The MIND Study - Microangiopathy IN Diabetes

Summary

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

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

Conditions2

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