E10
Conditions
Interventions
Group 1: To compare the accuracy, safety and usability of the devices subjects wear three systems for continuous glucose monitoring in parallel. The experimental phase (7x24 h, 8 calendar days) includ
Sponsors
Ascensia Diabetes Care Holdings AG
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. • MARD (mean absolute relative difference) complete sensor experiments of the CGM Systems versus blood glucose monitoring system • MARD (mean absolute relative difference) sensor experiments of the CGM Systems during dynamic phase versus venous YSI measurements The evaluated MARD will be compared between different system models. | — |
Secondary
| Measure | Time frame |
|---|---|
| • PARD (precision absolute relative difference) between the 2 POCTech CT-100B sensors in one subject • Time in range (TIR): • Mean glucose | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed