UK-developed non-invasive skin patch monitors blood glucose; a ‘slow-mo’ injection to regulate it

click to enlargeA team from the University of Bath has developed a graphene-based blood glucose sensor that if successfully commercialized could eliminate the diabetic finger-stick. The sensor patch measures the interstitial fluid located between cells within the body-hair follicles–each mini sensor measures an individual follicle, where glucose collects in tiny reservoirs. The sensor patch can monitor every 10-15 minutes for continuous measurement. At this developmental point, readings are not sent to a smartphone. The researchers are focusing on optimizing the number of sensors in the patch, demonstrating successful use over 24 hours, and clinical trials. The University of Bath study with researchers from their Centre for Graphene Science, Centre for Nanoscience & Nanotechnology, and the Department of Pharmacy & Pharmacology, was published in Nature Nanotechnology in March. New Atlas

A possible combination? Treating Type 2 diabetes usually requires medication to regulate insulin. Glucagon-like peptide-1 (GLP1) causes the pancreas to release insulin but has a short half-life. Researchers at Duke University have developed a way to bind GLP1 to a heat-sensitive elastin-like polypeptide which forms a gel-like depot that releases slowly into the body. In early tests with mice and monkeys, the ‘depot’ releases a constant rate of GLP1 for up to 14 days. The slower human metabolism means that this may be a feasible 14-30 day treatment–and translate to the controlled release of other medications. New Atlas

NHS, Public Health England testing multiple digital health devices for obesity, diabetes

NHS England, Public Health England, and Diabetes UK launched a pilot, announced on World Diabetes Day on 14 November, to test various digital health approaches to controlling obesity and Type 2 diabetes. Approximately 5,000 patients will be recruited for a test period of up to one year. Multiple apps, gadgets, wristbands, and other digital devices to measure their results against goals will be tested,  combined with health coaching and online support groups. NHS is also offering to some wearable devices which record activity levels and receive motivational messages and prompts. 

The test will use products and services from five companies and the patients will be recruited from eight areas of the country. The companies, programs, and tools are:

  • Hitachi – Smart Digital Diabetes Prevention program combines an online portal + coaching
  • Buddi Nujjer – a wristband which monitors the user’s activity, sleep patterns and eating frequency, paired with a smartphone application
  • Liva Healthcare – 12 months of a dedicated coach starting with a personal face-to-face meeting. The Liva platform and patient app supports the patient with smart goal setting and plans, lifestyle tracking, video communication, and online peer to peer support.
  • Oviva – An eight-week intensive lifestyle intervention with an experienced dietitian providing personalized advice and support.
  • OurPath – A six-week mobile and desktop digital program with structured education on healthy eating, sleep, exercise and stress management.

The pilot builds on Healthier You: The NHS Diabetes Prevention Programme, launched last year to support people who are at high risk of developing Type 2 diabetes. This adds digital tools to a coaching-intensive, educational, and activity-oriented program. Public Health England also has the Active 10 app, which encourages at least 10 minutes of daily brisk walking. NHS press release, Digital Health

LifeinaBox: portable refrigeration and monitoring for heat sensitive meds

click to enlargeOn this year’s trend–that the companies which look freshest and newest solve specific but important problems–is the debut later this year of LifeinaBox. It is a portable refrigerator/app combo for those who must travel with their medication at a stable, cool temperature, generally between 36 and 46°F (2 and 8°C).

According to CEO Uwe Diegel to this Editor, “There are about 3% of the population that are prisoners of their medication.” In France alone (where the company is), 1,5 million people are dependent on temperature-stable medication. The idea came from a critical situation experienced by his brother Olaf, when a hotel froze his insulin rendering it useless. Medications that must be kept cool are diabetes (insulin), some medications for arthritis and multiple sclerosis, plus growth hormones, but there are also topical steroidal creams that should not be at room temperature. 

The pre-ordering website (starting on 14 Sept) explains the app interface, which monitors the fridge temperature and battery life, also serving up medication reminders and health tips. The fridge itself is under two pounds (900 g) with a rechargeable battery and also directly powered by 110 or 220 v. current or car charger. It can hold refills and vials, for example with a capacity of eight regular medication pens. Other uses this Editor can envision are for disaster and crisis situations where rescue workers, EMTs, and military have to work quick, fast, and lean, throwing it into a backpack. Hat tip to Mr. Diegel via LinkedIn.

