E14
Conditions
Interventions
Group 1: In this post-market clinical investigation, the performance of the DiaExpert Sensor continuous glucose monitoring (CGM) system will be evaluated compared to that of the established CGM system
Sponsors
Mediq Diabetes GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of type 1 or type 2 diabetes mellitus - An understanding of and willingness to follow the protocol - Signed informed consent
Exclusion criteria
Exclusion criteria: - Hypoglycemia unawareness - Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment - HbA1c > 10% - Severe acute or severe chronic illness (at the physician’s discretion) - Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives - Skin alteration at the insertion sites (e.g. severe psoriasis vulgaris, severe scarring, severe lipodystrophia, severe rash) - Intake of substances known to affect the performance of the investigational CGM system, i.e., hydroxyurea, acetaminophen, and nutritional supplementation of ascorbic acid (vitamin C) - Intake of anticoagulants, except for acetylsalicylic acid in doses up to 100 mg - Infection with hepatitis B virus, hepatitis C virus, human immuno-deficiency virus or other chronic infectious disease - Planned medical procedures during the clinical investigation that could affect the performance of the investigational CGM systems, including magnetic resonance imaging, computer tomography scan, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound - Wearing a cardiac pace maker or other comparable medical devices - Female participants: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy) - Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the clinical investigation procedures, e.g., mental or visual incapacity, language barriers, alcohol or drug misuse - Employee or immediate family member of an employee of the sponsor or the clinical investigation site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this clinical investigation is the percentage of DiaExpert CGM readings within ±20% of the venous reference measurements with the YSI 2300 STAT Plus Glucose Analyzer, in comparison to the corresponding percentages of FreeStyle Libre 3 and Dexcom G7. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Analytical point accuracy (aggregate and sensor-specific), including agreement rates and mean absolute relative differences ? Clinical point accuracy characterized by error grid analysis ? Agreement outside the CGM systems’ measuring range ? Trend accuracy ? Sensor stability, in terms of point accuracy over time ? Alert reliability in terms of true alert and detection rates for different hypo- and hyperglycemic thresholds ? Technical reliability in terms of sensor survival, sensor failure modes and data availability ? User satisfaction evaluated with a validated questionnaire ? Differences in CGM-derived glycemic metrics | — |
Countries
Germany
Contacts
Public ContactManuela Link
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Outcome results
None listed