Evaluating contactless devices for measuring skin microcirculation in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.