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1. Medtronic presents pivotal artificial pancreas data at ADA, as Insulet details its own plans

Medtronic reported pivotal data for its hybrid closed-loop system at the American Diabetes Association conference in New Orleans, LA, over the weekend. The data show that the hybrid closed-loop system helped to decrease A1c levels as well as reduce variability in sensor glucose values for 124 patients with Type 1 diabetes.

No major adverse events were reported for the study, which encompassed 12,389 patient days.

The system includes a Medtronic MiniMed 670G insulin pump, fourth-generation glucose sensors and a control algorithm. In addition to the system itself, researchers monitored blood glucose levels more than four times daily via traditional finger-stick monitoring as well as via Abbott's i-STAT handheld device. Patients also calibrated the closed-loop sensors periodically.

The three-month study found that the hybrid closed-loop system resulted in a mean reduction of A1c to 6.9% +/- 0.6% from 7.4% +/- 0.9%. This was the primary outcome measure of the study. The standard recommendation is to reduce HbA1c to

Sensor glucose levels varied only slightly from baseline level established during a 2-week lead-in period. At the end of the study, 99 of the participants opted to enter the continued-access program for the hybrid closed-loop device.

"The HCL system was safe, acceptable, and associated with improved glucose control during extended at-home use," the researchers concluded.

A separate study of 12 adults and 16 adolescents found that overnight use of the closed-loop system improved time in the target glucose range for the adults and reduced nocturnal hypoglycemia in the adolescents.

Medtronic has previously said that it will submit this month to the FDA for its hybrid closed-loop system, with an approval anticipated for next spring.

For its part, smaller competitor Insulet also updated on its own artificial pancreas ambitions. Its artificial pancreas system incorporates its Omnipod insulin platform along with a DexCom continuous glucose monitor that's controlled by an algorithm it in-licensed from Mode AGC in February.

The system is currently in a feasibility study using the algorithm and a next-gen Omnipod prototype. Insulet expects to start on-body trials for the system later this year. It presented data on the recently in-licensed artificial pancreas algorithm at the ADA conference.

- here is the Medtronic pivotal ADA poster
- and the trial record
- here is the overnight trial poster
- and here is the Insulet announcement

2IBM Watson, ADA partner to apply cognitive computing to diabetes clinical and research


Patient advocacy and research groups are becoming increasingly sophisticated about how they invest in research and wield technology for the benefit of the patients they represent. Now, some are turning to IBM Watson Health to help make sense of their massive data repositories via cognitive computing--as well as to enlist its aid in providing better patient resources.

The latest deal on that front is between the American Diabetes Association and IBM Watson Health, announced at the former's conference on June 12. The pair aim to create a diabetes adviser for patients and healthcare providers based upon the ADA's repository of clinical and research data. In addition, they are issuing a challenge to developers for cognitive computing-based apps to improve diabetes prevention and management.

A few months ago, IBM Watson Health did a similar sort of deal with the American Cancer Society, aimed at better advising oncology patients and their providers based upon Watson's analysis of ACS information. And it's also done a series of deals to apply cognitive computing to oncology genomics data and clinical trials.

Its diabetes partnership with Medtronic ($MDT) that dates to last year is also starting to bear fruit."We have very promising results from our work with Medtronic to build a cognitive assistant for people with diabetes. Our research teams have applied cognitive analytics to real-life, retrospective data from 10,000 anonymized patients, and found that the technology was able to predict hypoglycemia two to four hours in advance of onset with 86% accuracy," Dr. Kyu Rhee, chief health officer at IBM Watson Health, told FierceMedicalDevices. The app, known as SugarWise, is slated to be released this summer.

The ADA project aims to address the needs of three core groups: healthcare providers, researchers, and patients and caregivers. It is slated to enable the creation of a cognitive diabetes database to guide treatment decisions and population health management; a research database to elicit hidden patterns to guide therapeutic discovery; and tools that can provide personalized information based on variables including demographics, disease stage, treatment regimen and behaviors.

"The timing is perfect:  With the rising diabetes epidemic and the shortage of health care providers, we need to use technology to help people living with diabetes have access to critical health information. By bringing together the Association's wealth of diabetes data with Watson's cognitive computing capabilities, we can drive the development of a wide spectrum of tools that can change the way diabetes is prevented and treated," ADA SVP of Medical Technology told FierceMedicalDevices.

In their call for cognitive apps, the partners are looking to incorporate these Watson-analyzed, ADA data. The challenge is intended to help integrate the data into the lives of people with diabetes or prediabetes; it opens this summer.

Beyond Medtronic and ADA, Watson Health also is involved in other diabetes projects. Last year, IBM Research presented data on a predictive model to provide individualized rankings of diabetes risk factors. And it just created a research partnership with Israeli HMO Maccabi to study diabetic retinopathy prediction based on 20 years of data for more than two million members.

