Evaluating contactless devices for measuring skin microcirculation in type 1 diabetes
The MIND Study - Microangiopathy IN Diabetes
This study is testing two new contactless devices to see how well they can measure blood flow in the skin of people with type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | HJN Sverige AB/Neko Health Industry-sponsored |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06989190 on ClinicalTrials.gov |
What this trial studies
This clinical investigation assesses two innovative contactless optical devices designed to measure skin microcirculation in patients with type 1 diabetes. The study utilizes the Neko Health TCI P4, which employs spatial frequency domain imaging technology to quantify skin microcirculation through molecular composition, and the Perimed Multiflow, which uses laser speckle technology to evaluate blood flow properties. By comparing these two devices, the study aims to provide a comprehensive understanding of microcirculatory health in diabetic patients, potentially aiding in the diagnosis of diabetic microangiopathy. The study will include participants with varying degrees of diabetes severity, focusing on both severe complications and milder forms of the disease.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-45 with severe type 1 diabetes complications or a broader range of severity levels in phase 2.
Not a fit: Patients with type 1 diabetes who do not exhibit any microangiopathy or related complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance diagnostic capabilities for microvascular complications in type 1 diabetes, leading to better patient management.
How similar studies have performed: While the use of contactless optical devices for microcirculation assessment is promising, this specific combination of technologies is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm
- VO Medicinska Specialiteter, Danderyd Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Sarah Tehrani, MD, PhD — Danderyd Hospital, Department of Internal Medicine, Stockholm, Sweden
- Study coordinator: Mattias Windå
- Email: mattias@nekohealth.com
- Phone: +46703169040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.