A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults with Type-1 Diabetes Mellitus

A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: a Single-Arm Pilot Study

The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.

Inclusion Criteria:

• 1.1nformed Consent signed by the subject
• 1.2 Male and female subjects 18 - 60 years of age (inclusive)
• 1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)
• 1.4 Type 1 diabetes diagnosed > 12 months ago
• 1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) for more than 6 months
• 1.6 BMI between 18.5 and 28.0 kg/m2
• 1.7 Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom G7)
• 1.8 Willingness to follow the study procedure

Exclusion Criteria:

• 2.1 In female subjects: pregnancy or breastfeeding period (self-reported)
• 2.2 HbA1c of > 9.0% (based on last measurement by treating physician but not older than 120 days) Note: To be repeated at the study site if measurement is older than 120 days or not available
• 2.3 History of cardiovascular diseases
• 2.4 Irregular 12-lead ECG upon investigator's judgement
• 2.5 Medical history of epilepsy or other neurological disease associated with seizure events
• 2.6 Atypical skin condition (e.g., Hyperkeratosis, Hyperpigmentation) or presence of tattoos or scars in the measurement area (wrist) that could impair validity of measurement upon investigator's judgement
• 2.7 Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
• 2.8 Not able to understand, write or read German
• 2.9 Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
• 2.10 Enrolment of the PI, his/her family members, employees and other dependent persons