Anyone leaving on a brand spanking newly insulin ticker is probably full with anticipation and excitement, merely at that place's always a little bit of trepidation when it comes to a new spell of medical technology. Leave it meet my needs? Will I like-minded using IT? Most importantly: wish it work? The fear of electric potential problems like efferent error, wrong buttons, and occlusions can contrive a pull in anyone's pumping anticipation.

Seemingly, those wrenches take up been flying around the Diabetes Profession quite a a number lately, especially finish summertime when the newest insulin pump hit the market.

We have unconcealed oodles of untried Tandem t:slim users who've stolen to the Internet, coverage along blogs and social networks that their pumping honeymoon fleetly came to an end with the onslaught of occlusions using Sanofi's Apidra insulin. Naturally we wondered what could make up the cause, whether or not this was strictly a t:lean issuance, and whether or not there is anything anyone can do about it.

About Occlusions

Occlusions are basically just blockages that prevent insulin from being delivered. If you induce a obstruction, pressure sensation will build and usually your insulin pump with alarm, letting you hump something has run afoul.

"There are several reasons why they take place, " says Dr. Brian Levy, an endocrinologist and Senior Director of Clinical Affairs at Animas. "They include kinking of tube that goes from the pump to the interpolation sidelong, or more importantly, the kinking of the catheter. Most cannulas are made of Teflon operating room plastic which can twist. It can also be payable to problems at the interpolation site, ignition that butt happen roughly the interpolation catheter or the presence of scar tissue. If a patient uses the same place on their abdomen, on that point can be chronic build-up of mar tissue."

Occlusions can and do happen in every insulin pumps, whether tubed surgery patch pumps, and they have happened with altogether cardinal types of fast-acting insulin on the market.

Only a 2008 research work published in the Daybook of Diabetes Science and Technology showed Apidra had the highest probability of occlusions in pumps over five days (despite the FDA's recommended site changes all 2-3 years). That was comparing Apidra to both Humalog and Novolog, although the probability of an "early occlusion" occurring during the first 72 hours was in reality highest in Novolog.

In a 2010 study of the optimum usage of insulin pump sets, published therein same journal, researchers found that during the 48-72 minute mark occlusions occurred independently of the insulin used. However, that study only involved in 12 patients and the authors even mark that occlusions are rarefied.

Apidra vs. t:slim?

The issue at hand is that after Tandem released the t:lose weight last summer, approximately new users started noticing something curious. Occlusions started occurring. A vernacular theme: all the patients used Apidra.

Melissa Lighthorse Harry Lee, a type 1 PWD in Texas, said that she started noticing the problem early on. "As early as my irregular magazine," she says.

Another old type 1, Bernard Farrell in Massachusetts, who's one of our resident tech gurus in the Diabetes Online Community, jumped on the t:melt off boat betimes connected and discovered the literal same problem. Some atomic number 2 and Melissa have since switched insulin brands, both to Humalog.

We also heard from D-Mom Jodee Martin, whose 13-year-grey-haired son recently went on the t:little. Afterward speaking with Tandem, she speculates that, "Apidra May non comprise congenial with the heart. The makers of Apidra suggest that Apidra be changed every two days in this pump, so that may be the job but our whole reason for getting a ticker with a 3ml cartridge was so that we could exchange every third daytime."

We contacted Tandem to see if they had whatever ideas what was loss on. Steve Sabicer, the society's PR rep, says they're looking into the issue, but are redolent that Apidra is just indicated for 48-minute use in any insulin heart (!), based on that 2008 study showing Apidra had a higher occlusion rate in pumps over several days.

Referable this and what they adage as the limited number of users on Apidra, Tandem did non include Apidra in their clinical trials — but focused instead happening the deuce most prescribed fast-acting insulin on the market, Humalog and Novolog, in its FDA submission.

Two-Daylight Limitation!!

What?! Apidra isn't "indicated" for role many than 48 hours in any insulin heart? When pumps are intelligibly meant to last at least 3 years?

It's true, confirms Sanofi repp Susan Brooks.

"Our Phase 3 ticker submission for Apidra was 48 hours, therefore we are indicated for 48 hours," she aforementioned. "When exploited as manageable, Apidra has shown a low rate of pump clogs and infusion-site reactions."

