diabetes
Conditions
Interventions
The study will use three marketed CGM systems (Dexcom Seven Plus (Dexcom, USA),
Abbott Navigator (Abbott Diabetes Care, USA) and the Medtronic Minimed Guardian
/ Paradigm system (Medtronic, USA)). A
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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)
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters will include blood glucose values, sensor glucose values and duration of sensor life. From the sensor glucose values the Mean and Median Absolute Relative Difference (MARD) compared to blood glucose values will be determined. Blood glucose values will consist of YSI values during the CRC period and fingerstick values thereafter. A separate analysis will be performed on the accuracy of the sensor in the hypoglycaemic (defined as a blood glucose value *3.9 mmol/L) and hyperglycaemic area (defined as a blood glucose value *10.0 mmol/L). | — |
Secondary
| Measure | Time frame |
|---|---|
| A separate analysis will be performed to assess sensor performance and accuracy per day of sensor life, before and after approved time of use. | — |
Countries
Netherlands
Outcome results
None listed