How will AI & Analytics empower Patients to monitor, manage, and control Chronic Diseases like Diabetes?

Context

2018 was an extremely difficult year for me – I saw my 84 year old father, a successful entrepreneur and self-made millionaire who has traveled across 70 countries, gradually succumb to severe and debilitating Type 2 Diabetes induced Chronic Kidney Disease (CKD) and failure. I was at his bedside when his doctors started him on Dialysis multiple times a week, which in turn induced sepsis and eventually death on Christmas Eve of last year!

Unfortunately, my father’s diabetes induced kidney disease is not an outlier - Diabetes was the seventh leading cause of death in the United States in 2015 based on the 79,535 death certificates in which diabetes was listed as the underlying cause of death.

Diabetes is the “Epidemic of the 21st Century”!

Here are relevant stats on the incidence of Diabetes in the US which are of concern – matter of fact, Diabetes has often been referred to as “the epidemic of the 21st century” [Ref 1]!

• Prevalence: In 2015, 30.3 million Americans, or 9.4% of the population, had diabetes. Approximately 1.25 million American children and adults have type 1 diabetes.
• Undiagnosed: Of the 30.3 million adults with diabetes, 23.1 million were diagnosed, and 7.2 million were undiagnosed.
• Prevalence in Seniors: The percentage of Americans age 65 and older remains high, at 25.2%, or 12.0 million seniors (diagnosed and undiagnosed).
• New Cases: 1.5 million Americans are diagnosed with diabetes every year.
• Pre-diabetes: In 2015, 84.1 million Americans age 18 and older had?pre-diabetes.
• Deaths: Diabetes remains the 7th leading cause of death in the United States in 2015, with 79,535 death certificates listing it as the underlying cause of death, and a total of 252,806 death certificates listing diabetes as an underlying or contributing cause of death.

With diabetes, the small blood vessels in the body are injured. When the blood vessels in the kidneys are injured, your kidneys cannot clean your blood properly. Your body will retain more water and salt than it should, which can result in weight gain and ankle swelling. You may have protein in your urine. Also, waste materials will build up in your blood.

Diabetes also may cause damage to nerves in your body. This can cause difficulty in emptying your bladder. The pressure resulting from your full bladder can back up and injure the kidneys. Also, if urine remains in your bladder for a long time, you can develop an infection from the rapid growth of bacteria in urine that has a high sugar level.

About 30 percent of patients with Type 1 (juvenile onset) diabetes and 10 to 40 percent of those with Type 2 (adult onset) diabetes eventually will suffer from kidney failure.

Diabetes and Kidney Disease

A diagnosis of kidney disease means that a person’s kidneys are damaged and cannot filter blood the way they should. This damage can cause wastes to build up in the body. Kidney disease can cause other health problems, such as heart disease. If you have kidney disease, it increases your chances of having a stroke or heart attack. Major risk factors for kidney disease include diabetes, high blood pressure, and family history of kidney failure [Ref 2].

Acute Kidney Injury (AKI):?Sudden and temporary loss of kidney function.

Chronic Kidney Disease (CKD): ?Any condition that causes reduced kidney function over a period of time. Chronic kidney disease may develop over many years and lead to end-stage kidney (or renal) disease (ESRD), as was the case with my father.

Diabetes continues to present a significant clinical and economic burden on the US healthcare system: the incidence of diabetes continues to rise in the United States and is projected to reach 15 per 1000 people by 2050. Despite the introduction of new medications for the treatment of type 2 diabetes, sustaining glycemic control remains a challenge.

Here are the costs associated with treating Diabetes in the US, which are fairly astronomical [Ref 1]:

• $ 327 billion: Total costs of diagnosed diabetes in the United States in 2017
• $ 237 billion for direct medical costs
• $ 90 billion in reduced productivity

Maintaining glycemic control, as measured by hemoglobin (Hb)A1c?levels, in patients with type 2 diabetes is crucial for reducing the serious clinical complications and subsequent economic costs associated with this chronic disease. However, according to real-world data in the 2007–2010 National Health and Nutrition Examination Survey, the proportion of patients reaching an HbA1c?goal of <7.0% is slightly more than 50%.