Study doubts benefit of basic blood glucose self-monitoring for non-insulin T2 diabetes

Is it the technology, or the human touch? It’s only one study, but the sample size is substantial–450 patients–as was the length of time, one year. This randomized group in the Monitor Trial study published earlier this month in JAMA Internal Medicine came from 15 primary care practices in central North Carolina. All were over 30, were Type 2 diabetics who did not use insulin for control, and had glycemic control (hemoglobin A1c) levels higher than 6.5% but lower than 9.5%, which placed them higher than normal but within excellent to fair control (Endocrineweb.com). The 450 patients were divided into three groups: one with no self-monitoring of blood glucose (SMBG) but were monitored at their doctor’s office, another monitored themselves once daily, and once-daily SMBG with enhanced patient feedback including automatic tailored messages delivered via the Telcare meter (acquired by BioTelemetry in December ’16).

There were no statistically significant differences among the group either in the A1C or another measurement, health-related quality of life and “no notable differences in key adverse events including hypoglycemia frequency, health care utilization, or insulin initiation.”

It seems that in this relatively benign group, self-monitoring alone or mildly enhanced–in other words, patient engagement in SMBG–made no significant difference. The UNC-Chapel Hill researchers concluded that “This pattern suggests that, for SMBG to be an effective self-management tool in non-insulin-treated T2DM, the patient and physician must actively engage in performing, interpreting and acting on the SMBG values.” (Editor’s emphasis) In other words, more–not less–human contact would be needed for SMBG to work better, at least with this group! This Editor would then like to see a comparison with insulin control. Also Healthcare Dive

A breakthrough wearable? Sweat analysis for cystic fibrosis and diabetes diagnosis.

click to enlargeResearchers at Stanford University School of Medicine and University of California-Berkeley have developed a wristband equipped with a sensor that can capture and analyze perspiration. The design stimulates the production of sweat, with the embedded sensors and microprocessors detecting the presence of different molecules and ions based on their electrical signals. In the abstract’s words, this is an “electrochemically enhanced iontophoresis interface, integrated in a wearable sweat analysis platform.” The wearable was tested in two separate studies for detecting a key indicator for cystic fibrosis (CF)–a high level of chloride ions–and in comparing levels of glucose in sweat to blood glucose for diabetes. The data is transmitted via smartphone to a server that analyzes the results in real time.

The potential for this wearable is considerable. First, for CF, it changes a 70-year-old protocol–that sweat is stimulated and collected in a 30-minute procedure, then sent to an outside lab to be analyzed with the usual delay. Children being screened for CF have trouble sitting still for the lengthy test. The second is that the test can be done anywhere with minimal training, making it suitable for underserved communities and developing areas of the world. The third is in CF drug development. CF genetics have multiple mutations, limiting drug usefulness. A test such of this in real time could speed drug clinical trials and human response.

The glucose testing was preliminary in comparing the glucose in sweat with standard blood glucose levels, but also proved that the platform could be used for other perspiration constituents, such as sodium and lactate. The ultimate intent of the researchers is to incorporate the technology into a smartwatch for continuous monitoring, but they recognize two challenges: reproducibility, to see whether measurements are consistent, and mapping all the constituents of sweat.

The report was published on 17 April in Proceedings of the National Academy of Sciences of the United States of America (PNAS). Abstract and full report (PDF, 6 pages). Stanford Medicine News Center

Health tech overstatement of the day: ‘a contact lens that tells you when you’re sick’

click to enlargeThis Editor likes Gizmodo, and doesn’t want to seem overly cynical or critical, but here we go again with an article that gives the impression that biosensing contact lenses are just around the corner. Our Readers will recall Google’s much hyped glucose-sensing lens developed with Novartis/Alcon dating back to 2014 [TTA 27 Mar 15]. This research is out of Oregon State University and is testing a transparent biosensor which will detect glucose levels in tears. The biosensor contains a transparent sheet of IGZO (gallium zinc oxide) transistors and glucose oxidase, an enzyme that breaks down glucose. In breaking down the glucose, it causes the pH level to shift and generate a measurable change in the electrical current going through the IGZO transistors. The researchers project that 2,500 of these transistors could be embedded in the lens, enabling multiple sensors detecting multiple chemicals which could lead to disease detection.

