Contactless imaging to detect early skin microangiopathy in type 1 diabetes
Official title: Microangiopathy IN Diabetes
Run by Karolinska Institutet · NCT07145567 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Danderyd, Stockholm County) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | June 2027 |
| Study ends | December 2027 |
| Registry record updated | August 28, 2025 |
| Trial ID | NCT07145567 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.