The MIND Study - Microangiopathy IN Diabetes to Evaluate Contactless Optical Devices for Skin Microcirculation in Type 1 Diabetes

What this Trial Is About

Researchers are evaluating two contactless optical devices that use spatial frequency domain imaging and laser speckle technology to measure skin microcirculation in people with type 1 diabetes. This study focuses on how these technologies can detect early changes in microvascular function before serious diabetic complications develop. It compares patients with different severities of diabetic microangiopathy to healthy individuals to better understand microcirculatory changes related to diabetes and peripheral arterial disease. The investigational devices include the Neko Health TCI P4, which measures molecular composition such as hemoglobin and oxygen levels in the skin, and the Perimed Multiflow, which assesses blood flow speed by tracking red blood cell movement. These complementary devices measure key microcirculatory properties like blood volume, oxygenation, and hemodynamics. The study examines responses at multiple body sites, including the forearm, palm, and both sides of the feet, under different heat provocation levels to observe differences between diabetic patients and healthy controls. Participants will undergo measurements on the same day as enrollment, including assessments of blood flow, oxygenation, and hemoglobin concentration during local heat tests. The study collects data on correlations between device readings and clinical signs of microangiopathy, neuropathy, and vascular health. Researchers will analyze differences across patient groups and body sites to identify early indicators of diabetic microvascular damage. The study is observational and includes healthy volunteers matched by age and sex. Participation involves a single visit for testing and data collection.

The MIND Study - Microangiopathy IN Diabetes