Why raise the yellow flag? If the lenses are to be used for continuous monitoring or even short term, thick lenses (like the old hard plastic or gas-permeable) require a period of wear-in to get the cornea habituated to it, and even after, there is the hazard of corneal abrasion. Irritation is especially hazardous for diabetics, who have a greater likelihood of eye injury and also related vision problems. Animal testing of the current version is over a year away. They don’t yet have a way to power the lens sensors. Contact lenses with sensors for various problems (e.g. Sensimed’s lens for glaucoma intra-ocular pressure) and Samsung’s Gear Blink embedded camera have been prototyped for years and none have made it into commercial release. Cost is a major unanswered question. While the researchers are to be applauded for the approach and applying it to other chemicals detectable in the eye, disease-sensing contact lenses will take years to be commercially available, if ever, and the article largely makes them seem just around the corner. Thin films applied to the skin for vital signs monitoring seem so much more…wearable [TTA 3 Feb]. Research to be presented at the American Chemical Society‘s annual meeting today (4 April). Photo is artist’s depiction of lens, courtesy of OSU

Weapons in the Perpetual Battle of Stalingrad that is diabetes management

A major area for both medicine and for healthcare technology is managing diabetes–Type 1, Type 2 and also pre-diabetes, which is the term used to describe those who are on the path to Type 2 diabetes. Type 1 diabetics, because they have had it for years, usually since youth, have one battle and are fighting that Perpetual Battle of Stalingrad. As this Editor has noted previously, technological tools such as closed-loop systems that combine glucose sensors with insulin pumps take much of the constant monitoring load off the Type 1 person. [TTA 20 Aug, 5 Oct]

But the panel at MedCityNews’ ENGAGE touched on a point that rankles most pre-diabetics and Type 2 diabetics–the lack of empathy both healthcare and most people they know, including family, have for their chronic condition. Many feel personal shame. And digital health ‘solutions’ (a tired term, let’s retire it!–Ed. Donna) either drown the patient in data or send out, as Frank Westermann of Austria’s mySugr said, a lot of negative messaging. Adam Brickman of Omada Health, whose ‘Prevent’ programs are mainly through payers and employers, noted it was a real challenge to get people to change their lifestyle, but also change their state of mind. Their model includes peer support and health coaching, specifically to include that empathy. Home support also makes all ther difference between those who successfully manage their condition and those who don’t, according to Susan Guzman of the Behavioral Diabetes Institute. The approach is certainly not one-size-fits-all.  MedCityNews  In September, Omada received a sizable approval on its approach via a Series C round of $48 million. Current clients include Humana and Costco. Forbes attributes the size of the round to Omada’s approach in tying participant outcomes to over 50 percent of its compensation.

 

IBM Watson Health computes into diabetes management, UK care budgeting (US/UK)

click to enlargeIBM Watson Health, the advanced cognitive computing division of IBM, with Medtronic has developed an app that may, when marketed after FDA approval, help to ease for diabetes patients their daily ‘Battle of Stalingrad’. Sugar.IQ is an app that finds patterns in diabetes data through combining Watson’s cognitive computing capabilities with diabetes data from Medtronic and other sources. The app then uses continuous glucose monitoring data from Medtronic insulin pumps and glucose sensors to give specific, personalized information to the patient on their health trends and how to better manage their diabetes. The analytic features are impressive. Glycemic Assist lets the patient ask the app to follow specific food or therapy-related actions and events to see their exact impact. The Food Logging feature can track specific foods in a diary to determine the effects of specific foods. It is being tested presently on 100 MiniMed Connect users. Previewed at last week’s Health 2.0 conference. HealthcareITNews (photo), Medtronic blog post, Medtronic release (PDF) (This MiniMed Connect is not to be confused with the Medtronic MiniMed 670G artificial pancreas–hybrid closed-loop insulin delivery system for type 1 diabetes patients–just approved by FDA. MedCityNews)

In the UK, Harrow Council in northwest London is using IBM Watson Health’s Care Manager for social care service matching and budgeting. Using “cognitive technologies that provide personalised insight and evidence based guidelines”, Watson will match individuals’ needs and budgets to providers, and will be further able to manage costs over the ten-year agreement by “control(ling) the contract and payments between the individual commissioning for support, and social care providers competing to supply the service.” It’s not entirely clear to this Editor how the individual flexibility of care and services works with the recipient, however. The IBM Watson Health announcement follows on last May’s announcement with Alder Hey Children’s NHS Foundation Trust and the Hartee Centre to transform Alder Hey into the UK’s first “cognitive hospital”. DigitalHealth.net  Hat tip to reader Paul Costello of Viterion Digital Health

Diabetes management: the Next Big Health Tech Thing?

