Diabetes technology is getting closer to making life easier for patients.
For diabetics, keeping blood sugar levels within normal range – not too high or too low – is a lifelong problem. New technologies to lighten the burden are emerging rapidly, but insurance reimbursement challenges, supply shortages and shifting competition make it difficult for patients to access these technologies quickly.
A new product is quick – acting insulin from novo nord. It is designed to help reduce the high blood sugar spikes that often occur when people with diabetes eat diets that contain carbohydrates.
The new formula, called Fiasp, adds nicotinamide (vitamin B3), which is about twice as fast as the current insulin used in meals. This new type of insulin enters the bloodstream in three minutes.
Another improvement is the FreeStyle Libre Flash, abbott’s new monitoring device. It is new in the us but has been listed in Europe since 2014. It is a circular patch, with a catheter can be inserted in the arm for 10 days, there is also a durable scanning device, the user on the patch swing to read the level of sugar in their organization, it reflects the blood sugar levels.
FreeStyle flickers allow users to monitor glucose levels without frequently stinging their fingers for blood tests.
Libre works differently from the two existing continuous glucose monitors (CGM) produced by Dexcom and Medtronic. Libre does not require blood tests by users to perform blood tests, while other monitors must perform finger calibration twice a day.
In addition, freedom permits longer wear – 10 days (Europe 14) and two current CGMs for seven days. And while abbott has yet to provide U.S. cost information, its prices are likely to be relatively low. In Europe, the free system costs about four euros ($4.70) a day.
However, unlike existing devices, freedom does not alert users when their blood sugar levels are too high or too low. And the U.S. version does not allow “sharing” capabilities, and relatives can track the blood sugar levels of Dexcom’s glucose monitors remotely through a smartphone app.
Type 1 diabetes requires regular insulin doses to allow cells to use glucose because the pancreas does not produce insulin itself. For type 2 diabetes, the insulin being made is not sufficient to meet the needs of the body.
About a quarter of patients with type 2 diabetes take insulin, and a few of them take quick insulin before meals. These doses may lead to low blood sugar levels or high blood sugar levels, if the time and amount are not exactly matched with the carbohydrate in the diet. There is a lot of user error space.
In the United States, free radicals are more useful for people with type 2 diabetes, said Dr. David t. Ahn, an expert in diabetes technology at the university of California, Los Angeles. Most type-2 people do not use CGM, nor do fingertick tests frequently.
Ahn said: “I think this is really giving people power, this is really exciting,” you see directly from the literal movement, diet, rest and pressure effects on blood sugar.
Of course, he added: “everyone is good, but the most important question is whether the cost is reasonable, at least for now I think the insulin person may be worth it, acting insulin.”
Jared Watkin, President of abbott’s diabetes care unit, told Shots that Libre was designed for diabetics who need frequent blood sugar tests, and that the lack of an alert was intentional. The study shows that “alarm fatigue” is one of the two main reasons why many patients are reluctant to use CGM system. Another reason is cost.
He pointed out that the study of freedom also suggests that even without warning, in the use of this equipment will also be able to get a better blood sugar control, and compared with only fingers touch, overnight to experience less of hypoglycemia, this may be because they are more insulin dose adjustments.
Aaron Kowalski is JDRF’s chief mission officer, formerly the juvenile diabetes research foundation, which funds most of the research on diabetes technology. He says look at how the United States does not accept CGM type 1 diabetes patients in the free market. “If you come from your fingertips, it makes sense… For some of the first class, I think it would be a very good choice.
Closing loops: progress and pitfalls.
Continuous glucose sensing and short-acting insulin is developing so-called “closed-loop” or a critical part of artificial pancreas system, it is designed to make insulin automation, to make itself does not need to make patients with complex and error recount how many of their dietary carbohydrates or reduce their insulin doses of exercise.
In September 2016, the us food and drug administration approved the Medtronic 670 g, this is the first part through an algorithm to realize closed loop target device, the algorithm allows the system to the blood sugar of CGM in the user instructions the insulin pump to cut off the transmission, or if the level is too high, increase it.
Several other companies are working on similar technologies. One, a start-up called Bigfoot Biomedical, is working with abbott to use the next-generation version of the Libre sensor. In addition to medtronic, other major closed-loop competitors Insulet, Tandem and Beta-Bionics collaborate with Dexcom.
At the same time, a group of do-it-yourself hackers have come up with ways to create their own closed-loop systems using old equipment and instructions provided free of charge. Since this effort is not regulated by the FDA, the people who have done it – believe there are now thousands of people – are taking risks themselves. There are no major issues.
Bumps along the road, but overall optimism.
Not surprisingly, everything in this field is not going well. Medtronic, because of the large demand for manufacturing plants in Puerto Rico by a maria hurricane damage, so can’t ship will be part of the 670 g new users, may not be able to meet the demand by 2018.
In addition, Anthem insurance has said it will not cover 670G because it has concluded that “the long-term security and effectiveness of the system is not enough”.
At the same time, although Medicare in January 2017 agreed to cover the beneficiary to use insulin Dexcom continuous glucose monitor, but the agency recently determined that if the beneficiary use random read blood sugar levels via bluetooth smartphone applications, the device will not be overwritten, do not meet the definition of “durable medical equipment”.
This decision means that the elderly must carry a separate receiving device and cannot access Shared functions. Dexcom is working with federal regulators to come up with a solution. Ahn wrote in a recent blog post: “while Dexcom’s CGM approval is a huge win on the whole, it is ridiculous to limit the integration of smart phones.”
In another blow to the world of diabetes technology, Animus, the main pump manufacturer, recently announced its withdrawal from the market, transferring some 90,000 existing customers to medtron. Not surprisingly, some of medtronic’s rivals are offering deals to tempt their own products.
Kowalski said: “despite the obstacles, I am very optimistic about the future of the patients with type 1 diabetes, these tools really started to improve blood sugar, make life easier, it is a good thing, the choice of the more the better”.