Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth

1. Pediatric subjects ≥6 and < 18 years with Type 1 Diabetes

2. HbA1c < 11 % at Screening

3. Subject/legal guardian has signed an informed consent form before any study related activities and is willing to comply with protocol requirements

4. Clinically confirmed diagnosis of diabetes mellitus for ≥ 1 year

5. Pretreated with CSII or ICT with a minimum duration of 3 month

6. Patient and parents are physically and mental able to exercise as determined the "Eversense" System

7. Patient must be willing to document every diabetes relevant information (meals, carbs, physical activity, extraordinary stress,…)

8. Patient is willing to follow protocol and procedures for study

9. Patient has the possibility to use a smartphone which is compatible with the system in daily life

1. Patients are unwilling to follow the study procedures

2. Patient is absent for a longer time (no possibility for visits)

3. Patient is unable to tolerate tape adhesive in the area of sensor placement

4. Patient has any unresolved adverse skin condition in the area of sensor placement (e.g. atopic dermatitis, psoriasis, rash,…)

5. Patient is allergic to components of sensor material (Polymethylmethacrylate, dexamethasone, local anesthesia)

6. Eating disorder: e.g. bulimia, anorexia

7. Infections with hepatitis B, C or HIV

8. Coagulation disorder, wound healing disorder

9. Pregnancy

10. Mental incapacity or psychiatric disorders (Major Depression, anxiety disorders, schizophrenia)

11. Language barriers

12. Medication which is influencing metabolic control as systemic steroids, other non-Routine hormones

13. Medication influencing coagulation as Marcumar or systemic Xa-Antagonists as well as known bleeding disorders

14. People known to M. Addison

15. Untreated coeliac disease (Transglutaminase at screening elevated 2x>upper limit)

16. Severe diseases as cancer, heart failure, M. Parkinson, diabetic nephropathy or neuropathy or cardiomyopathy

17. Severe hypoglycemia in the past 3 months (defined as seizure or loss of consciousness)

18. Alcohol or drug abuse other than nicotine

19. Precluding adequate understanding or cooperation

20. A condition requiring or likely to require magnetic resonance imaging (MRI) during the study duration.

21. Any condition that in the investigator's opinion would make the subject unable to complete the study

22. Participation in another clinical investigation within 30 days or intent to participate during the study period

23. Patients with Diabetes mellitus Type 2.