Collection of continuous glucose monitoring and reference glucose values to develop and test algorithms for a continuous glucose monitor

Academic Medical Centre (Netherlands)0 sites12 target enrollmentOctober 25, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 25, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Observational

Sex

All

Sponsor

Academic Medical Centre (Netherlands)

•1\. Aged 18 years or above
•2\. Diagnosed with Type 1 diabetes mellitus at least 6 months according to the WHO definition
•3\. Body Mass Index (BMI) \<35 kg/m²
•4\. Willing to wear a Continuous Glucose Monitoring (CGM) device for the duration of the seven study days and undergo all study procedures
•5\. HbA1c \<10%
•6\. If patient is on antihypertensive, thyroid, anti\-depressant or lipid lowering medication, patient must have stability on the medication for at least 1 month prior to enrolment in the study and for the study duration
•7\. Signed informed consent form prior to study entry

•1\. Patient is pregnant, or breast feeding during the period of the study
•2\. 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
•3\. 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
•4\. Patient is actively enrolled in another clinical trial or took part in a study within 30 days
•5\. Known adrenal gland problem, pancreatic tumour, or insulinoma
•6\. Retinopathy except background retinopathy according to eye fundus examination during the last year
•7\. Known bleeding diathesis or dyscrasia
•8\. Inability of the patient to comply with all study procedures
•9\. Inability of the patient to understand the patient information
•10\. Patient donated blood in the last 3 months