FDA and the Diabetes Patient Community

Patient Network Live Chat: Diabetes - Glucose Monitors and Test Strips

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Talk with FDA expert Courtney Lias and
Patient Advocate Bennet Dunlap (Yea Bennet!)
about Glucose Monitors and Test Strips

Monday, March 31, 1:30–2:30 pm (EDT) Talk, share, and connect with the

FDA and the Diabetes Patient Community

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Do you want to learn more about the role of the FDA in the regulation of medical devices, such as glucose monitors and test strips, used in the management of diabetes? Do you want to learn what the FDA is doing to increase the accuracy of blood glucose monitors and test strips?

When you participate in this friendly online chat, you will:

Enjoy an informal, open discussion with a fellow patient advocate, CDRH subject-matter-expert and others in the diabetes community.Learn more about the role of the CDRH, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes. Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving healthcare providers and people with diabetes better tools to manage blood glucose levels.

Whether you want to just listen to the interview, ask relevant questions about the medical device regulatory process or just speak your mind on the newest draft guidance document…. you should join in the conversation.

Register for this event and be sure to mark your calendars and join us on March 31st, 2014.

link to original text on FDA.gov

Pitstop fail!

Allow me set the scene

Arden's school has a half-day scheduled and one of her friends has organized an outing for a few of the girls after school. The group is being picked-up by one of the mothers for lunch and a manicure, I am not attending. We will manage BGs as we do while Arden is at school, a sleepover or other out of the home events.

What could go wrong? How about, literally everything...

We were battling a stubborn blood glucose number all morning, it was one of those 180ish numbers that just won't budge.  Arden's pump was due to be changed later in the day but I thought it could make it just a little longer - I was wrong.

Arden's morning snack sent her BG into the 300s but we didn't know immediately because her DexCom sensor gave out just after we bloused for the snack. Are you following so far? Pump site going bad, just ate, CGM not reporting.

When Arden texted that she was getting ready to leave school, I asked for her CGM number and she replied, "It says ???". Okay, no problem, "we can just test a little more while you're out", I said. Knowing that they would be at the restaurant in under ten minutes, I asked her to test so that we could bolus for lunch... Arden tested and was over 340. 

It was then that I decided to go to the restaurant and perform a 'diabetes pitstop' in our car. Seemed easy, and I had a plan. I wanted to changed her pod, swap her CGM and inject insulin for her high BG and the food she was about to eat. I didn't want all of this to ruin her outing so I didn't think twice about letting her eat with the high BG, normally we'd wait.

In my imagination, I saw Arden hop into my car; we'd switch her pod and pop off the old one, inject some insulin, swap her DexCom receiver, and she'd be back inside before anyone realized that she had left. Smooth, like a pitstop.

Arden got into my car and I told her my plan, she looked at me like I had two heads. She was not thrilled about trying all of this in a car.

Putting on the new pod went smoothly, but she wasn't terribly comfortable getting an injection in the cramped car. After a bit of drama, we injected and moved on to the DexCom receiver and that's where, to use a topic specific metaphor, the wheels came off. 

Arden has been wearing a DexCom CGM for years and years and we have never, I want to reiterate - NEVER hit a vein upon insertion - until we tried to do it in my car, outside of a restaurant... while her friends were waiting for her. The blood would not stop, it was gushing out from under the sensor and going in every direction possible.

Arden freaked out just a little and I began to feel defeated and then she said something that broke my heart, "Let's just go home".

I removed the sensor, stopped the bleeding with some glove compartment napkins (Huge thanks to my wife for suggesting that I keep napkins in my glove compartment) and worked to help Arden find a little calm. When she relaxed I told her this...

There are going to be times when diabetes is difficult but we can't let it beat us, we can't give in to the feeling that is telling us to go home. We live our life no matter what. This isn't how you hoped today would go and I am sorry that my plan didn't workout very well but you are going to pull yourself together, go back inside and eat with your friends. Then I want you to get your nails done and forget about all of this, it's over - you're fine.

I felt like crap when I dropped her off at the door to the restaurant, I couldn't believe that so much went so wrong, all at once. Moments before, Arden asked me why we were having so many problems and I responded, "It's just bad luck - randomness that seems like it's not". She laughed when I told her I was sure that we had used up our allotted 'bad luck' for the month in the last five minutes.

Arden went on to eat and laugh with her friends, she got her nails painted purple and had a wonderful afternoon. I'm grateful that I didn't give-in to the pressure that diabetes put on us, I think that it would have been a serious personal setback for Arden and perhaps me, if I would have taken her home.

Proud to say that this blog entry is a Best of the 'Betes Blog winner. Thank you for nominating me!

There is a ton of value in persevering through moments like these because you can't replace or recreate the tough situations that teach us the most. I know that none of us want these challenges, but there is so much that you can take from them... sometimes they are worth the hassle.

That was fast DexCom!

