E14
Conditions
Interventions
Group 1: To collect data for optimization of the CareSens Neon‘s algorithm subjects (persons with type 1 diabetes) wear two investigational devices and one FreeStyle Libre 3 CGM system in parallel. Th
Sponsors
i-SENS, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with type 1 diabetes who have been using intensive insulin therapy for at least 3 months - Patients who voluntarily decided to participate in the study and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment 2. Hypoglycemia unawareness 3. Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy) 4. Known severe tape reactions or allergies 5. Skin alteration at the insertion sites (i.e. Psoriasis vulgaris, scars, lipodystrophia) 6. MRT, CT, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound needed during the course of the study. 7. Patients unwilling to abstain from use of nutritional supplements containing xylose 8. 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 9. 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 10. Dependency from the sponsor or the clinical investigator 11. HbA1c > 10%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collecting data with the CareSens Neon CGM-system for algorithm optimization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Various performance and accuracy parameters will be compared between CareSens Neon and FreeStyle Libre 3. User friendliness of CareSens Neon (assessment by questionnaire) | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed