The MIND Study - Microangiopathy IN Diabetes
Recruiting now
Conditions studied: Diabetes Type 1
In brief
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.
Key facts
- Study ID
- NCT06989190
- Run by
- HJN Sverige AB/Neko Health
- People needed
- 400
- Starts
- 2023-12-19
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-05-25
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- VO Medicinska Specialiteter, Danderyd Hospital — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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