Contactless imaging to detect early skin microangiopathy in type 1 diabetes
Microangiopathy IN Diabetes
This project will test whether a contactless imaging device (TCI P4) can measure skin microcirculation differences in people with type 1 diabetes compared with healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Danderyd, Stockholm County) |
| Trial ID | NCT07145567 on ClinicalTrials.gov |
What this trial studies
This observational study uses a novel contactless Spatial Frequency Domain Imaging (SFDI) device, the TCI P4, to capture two-dimensional maps of skin structure and molecular composition (including hemoglobin, oxygenation, and water) in people with type 1 diabetes and healthy controls. The TCI P4 projects patterned multi-wavelength light and records narrow-band reflections to derive microcirculatory parameters without touching the skin. Established comparators such as laser speckle contrast imaging (LSCI), the EPOS system, laser Doppler flowmetry, iontophoresis, and local thermal hyperemia will be used to benchmark the device's measurements. Imaging findings will be correlated with the degree of microangiopathy to see if the device can detect early diabetic microvascular changes.
Who should consider this trial
Good fit: Ideal candidates are adults with type 1 diabetes who have no active infection or inflammatory condition and no damaged or scarred skin at the imaging sites, as well as healthy volunteers for comparison.
Not a fit: Pregnant or breastfeeding people, those with active infections, significant skin damage at target sites, or those unable to understand study information are not eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this method could enable earlier, non-invasive detection of diabetic microvascular complications so treatment or preventive measures can start before severe damage occurs.
How similar studies have performed: Related non-invasive techniques like LSCI and EPOS have shown promise in detecting microvascular changes, but the contactless TCI P4 SFDI approach is novel and not yet clinically validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Danderyd, Stockholm County
- Danderyd University Hospital — Danderyd, Stockholm County, Sweden (Recruiting)
Study contacts
- Study coordinator: Sara Tehrani, Medical Doctor
- Email: sara.tehrani@ki.se
- Phone: +46 08 123 550 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.