Microangiopathy in Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Microangiopathy, Microvascular Complications. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Microangiopathy IN Diabetes
Overview
This clinical trial aims to evaluate the use of a contactless and non-invasive technique to measure the properties of the skin's microcirculation and its regulatory functions in both healthy individuals and patients with microvascular disease associated with type 1 diabetes. It is hoped that the study results will lead to the development of a useful method for detecting diabetic complications at an early stage, thereby enabling treatment and preventive measures before the onset of severe microangiopathy.
Detailed description
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.
Primary outcome measures
- Peak perfusion in response to local thermal hyperemia [Time frame: Investigation will take within 1 day from enrollment.]
Secondary outcome measures (1)
- Perfusion heterogeneity in sole of feet [Time frame: Investigation will take place within 1 day from enrollment.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Danderyd University Hospital — Danderyd
Identifiers
NCT: NCT07145567 · 2023-02232-01