Are thin-film/adhesive patch glucose monitors the thing this year? University of California San Diego Health (UCSD Health) opened earlier this month a clinical trial of their self-adhesive ‘tattoo’ type glucose monitor. This monitor measures the glucose present in perspiration through two electrodes embedded in the thin adhesive film that apply a small amount of electrical current to make glucose molecules in the skin rise. The clinical trial sampling people with Types 1 and 2 diabetes ages 18-60 with fasting plasma glucose (FPG) > 126 mg/dL, or hemoglobin A1c (HbA1c) > 6.5%. Those in the trial will be comparing their readings from the thin film monitor with a standard glucometer through June 2019. Patients wearing the sensors will receive a minimum of two doses of pilocarpine gel to induce sweat, at fasting and at time points ranging between 15 to 200 minutes post meal. Neither the article nor the clinical trial explain the reading process.
In a Mobihealthnews interview with Patrick Mercier, codirector of UCSD’s Center for Wearable Sensors, the sensor can be produced for under $1, comparable to a blood glucose test strip.
Tattoo-type sensors and strips made the news about two-three years ago in their early stages of development and now are resurfacing with both trials and investment. Sano received $6 million from Fitbit for its combination of sensor and mobile app. The University of Bath has designed a multi-sensor patch that doesn’t need gel to raise a sweat; it measures interstitial fluid located between cells within the body-hair follicles [TTA 24 Apr]. We are rapidly moving towards less-invasive monitoring systems and better diabetes management.
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
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/healbe-gobe-top-4-970×0.jpg” thumb_width=”150″ /]At CEWeek NYC last June, this Editor spent some time with Healbe’s co-founder, who demonstrated to me a prototype of the Healbe GoBe 100% Automatic Body Manager fitness tracker. I walked away underwhelmed at its performance and skeptical of its main claim to fame–automatic measurement of caloric intake via measuring blood glucose conversion to fluid in cells. This was reinforced by a trail of tech product reviewers digging into its development, the controversial science behind it and a growing rebellion on Indiegogo, where contributions exceeded $1 million. Then it took delays–first September, then November. Few in the industry believed it would ever ship.
However, it has, and at least one intensive review after a month of wear is in from Engadget. Topline: it’s not a scam (which will disappoint some) (more…)
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/01/102337982-tattooHR.530×298.jpg” thumb_width=”150″ /]A possible advance in the perpetual Battle of Stalingrad
that diabetics face in their self-monitoring has been developed through research at the University of California at San Diego
(UCSD)’s Center for Wearable Sensors
. A flexible skin tattoo-like patch has been used to monitor pre- and post-meal blood glucose levels. It works by using a small electrical current directed to the two small electrodes in the clear patch which activate an enzyme that reacts with glucose, giving a reading to the researchers on the seven subjects which correlates to conventional needle-stick metering. It’s not so advanced yet that it delivers information to a smartphone or dedicated meter, but directionally it’s in the right direction. And think of the savings both in disposables and cost ($1 each). The Center for Wearable Sensors is further developing (more…)
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/07/116-fam_1a.jpg” thumb_width=”175″ /]Despite Sergey and Larry’s
vapors over healthcare [TTA 10 July
is joining with the Alcon
eyewear/eyecare division of Novartis
to further develop the smart contact lens
. With a licensing deal between them, the initial Google X
-Novartis project is the smart contact lens that contains a low power microchip and a hair-thin electronic circuit. It would initially measure blood glucose for diabetics, but also in Novartis’ president’s words, would meet additional “unmet medical needs” within the next five years. Our profile of the lens exactly six months ago [TTA 17 July
] has additional detail, including the practicality (and injury potential) of contact lenses for diabetics, especially thicker ones with ‘circuitry’. (Also see the comment below the article.) Another area (and a much-needed, thus profitable one) is age-related farsightedness and creating an ‘autofocusing’ lens much like a zoom lens. Certainly a partner like Alcon will help work through the questions and also steer the X-Marks-The-Spot lens through the usual FDA review that marks the muddy spot before the rainbow. Google Smart Contact Lens Focuses On Healthcare Billions (Forbes)
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/02/gimlet-eye.jpg” thumb_width=”130″ /][grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/01/Hand-holding-zoomed-in.jpg” thumb_width=”150″ /]It’s unusual that a smart contact lens that measures blood glucose makes lead worldwide news while it is still in clinical studies, but when it is from Google, The Gimlet Eye wants to be the first to try it.
Google’s blog and a single interview they granted to the Associated Press have confirmed the earlier rumor on a blood glucose-measuring contact that first appeared last Friday [TTA 10 January; item from FierceMedicalDevices in the 4th paragraph, Google’s meeting with FDA on a powered contact lens]. The AP article also confirmed its genesis in University of Washington/NSF research. The Google lens under development might have tiny LED lights that visually advise the wearer on their glucose levels, as well as transmit the information via a wireless chip. Last week’s speculation was on a Google Glass-like display à la iOptik.
Research specifically directed towards continual monitoring of the blood glucose in tears has been ongoing and other companies have developed powered lenses. A key question is the equivalence and accuracy of monitoring tears versus blood. (more…)