Next Generation Diabetes Screening and Diagnosis Technologies

Diabetes is a silent killer that takes close to 1.5 million lives every year globally. The World Health Organization believes that diabetes will be the 7th leading cause of death by 2030. Diagnosis remains a major challenge: One in two diabetic adults remains undiagnosed globally. Novel approaches may be necessary to improve early detection, screening, and diagnosis to reduce long-term costs. 

Diabetes Diagnosis—A Global Concern
Diabetes is a silent killer that takes close to 1.5 million lives every year globally. The World Health Organization believes that diabetes will be the 7th leading cause of death by 2030. Diagnosis remains a major challenge: One in two diabetic adults remains undiagnosed globally. Novel approaches may be necessary to improve early detection, screening, and diagnosis to reduce long-term costs. 

New Non-Invasive Technologies to Improve Mass Screening for Diabetes 
According to Frost & Sullivan, the total global diabetes diagnosis market was valued at $2.65 billion in 2016 and growing at a compound annual growth rate of 11.0% to reach $4.96 billion by 2022. This market segment comprises the point of care testing for HbA1c and glucose testing at the point of care. Diagnosing diabetes traditionally involved an invasive procedure, but thanks to devices such as Luminor Medical Technologies’ Scout DS, which uses light to detect diabetes-associated biomarkers in the skin, and handheld breath analyzers, noninvasive screening can be done in a doctor’s office. 

The Scout DS Device
The Scout DS can encourage mass screening for diabetes. It uses visible light to fluoresce, detect, and measure advanced glycation end-products (AGEs) and other biomarkers in the skin associated with pre-diabetes and Type 2 diabetes. The device processes more than 200 data points through a proprietary algorithm to determine a patient’s risk level; the entire process can be completed in 90 seconds. Those with elevated risk can schedule appointments with physicians to check for diabetes status. The device is non-invasive and painless, and no fasting or bloodwork is necessary.     

The Breath Test Approach
University of Oxford researchers have developed a handheld device to detect the presence of acetone, a marker for diabetes, in breath. An absorbent polymer traps the acetone and releases it into a device cavity, where a laser probes its concentration. The non-invasive method can help diagnose diabetes and also monitor glucose levels. The device is still in the research stage, but scientists hope to make it commercially viable. 

Addressing the Challenge Associated with Distinguishing Between Diabetes Types 
Currently, widely used diabetes diagnosis tests can measure oral glucose tolerance or levels of glycated hemoglobin (A1C), fasting blood glucose, and random blood glucose. Observational diagnosis challenges include distinguishing between Type 1 and Type 2 diabetes. More children are developing Type 2 diabetes and more adults are developing Type 1 diabetes. LADA (latent autoimmune diabetes in adults) diagnosis remains a challenge; it is often misdiagnosed as Type 2, especially in older and obese patients. Laboratory-based, autoantibody tests aid in the diagnosis of Type 1 diabetes and LADA, but the process requires trained staff to handle radioactive materials and costs hundreds of dollars. Research is ongoing to improve first-attempt diagnostic accuracy of diabetes type, and to make the screening process less cumbersome. Emerging approaches include: 

Microchip Antibody Diagnostics to Detect Type I Diabetes
GI Stat, a spinoff from Stanford University, has developed an affordable, portable, microchip-based testing technique to detect Type 1 diabetes that could speed up diagnosis. This fluorescence-based testing method detects the presence of three auto-anitbodies using only a few drops of patient blood. The chips costs about $20 to make; the product is in the commercialization process. 

Medical Imaging
Avid Radiopharmaceuticals, an Eli Lilly subsidiary, is developing a PET-imaging based approach to measure β-cell mass in the pancreas to help assess the level of insulin production. It is in the Phase 1 trial stage. 

Early Diagnosis of Diabetes Complications
The primary aim of diabetes management is to prevent organ-related complications. Start-ups are helping to solve some of the challenges associated with early diagnosis of diabetes complications, including:
 
Retinopathy
BeatO, an Indian start-up, is leveraging telemedicine for diabetic retinopathy screenings. Trained technicians bring equipment to a patient’s home to take retinal images (without dilation), which are then reviewed by ophthalmologists who provide opinions virtually. 

Neuropathy
Yostra Labs, another Indian start-up, has developed a handheld device called Sparsh to gauge nerve damage. It combines 3 touch test—tactile, vibration perception, thermal perception thresholds—in a single device; the accompanying app records all results. The device is aimed at eliminating physician subjectivity in manual touch tests and provides exact pressure readings in the app. 

Diabetic Foot
Podimetric, an US-based start-up, is using foot temperature monitoring to help in the early diagnosis of diabetic foot. The device consists of a smart, connected foot mat that collects foot temperature scans. Patients step on the mat for 20 seconds, and the scans taken are sent directly to their care provider. Care providers can consult Podimetrics’ podiatrists online for clinical decision support and population management. 

What's the Future?
A major industry challenge is encouraging diabetics to undergo periodic examinations. Solving this issue at a population level can reduce avoidable costs associated with diabetes complications. Affordable point-of-care testing technologies are essential for regular screenings.

Copyright © 2017 Frost & Sullivan

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