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โ† Trials
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The MIND Study - Microangiopathy IN Diabetes

Recruitingn/aAges 18 Years - 60 YearsAllHJN Sverige AB/Neko Health
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Phase 1: Severe Diabetic Complications (50 patients) Inclusion Criteria: * 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 Phase 2: Scale of severity. In phase 2, patients are included with a broad range of severity levels. Patients with diabetes type 1 will be included. Inclusion criteria: * 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. * Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy (group b), 100 patients. * Patient with moderate microangiopathy. moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure (defined as estimated glomerular filtration rate \<60 mL/min/1.73 m2 body surface) up to CKD-class 3A, and manifest neuropathy, (group c), 50 patients. Healthy controls: \- Healthy control matched to the type 1 diabetes patients in age and gender, with no known risk of increased cardiovascular disease. 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 or inflammatory condition * Pregnant or breastfeeding women * Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices
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What it tests

  • Not listed
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Where

1 site
VO Medicinska Specialiteter, Danderyd Hospital
Stockholm, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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