Microangiopathy in Diabetes

This study will employ investigational devices to evaluate microvascular function and correlate it to degree of microangiopathy in persons with diabetes type 1 and healthy controls.

The investigational device, TCI P4, is a novel, contactless, non-invasive, non-CE marked, class IIa Spatial Frequency Domain Imaging (SFDI) system. The device utilizes an LED light projector to cast patterned, multi-wavelength light onto the skin while multiple cameras capture narrow-band reflections. This method yields two-dimensional data on skin structure and molecular composition (including hemoglobin, oxygen, and water). Established comparators such as laser speckle contrast imaging (LSCI) and the EPOS system are employed to benchmark device performance and validate measurements.

Inclusion criteria

• Diabetes mellitus type 1.
• Cohort specific inclusion criteria apply, please review 'groups' section.

Exclusion criteria

• Patients unable to understand patient information due to cognitive impairment.
• Patients unable to understand patient information due to language barriers.
• Ongoing acute infection disease or inflammatory condition.
• Pregnant or breast-feeding women.
• Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices.