Comparison of the Measurement Performance of POCTech CT-100B System, Dexcom G5® Mobile Continuous Glucose Monitoring System and Abbott FreeStyle® Libre System
- Conditions
- E10Type 1 diabetes mellitus
- Registration Number
- DRKS00023538
- Lead Sponsor
- Ascensia Diabetes Care Holdings AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
• Clinical diagnosis of type 1 diabetes for at least one year
• Age 18-70 years
• An understanding of and willingness to follow the protocol and sign the informed consent
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
• Hypoglycemia unawareness
• Results of screening of laboratory blood values are in the opinion of the investigator not acceptable and the safety of the patient or study personnel is impaired
• Female subjects: pregnancy, lactation period, lack of a negative
• pregnancy test (except in case of menopause, sterilization or hysterectomy)
• Intake of Paracetamol / Acetaminophen needed
• Known severe tape reactions or allergies
• History of frequent catheter abscesses associated with pump therapy
• BMI < 20 kg/m²
• Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
• Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, language barriers, alcohol or drug misuse
• Dependency from the sponsor or the clinical investigator
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CGM measurement performance will be measured for each of the CGM systems and will be analyzed using Self-Monitored Blood Glucose (SMBG) measurements as reference. During dynamic days venous YSI measurements will be used as reference in additional.<br>• MARD (mean absolute relative difference) complete sensor experiments of the CGM Systems versus blood glucose monitoring system<br>• MARD (mean absolute relative difference) sensor experiments of the CGM Systems during dynamic phase versus venous YSI measurements<br>The evaluated MARD will be compared between different system models.
- Secondary Outcome Measures
Name Time Method • PARD (precision absolute relative difference) between the 2 POCTech CT-100B sensors in one subject<br>• Time in range (TIR):<br>• Mean glucose