Managing?blood glucose?can prevent or slow the progress of many?complications?of diabetes, giving one many more years of healthy, active life.

Managing diabetes means getting as close to a normal (non-diabetic)?blood?glucose?level?as you safely can. Generally, this means levels between 70 and 130?mg/dl?before meals, and less than 180 two hours after starting a meal, with a glycated hemoglobin (A1C) level less than 7 percent. Those targets should be personalized depending on a variety of factors. No one knows why high glucose levels cause complications in people with diabetes. But keeping glucose levels as low as possible prevents or slows some complications [Ref 2].

For the Diabetes Control and Complications Trial (DCCT), researchers followed 1,441 people with?type 1 diabetes?for several years. Half of the people continued standard diabetes treatment while the other half followed an intensive-control program. Those on intensive control kept their blood glucose levels lower than those on standard treatment, although the average level was still above normal.

Here's what they found in the tight-control group as compared with the standard-treatment group:

• Diabetic eye disease started in only one-quarter as many people.
• Kidney disease started in only half as many people.
• Nerve disease started in only one-third as many people.
• Far fewer people who already had early forms of these three complications got worse.

So why are Diabetes Patients challenged to maintain lower blood glucose levels?

I was personally diagnosed with Type 2 Diabetes last year and my father’s death from Diabetes induced Kidney failure was a wake-up call to say the least! Given my engagement with other type 2 Diabetes patients, almost all of whom are on similar routines of losing weight thru diet control and exercise and life style changes, monitoring, measuring and controlling their blood sugar levels using standard glucometers , by pricking their fingers and collecting the blood on test strips which feed the Glucometer. This is painful, onerous, avoidable and often the reason that diabetes patients do not check their glucose levels as frequently as is recommended, hence often unaware of their sugar levels, leading them to deviate from their diet and exercise regimen, that exacerbates their condition over time!

Current advances include Continuous Glucose Monitoring (CGM) which are now being integrated with Artificial Intelligence (AI) especially Machine Learning , Natural Language Generation (NLG) and Natural Language Processing (NLP) , which not only monitor glucose levels in the blood on a 24x7 basis, but apply predictive analytics to trigger alerts via text messages letting the patient know his/her glucose levels are approaching high or low thresholds, enabling them to proactively take their doctor prescribed medication or insulin as needed, thereby minimizing the occurrence of unforeseen or adverse events with debilitating impact on the health of the patient.

The FreeStyle Libre Continuous Glucose Monitoring (CGM) System and Smartphone App from Abbott Labs

I am currently using the FreeStyle Libre CGM system from Abbott Labs which comes with a 14 day sensor I wear on my arm, that I can scan on demand with my FreeLibre smart phone app (see photos below) that instantly tells me my glucose level and also charts it on a daily, weekly, and monthly basis.

The FreeStyle Libre Continuous Glucose Monitoring System, Sensor and Smartphone App. All Photos courtesy Abbott Diabetes Care [Ref 3]

The FreeStyle Libre system provides three critical pieces of data with each scan (see photos above and below):

• A real-time glucose reading.
• An eight-hour historical trend.
• A directional trend arrow showing where glucose levels are headed.

The touch-screen reader also holds up to 90 days of data, which allows people to track their glucose levels over time (see photo), and also share this with their doctor during consultations, for a meaningful, fact and insights based conversation re: managing, treating and even reversing their diabetes [Ref 3].

I will humbly confess that this system has worked well for me, and has induced a data and insights driven focus and discipline re: my food habits, daily exercise, meditation, as well as my weight loss regimen, and has helped me maintain my daily glucose levels fairly close to the range stipulated by my doctor, which I am grateful for. The system also automatically records my blood sugar levels in the cloud and communicates these to my endocrinologist or Primary Care Physician (PCP), making for meaningful wellness and disease management discussions based on data driven insights vs. conjecture, anecdotal information or opinions.

