Can a new app jointly developed by IBM with its Watson AI technology in partnership with the medical device maker Medtronic provide a new form of support for people with diabetes by safely avoiding low blood glucose (BG) levels (called hypoglycemia), in advance? If so, and assuming regulatory approval, this technology could potentially be a very significant boon to the care of this disease.
Basics of Managing Blood Glucose Levels
The daily management of diabetes involves a diverse mix of factors including, but not limited to, regulating insulin dosages, checking BG readings, measuring carbohydrate intakes at meals, gauging activity and exercise levels, and controlling stress levels. There is no perfect algorithm to do this as everyone with this medical condition is different from one another and their bodies react in individual ways in trying to balance all of this while striving to maintain healthy short and long-term control of BG levels.
Diabetes care today operates in a very data-driven environment. BG levels, expressed numerically, can be checked on hand-held meter and test strips using a single drop of blood or a continuous glucose monitoring system (CGM). The latter consists of a thumb drive-size sensor attached with temporary adhesive to the skin and a needle attached to this unit inserted just below the skin. This system provides patients with frequent real-time readings of their BG levels, and whether they are trending up or down, so they can adjust their medication accordingly. That is, for A grams of carbs and B amounts of physical activity and other contributing factors, C amount of insulin can be calculated and dispensed.
Insulin itself can be administered either manually by injection or by an insulin pump (also with a subcutaneously inserted needle). The later of these consists of two devices: The pump itself, a small enclosed device (about the size of a pager), with an infusion needle placed under the patient’s skin and a Bluetooth-enabled handheld device (that looks just like a smartphone), used to adjust the pump’s dosage and timing of insulin released. Some pump manufacturers are also bringing to market their latest generation of CGMs that integrate their data and command functions with their users’ smartphones.
(The links in the previous two paragraphs are to Wikipedia pages with detailed pages and photos on CGMs and insulin pumps. See also, this June 27, 2015 Subway Fold post entitled Medical Researchers are Developing a “Smart Insulin Patch” for another glucose sensing and insulin dispensing system under development.)
The trickiest part of all of these systems is maintaining levels of BG throughout each day that are within an acceptable range of values. High levels can result in a host of difficult symptoms. Hypoglycemic low levels, can quickly become serious, manifesting as dizziness, confusion and other symptoms, and can ultimately lead to unconsciousness in extreme cases if not treated immediately.
New App for Predicting and Preventing Low Blood Glucose Levels
Taking this challenge to an entirely new level, at last week’s annual Consumer Electronics Show (CES) held in Las Vegas, IBM and Medtronic jointly announced their new app to predict hypoglycemic events in advance. The app is built upon Watson’s significant strengths in artificial intelligence (AI) and machine learning to sift through and intuit patterns in large volumes of data, in this case generated from Medtronic’s user base for their CGMs and insulin pumps. This story was covered in a most interesting article posted in The Washington Post on January 6, 2016 entitled IBM Extends Health Care Bet With Under Armour, Medtronic by Jing Cao and Michelle Fay Cortez. I will summarize and annotate this report and then pose some of my own questions.
The announcement and demo of this new app on January 6, 2016 at CES showed the process by which a patient’s data can be collected from their Medtronic devices and then combined with additional information from their wearable activity trackers and food intake. Next, all of this information is processed through Watson in order to “provide feedback” for the patient to “manage their diabetes”.
Present and Future Plans for The App and This Approach
Making the announcement were Virginia Rometty, Chairman, President and CEO of IBM, and Omar Ishrak, Chairman and CEO of Medtronic. The introduction of this technology is expected in the summer of 2016. It still needs to be submitted to the US government’s regulatory review process.
Ms. Rometty said that the capability to predict low BG events, in some cases up to three hours before they occur, is a “breakthrough”. She described Watson as “cognitive computing”, using algorithms to generate “prescriptive and predictive analysis”. The company is currently making a major strategic move into finding and facilitating applications and partners for Watson in the health care industry. (The eight Subway Fold posts cover other various systems and developments using Watson.)
Hooman Hakami, Executive VP and President, of the Diabetes Group at Medtronic, described how his company is working to “anticipate” how the behavior of each person with Diabetes affects their blood glucose levels. With this information they can then “make choices to improve their health”. Here is the page from the company’s website about their partnership with IBM to work together on treating diabetes.
In the future, both companies are aiming to “give patients real-time information” on how their individual data is influencing their BG levels and “provide coaching” to assist them in making adjustments to keep their readings in a “healthy range”. In one scenario, patients might receive a text message that “they have an 85% chance of developing low blood sugar within an hour”. This will also include a recommendation to watch their readings and eat something to raise their BG back up to a safer level.
- Will this make patients more or less diligent in their daily care? Is there potential for patients to possibly assume less responsibility for their care if they sense that the management of their diabetes is running on a form of remote control? Alternatively, might this result in too much information for patients to manage?
- What would be the possible results if this app is ever engineered to work in conjunction with the artificial pancreas project being led in by Ed Damiano and his group of developers in Boston?
- If this app receives regulatory approval and gains wide acceptance among people with diabetes, what does this medical ecosystem look like in the future for patients, doctors, medical insurance providers, regulatory agencies, and medical system entrepreneurs? How might it positively or negatively affect the market for insulin pumps and CGMs?
- Should IBM and Medtronic consider making their app available on and open-source basis to enable other individuals and groups of developers to improve it as well as develop additional new apps?
- Whether and how will insurance policies for both patients and manufacturers, deal with any potential liability that may arise if the app causes some unforeseen adverse effects? Will medical insurance even cover, encourage or discourage the use of such an app?
- Will the data generated by the app ever be used in any unforeseen ways that could affect patients’ privacy? Would patients using the new app have to relinquish all rights and interests to their own BG data?
- What other medical conditions might benefit from a similar type of real-time data, feedback and recommendation system?