Diabetes developments – by Simon O’Neill
In a regular blog series, Simon O’Neill, Diabetes UK’s Director of Health Intelligence and Professional Liaison, rounds up the latest diabetes news.
This week Simon reports on the latest technologies, medicines and treatments.
Medtronic 670G/Enlite 3 Hybrid Closed Loop System
In my last report I mentioned that Medtronic were about to finish their trial of this hybrid closed loop system (hybrid in that the user still has to input carbohydrate intake and exercise for the device to work optimally and has to make decisions on correction boluses – although it appears safe even if you forget to do this, but is less able to keep the user in the target range).
The trial has now ended and Medtronic are planning to submit the system to the FDA by the end of June for approval. If everything goes to plan, the device could be available in the US earlier than anticipated, with an optimistic release date of April 2017.
Patient Power has really come to the fore with this device. Of the 124 users, 80% have chosen to continue using the device, which has been allowed by the FDA, giving a strong indication that the FDA feel it is safe to use in a real world setting. Several of the people on the trial chose to write directly to the FDA and this patient led initiative appears to have given some extra kudos to the system becoming available as soon as possible.
The larger 1,000-person, six-month post-approval outcomes study for the 670G will still be going ahead, comparing the 670G with just an insulin pump or a more usual insulin pump/CGM combination but without the algorithm to make automatic adjustments to insulin dose. The aim would be to demonstrate that a closed loop system can improve both HbA1c and hypoglycaemia.
The ups and downs of Pioglitazone
A five-year study, the “Insulin Resistance Intervention after Stroke” trial or IRIS, has recently reported its findings into the effects of pioglitazone in people at high risk of T2D. The 4,000 or so participants in the trial had also all had a recent stroke or transient ischemic attack – a mini-stroke.
When compared with a placebo, pioglitazone led to a 24% reduction in fatal and non-fatal heart attacks and strokes. This is the first drug to have been shown to reduce the risk of stroke. Perhaps of more interest was that the rate of new T2D cases was also reduced by 52%. Previous trials looking at the role of Metformin in T2D prevention only saw a 31% reduction.
However, at the same time a group from Canada have just published a large study of 145,806 people who began treatment with anti-diabetic drugs between January 2000 and July 2013. They found that, compared to other anti-diabetic drugs, pioglitazone was associated with a 63% increased risk of bladder cancer, with the risk rising with any increased dose or duration of use.
This issue has been raised several times in the past – with the EMA in 2011 stating that although there was an increased risk it was relatively small so, for people who cannot be adequately treated by other treatments, pioglitazone should remain a treatment option. Pioglitazone can also lead to weight gain and an increased risk of bone fractures.
The IRIS researchers have suggested that these results could have real benefits for certain groups of people but they need to be made aware of the potential down sides as well as the positives and clinicians should only consider prescribing in people with a low risk of bladder cancer and should be encouraged to report any early signs of bladder problems as quickly as possible.
Smart Insulin Pens
Insulin pens have been around since the 1980s and are probably the most common way of administering insulin in the UK. They were designed to facilitate easier insulin dosing as well as being more comfortable and easy to use than disposable syringes. However, they do have their limitations too, as anyone who has found themselves wondering if they gave that last dose or not, will recognize.
Several companies have developed add on devices to provide more information from the pen. These include things like the Timesulin cap for disposable insulin pens which lets you know when you last took a dose of insulin. Indeed, some of the insulin manufacturers have also built in timers to their latest reusable pens – such as the NovoPen 5 and Echo which tell you both when you roughly last took a dose of insulin and how much you took.
But other companies are looking at making insulin pens even smarter than that. A company called VigiPen has developed the Bee Smart system. This attaches to your existing insulin pen, but enables you to log the amount of insulin units injected and your blood sugar level (if you’ve taken it). This information is then automatically sent to a logbook on your mobile phone. The logbook stores all the data and then produces weekly and monthly reports. At least four or five other companies are developing similar products – including the Gocap, KiCoPen, ESYSTA, Pendiq and the DataPen.
A couple of companies are promoting non-invasive blood glucose products – though neither is yet on sale, and evidence of their accuracy and reliability are not yet available. But both promise that the device should be available within the year.
The first is from Nemaura Medical and is called the SugarBEAT. This is a daily disposable patch which is worn on the skin attached to a reusable small electronic device. This draws interstitial fluid from the skin, using a mild electrical current and, via Bluetooth, sends the readings to an app on your phone or watch. As this is done in real time, you can also set alerts for high or low glucose. It will need to be calibrated with a single fingerprick blood test each time you apply a new patch. The company say that the device should be ready by the end of 2016
The second device is called Glucowise. Unlike the SugarBEAT patch, this is a device which is held against the skin. It is positioned to gently squeeze the skin between the thumb and forefinger or the earlobe to measure blood glucose levels.
The device then displays the reading in real-time on the screen. It does this by sending low-power radio waves through the body. The signals are then received by a sensor on the opposite side of the device, where the data about the characteristics of the blood are collected and analysed. They claim that this will be as accurate as blood glucose monitoring because it is measuring the level of glucose at the capillary level. The company hope to be taking orders at the end of 2016 once trials have been completed. Neither device has yet got approval – and both will have to demonstrate accuracy and reliability before they can. No price data is yet available either.
Another device in the early stages of development is a graphene patch that can both sense blood glucose levels and administer metformin – or at least that’s what the company are trying to achieve.
Scientists in South Korea have developed a patch which can measure changes in the pH level and temperature of sweat and use that to estimate blood glucose. When blood glucose levels rise, part of the patch dissolves to reveal microneedles that can inject metformin into the skin. The patch has been trialed on mice and two healthy human subjects – but much more work is needed before it could come to market.
Why do people stop using pumps and Continuous Glucose Monitoring (CGM)?
The Type 1 diabetes (T1D) Exchange was set up as a resource for people with diabetes and clinicians to facilitate better care and increase access to new treatments and research. The Exchange consists of; a Clinic Network of more than 70 clinics across the US; a Clinic Registry with data from over 26,000 people with T1D; a Biobank housing a vast collection of biosamples; and Glu, a patient/caregiver online community.
They decided to ask why people who use insulin pumps and/or CGM stop using them, despite the evidence to show that they improve diabetes control. Nearly 2,500 took part and some interesting findings emerged.
They found that 3% of people using a pump had discontinued use within a year of starting. Those who stopped using the pump were more likely to be under 50, with a lower educational and socio-economic background, a higher HbA1c (over 75 mmol/mol or 9.0%) and were less likely to self-monitor. The most common reasons for stopping were; problems with insertion/adhesive (60%); using a pump was too expensive/not covered by insurance (45%); it interfered with sports activities (42%); was uncomfortable to wear (38%); they disliked wearing it (36%); it interfered with intimacy (34%); it didn’t work properly (28%); or they had high blood sugars when using the pump (28%).
More people chose to stop using CGM than a pump – 27% within the first year. Characteristics were again lower socioeconomic status and higher HbA1c. The main reasons for stopping CGM were: problems with the CGM working properly/accuracy (71%); problems with the sensor insertion/adhesive (61%); too expensive/not covered by insurance (58%); uncomfortable to wear (41%); they were already wearing a pump and did not want two sites on body (33%); the device was too big (28%).
The Type 1 diabetes Exchange will use this information to help companies incorporate these sort of human factors in to their design so that they become more acceptable to more users.
Next week’s update will focus on research and other issues.