Innovative medical devices for diabetes are often thought of as falling into two main categories, insulin pumps and continuous glucose monitors – with devices that link the two, artificial pancreas systems, representing a nascent third category.
Perhaps there is a fourth: all these devices require software, from algorithms to apps to artificial intelligence. Two of the companies active in this space, Glooko and Bigfoot Biomedical, are taking different approaches – one integrating data from different sources to track the condition and one working to create a seamless system for insulin delivery. Both are agreed, however, that the future of diabetes management starts with the smartphone.
Continuous glucose monitors (CGMs) come with apps that the patient can use to keep an eye on their blood sugar, and that alert the user when they need to take insulin or do a quick blood test to ensure the device is accurate. And there are plenty of separate apps diabetics can use to track their symptoms and treatment. Glooko aims to combine these systems and more.
“We’ve got a mobile app that syncs with all the major diabetes devices on the market,” says Michelle de Haaff, a vice-president at Glooko. “A Dexcom or an Abbott Libre CGM, they’ve got an app, but they don’t allow [patients] to see that data along with their insulin. It’s very isolated. Our focus is bringing all the disparate data sources together, allowing the user to add context.”
The patient can input their diet, and the app also syncs with fitness trackers to better understand the patient’s insulin needs. Users can also share the data with their doctor.
This gives Glooko access to massive amounts of information – Ms de Haaff says the company has over eight billion data points – which the company uses to create specific algorithms to give patients better advice. One such algorithm, the Mobile Insulin Dosing System, is designed to help the user titrate their insulin dose, and a recent feasibility trial has indicated that MIDS users achieved better glycaemic control than a control group.
“They are able to get to their optimal insulin dose faster and more effectively than those who are either trying to do it on their own, through some maths, or who are only changing their dose when they visit a doctor every few months,” Ms de Haaff says. A pivotal US trial of this algorithm is to launch in 2018 with an FDA submission to follow.
Having the product regulated by the FDA is crucial to its distribution, Ms de Haaff says. The company wants doctors to suggest the app to their patients, and doctors want clinical data and the FDA’s rubber-stamp. The app itself is free, but the user must pay a subscription, with different options ranging from around $15 to $40 per patient per month.
Some patients do pay out of pocket, but this is relatively rare, Ms de Haaff says. Instead, subscriptions are usually paid for by insurance companies – Ms de Haaff mentions Aetna and Blue Cross Blue Shield – which cover the Glooko software since the company provided data proving its cost-effectiveness.
The technology under development at Bigfoot Biomedical is in some respects similar to Glooko’s – but Bigfoot is incorporating hardware, too. The company acquired the assets of a group called Asante, including an insulin pump, and obtained injector pen technology through the acquisition of Timesulin this summer. It has also licensed rights to Abbott’s FreeStyle Libre glucose monitor – arguably the most advanced CGM on the US market (Dexcom crashes as Abbott FreeStyles its way to the US, September 28, 2017).
“We’re using technology to actually, if you’re taking shots, tell you how much insulin to inject,” says Bigfoot’s chief executive, Jeffrey Brewer. “Or, if you’re using a pump, then it will be automatically infused based on the artificial intelligence engine that we’ve developed – that is going to predict glucose values and titrate insulin in real time.”
Bigfoot contends that current technology needs to be simplified, with the smartphone integrated as part of a class 3 – high risk – medical device. The system for insulin pump users will be called Loop, and that for patients who take their insulin via disposable pens is to be called Inject. Both are in mid-stage development, and will be going into pivotal US trials at the end of next year.
Pivotal studies of these devices generally focus on showing non-inferiority to existing sensors or pumps on safety endpoints.
“We’re going to do more than that,” says Mr Brewer. “In a trial of the infusion system, in, say, a few hundred people for three months we’ll be able to show lowering HbA1c [a measure of blood sugar], we’ll be able to show increased time in safe glycaemic range and decreased hypoglycaemia episodes. But more importantly we have some ambitious objectives with regard to quality of life and ease of use.”
Bigfoot wants approval for a label stating that its systems can make patients’ lives easier, and hopes to be able to prove that they can improve the psychological burden of chronic disease. Whether it will be able to achieve this is not clear; Mr Brewer conceded that this is the first time such a label has been sought.
Relying on artificial intelligence – Bigfoot defines this often nebulous concept as a system that can use data to automatically configure insulin delivery without requiring input from doctors – to take the calculation and planning out of insulin administration surely appeals greatly to diabetics. But, like Glooko, Bigfoot also has a major focus on getting insurers to pay for its technology.
“We believe in putting front and centre the value proposition in terms of the healthcare economic impact – how you see a return in terms of avoided hospital visits,” Mr Brewer explains. He says that every time a patient overdoses on insulin and ends up in hospital for a hypoglycaemia episode the cost to the payer is around $35,000.
Device developers’ increasing focus on convenience as well as efficacy is probably wise. Products like Abbott’s Libre or Medtronic’s 670G work well enough, but what patients increasingly want – and will be more likely to use properly, thus lowering healthcare costs – are systems that work together seamlessly.
Glooko’s MIDS and Bigfoot’s Loop and Inject promise much. It is now a question of obtaining concrete data good enough for approval and widespread reimbursement.