Senseonics’ Eversense: 90-day Implanted CGM Enters US Pivotal Trial
www.DiaTribe.org, 2/26/2016
This pivotal trial will evaluate the accuracy and safety of the Senseonics’ implantable, 90-day Eversense CGM system. Eversense CGM measurements will be compared to a laboratory reference device at several in-clinic visits over the 90-day wear period.
Current CGM offerings (Medtronic and Dexcom) in the US involve a sensor inserted through the skin and a transmitter that is attached externally to the body; these sensors last only seven days before they need to be replaced (though some people wear them slightly longer). Eversense uses a longer-term, 90-day implanted sensor, which is placed in the upper arm in a simple 5-10 minute in-office procedure. Since the sensor doesn’t contain a battery, a transmitter device is worn externally over the sensor to power the sensor and send the data to a smartphone. Both the smartphone and transmitter will alert the user of a high or low. Even if the phone is out of range, the transmitter will provide on-body vibe alert to indicate a high or low. Senseonics has completed a pivotal trial in Europe, where Eversense is still awaiting approval. If this new US trial finds the Eversense system is safe and effective, it opens the door for a US FDA submission.
For more information about the trial, please contact Emily Gades at 925-930-7267 or egades@diabloclinical.com, or from ClinicalTrials.gov, go to http://tinyurl.com/zlnrqxq
CU scientists identify factor that may trigger type 1 diabetes
Aurora, Colorado, 11 February 2016
A team of researchers, led by investigators at the University of Colorado School of Medicine, have identified a new class of antigens that may be a contributing factor to type 1 diabetes, according to an article published in the 12 February 2016 issue of the journal Science.(http://science.sciencemag.org/content/351/6274/711)
In autoimmune disease, the key question is why the immune system attacks the body’s own tissues. Type 1 diabetes is the autoimmune form of diabetes, in which insulin-producing beta cells in the pancreas are destroyed by immune cells, especially those known as T cells. Insulin is the hormone that regulates levels of glucose in the blood and without insulin, a life-threatening disease results.
Read more: http://tinyurl.com/jd6rkj5
What’s Up with Viacyte?
San Diego, 4 February 2016
ViaCyte, Inc., a leading, privately-held regenerative medicine company with the first pluripotent stem cell-derived islet replacement therapy for the treatment of type 1 diabetes in clinical-stage development, today announced that ViaCyte and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, have agreed to consolidate the assets of the Janssen BetaLogics group into ViaCyte. The agreement provides ViaCyte with an exclusive license to all BetaLogics intellectual property in the field of metabolic disease, including diabetes, and the transfer of related assets to ViaCyte.
Human embryonic stem cells
“For more than a decade BetaLogics and ViaCyte have been independently working toward a stem cell-derived therapy for diabetes. By combining the intellectual property and other assets of BetaLogics with ViaCyte, we will further strengthen our advanced program focused on insulin-dependent diabetes and solidify our leadership in the field,” said Paul Laikind, PhD, President and CEO of ViaCyte. “We look forward to delivering effective new treatments for this difficult disease.”
Read more: http://tinyurl.com/zut6bon
New Tools to Help You Optimize Your Insulin Doses
www.diaTribe.org, 26 February 2016
At the 2016 ATTD Conference in Milan, there was a big focus on new tools to help people with diabetes optimize their insulin doses. Here are some products for Type 1 folks to watch for:
• DreaMed Diabetes’ MD Logic Pump Advisor is a web-based algorithm that will recommend specific insulin pump setting changes based on past pump, exercise, CGM, fingerstick and food data, in partnership with Glooko. DreaMed received $3.4 million from the Helmsley Charitable Trust’s Diabetes Data Innovation Initiative to develop the Pump Advisor.
• Tidepool expects to release its Nutshell app within the next fewe months, improving mealtime insulin dosing by answer: “What happened the last time I ate this?”
Nutshell will not provide dosing advice like the apps above, though it will help patients easily search for previous meals (e.g., “tacos” or food at “The Little Chihuahua”) and see what insulin dose they took and what happened to their glucose. This will be most seamless for those using a pump and CGM, though we believe patients on a glucose meter and/or injections can still use Nutshell. The app’s premise is that all of us tend to eat the same meals, and it makes perfect sense to look at what happened last time and make more informed decisions this time.
Read more: http://tinyurl.com/hm48twt
