NCT06989190 The MIND Study - Microangiopathy IN Diabetes
| NCT ID | NCT06989190 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HJN Sverige AB/Neko Health |
| Condition | Diabetes Type 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-12-19 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief 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 Criteria
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/o
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