E14
Conditions
Interventions
Group 1: Persons with type 1 diabetes: To compare the performance and accuracy of the devices, subjects wear 3 systems for continuous glucose monitoring in parallel (1 investigational system, 2 compar
Sponsors
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of type 1 diabetes mellitus for at least one year - HbA1c < 10% - An understanding of and willingness to follow the protocol / study procedures - Signed informed consent
Exclusion criteria
Exclusion criteria: - Hypoglycemia unawareness - A severe hypoglycemia within the last three months - Severe acute or severe chronic illness (at the physician’s discretion) - Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy) - Known severe skin reactions or allergies to medical adhesives, allergic contact dermatitis - Abnormal skin at the systems application sites (e.g. (severe) psoriasis, recent burn injury, (severe) eczema, (severe) scar, extensive tattoo, (severe) rash, (severe) lipodystrophy, etc.) - History of frequent catheter abscesses associated with pump therapy - Use or intake of medications containing ascorbic acid (vitamin C), salicylic acid (> 100 mg per day), icodextrine or maltose and substances, which can result in icodextrine or maltose present in blood (dialysis solutions, antibody medications etc.) - X-ray, MRT, CT, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound needed during the course of the study - Infection with HBV, HCV, HIV or other chronic infectious disease - Wearing a cardiac pace maker or other comparable medical devices - 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, alcohol or drug misuse, cognitive impairment, tremor - Not able to understand, write and read German - Incapacity to grant consent - Dependency from the sponsor or the clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| System measurement performance will be measured for the FiberSense CGM system and will be analyzed using the mean of the duplicate SMBG measurements as reference. - MARD (mean absolute relative difference) of complete sensor experiments of the systems versus blood glucose monitoring system (all data) | — |
Secondary
| Measure | Time frame |
|---|---|
| - MARD stratified by day - MARD of each comparator device versus blood glucose monitoring system (all data) - System accuracy of the blood glucose meter (Contour Next One) versus laboratory analyzer - Consensus error grid analysis for the systems versus blood glucose monitoring system (all BG data) - Evaluation of user questionnaire | — |
Countries
Germany
Contacts
Public ContactManuela Link
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed