Status:
RECRUITING
The MIND Study - Microangiopathy IN Diabetes
Lead Sponsor:
HJN Sverige AB/Neko Health
Conditions:
Diabetes Type 1
Eligibility:
All Genders
18-60 years
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 wi...
Detailed Description
This clinical feasibility study aims to evaluate the potential of contactless and non-invasive technologies for measurement of skin microcirculatory properties and their regulatory function in healthy...
Eligibility Criteria
Inclusion
- Phase 1: Severe Diabetic Complications (50 patients)
- 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
- 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
Key Trial Info
Start Date :
December 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06989190
Start Date
December 19 2023
End Date
December 1 2026
Last Update
May 25 2025
Active Locations (1)
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1
VO Medicinska Specialiteter, Danderyd Hospital
Stockholm, Sweden, 182 88