Feasibility Study of a Transdermal Continuous Glucose Monitoring (CGM) System in Diabetic Patients

Inclusion Criteria:

1. Male or female age ≥ 18 and < 65 years old.

2. Diabetes mellitus type I requiring insulin in the management of glucose control forat least one year prior to enrollment.

3. Women who are not pregnant, lactating or planning a pregnancy during theirparticipation in the clinical study. If of child bearing potential, the patient mustagree to abstain from sexual intercourse or use reliable forms of contraception (e.g. condom or diaphragm with spermicide or oral contraceptives) to preventpregnancy for the length of the clinical study.

4. Willingness, ability and commitment to comply with the testing, procedure andfollow-up outlined in this protocol including (but not limited to) frequency ofclinic visits, use of pre-specified glucose monitoring devices.

5. In the opinion of the investigator, absence of any physical limitations, addictivediseases, or underlying medical conditions (including mental health) that maypreclude the patient from being a good study candidate.

6. For the time of the wearing phase willingness to abstain from taking a sauna,bathing, swimming, diving and contact sport activities.

7. Fully vaccinated with EMA approved vaccine against SARS-COV-2 virus or recoveredfrom Covid-19 disease, (status vaccinated or recovered according to current Coronaregulations as recommended by STIKO). If applicable, a negative result of a currentCorona test (depending on the guidelines of the study center).

8. Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

1. Persons who use medication containing icodextrine or maltose and which can result inicodextrine or maltose present in blood (dialysis solutions, antibody medicationsetc.), anamnesis based.

2. Persons on peritoneal dialysis.

3. History of significant hypoglycemia unawareness, or a history of severe hypoglycemia (requiring emergency medical intervention) within the last 6 months.

4. Currently pregnant, as demonstrated by a positive pregnancy test at screening and/orDay00 prior to enrolment.

5. Any active acute or chronic infectious disease that, in the opinion of theinvestigator, might interfere with the performance of this study or would pose anexcessive risk to study staff (e.g., Hepatitis B and C, HIV, Covid-19).

6. Extensive skin changes/diseases that preclude wearing the required number of deviceson normal skin at the proposed application sites (e.g., extensive psoriasis, recentburns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos,dermatitis herpetiformis).

7. Have a known allergy to medical-grade adhesives, or known hypersensitivity to any ofthe products used in the study.

8. Blood donation of more than 500 ml within the last three months or hematocrit value <30% or > 50%.

9. Currently participating in another investigational study protocol where the testingor results may interfere with study compliance, diagnostic results, or datacollection.

10. Has a MRI scan, CT scan, diathermy or a flight scheduled during the proposed studyparticipation.

11. Has vaccination/booster against COVID-19 scheduled during or less than 2 weeks priorto the proposed study participation.

12. An identified protected vulnerable patient (including but not limited to those indetention, or a prisoner).