The following links explore new methods in non-invasive, semi-invasive, and subcutaneous, measuring of blood glucose. We will examine the research behind these new technologies, how each new technique works, FDA status, and the companies involved with the funding of each project.
|Non-Invasive||Measures glucose without breaking the skin.|
|Semi-Invasive||Measures glucose with a minimal breach of the outer skin layers.|
|Surgical||Measures glucose by means of an implanted device.|
|Continuous||Measures glucose at a constant.|
GlySens Incorporated is a privately held corporation located in San Diego, California that’s been around since 1998. Their focus is on an implantable long term continuous glucose monitoring sensor that will help people with diabetes monitor their glucose levels accurately without the usual fingersticks. The system will include 2 parts: the implanted sensor and an external monitor with a display.
Hypomon by AIMedics
AiMedics, established in October 2001 as a commercial spin-off of the University of Technology, Sydney (UTS), specializes in non-invasive monitoring for various diseases, including diabetes, epilepsy, fatigue, and Sudden Infant Death Syndrome. One of AiMedics’ primary focuses is the development of HypoMon®, a real-time, non-invasive, device that detects low blood glucose levels in people with diabetes who use insulin.
The Glucoday S by A.Menarini Diagnostics
Only the size of a portable audio device like a Walkman tape player, this device features: a one-point calibration per 48 hour monitoring period, wireless real-time display on instrument and pc, blind or displayed mode operation, alarm (buzzer or vibration) in case of hypoglycemia or hyperglycemia, less than 2 min delay in response time, long life on board biosensor (up to 6 months after the first use at room temperature) and an accessible database.
Photonic Glucose Sensor by Onsens
Onsens is proud to introduce the world’s first Optical Hypoglycemia Detector (OHD), now in full prototype and testing stage. The Cybiocare OHD is designed as a totally non-invasive way to help prevent hypoglycemia among the millions of people with diabetes today. Upon completion, the wearable, watch-size Cybiocare OHD will warn diabetics when blood glucose drops below a certain critical level.
Scout DS by VeraLight
The Scout DS is a non-invasive, near-infrared screening device for pre and Type 2 diabetes. Described as an optical skin test, the goal is for the device to replace conventional screening so no blood is drawn or fasting is necessary. The technology is based around detecting Advanced Glycation End Products (AGEs) in the skin. AGE levels are typically higher in people with diabetes. Previous testing of AGE values was done using a punch biopsy of the skin and only a few labs could actually complete the test.
LighTouch Medical measures blood glucose noninvasively by projecting a specific color of light into the user’s fingertip. The light that bounces back to the monitor is analyzed for blood glucose results. The technique is based on Raman-based spectroscopy. It specifically monitors a patient’s hematocrit levels and other medically useful blood analytes.
Optiscan, a privately-held company in Hayward, California, has developed a continuous bedside glucose monitoring system called the OptiScanner. It is currently being developed for use with terminally ill patients. Unlike the Near-IR approach, Optiscan opted to measure glucose in the middle infrared or Mid-IR range. One big advantage of using this IR region is that there is minimal interference from other molecules like urea. Another is that blackbody radiation can be used, ie, the device can actually use the human body’s own inherent radiation, rather than apply an external radiation source.
OrSense Ltd. is a medical device company based in Israel. Their first product, the NBM 200-G is based on its proprietary Occlusion Spectroscopy technology. Orsense claims this technology overcomes obstacles that have plagued other companies attempting to measure glucose optically through the skin.
Senseonics Inc, based in Germantown, MD, received approval from an FDA advisory panel on March 29, 2018 for its entirely implantable 90-day continuous glucose monitoring system called Eversense. The Eversense CGM system has been available in Europe since 2016 where Senseonics recently launched an extended length 180-day version. Depending on final FDA approval, Eversense may become available in the US sometime in the middle of 2018. Senseonics hopes to start studies for approval of the 180-day version this summer.
Sentek Group, Inc. is developing a non-invasive diagnostic tool targeting diabetes patients that uses a patented Crystalline Colloidal Array (CCA) technology exclusively licensed from the University of Pittsburgh. While Sentek plans to exploit several applications of the technology, the company’s first commercial efforts are for the Glucoview ocular insert that will enable diabetics to continuously monitor their blood glucose levels, and unlike most competing technologies, it will not require finger stabs.
Monitors With No New Info
This small R&D company, based in Dortmund, Germany, claims it is close to the production of what is believed to be a near IR device, although it’s operational range of 80% humidity or less may indicate a middle IR device. It has been developed in conjunction with a Korean company, Samsung Fine Chemicals Co., Ltd. Called the GluControl® GC300 and measuring 17.6 x 11.6 x 6 cm, with a weight of 500 grams (18 oz.), it is designed for home use.
Silicon Microneedle by Kumetrix
Kumetrix is engineering silicon microneedles designed to draw blood and perform chemical measurements. Their micro-needle is about the size of a human hair, as can be seen in the picture below, and has been integrated with a micro-reservoir or cuvette
Since 1995, Sensys Medical, Inc., formerly Instrumentation Metrics, has been focused on advancing technology for non-invasive blood glucose monitoring. The Company intends to commercialize a device that will dramatically advance the practice of blood glucose monitoring and the science of diabetes disease management.
Sontra’s continuous non-invasive glucose monitor, the Symphony™ Diabetes Management System, is being co-developed with Bayer Diagnostics. Their glucose monitor measures glucose diffusing through ultrasonically permeated skin continuously for up to twenty-four hours. The product consists of a SonoPrep instrument, a glucose biosensor patch with an RF transmitter, and a glucose meter. For the home use monitor, the glucose biosensor will be worn under clothing to reduce lifestyle constraints. The PDA/ glucose meter will provide on-demand blood glucose readings in addition to trends and alarms that will minimize the frequency of high and low blood glucose levels.
Visual Pathways Inc. is a vision-care diagnostic company with headquarters in Prescott, Arizona. The company received a federal grant to develop a prototype of its GlucoScope™ Monitor, which measures glucose levels in the fluid of the anterior chamber of the eye, in 2003. The handheld device looks like a small pair of binoculars and uses infrared light to rapidly measure glucose levels in the eye. The federal funding was provided by National Medical Technology Testbed Inc. under the U.S. Department of the Army Medical Research Acquisition Activity.