (1)

• serum and urine electrolyte concentrations (sodium, potassium, chloride, calcium, magnesium, urea, osmolarity, pH, lactate, p(O2), standard bicarbonate, p(CO2), 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)

Interventions

Non-invasive CGMS (continuous glucose monitoring system) DEVICE

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.

Hyperglycemic and hypoglycemic glucose clamp PROCEDURE

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. .

Non-invasive CGMS (GlucoDay) DEVICE

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead
• Pendragon Medical AG Switzerland: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

• Caduff A, Lutz HU, Heinemann L, Di Benedetto G, Talary MS, Theander S. Dynamics of blood electrolytes in repeated hyper- and/or hypoglycaemic events in patients with type 1 diabetes. Diabetologia. 2011 Oct;54(10):2678-89. doi: 10.1007/s00125-011-2210-9. Epub 2011 Jun 15.

  PMID: 21674178 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Tim Heise, MD

  Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 2, 2010
• Study Start: January 1, 2003
• Primary Completion: March 1, 2003
• Study Completion: May 1, 2003
• Last Updated: February 2, 2010

Record last verified: 2010-01

Locations

DE (1)