Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Dec 14, 2012

Keywords

ClinConnect Summary

The study will use two CE marked Continuous Glucose Monitoring (CGM) systems; Dexcom G4 Platinum CGM CE-marked 2012 (Dexcom, USA) and the Medtronic Paradigm Veo system with Enlite Sensor CE-marked 2011 (Medtronic, USA). Both the Dexcom G4 Platinum and the Medtronic Enlite sensors will be obtained through normal commercial channels rather than directly from the manufacturer. The two CGM sensors will be worn concomitantly by the participant during the visit to the Clinical Research Center (CRC). This visit will have a duration of 6 hours. Blood will be drawn for the determination of glucose l...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • aged 18 years or above
• • diagnosed with Type 1 diabetes mellitus at least 6 months according to the WHO definition
• • Body Mass Index (BMI) \<35 kg/m²
• • willing and able to wear a CGM device for the duration of the study and undergo all study procedures
• • HbA1c \<10%
• • signed informed consent form prior to study entry
• Exclusion Criteria:
• • Patient is pregnant, or breast feeding during the period of the study.
• • Patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
• • Patient may not use acetaminophen (paracetamol) while participating in the study
• • Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
• • Patient is actively enrolled in another clinical trial or took part in a study within 30 days
• • Known adrenal gland problem, pancreatic tumour, or insulinoma
• • Inability of the patient to comply with all study procedures
• • Inability of the patient to understand the patient information.
• • Patient donated blood in the last 3 months