A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Bl… (NCT06097689) | Clinical Trial Compass
CompletedNot Applicable
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
Switzerland21 participantsStarted 2023-11-24
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 investigati…
What they're measuring
1
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
Timeframe: The data is collected during the study procedure (6 to 8 hours)