The Guardian Continuous Glucose Monitoring (CGM) system with the Artificial Intelligence (AI) powered Sugar.IQ App from Medtronic and IBM Watson Health

A similar system from Medtronic branded Guardian CGM helps people with type 2 diabetes who need to take insulin to maintain their glucose levels. The system includes a small sensor that can be worn up to seven days and a slim, discreet Bluetooth??transmitter that can be worn almost anywhere.

The Guardian-Connect App Displays sensor glucose data, trends and alerts in a simple and easy to use design, as shown below.

Medtronic has also partnered with IBM Watson Health to leverage Watson’s AI capabilities and integrate this with their Guardian CGM system, thru an AI enabled app called Sugar.IQ . Sugar.IQ, the “personal diabetes assistant” continually analyzes how an individual’s glucose level responds to food intake, insulin dosages, daily routines, and other information provided by the app user. With the Sugar.IQ? app, people with diabetes can uncover patterns and insights that affect their glucose levels, which can give them information throughout the day to help stay on track [Ref 4].

Research presented at the American Diabetes Association 2018 conference found that people who used the Sugar.IQ app spent an average of 36 minutes more per day in healthy glucose range [70-180 mg/dL] than they did before using the app.?The time equates to an additional nine days a year in healthy glucose range, which can provide a number of benefits as articulated above [Ref 4].

The emergence of 'Smart Diabetes Wellness and Disease Management' as a Service

While the CGM systems articulated above alert patients re: their Glucose level variance and actions thereof in terms of medication or insulin, we are also witnessing the emergence of Diabetes focused Wellness and Disease Management companies who provide monitoring, analysis, and counseling to incent diet, exercise and life style changes for measurable impact. Two startups who have crafted a compelling portfolio of Diabetes Management services are Livongo Health and Virta Health, that I have been intrigued with.

Diabetes Monitoring and Just-in-Time Intervention from Livongo Health

Livongo Health offers a blood glucose monitor accompanied with a service designed to intervene and help coach people through managing diabetes.?Livongo?Health helps with best practices, but is also designed to intervene before things start to exacerbate. By collecting enough data and applying analytics and intelligence, Livongo Health aspires to create a tool that will be able to figure out the right touch for getting people to manage — and care about — their chronic conditions (see photo below). [Ref 5].

Photo courtesy: Livongo Health [Ref 5].

The actual product is a cellular-connected blood sugar monitor, which takes your blood sugar readings and then sends that information to Livongo Health’s monitoring services. If the reading falls outside of normal bounds, the company will flag that person and offer some kind of recommendation — like drinking a glass of fruit juice, or going for a walk. If it strays too far out of the norm, they’ll get a call from a specialist who will walk them through what to do next.

The just-in-time intervention is Livongo Health’s unique selling proposition (USP), because the service aims to get a call to the person within 90 seconds after the reading comes through.?The company seeks to reduce the barrier to getting people to use the devices as much as possible. For example, strips for blood sugar tests are also free, and all the data is stored and is easily accessible so the users don’t have to constantly take notes on what their current status is.

Livongo Health works with self-insured employers and pharmacy benefit providers to offer the company’s products to prospective patients as an option. While the company is only a little more than three years old, it has purportedly already collected enough data to demonstrate that Livongo Health is able to save as much as $100 a month for payers in the long run [Ref 5].

Nutritional Ketosis, Diabetes Monitoring and Right Time Intervention as a Service from Virta Health

Virta Health had adopted a very disparate and clinically proven approach to Diabetes management and aspires to “reverse type 2 diabetes in 100 MM patients by 2025”. Their approach is one of significantly altering your diet with monitoring and as needed consulting and interventions, offered as a service [Ref 6].

Type 2 diabetes is a disease of high blood sugar driven by insulin resistance, since your cells aren't responding as well to the signal of insulin, and you can't access the sugar in your blood properly. The sugar in your blood is mostly driven by how many carbohydrates you eat, since carbs are just strings of sugar. When you are insulin resistant, you develop carbohydrate intolerance, since you can't efficiently use the sugar broken down from carbs. Continuing to eat carbs is what keeps your blood sugar high. But you have another option - you actually don't have to eat carbs for energy. You can get your energy from fat, which won't raise your blood sugar.

