Tagged: blood glucose control

  • A 2017 research project found that only 6 out of 18 FDA-approved blood glucose monitoring (BGM) systems tested were accurate
  • Each day BGM systems are used by millions of people with diabetes to help them self-manage their condition, and avoid devastating and costly complications
  • Thousands of similar smart devices support the prevention and self management of other chronic lifetime conditions, whose prevalence levels are high
  • The increasing demand for healthcare, its escalating costs, and rapidly evolving technologies are driving the growth of such remote self-managed devices
  • The most valuable aspect of such devices is the data they produce
  • These data tend to be under valued and under utilized by healthcare providers
  • This has created an opportunity for giant technology companies to enter the healthcare market with a plethora of smart devices and start utilizing the data they collect to enhance patient outcomes and lower costs
  • Giant technology companies could dis-intermediate GPs and re-engineer primary care

Digital blood glucose monitors and the disruptive impact of giant tech companies on healthcare

A 2017 research project, which tested 18 FDA-approved digital blood glucose monitoring (BGM) systems, which are used daily by millions of people with diabetes to check the concentration of glucose in their blood, found that only 6 were accurate. The research, led by David Klonoff of the Diabetes Research Institute at San Mateo, California, was funded by Abbott Laboratories.
This Commentary describes both traditional and next-generation BGM systems, and Klonoff’s research. The Commentary suggests that BGM systems are just one part of a vast, global, rapidly growing market for consumer healthcare devices, and argues that the most valuable aspect of these devices is the data they collect. With some notable exceptions, healthcare professionals do not optimally utilize these data to enhance care and reduce costs. This has created for an opportunity for technology companies to enter the healthcare market and re-engineer primary care. The one thing, which might slow the march of giant technology companies into mainstream healthcare, is the privacy issue.

Traditional and next-generation BGM systems
Traditional BGM systems
Regularly, each day, BGM systems are used by millions of people with diabetes to help them manage their condition. Managing diabetes varies from individual to individual, and peoples with diabetes usually self-monitor their blood glucose concentration from a small drop of capillary blood taken from a finger prick. They then apply the blood to a chemically active disposable 'test-strip'. Different manufacturers use different technology, but most systems measure an electrical characteristic, and use this to determine the glucose level in the blood. Such monitoring is the most common way for a person with diabetes to understand how different foods, medications, and activities affect their condition. The challenge for individuals with diabetes is that blood glucose levels have to be tested up to 12 times a day. People obliged to do this find finger pricking painful, inconvenient and intrusive, and, as a consequence, many people with diabetes do not check their glucose levels as frequently as they should, and this can have significant health implications. If your levels drop too low, you face the threat of hypoglycemia, which can cause confusion or disorientation, and in its most severe forms, loss of consciousness, coma or even death. Conversely, if your blood glucose levels are too high over a long period, you risk heart disease, blindness, renal failure and lower limb amputation.

Next generation BGM system
Abbott Laboratories Inc. markets a BGM system, which eliminates the need for routine finger pricks that are necessary when using traditional glucose monitors. Instead of finger pricks and strips, the BGM system, which measures interstitial fluid glucose levels, comprises a small sensor and a reader. An optional companion app for Android mobile devices is also available. The sensor is a few centimetres in diameter and is designed to stay in place for 10 days. It is applied to the skin, usually on the upper arm. A thin (0.4 mm), flexible and sterile fibre within the sensor is inserted in the skin to a depth of 5 mm. The fibre draws interstitial fluid from the muscle into the sensor, where glucose levels are automatically measured every minute and stored at 15-minute intervals for 8 hours. Glucose levels can be seen at any time by scanning the reader over the sensor. When scanned the sensor provides an answer immediately. It also shows an 8-hour history of your blood glucose levels, and a trend arrow showing the direction your glucose is heading. The device avoids the pain, and inconvenience caused by finger-prick sampling, which can deter people with diabetes from taking regular measurements. In the UK the system costs £58 for the reader, plus £58 for a disposable sensor, which must be replaced every 10 days and from November 2017 have been available on the NHSAbbott Laboratories is a global NASDAQ traded US MedTech Company, with a market cap of US$86bn; annual revenues of US$21bn, and a diabetes care division, which produces annual revenues of some US$600m.
Klonoff’s research on BGM systems

BGM systems used by Klonoff and his team for their research were acquired over-the-counter and independent of their manufacturers. All were tested according to a protocol developed by a panel of experts in BGM surveillance testing.
Klonoff’s research specified that for a BGM system to be compliant, a blood glucose value must be within 15% of a reference plasma value for a blood glucose >100 mg/dl, and within 15 mg/dl of a reference plasma value for a blood glucose approved” a BGM system had to pass all 3 trials.  Only 6 out of 18 passed by achieving an overall compliance rate of 95% or higher. 


