The MIND Study - Microangiopathy IN Diabetes

Launched by HJN SVERIGE AB/NEKO HEALTH · May 16, 2025

Keywords

ClinConnect Summary

The MIND Study is a clinical trial designed to better understand how diabetes affects small blood vessels in the skin. Researchers will use two special non-invasive devices to measure blood flow in patients with Type 1 diabetes. The aim is to see how these devices can help identify problems related to diabetes, particularly in those who may already have serious complications like kidney issues or eye problems.

To participate, you need to be between 18 and 45 years old and have Type 1 diabetes. There are different groups within the study based on how severe your diabetes complications are, including those with no complications and those with mild to moderate issues. The trial is currently looking for participants, and healthy individuals of the same age and gender may also be included as a comparison group. If you decide to join, you will undergo some tests with the new devices, and your information will help improve understanding and treatment for diabetes-related complications in the future.

Gender

ALL

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