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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-12-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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/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 Criteria: * 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
Contact & Investigator
Sarah Tehrani, MD, PhD
PRINCIPAL INVESTIGATOR
Danderyd Hospital, Department of Internal Medicine, Stockholm, Sweden
Frequently Asked Questions
Who can join the NCT06989190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Diabetes Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06989190 currently recruiting?
Yes, NCT06989190 is actively recruiting participants. Contact the research team at mattias@nekohealth.com for enrollment information.
Where is the NCT06989190 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06989190 clinical trial?
NCT06989190 is sponsored by HJN Sverige AB/Neko Health. The principal investigator is Sarah Tehrani, MD, PhD at Danderyd Hospital, Department of Internal Medicine, Stockholm, Sweden. The trial plans to enroll 400 participants.
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