Actively Recruiting

Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06989190

The MIND Study - Microangiopathy IN Diabetes

Led by HJN Sverige AB/Neko Health · Updated on 2025-05-25

400

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The MIND Study - Microangiopathy IN Diabetes

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe type 1 diabetes with microangiopathy or diabetic feet, including proliferative retinopathy, macroalbuminuria, kidney failure with at least CKD-class 3B, and severe neuropathy with or without foot ulcers
  • Age primarily 18 to 45 years; if needed, extended to 18 to 60 years
  • Patients aged 18 to 45 years with no or early reversible microangiopathy (simplex or background retinopathy)
  • Patients aged 18 to 45 years with mild microangiopathy, mild to moderate non-proliferative retinopathy, microalbuminuria, or early signs of neuropathy
  • Patients aged 18 to 45 years with moderate microangiopathy, moderate or proliferative retinopathy, macroalbuminuria or kidney failure up to CKD-class 3A, and manifest neuropathy
  • Healthy controls matched by age and gender with no known risk of increased cardiovascular disease
Not Eligible

You will not qualify if you...

  • Unable to understand study information due to cognitive impairment
  • Unable to understand study information due to language barriers
  • Current acute infection or inflammatory condition
  • Pregnant or breastfeeding women
  • Damaged or scarred tissue in areas of interest for investigational or comparator devices

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VO Medicinska Specialiteter, Danderyd Hospital

Stockholm, Sweden, 182 88

Actively Recruiting

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Research Team

M

Mattias Windå

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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