The reason? Back when Apidra was sanctioned in 2004, IT was textbook for insulin to be approved for just 48 hours. Crazy, huh? IT wasn't until several years later — 2009 for Novolog and 2011 for Humalog — that the regulations were increased to three days for insulin in a cannula, and seven days for insulin in the pump reservoir (presumably because insulin degrades with hotness exposure, and the personify is quite warm).

We wondered why this fact is so under-publicized, leaving patients to memorise active this restriction the hard way?!

Furthermore, Sanofi has no plans to try approval for a 72-60 minutes use of Apidra, Van Wyck Brooks says, so that agency we won't get any official answers about what happens to Apidra after three days.

World Health Organization's Dissuasive Patients?

It doesn't seem that Sanofi has genuinely stepped up to make this limitation clear to patients, but what about the pump companies? You'd think they'd at least privation to warn patients of this assertable fail in advance.

We contacted Animas, Medtronic and Insulet to find out if they'd experienced some revenant issues with Apidra insulin, or were alert patients to potential problems. None of them would comment other than a transcribed statement that "when used Eastern Samoa orientated," there should cost minimal issues with occlusions no count what insulin is used.

Uh huh, right. Just what PWDs want to take heed when problems pass off — it'sour error. Grrr.

Sean Gallagher, senior director of marketing at Insulet Corp., did clear upward one matter: he says the pump companies "are not necessary from a regulatory point of view… to test with different insulins for carrying into action." Right — so if it's not required, wherefore would any accompany invest in this?

On the flipside, the insulin companies aren't required to trial run their products in all pump on the securities industry either. IT turns out the only pumps that Apidra was designed in during their FDA clinical trials aren't flat ready-made any longer — the Disetronic H-Tron plus V100 and D-Tron with Disetronic catheters (Rapid, Rapid C, Rapid D and Tender) and the Minimed Models 506, 507, 507c and 508 with MiniMed catheters (Sof-set Ultimate QE, and Quick-put up). Medtronic doesn't even give rise those models any longer, and of run over, Disetronic was acquired by Roche and has now morphed into the Accu-Chek Look.

Au fon, occlusions happen in all insulin pump and with every rather insulin, and there are plenty of patients who have managed to use Apidra in their t:slim without an issue — but we regain information technology interesting that the only pump company to publish an official statement close to victimization a particular insulin is Tandem regarding Apidra:

"The t:small Pump is indicated for use with Novolog and Humalog, simply we have no reason to think that there is anything in the t:slender's pumping mechanism that could conduce to a high incidence of occlusions using Apidra.  There are distinct labeling differences between rapid-acting insulins and their use in pumps, particularly as IT relates to how oftentimes the reservoir should be changed.  These are things you should discuss with your physician equally part of your decision process."

Some folks wonderment if there's something astir the t:little particularly that doesn't host Apidra well. One theory, posed past Manny Jimenez, the Tandem customer avail rep that Melissa radius to, is that at that place is no information about how Apidra responds to the pressure of the t:small's unequalled microdelivery chamber, which is an interior bagful that is pressurized versus the traditional plastic cartridges that arrest insulin.

No single has vetted this theory, and they probably South Korean won't any metre presently. I guess this means we'rhenium back to being guinea pigs…

But Call Us 'Ginzo PWDs'

Happening her blog Sweetly Voiced, Melissa shared that when she used Apidra in her t:slenderize, the legal age of occlusions happened afterward 48 hours, but she is not having any occlusion issues the least bit in real time on Humalog going for the full trine days of usage. That's the same finding Bernard came up with, when dynamical his insulin routine.

Dr. Levy, who also practices as an endocrinologist in addition to his put to work at Animas, says helium hasn't seen some issues with his patients using Apidra in their insulin pumps, only he notes that "the longer one wears an insulin pump without changing the catheter, the more prospective an occlusion will occur."

On that note, Insulet's Gallagher shared this skid showing how your BG creeps risen the yearner you keep your pump on:

"This is precisely why instructions for use to change their intromission site every 72 hours," Dr. Levy en masse says. "And we bang that many patients do not, for many reasons. It could be cost, operating theatre it's a pain to change the insertion situation, or forgetfulness. So that's likely the most common reason why there is an insertion site publish."

When it comes down to making a decision on what to do, we PWDs just need to with kid gloves moot our priority preferences for pump models and type of insulin — and if we aren't willing to via media along one, we may find ourselves dynamic our pump sites every 48 hours.

{Editor's note: Amy uses in Apidra in her Omnipod, and actually does need to change her site every 2 days; looks like we may have discovered the explanation for that.}