Medtronic's latest real-world device data, Onduo and Orpyx's expanding partnership and more diabetes news from ADA 2019

News from Medtronic, Onduo, Livongo, Abbott and others.
By Dave Muoio
04:03 pm

On Friday, the American Diabetes Association kicked off its annual conference in San Francisco, where academics, vendors and other stakeholders congregated to unveil new study results and major announcements related to diabetes management. And while MobiHealthNews already put together a roundup featuring an opening salvo of the show’s announcements, the past few days have seen a tidal wave of new info spill out of the diabetes industry.

Here’s a roundup of the latest news most pertinent to the digital diabetes management industry.

A busy show for Medtronic

There was hardly a shortage of data and announcements from Medtronic regarding its diabetes management devices.

On Friday evening, the medical technology company announced a partnership with Tidepool that the pair hope will lead to an interoperable automated insulin pump system. For its part, Medtronic will be developing a Bluetooth-enabled MiniMed pump designed to work with the Tidepool Loop, an open-source iPhone and Apple Watch app that the group hopes to have FDA-cleared for automated insulin delivery. Medtronic will be supporting Tidepool financially, and through the development of an SDK for iPhone-to-pump communication.

"We think that Medtronic is making a very bold and important move here that shows tremendous courage and is the absolutely right thing for the diabetes community," Howard Look, founder and CEO of Tidepool, said in a statement. "Medtronic makes incredibly robust and reliable pump hardware, and they have extensive marketing, sales, and support organizations for people with diabetes and for healthcare providers. This network can help bring closed-loop systems to more people living with diabetes.”

This afternoon, the device maker went on to unveil real-world data regarding the use of its Guardian Connect CGM and Sugar.IQ diabetes assistant app (developed with IBM Watson Health) among more than 3,100 people with diabetes. Here, the company said that patients using the Guardian Connect system and the app stayed within their glycemic range 4.1% more often than those using the system without the app. An additional Glycemic Assist feature that allows users to review how specific foods impacted their response also boosted their time in range by another 4%.

“Sugar.IQ is the first app to use machine-learning to detect glucose level patterns for advanced notification of low and high events associated with diabetes,” Michael Hill, VP and general manager of the Multiple Daily Injection Solutions business within the Diabetes Group at Medtronic, said in a statement. “These results suggest the Sugar.IQ diabetes assistant, together with our Guardian Connect system, may help patients better understand glucose trends and increase their time in range, aiding in behavior change which may ultimately help improve clinical outcomes.”

Finally, the company said Saturday that it has kicked off two new diabetes trials. The first will involve a Bluetooth-enabled MiniMed 780G advanced hybrid closed loop system, and will enroll up to 350 adult and pediatric patients. The second will examine the Guardian CGM sensor among 460 adult participants aged two years to 80 years.

Onduo-Orpyx partnership update

Verily-Sanofi joint venture Onduo and diabetic foot ulcer sensor company Orpyx Medical Technologies extended their collaboration today with the announcement of a new digital diabetes management offering for buyers.

Now, companies who are employing the Onduo Virtual Diabetes Clinic — a system of integrated software, devices and services — may choose to expand their programs and provide Orpyx’s sensors to those with diabetes. Conversely, those working with the sensor maker may also choose to provide their population with access to the Virtual Diabetes Clinic.

"There are a lot of diabetes management companies that do lifestyle and coaching.  At Onduo, we do the same but our clinic is particularly focused on bringing deep clinical interventions that can help those who need more.  One of the top complications — and cost drivers — of living with type 2 diabetes is foot ulcers.  This joint offering with Orpyx gives us one more arrow in our quiver to help target and address the interventional needs for those who need it.”

Virta Health shares two-year data

Two-year data from Virta Health’s ongoing five-year study of its digital Type 2 diabetes therapeutic boasted significant reductions in HbA1c, fasting glucose, fasting insulin, weight, systolic and diastolic blood pressure and other key metrics, according to a writeup published in Endocrinology. Of note, the nutritional ketosis-based treatment reversed the condition in 55% of patients, and reduced or eliminated the need for insulin among more than 90% of those who had been using it at the study’s onset.

On the other hand, there were some dips comparing the data to the year one check in — namely, a 60% rate of condition reversal, and an attrition rate that increased from 17% at one year to 26% at two.

“These results provide evidence that sustained improvement in diabetes status can be achieved through the continuous remote monitoring and accountability mechanisms provided by this multi-component CCI including recommendations for low-carbohydrate nutrition,” the researchers concluded.

Wearable insulin delivery device lowers blood sugar

Valeritas, maker of the V-Go Wearable Insulin Delivery Device, highlighted new data implying that Type 2 diabetes patients who switched to the device from basal insulin regimens could lower their average blood sugar levels. The retrospective analysis included 73 patients, and demonstrated an average A1c reduction of −1.3. Hypoglycemia fell from 23% to 19% among the participants, while severe hypoglycemia was reduced from 10% to 3%.

“Insulin therapy is often intensified utilizing a stepwise approach of adding one injection at a time due to the increased burden and complexity associated with basal-bolus therapy,” Dr. Trisha Zeidan, the study’s principal investigator and an endocrinologist at the Premier Physician Network, Bull Family Diabetes Center, said in a statement from Valeritas. “Although this stepwise approach is well accepted, research demonstrates in one year, the majority of patients will require full basal-bolus therapy to manage their diabetes.  In our experience, V-Go offers a straightforward way to intensify directly from basal to basal-bolus therapy and has been well accepted by patients and proven effective, which is conducive to patient self-management.” 

Lilly study shows Livongo promotes self-efficacy

A study conducted by Livongo and Eli Lilly and Company suggests that the majority of patients enrolled in the Livongo for Diabetes program report high psychosocial self-efficacy or infrequently overwhelmed by their condition after 12 months. More specifically, among a cohort of 957 participants aged an average of 55 years, 61 percent of diabetes patients improved their scores on the Diabetes Empowerment Scale — Short Form (DES-SF) and the Diabetes Distress Scale 2 (DDS2), while 94 percent scored higher on at least one of the validated surveys.

"These study findings are exciting as they indicate the Livongo for Diabetes program is fulfilling our mission of empowering our Members to better manage their conditions on their own terms," Dr. Bimal Shah, chief medical officer of Livongo, and senior author of the study, said in a statement. "Our Members who chose to complete the DES-SF or DDS2 are more confident after using Livongo and people with diabetes who were on insulin or had comorbid conditions saw improvements in their empowerment scores. This suggests that people with complex treatment regimens using Livongo have a great opportunity to learn more about their diabetes management."

Freestyle Libre leads to 1% HbA1c drop

Use of Abbott’s FreeStyle Libre CGM system significantly reduced the HbA1c levels of 363 European Type 2 diabetes patients receiving intensive insulin therapy, according to a late-breaking retrospective analysis. The nearly 1% change was observed after at least three months of using the system.

"These real-world findings highlight how Abbott's FreeStyle Libre system can fundamentally change how people manage their diabetes, especially for people living with Type 2 diabetes," Dr. Helene Hanaire of the University Hospital Center of Toulouse in Toulouse, France, and one of the lead authors of the study, said in a statement. "By using the real-time results, trends and patterns from the technology right at their fingertips, people with diabetes are becoming more actively engaged in making better decisions to control their glucose levels and improve their own health."

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