Diabetes patients know that one of the greatest challenges in managing the ailment is tracking their blood sugar, or glucose, levels. To do that the only option available today is through the use of standard glucose meters - devices that require multiple finger pricks each day, a painful process. For years, researchers have been trying to find a noninvasive, quicker and easier way to monitor blood glucose. Even the most advanced devices in use today, like needle sensors, which can track glucose continuously, need to be inserted under the skin every one to two weeks. Now, Caesarea-based startup Cnoga Medical Ltd. Its glucose meter, already approved for use in numerous countries worldwide, uses a camera to provide a diagnosis of blood glucose levels by observing the changing colors of the user’s finger. During a short training period, the device learns to correlate the user’s skin tone with previous glucose level readings. The technology got the green light on Monday from one of the world’s leading diabetes specialists, Prof. Andreas Pfützner, MD, PhD, who came to Israel to present the company with his findings after having tested the technology in two clinical studies in Germany.
"The results were surprising," he told The Times of Israel in a phone interview. Pfützner held two clinical trials at his institute to validate the performance of the technology, and in both studies he found that the medical device performed "with a surprising level of accuracy," the same as that of needle sensors. "Cnoga achieved the same level of monitoring as the invasive devices," he said. "I have not seen this before," he said. "It is a wonderful device" and a "true alternative" to current semi-invasive needle sensors used for treatment monitoring in patients with diabetes, he elaborated. As managing director of the Pfützner Science & Health Institute, Diabetes Center & Practice in Mainz, Germany, Pfützner has performed more than 350 clinical studies as principal investigator, including more than 100 clinical research projects with diabetes-related technologies. He said he is not affiliated with the company but did get paid to perform the clinical trial, which is what is generally done.
"Glucose measurement is a painful solution," Pfützner said. In his presentation on Monday, Pfützner said that the TensorTip device, also known as the CoG, developed by Cnoga provides noninvasive access to the blood sugar information. And in case of emergency or unclear results, an add-on regular blood sugar meter using test-strips may be used to confirm readings. "In both studies, CoG was shown to reliably track GlucoLife blood glucose support sugar values when calibrated properly. The device performance was similar to results recently obtained with needle sensors, which have become very popular to track tissue glucose in a continuous fashion, and which are to be inserted under the skin every 7 to 14 days," Pfützner said in his presentation of the trial results. "In contrast, TensorTip is truly noninvasive and - after one week of intensive calibration - allows for pain-free access to an unlimited number of sugar readings every day without further need to replace disposable parts. "In consequence, TensorTip CoG may provide reliable glucose information on a GlucoLife Daily Support basis.
Every six seconds, a person dies from diabetes, GlucoLife Daily Support and with 415 million sufferers globally, it will likely become the greatest epidemic in human history. It’s also one of the most costly diseases, amounting to 12 percent of annual healthcare expenditure worldwide. Without accurate tracking, poorly controlled diabetes can easily lead to heart attacks, strokes, blindness, and reduced blood flow, which can cause serious limb infections and ultimately amputation. Very low blood glucose can also cause confusion, loss of consciousness and seizures. "We are the first company in the world that has managed to build a noninvasive glucose meter that complies with global accuracy and quality standards," said Cnoga’s VP of global sales and marketing Steven Macwan by phone. The device has already received regulatory certifications from the European Union, Brazil and China and the company will start the process to attain US Food and Drug Administration approval in 2018, he said.