E14
Conditions
Interventions
Group 1: In this clinical investigation every participant will wear during the participation period (14 x 24 h, 15 calendar days) in parallel one sensor each of a novel and an established CGM system.
Sponsors
Institut für Diabetes-Technologie Ulm GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of type 1 or type 2 diabetes mellitus 2. Age = 18 years, additional for participants with type 1 diabetes age =70 3. An understanding of and willingness to follow the protocol 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Known hypoglycemia unawareness 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment 3. HbA1c > 10% 4. Severe acute or severe chronic illness (at the physician’s discretion) 5. Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives 6. Skin alteration at the insertion sites (e.g. severe psoriasis vulgaris, severe scaring, severe lipodystrophia, severe rash) 7. Intake of substances known to affect the performance of the investigational CGM system, i.e., nutritional supplementation of ascorbic acid (vitamin C) 8. Intake of anticoagulants, except for acetylsalicylic acid in doses up to 100 mg 9. 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 10. Wearing a cardiac pace maker or other comparable medical devices 11. Female participants: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy) 12. 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 13. Financial dependence on the sponsor or the clinical investigation site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this clinical investigation is the percentage of CGM readings within ±20% of the reference measurements (20% agreement rate), in comparison to the corresponding percentages of an established system. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Accuracy - Stability - Alert reliability - Technical reliability - User satisfaction | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie Ulm GmbH
Outcome results
None listed