Your smartphone can help you peek through a home security camera while you're at work, and it can show you a real-time map filled with cars ready to give you a lift on a moment's notice.
But when it comes to displaying blood-sugar levels for diabetics, the promise of an accurate and simple smartphone app still seems like a far-off goal. This week Twin Cities device maker Pops! Diabetes Care enrolled its first patient in a clinical study it is sponsoring to see whether a device it calls the "Pops! one" can finally fill that long-sought niche.
The company submitted the device for clearance to the Food and Drug Administration last spring. Although Pops doesn't need a study to get a green light from the FDA, CEO Lonny Stormo said the company wants to develop the clinical data anyway.
That's why it's partnering with the Children's Minnesota health care system on a six-month study of 50 young patients with type 1 diabetes, previously called juvenile diabetes, who will use the Pops device to measure their blood-glucose levels and tell them when they need to inject insulin.
"We want to be an evidence-based company," Stormo said. "We believe in our system, we believe the system is going to change the lives of people with diabetes, that better [user] experience will lead to better outcomes. We want to publish that evidence and get it out there. And we believe that helps our sales model."
Diabetes is a rapidly growing disease, and billions of dollars in sales are up for grabs in the market for patient-operated diabetes devices. Past studies have shown that more-frequent testing of blood glucose levels results in improved control of a person's blood-sugar levels.
Minnesota-run Medtronic PLC is one of the major corporate players, though much of its technology today is focused on semi-automated insulin pumps that operate using a continuous glucose meter that users wear day and night. Illinois-based Abbott Laboratories, a major supplier of traditional blood-testing strips and continuous glucose meters, made a recent splash in the market by teaming up with diabetes-tech start-up Bigfoot Biomedical to develop a system that will enable accurate and secure glucose monitoring with a smartphone app as a central feature.
Meanwhile, open-source solutions that move real-time glucose data from body-worn monitors onto smartphones and wearable devices have proliferated via hashtags like #WeAreNotWaiting.
Many of those solutions are intended for the most frequent insulin users, for whom diabetes is a constant struggle, especially during sleeping hours. The Pops! device is intended for diabetics with moderate insulin needs — people who are dosing at least four times a day but do not need a pump that administers small doses constantly.
The device's three components work in concert to cut down on user headaches that prevent diabetics, including Stormo, from doing more frequent testing of their blood sugar.
The most visible piece is the blood-testing device itself. Slightly smaller than a typical smartphone, the device's gold cover slides down to reveal a disposable cartridge with three tiny lancets and glucose meters that are intended to be easier and less painful than using a typical finger-stick unit with individual test strips. Each replacement cartridge can be used for three tests.
The device, which can attach directly to the back of a cellphone, uses a Bluetooth connection to send the glucose data to the company's app, which is downloaded from Apple's App Store. (An Android compatible version is planned for next year.) The app displays encouraging messages when the user's glucose stays in range, and it can also show historical trends and connect users via a "friends" button.
Finally, the app communicates with a remote cloud-computing system, which allows data to be analyzed and viewed remotely by parents or doctors, while pushing out reminders and notifications, among other functions.
"We find that the more contact you have with families, and the more input and encouragement you can provide for these kids and families, the better," said Dr. Laura Gandrud, the pediatric diabetes physician who is principal investigator of the study at Minnesota Children's. "With this system, they are getting reminders and feedback. … What we will test is, can we increase the engagement of these kids?"
The study is open to up to 50 patients with diabetes at Children's between the ages of 10 and 25 who require multiple injections of insulin per day but do not use an insulin pump. The study is aimed at people who have type 1 diabetes, which is the more severe form in which the body's immune system destroys cells in the pancreas that make insulin to keep blood sugar in check.
Stormo said people who have advanced type 2 diabetes may also eventually be good candidates for the device.
The study's primary purpose is to measure changes in a patient's hemoglobin A1C levels over six months, as compared to that same patient's readings in the prior six months. Secondary outcomes measured in the study will include changes in the number of blood-glucose readings done per day, the range of variability in A1C levels and self-assessed quality of life indicators.
Gandrud is one of Pops!' medical advisory board members, but neither she nor Children's Minnesota has a financial stake in the company.
Founded in 2015, Pops! has already held two fundraising rounds, including a $1.2 million round earlier this year that was disclosed in securities filings. Minneapolis med-tech accelerator TreeHouse Health is the only publicly disclosed investor.
Pops! has four employees and is contracting with outside providers for many of the things its needs done, including app design and manufacturing.
Stormo said the company is considering an unusual sales model in which the entire device platform would be offered under a subscription service, though it's not yet clear whether the patient or some other entity would typically be underwriting the cost.
"While the medical device industry is out trying to engage patients, we think if you say 'engage patients' you've already lost the game," Stormo said. "What we need to do is simplify the user experience, make a great user experience, and that's what we're doing."