Preventing Vascular Complications in Type 1 Diabetes: Muscle Metabolic Monitoring

Period of Performance: 09/18/2017 - 09/17/2018

$183K

Phase 1 STTR

Recipient Firm

Infrared RX, Inc.
ATHENS, GA 30602
Principal Investigator

Abstract

Project Summary/Abstract While much has been accomplished in managing hyperglycemia, morbidity and mortality in patients with type 1 diabetes (T1D) often results from cardiovascular complications. Evidence suggests peripheral artery disease and skeletal muscle mitochondrial dysfunction. One reason is the lack of reliable tools to characterize skeletal muscle microcirculation and mitochondrial capacity ? key elements in regulating effective mobility and insulin use in health and disease. Our central hypothesis is that near infrared spectroscopy (NIRS)-based technology can uniquely assess skeletal muscle function in patients with T1D because it accounts for macrovascular, microvascular, and pharmacologic influences on muscle function. In addition, the attributes of this technology are inherently valuable to the study and care of complications of type 1 diabetes patients because it is safe, reliable, non-invasive and scalable for widespread use. To that end, we propose the following specific aims: Specific Aim 1: we will develop an automated analysis platform for NIRS-derived measures of skeletal muscle mitochondrial capacity. Specific Aim 2: we will define the value proposition of NIRS-based microvascular and mitochondrial assessment. Analysis platform validation will include test-retest NIRS measurements and comparison measurement of microcirculation and mitochondrial using magnetic resonance imaging (MRI) and 31P magnetic resonance spectroscopy (MRS). Patients with type 1 diabetes (n=16) and aged-matched healthy subjects (n=4) will be evaluated. Our value proposition will be defined through customer discovery with internists, endocrinologists, and cardiologists. The endpoint for the second aim will be a detailed testing protocol and fully automated web-based analysis program, including error analysis and error correction recommendations. We will provide beta-testing access to the automated analysis product. End-user data will inform the next phase of product development ? a fully integrated and automated data acquisition and analysis platform. Importantly, Infrared Rx, Inc. will engage the expertise of team- members with healthcare software and marketing expertise to drive the customer discovery process. The NIRS based technology is noninvasive, inexpensive and portable. By making the methods simple to perform and obtain results; NIRS has the potential to be a clinical evaluation tool for patients with Type 1 Diabetes.