The marriage of apps and software with type 2 diabetes care has been rocky at best because successful management of the condition eludes simple cause-and-effect algorithms. However, because of a lesson learned at a summer camp, a new software system promises to improve that relationship.
The software management system Insulia, from Voluntis, a French/U.S. company, is expected to be available on a prescription basis in the coming months for people with type 2 diabetes who use long-acting insulin, according to company CEO and founder Pierre Leurent. In December 2016 the system received both its 501(k), or market clearance by the Food and Drug Administration in the United States, and its CE mark to be sold in the European Union.
“The system goes beyond simply making recommendations to the patient based on blood sugar readings,” Leurent says. “It collects data, analyzes data, makes insulin-dosing recommendations based on that information, and allows for remote following and all of it in partnership with the patient’s care giver. It’s incredibly comprehensive.”
One key aspect of Insulia’s effectiveness is that the patient’s physician, or caregiver, is not only involved in using the software with the patients, but can be active along with the patient in working with the software to improve care, Leurent says.
Information from Voluntis describes the process of getting set up with Insulia as being fairly straightforward. A patient meets with his or her doctor and together they set up a treatment plan based on the patient’s profile, insulin dose, and targets for blood glucose levels. This information is put into Insulia, which is simultaneously available to the patient via an app on their Android or iOS phone, tablet, or via a web portal. Based on glucose levels and targets the Insulia algorithm then makes instant recommendations for basal dosing directly to the patient. The patient data is then automatically shared with the health care team.
In the United States patients using Insulia typically input glucose readings at least once a day for the algorithm to have a baseline from which to work. In Europe many glucose meters are connected to Bluetooth and there’s no need for data input by the patient. Leurent says blood glucose monitor and Bluetooth connectivity is coming to the U.S. in the near future. Leurent knows that having a system that minimizes patient input, while delivering information and recommendations instantly to patients, is crucial to having a system work effectively because he learned it at summer camp.
In 2002, a year after the company started, Leurent and Voluntis partnered with the Juvenile Diabetes Association in France to provide remote blood glucose monitoring to children with diabetes at summer camps. Leurent, who is an engineer, had started out in electronic medical record development but wanted to move into an area where he could develop programs and systems to help people with chronic conditions better monitor their health.
“Even when I was in medical records work I saw the potential to have patients get more involved with chronic disease management, and to do so with their caregivers,” Leurent says. “Since then we have worked in various areas, such as cardiovascular, oncology, and helping people with hemophilia. But, we made a specific effort in diabetes from the beginning.”
The Voluntis remote monitoring system worked fine at the summer camps, but afterward a curious thing happened. “After the camp, the kids stopped using the solution,” Leurent says. “They stopped using it because it was passive. They had to input all this information, but then they didn’t see any meaning come out of it for themselves. The information that was gathered was helping the caregivers, who would see it and share it weeks or months later, but it didn’t help the patients immediately, or at the time.”
That was an “ah ha” moment for Leurent. In 2003 he set his sights on developing a system that delivered instant feedback—which is how Insulia now works—so patients could benefit on a day-to-day basis. In 2005, in Paris, Voluntis conducted a clinical trial (a first for diabetes software) on ten patients for four months to gauge the effectiveness of his system. Six years later, with an improved system, Voluntis ran another clinical trial; this one for two years on 667 patients and, yet again, it was a first of its kind.
“We ran a trial to capture economic data of improved treatment using our system,” Leurent says. “We found subjects lowered their A1c an average of 0.9 percent on our system. That translated into major costs savings through avoidance of hospitalization and surgery, savings on lost work time, physician visits, even savings on transportation to hospital.”
The trial led Leurent to conclude that Insulia, and other systems like it, can help to reorganize care management for people with diabetes. If each patient has the tools to act on behalf of the physician and also in concert with the physician, better care can be achieved through a proactive model where both concerned groups collaborate empowered by technology. Leurent makes these comments aware that not every patient is eager to embrace the wonders of the newly digitized era.
“There are two major groups,” he says. “There is the heavy technology user who feels more empowered by the software and by what it can do. And there is the less intensive user. But, they feel reassured because they are more in touch with their healthcare provider through the technology.”
Leurent and Voluntis are now in the process of determining the cost of the system in the U.S., as well as working with insurance companies and other interested groups, to ensure the system is made available to as many patients as possible. But, he says, the future of this “doctor in a pocket” approach, in which patients become more active in working with their healthcare provider to improve their own care through technology, is fast approaching.
“I think it’s an exciting time,” Leurent says. “The market is accelerating. It’s a convergence of many factors—technology, ease of use, physician buy-in—but it all means better care for people with type 2 diabetes. That’s such a positive thing.”