Big Data? Passé. Health IT security and hacking? At a peak. So what’s the Next Big Thing? If you’re tracking where the money’s going, it’s diabetes management. This week saw the joint venture Onduo formed by the controversial [TTA 6 Apr] life sciences-focused Verily (Google Alphabet) and Big Pharma Sanofi with a nest egg of $500 million. Onduo will be combining devices with services to help Type II diabetics. Based upon CEO Joshua Riff’s statements to MedCityNews, their platforms are yet to be developed, but “will be a digital platform that will involve software, hardware, and very importantly service” to change patient behaviors. Partnerships with Sutter Health in Northern California and Allegheny Health Network of western Pennsylvania will test their approaches in a clinical setting. Xconomy, Reuters

Verily’s other diabetes project include the £540 million bioelectronics partnership announced in August with UK-based GSK in Galvani Electronics [TTA 3 Aug] with a focus on inflammatory, metabolic and endocrine disorders, including Type II diabetes. With Dexcom, Verily is also building an inexpensive, smaller next-gen continuous glucose monitoring sensor; Mr Riff was coy about whether this sensor would be used but allowed that sensors might be used in Onduo’s approaches. Verily is also developing the well-known glucose-reading contact lens with Novartis [TTA 1 Sep 15].

Also this week, Glooko and Sweden’s Diasend announced their merger (more…)

Wearables for diabetes, more get thinner on a ‘smart skin’ diet

click to enlargeA team from the Seoul (South Korea) National University, University of Texas-Austin and wearable health sensor developer MC10 [TTA previous articles] have developed a translucent, thin graphene ‘cuff’ with sensors for blood glucose and a not-quite-complete metformin delivery mechanism for those with Type 2 diabetes. The graphene is ‘doped’ with gold to have it transmit blood glucose readings inferred on mechanical strain, skin temperature, and chemical composition of sweat. The mobile app calculates the metformin medication dose needed and the wristband administers it through an array of microneedles. This would not be a semi closed-loop system (dubbed here a ‘robopancreas’) which Type 1 diabetics now can use for insulin delivery, as there’s a delay in sensing and delivery. It also cannot in present form correct for excessively low blood glucose. IEEE Spectrum, Nature (abstract) Hat tip to former TTA Ireland Editor Toni Bunting

click to enlargeAnother wearable sensor bracelet with a distinctly ‘home-brewed’ feel is out of academia, from the Abdullah University of Science and Technology’s Integrated Nanotechnology Laboratory in Thuwal, Saudi Arabia. The research team pulled together office supplies–no, you are not misreading this: (more…)

mHealth Grand Tour: ‘magical’ for cyclists, clinical level information for diabetes

click to enlarge

From the HIMSS Connected Health Conference (CHC)/mHealth Summit

The last Executive Spotlight/keynote on Wednesday morning stepped outside most of this year’s CHC content, first for presenting a European mHealth program and diabetes patients not as overweight, inactive and co-morbid but as athletes. Presented by Benjamin Sarda, Head of Marketing for Orange Healthcare, the mHealth Grand Tour has developed in three years from a fully organized, challenging 2,100 km Brussels-Barcelona ride primarily (but not exclusively) for cyclists with Stage I and II diabetes as a test bed for blood glucose monitoring under extreme exercise, to a 1,500 km Brussels-Geneva three-stage tour with even greater ascent, extreme monitoring and also a full spectrum of vital signs feedback via smartphone to the riders. This past September, 24 riders accumulated 7 million measurements. The cyclists used these measurements (left) click to enlargeclick to enlargeto help manage their food intake, blood glucose, performance and overall wellness. The data is currently being analyzed by France’s Society of Diabetes (SFD), but an early result is that medication compliance was 97 percent. Some had difficulty (with a 22,000 meter climb, who wouldn’t?) but the app helped them manage their ride and what they can do that day. Orange’s interest as a telecom is obviously data but their work with multiple research and mHealth partners (including the Personal Connected Health Alliance which is part of the CHC) and with organizations like the JDRF are part of their big scale. It also represents a ‘jump shift’ in thinking about what is possible in living with diabetes.

What happened in between? Plenty! (More coverage to come.)

Med reminder app improves adherence 7-10 percent

click to enlargeMedisafe, a medication reminder app from Haifa, Israel with offices in Boston, partnered with IMS Health for a study of their app with a test group of 700 patients total with diabetes, hypertension and hyperlipidemia (high cholesterol). Over the study period–six months for hyperlipidemia and hypertension, three months for diabetes–adherence improved 10.7, 5.4 and 7.7 percent respectively versus a control group. The app was rated by IMS’ AppScript app curation team in a recent report as the highest-rated medication management app in terms of AppScript score. Medisafe also enables care collaboration among physicians, patients and families, and also provides personalized content. PR Newswire release. MedCityNews.

