The MIND Study - Microangiopathy IN Diabetes
ConditionDiabetes Type 1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorHJN Sverige AB/Neko Health
About this trial
This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1.
Eligibility criteria
Qualifiers
Severe type 1 diabetes (microangiopathy / diabetic feet), severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers.
Age range: primarily 18-45 years, if not sufficient number of subjects can be found, then 18-60 years span is considered
Age range: 18-45 years (younger patients are targeted for focus on microvascular complications, rather than age-related cardiovascular disease)
Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a), 100 patients.
Disqualifiers
Patients unable to understand patient information due to cognitive impairment
Patients unable to understand patient information due to language barriers
Ongoing acute infection or inflammatory condition
Pregnant or breastfeeding women
Trial design
Treatments tested in this trial
- Not listed
Trial groups
400 Participants
are grouped into 5 trial groupsLocations
1VO Medicinska Specialiteter, Danderyd Hospital182 88, Stockholm Sweden
Sponsors and collaborators
HJN Sverige AB/Neko Health
Lead sponsor
Source ClinicalTrials.gov