Looks like it is alarm week around here. The other day Arden mistook a dumpster for her OmniPod and now our DexCom G4 sounds like it has a sick speaker.

BeeeeeeeeerrrrrrrrrddddddEEEEEEnnnnpppp

Out of no where Arden G4 started to sound like it was being strangled. Quick beeps lasted twice as long and the sound it made was, in my wife's words, "like nails on a chalkboard". What I'm going to share next, is the only reason this story merits it's own blog post.

I called DexCom customer service around 4:30 pm EST and left my information in their phone cue so I wouldn't have to hold. They called back within 30 minutes.

The CSR went over my concern, we did a few minutes of troubleshooting and I was promised a replacement. 

It arrived the next day at 10 am - 17 hours later.

In a world where blogs often complain and Facebook post are frequently about what is wrong - I just wanted to say that DexCom treated us judiciously and with amazing swiftness.

All that is left is to wait for a sensor change so we don't have to cringe every time the receiver wants to remind us of something. Currently, the speaker is as shrill as anything that I've ever heard. The CSR said he's never heard of a speaker malfunctioning, I told him that it almost sounds like it's loose and moving around inside of the shell - has anyone else had this happen?

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Arden's Day Blog RSS

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Opinions are my own. I do not have a financial relationship with DexCom. If I did, I'd tell you. This is just a great example of a good company doing right by a customer - and I wanted to share.

I Don't Care What You Smell

My wife's car has seen better days and so we ventured out last Saturday to browse a few lots. We didn't have a lot of time, the day was busy and so we only had a few hours in between Arden's early basketball game and her afternoon softball practice.

first we needed to get a bite to eat

It was still early but we located a restaurant that was serving lunch. We parked the car and were heading inside when Arden stopped walking. Kelly and I turned to see why she dropped back and saw the most disappointed look on her face and her hand searching in her purse for her OmniPod PDM.

"what's wrong?"

Arden began to tell us that her pod just experienced and error and shut off, "we have to go home to change my pod...". It was only then that I realized how excited Arden was to test drive a car. She looked completely bummed.

It took us a second to get our bearings but in a moment we were able to relieve Arden's concerns. Turns out that her OmniPod wasn't alarming, nothing shut off, the beeping was coming from a nearby cardboard recycling dumpster that was signaling an all clear to nearby workers.

That's not your pod Arden... that's the dumpster!

Belly laughs ensued... and we added 'dumpster' to the list of mechanical things that we've mistaken for Arden's insulin pump.

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Urgent Product Recall: FreeStyle® Blood Glucose with OmniPod PDM

Due to the important nature of this information, I'll be posting the entire press release from Abbott's site without their prior permission. I am not sure what prompted this recall but I'm working to find out.

From AbbottDiabetesCare.com

IMPORTANT: URGENT PRODUCT RECALL 
FreeStyle® Blood Glucose Monitoring System

February 19, 2014

Dear Valued OmniPod® Customer,

Recently, it has come to our attention that FreeStyle® Blood Glucose Test Strips may produce erroneously low blood glucose results when using the FreeStyle® blood glucose meter built into the OmniPod® Insulin Management System. Erroneously low blood glucose results that are not recognized may pose significant risks to your health.

Please take the following steps:

1. If you are using the FreeStyle® Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM), you must discontinue use of any FreeStyle® Blood Glucose Test Strips you may have until you obtain replacement strips from Abbott Diabetes Care. To receive replacement strips at no cost contact Abbott Diabetes Care Customer Service at 1-877-584-5159.

2. Continue using your OmniPod Insulin Management System (OmniPod) to deliver your insulin therapy. While waiting for your replacement strips to arrive, use the FreeStyle® Freedom blood glucose meter that you may have previously received with your welcome pack. FreeStyle® test strips when used the FreeStyle® Freedom blood glucose meter will produce accurate blood glucose results. 

If you would like to continue using the OmniPod system to recommend dosing, follow your OmniPod® Insulin Management System instructions for manually entering blood glucose readings. 

As always, control solution should be used to check the performance of your test strips and meter until you receive your replacement test strips. If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider immediately. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). 

Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.

3. Abbott Diabetes Care will provide further information when you call on the process to obtain your test strips going forward. 

FreeStyle® Blood Glucose Test Strips are the only strip type that is approved for use with your OmniPod® Insulin Management System. Please read your product information booklet and test strip insert carefully to ensure that you are using the correct test strip type for your OmniPod® Insulin Management system. OmniPod® Insulin Management System is not labeled for use with FreeStyle Lite® Blood Glucose Test Strips.

We recognize the importance of blood glucose testing and are committed to responding quickly to customers' requests for replacement test strips.

We want to assure you that our first priority is you, our customer. We sincerely regret any inconvenience this situation may cause. If you have any further questions, please call Abbott Diabetes Care Customer Service.

Sincerely,

Kelly E. Duffy  Division Vice President, Quality Assurance and Compliance Abbott Diabetes Care