Alphabet action versus diabetes with Life Sciences’ contact lens and Sanofi

click to enlarge Monday’s Big Story. As previously reported [TTA 25 Aug], the new Google holding company Alphabet is bringing the Life Sciences group formerly under Google X into its own company, with a new name TBD. On Monday, Life Sciences and Paris-based pharma Sanofi announced a partnership on projects related to diabetes monitoring and treatment. According to BioSpace, “at least part of the partnership will be focusing on helping Life Sciences create small, Internet-based devices that either automatically adjust insulin levels, or make suggestions based on real-time monitoring. ”

Clearly Life Sciences’ raison d’etre includes a focus on this disease, others that may relate to it, and in developing devices that others may market. Your Editors have been tracking their research for well over a year. A roundup of Life Sciences’ partnerships include more than diabetes:

**Novartis division Alcon for the glucose sensing contact lens [TTA 17 July 14, patent report 27 Mar 15 ]

** DexCom to develop a Band-Aid sized wearable for glucose monitoring, announced 15 August

**A 10 year deal with Abbvie for age-related disease exploration (which relates to the accelerated aging associated with diabetes)

**Biogen for multiple sclerosis (MS) treatments

We continue to have doubts about the practicality of the contact lens and the viability of embedded sensors in lenses, as the eyes are extremely sensitive and especially vulnerable for those with diabetes. But directionally on this disease, which is expanding almost uncontrollably worldwide, the research and devices which Life Sciences can develop for a variety of companies looks promising. Business Insider, Re/Code, Digital Trends

Hacking your way to managing your illness

click to enlargeHealth + Hacking doesn’t necessarily mean another data breach. In another context, it means Patients Are Doing It For Themselves and not waiting for an app to help them manage their medical situation. They are self- constructing, deconstructing or repurposing software (or hardware like Fitbits, smartwatches and smartphones) to create customized solutions for themselves and to share with others. A lively young Swedish engineer, through building her own mobile apps to help manage her Parkinson’s disease, is building apps for others and finds her biggest challenge is the wide variety of symptoms.Stage 1 diabetes is a health hackers magnet, with hacks creating new features for continuous glucose monitoring (more…)

46 percent of undiagnosed chronic disease discovered through corporate wellness program

A HealthMine survey of corporate wellness program participants found that 46 percent of respondents who were diagnosed with a previously unknown chronic disease discovered it as a result of their wellness program. Corporate wellness programs have been light on ROI metrics (many are at heart incentive programs). While the survey was conducted by a provider of these programs (HealthMine’s Automatic Health) and should be seen in that light, it also indirectly confirms the proactive value of health screenings. Employees want more as well. Participants in an earlier survey that they would like programs to offer vision (74 percent), genetic testing (75 percent), blood pressure (73 percent), cholesterol (69 percent), cancer (58 percent), and hearing (58 percent). The MedCityNews article also makes the excellent point that employers, through these wellness programs, are directly or indirectly accessing employee personal health information–a legally fraught area.

Medtronic favoring early-stage acquisitions, diabetes; American Well and Teva

Medtronic plc, now firmly planted in the Auld Sod of Ireland, reported a tidy $7.304 bn in its 4th quarter global revenue closing 24 April versus a prior year of $7.257 bn, with a net loss of $1 million. Their report yesterday (2 June) was primarily centered around the integration of Covidien and the foreign currency loss. Results were especially strong in the US with an 8 percent gain in fourth quarter. Earlier speculation that the major Covidien acquisition in addition to Corventis, Zephyr Technologies (through Covidien) and telehealth provider Cardiocom would slow future investments seems to be the direction CEO Omar Ishrak is taking, based on his comments during the analyst call. The Covidien strategy of making early-stage company acquisitions is to his liking and with new revenues from Covidien (and a more favorable tax domicile) certainly there is not a lack of funds despite a small loss in fourth quarter revenues. Another change from being a cardiac-centric device company is apparent in the growth area of global diabetes, shifting from pumps to diabetes management. They have a minority investment in diabetes manager Glooko, a partnership with IBM Watson Health for diabetes management, and acquired a Dutch clinic and research center, Diabeter. Jonah Comstock at Mobihealthnews has more on that call.

In a surprising move, Israel’s Teva Pharmaceuticals is putting a reported ‘tens of millions of dollars’ into American Well and their telemedicine (virtual consult) platform. The pharma interest at once may be narrow in utilizing these consults in clinical trials, but as we have seen with Merck’s telemedicine clinics in Kenya, there’s also a focus on monitoring critical medication at long distances. Late last year American Well completed an $81 million Series C, but it is not clear whether Teva is a part of this and the news is just now catching up. MedCityNews, Globes (Israeli business website)