NCT06989190Recruiting
The MIND Study - Microangiopathy IN Diabetes
Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 8 May 2025
- Start date
- 19 Dec 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- HJN Sverige AB/Neko Health
- Diseases
- Type 1 diabetes
- NCT number
- NCT06989190
What you commit to
- Study type: Observational
- Planned participants: 400
- From 19 Dec 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients unable to understand patient information due to cognitive impairment
- Ongoing acute infection or inflammatory condition
Other
- Patients unable to understand patient information due to language barriers
- Pregnant or breastfeeding women
- Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices
Who the study is looking for
- 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.
- 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.
Criteria the registry did not label
- Phase 1: Severe Diabetic Complications (50 patients)
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VO Medicinska Specialiteter, Danderyd Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.