Klonoff’s findings add credibility to patients’ concerns about the accuracy of BGM systems, which triggered responses from both manufactures and the US Food and Drug Administration  (FDA). Manufacturers suggest that increasing the accuracy of BGM systems would raise their costs, and reduce their availability, which patients do not want. The FDA tightened approvals for BGM systems, and in 2016 issued 2 sets of guidelines, one for clinical settings, and another for personal home-use. The guidelines only apply to new products, and do not impact BGM systems already on the market. So while the FDA’s tighter accuracy requirements are a positive change, there are a significant number of less-accurate BGM systems still on the market. 
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Next-generation BGM systems
Next generation BGM systems use ‘sensing’ technology, and have the capacity to automatically track and send blood glucose readings to the user’s smartphone, then onto their healthcare provider through the cloud where they can be amalgamated with other data. Analytics can then track an individual’s data, and compare them to larger aggregated data sets to detect trends, and provide personalized care.

Large rapidly growing remote self-managed device market

Although BGM systems address a vast global market, they represent just one part of a much larger, rapidly growing, remote monitoring market to help prevent and self-manage all chronic lifetime conditions, while improving healthcare utilization, and reducing costs. In 2015 some 165,000 healthcare apps were downloaded more than 3bn times. Of these, 44% were medical apps, and 12% were apps for managing chronic lifetime conditions. Today, mobile devices enable people to use their smartphones to inspect their eardrums, detect sleep apnoea, test haemoglobin, vital signs such as blood pressure, and oxygen concentration in the blood. This is a significant advance from the early precursor of activity tracker and step counting.

Chronic lifetime conditions
21st century healthcare in developed countries is predominantly about managing chronic lifetime illnesses such as diabetes, cancer, heart disease and respiratory conditions. These 4 diseases have high prevalence levels, relatively poor outcomes, and account for the overwhelming proportion of healthcare costs. For instance, in the US alone, almost 50% of adults (117m) suffer from a chronic lifetime condition, and 25% have multiple chronic conditions. 86% of America’s $2.7 trillion annual health care expenditures are for people with chronic health conditions. This chronic disease pattern is replicated throughout the developed world, and has significant healthcare utilization and cost implications for public and private payers, individuals, and families.
Healthcare providers tend not to optimally utilize data

Although personal remote devices are increasingly important in the management of chronic conditions, the data these devices create are underutilized, despite their potential for improving outcomes and reducing costs. This is partly because doctors and health providers neither have the capacity nor the resources to exploit the full potential of these data; partly because doctors tend to resist technology to improve doctor-patient interactions, and partly because remote healthcare devices have not been validated for clinical use. 

Although health professionals tend to prefer to use more expensive medical grade devices, which ensure data validity, but often drive up costs, research validating the data collected by remote self-managed devices for clinical use is beginning to emerge. In 2016 Analog Devices, a US multinational semiconductor company specializing in data conversion and signal processing technology, and LifeQa private US company with advanced bio-mathematical capabilities, announced a joint venture to establish whether data from wearable’s are accurate enough for clinical use.
A study published in 2017 in the journal Nature Biotechnologyprovides some validation for data derived from apps to be used clinically. Using ResearchKit, an open source framework introduced by Apple in 2015 that allows researchers and developers to create powerful apps for medical research, the 6-month study enrolled 7,600 smartphone users who completed surveys on how they used an app to manage their asthma. Researchers then compared these patient-reported data with similar data from traditional asthma research, and found that there were no significant differences. Although there still remains some methodological challenges, the findings gave scientists confidence that data derived from an app could be reliable enough for clinical research. If data from self-managed remote monitoring devices are validated, then such devices could be used to unobtrusively and cost effectively enter the daily lives of patients to collect meaningful healthcare patient data, which could be used to enhance outcomes. Early research adopters of ResearchKit include the University of Oxford, Stanford Medicine, and the Dana-Farber Cancer Institute.

Giant technology companies entering healthcare market
The increasing validation of data generated by mobile devices and the continued underutilization of such data by health providers has created an opportunity for giant global technology companies to enter the healthcare market by: (i) developing and marketing self-monitoring devices directly to consumers, (ii) collecting, integrating, storing and analysing data generated by these remote devices, and (iii) supporting research initiatives to validate data from remote devices for clinical use.

Apple Inc.
Just one example of giant technology companies entering the healthcare market is Apple Inc., which has a market cap of about US$1tn and 700m users worldwide. In 2017, Apple announced that it has been testing a BGM system, which pairs with the company’s existing Watch wearable. In August 2017, the US Patent and Trademark Office officially published a series of 50 newly granted patents to Apple. One covers an invention relating to health data, and more specifically to a smartphone that computes health data. 
The technology involves emitting light onto a user’s body part and measuring the amount of light reflected back. This data can then help to determine body fat, breathing and even emotional health. This, and other patents issued to Apple fuel rumors that the company is preparing to turn its flagship smartphone into a predominantly healthcare-focused device.

Given the size and momentum of technology giants entering the healthcare market, and given the powerful demographic, technological, social and economic drivers of this market, it seems reasonable to assume that in the medium term, giant technology companies are well positioned to dis-intermediate primary care doctors, and re-engineer primary care. One thing that could slow this march, is the question of privacy. Health records are as private as private gets - from alcohol or drug abuse to sexually transmitted diseases or details of abortions: things we may never want to reveal to employers, friends or even family members. Significantly, these data are permanent, and privacy at this point is non-negotiable.
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