"Our collaboration builds on years of work out of IBM Research to explore how cognitive computing can advance our understanding of diabetes through predictive modeling, data-driven care management, prevention and disease modeling," noted Watson Health's Rhee.

- here is the release

Related Articles:
IBM Watson Health creates American Cancer Society, global health initiatives

3. Abbott's Freestyle Libre reduces hypoglycemia, offers comparable monitoring without finger-sticks: Study

Abbott reported the latest data for its FreeStyle Libre system that doesn't require twice-daily finger sticks for calibration, as CGMs typically do. The 6-month randomized, controlled trial was conducted in Europe; it compared the use of the FreeStyle Libre to traditional finger stick-based blood glucose self-monitoring systems. The study found that Libre users reduced time spent in hypoglycemia by more than one-half and cut serious hypoglycemia by half.

Interestingly, HbA1c--an average measurement of blood glucose levels over 90 days--did not increase compared to the finger-stick group, which Abbot takes as a sign that the "the FreeStyle Libre system can safely and successfully replace the need for routine finger sticks." There is typically an inverse relationship between the risk of severe hypoglycemia, or low glucose levels, and HbA1c reduction, the company noted.

"Hypoglycemia is the main barrier to attaining optimum glucose control in persons with insulin-treated diabetes. Moreover, hypoglycemic events can not only lead to adverse clinical outcomes including cardiovascular events and death, but they can also incur significant emergency healthcare costs," said the study's chief investigator, Dr. Jan Bolinder of the Karolinska Institutet in Stockholm, Sweden, in a statement.

"This clinical trial has proven that patients will test more often when they have an easier and more convenient way to do so utilizing a device like FreeStyle Libre, leading them to ultimately being healthier, which is our goal for our patients," he added. Traditional finger-stick blood glucose monitoring is recommended for at least four to 8 times daily for Type 1 and Type 2 diabetics.

The 23-site study included 252 patients. It found that FreeStyle Libre versus traditional self-monitoring of blood glucose resulted in a 38% reduction of time spent in hypoglycemia, including a 40% reduction of nocturnal hypoglycemia and a 50% reduction in serious hypoglycemia. After 6 months of use, HbA1c did not increase.

Participants using the FreeStyle Libre sensors scanned them an average of 15 times daily. The system requires that a handheld reader or smartphone be waved over the adhesive sensor to record glucose data. Abbott recently introduced data-sharing and smartphone app compatibility for the FreeStyle Libre system. The device has long been CE marked, but the route to an FDA approval remains murky.

"We cannot underestimate the power of knowledge--especially for someone who is managing a chronic condition. Our goal is to help our customers be healthier and live fuller lives, and it's clear from this trial that FreeStyle Libre provides our customers just what they need to do that," said Abbott Diabetes Care SVP Jared Watkin.

- here is the announcement

4. J&J rolls out wearable insulin patch data in advance of 2016 launch


Johnson & Johnson has been sitting on its OneTouch Via patch-based insulin delivery system for a while now. It acquired the technology when it bought startup Calibra Medical in 2012, and the technology had just been cleared by the FDA.

But J&J has waited until now to launch the Calibra mealtime insulin patch. It is slated to debut the patch in limited ex-U.S. markets before year end, with a U.S. launch planned for "shortly thereafter," the company said.

"As an injection-free insulin delivery patch, OneTouch Via will help people stay on top of their treatment and also allow them to stay in those vital moments in life," said John Wilson, worldwide VP of insulin delivery at J&J's Animas, in a release. "It is our hope that once commercially available, it will eliminate the barriers many people living with diabetes face surrounding mealtime insulin and ultimately improve health outcomes." Calibra Medical is a J&J Diabetes Care company and is a collaboration between the conglomerate's insulin delivery business Animas and its glucose-monitoring focused LifeScan.

In preparation for the long-awaited launch, J&J has released the latest data for the wearable, on-demand insulin delivery system at the American Diabetes Association (ADA) conference.

The study of 44 patients with either Type 1 or Type 2 diabetes was of OneTouch Via patch use over 60 days instead of their bolus injection device. One-quarter of users had previously relied on syringe/vial injections, while the other three-quarters used insulin pens. More than half of study participants said they dosed with insulin more often than they would with a pen or syringe. In addition, almost all patients said they could use it to dose discreetly in public, while about 9 out of 10 said they were less worried about forgetting an insulin dose.

Most of the healthcare providers in the study preferred the OneTouch Via over both insulin pens (75%) and syringes (100%).

The OneTouch Via delivers rapid-acting, or bolus, insulin at mealtimes. Users press two buttons on the device to deliver the insulin bolus--an action that can be done even through clothing. The water-resistant patch can be worn continuously for up to three days.

"People with diabetes can often feel embarrassment or discomfort when they need to inject insulin at mealtimes or when snacking," said LifeScan CMO Dr. Brian Levy. "Because patients in the study were empowered to dose discreetly with the OneTouch Via, they felt encouraged to dose more often--and ultimately, they reported missing fewer doses and better adherence to their treatment regimen."