Diabetes Mellitus Type 1 Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
The study will use three marketed CGM systems (Animas Vibe [Animas Corp, USA and Dexcom Inc, USA], Abbott Navigator [Abbott Diabetes Care, USA] and the Medtronic Minimed Guardian/Paradigm system [Medt
which ones will be determined by randomization. Sensors will be worn until the end-of-life of the sensor. Patients will be asked to perform at least five fingersticks per day for blood glucose measure
Sponsors
Academic Medical Centre (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. Diagnosed with Type 1 diabetes mellitus (DM) at least 6 months according to the WHO definition 3. Body Mass Index (BMI) <35 kg/m² 4. Willing and able to wear a CGM device for the duration of the study and undergo all study procedures 5. HbA1c <10% 6. Signed informed consent form prior to study entry
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant or breastfeeding 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 3 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. Inability of the patient to comply with all study procedures 7. Inability of the patient to understand the patient information 8. Patient donated blood in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood glucose values 2. Sensor glucose values 3. 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 Yellow Springs Instruments (YSI) values during the CRC period and fingerstick values thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Accuracy of the sensor in the hypoglycaemic and hyperglycaemic area 2. Analysis to assess sensor performance and accuracy per day of sensor life, before and after approved time of use | — |
Countries
Austria, France, Germany, Italy, Netherlands
Outcome results
None listed