Virta uses a tool called nutritional ketosis , which allows you to use fat as your primary source of energy, instead of carbs. When you are burning fat for your primary energy source, your body will produce molecules called ketones. Research shows that ketones reduce inflammation, provide a steady flow of energy for important organs like your heart and brain, and even can reduce hunger and cravings. The peer-reviewed, published results from Virta's clinical trial show that diabetes can be reversed in as little as 10 weeks (https://diabetes.jmir.org/2017/1/e5/ ), and results can be maintained or improved upon after 1 year (https://link.springer.com/article/10.... ).

Virta claims that that their peer reviewed, published research has demonstrated that [Ref 6]:

• 87 % of insulin users reduced or eliminated usage after 10 weeks,
• 60% of patients have reversed their type 2 diabetes after 1 year
• An average weight loss of 30 lbs after 1 year on the program
• Patients have seen an average of 1% reduction in A1C levels after 10 weeks

Photo courtesy: Virta Health.

The Virta Health service costs around $ 370/month for one year after a one time $ 500 initiation fee paid upfront, with $ 199 per month for subsequent years. The Virta App (shown above) that runs on your smartphone,?collects your biomarker data, like blood glucose, blood ketones, weight, and blood pressure to help your care team adjust the Virta Treatment around your individual biochemistry [Ref 6].

I am definitely intrigued?by the promise of the Virta treatment and will sign up for the treatment to test the efficacy of their program and find out for myself if it really works, as promoted.

"Chronic diseases like Diabetes are the 'Epidemics of the 21st century' that are extremely debilitating and astronomically expensive to treat and manage for Patients, Providers, Payers and Policy Makers."

In closing….

Chronic diseases like Diabetes are the 'epidemics of the 21st century' that are extremely debilitating and often fatal for patients, and are astronomically expensive to treat and manage, for patients, providers, payers and policy makers. Thanks to advances in clinical informatics abetted by healthcare IT, medical devices, artificial intelligence (AI) and analytics, we are witnessing a paradigm shift in the diagnosis as well as the monitoring, measurement, predictive analytics enabled alerting and timely interventions, which hold immense promise for Diabetes patients in the real world like many of us, as articulated above.

If you are aware of other novel technology (Medical Devices/IT/AI/Analytics) enabled approaches (platforms /solutions /services) to monitor, manage, control, or reverse type 2 Diabetes,?I would love to connect with you and learn more – please send me an email at [email protected] , or leave me a voice-mail on my Google Voice # (972) 891-9295.

As always, I welcome your comments and feedback here, on?my blog ,?and on?Twitter at @HITstrategy. ?If you have found?these insights valuable, please subscribe to my blog at?www.HealthScienceStrategy.com ?with your email address or RSS reader.

Disclaimer: The perspective and views expressed in this Blog post are my own and do not represent those of my current or previous employers.

REFERENCES:

1.?????‘Statistics about Diabetes – Overall Numbers, Diabetes and Pre-Diabetes’ , the American Diabetes Association

2.??????‘Diabetes – a major Risk Factor for Kidney Disease’, National Kidney Foundation web-site,

3.?????FreeStyle Libre Continuous Glucose Monitoring (CGM) Systems from Abbott Labs: https://www.abbott.com/life-changing-tech/revolutionizing-cgm-with-freestyle-libre.html

4.?????The Guardian AI-enabled CGM system from Medtronic: https://www.medtronic.com/us-en/transforming-healthcare/aligning-value/collaboration-in-healthcare/leveraging-actionable-data/ibm-watson-sugar-iq.html

5.?????Matthew Lynley, ‘Smart Diabetes Management Service Livongo Health rasises $ 52.5 MM and looks to new markets’ , Tech Crunch Magazine, 2017

6.?????‘How Virta Health works’ , from the Virta Health web-site