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MiniMed 530G with Enlite: Your Top Questions Answered

By Karrie Hawbaker

Public Relations Manager

Posted:  10/3/2013 7:12 PM

Tags:

Since announcing the news that we received FDA approval of MiniMed® 530G with Enlite on Friday, it’s been great to hear so many of you share in our excitement about this new product and critical first step toward a fully automated artificial pancreas. Hearing from you here on The LOOP as well as on Facebook and Twitter, as always, is really wonderful. In addition to sharing enthusiasm for this new technology, you’ve asked many very good questions. To answer some of these top questions, we’ve invited a very special guest blogger to The LOOP – Mark O’Donnell. As vice president of regulatory affairs here at Medtronic Diabetes, Mark has been instrumental in partnering with the FDA in order to allow us to bring this groundbreaking new technology to the U.S. diabetes community.

Hello LOOP readers. First, thank you so much for sharing your comments and questions with us – whether it’s by giving us a call, talking to your local Medtronic representative or through social media channels. Hearing your stories and excitement for MiniMed 530G reminds me and everyone else at Medtronic the reason we all come to work every day – to improve the lives of people with diabetes. It’s also great to hear your thoughts and concerns. Speaking of which, here are my answers to the most common questions you’ve heard so far.

1. Can my child (under the age of 16) use the MiniMed 530G system with Enlite? Why not?
MiniMed 530G with Enlite is currently not approved for use in children under the age of 16. I can certainly understand how this can be frustrating or confusing for many parents of young children with diabetes. Please know that we are actively pursuing the clinical evidence to support an indication for children 2-15 but can’t provide a timetable for when we’ll have such an indication. In the meantime, I encourage you to talk to your child’s doctor. Like with any aspect of your child’s diabetes care, your physician is the best person to tell you what the best diabetes technology is for your child. 

I also want to emphasize that Medtronic is extremely committed to pursuing this clinical evidence. The FDA has already approved two additional studies in children (2-15) to determine the appropriateness of this therapy in children under 16 and the studies will begin enrolling participants soon.

Understandably, this leads us to the next question:

2. Why weren’t children included in the clinical data Medtronic submitted to the FDA?
Our approval for the system was based on a clinical study of people with diabetes above 16 because the study protocol (its design and implementation) was very challenging. Participants were forced into hypoglycemia through exercise and kept there. It was determined that this would not be appropriate for children. The study was an “in-clinic” study, which took place in a controlled setting with the support of a healthcare team.

Now that the product has been approved, we can conduct an “in-home” study that measures the safety and effectiveness of the product as participants use it in “real-world” settings, which is more appropriate for children.

3. How long have you known about this labeling and its impact on the New Technology Guarantee program?
Many of you are familiar with the New Technology Program we started last December. Medtronic customers who purchased a MiniMed Revel insulin pump and CGM during this time were offered a free upgrade to our new technology (the MiniMed 530G) once it became available. We’re working hard to provide the new product and training to these customers age 16 and over as quickly as possible.

However, since the MiniMed 530G system was not approved for children under the age of 16, we are not allowed to promote this device for those children. That means we cannot satisfy and ship the MiniMed 530G under the New Technology Program. I encourage you to talk to your healthcare team about the best option for your child.

I understand this is frustrating and disappointing. However, during the New Technology Guarantee program we didn’t know what the final indications for use was going to be. (We get these final indications for use from the FDA when we get product approval.) While we did know that our study had only involved adults and children 16 and over, we didn’t know for sure what the labeling would be given that the MiniMed Revel system is indicated for children age 7 and older.

4. How can my child participate in the upcoming clinical studies?
This is a great question and one we love to hear. Participating in clinical trials is really valuable to the diabetes community. If it’s something your family is interested in exploring, you can check www.clinicaltrials.gov, which is where the studies will be posted when the trial sites begin enrolling in a few months. The LOOP team also tells me that they’ll post updates here once enrollment has begun.

5. Why did you call the MiniMed 530G an “artificial pancreas” system?
At Medtronic our goal is to develop a fully automated artificial pancreas for people with diabetes – a system that will be designed to automatically deliver the amount of insulin you need with very minimal interaction from you. We are not there yet, even with the MiniMed 530G system. However, the MiniMed 530G system is a critical first step on the journey toward that goal. With Threshold Suspend, it is the first FDA approved device that can stop insulin delivery temporarily if a sensor glucose value reaches a preset low level and the patient doesn’t react to the alarm. This is the first system that takes action based on sensor glucose readings and the first product approved under the FDA’s new category Artificial Pancreas Device System – Threshold Suspend.

This is one of three categories designed by the FDA as types of artificial pancreas device systems. You can read about all three categories here. This is where the language “artificial pancreas device system” comes from.

The fact that the FDA has clearly defined these three categories is great news for the diabetes community, as it gives us a path forward in developing iterative steps toward a fully automated artificial pancreas system. Those iterative steps are important because a fully automated system is not going to arrive suddenly. Our plan is to step-by-step develop innovative technologies with increasing levels of automation in order to advance to our ultimate goal – a fully automated artificial pancreas system.

If you have any additional questions, please feel free to share them in the comments and the LOOP team and I will be happy to answer as much as we can. 

Important Safety Information
Medtronic Diabetes insulin infusion pumps, continuous glucose monitoring systems and associated components are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems. MiniMed 530G with Enlite is intended for the delivery of insulin and continuous glucose monitoring for the management of diabetes mellitus by persons 16 years of age or older who require insulin.

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately.

The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a home glucose meter. A confirmatory fingerstick is required prior to making adjustments to diabetes therapy. MiniMed 530G with Enlite is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm and take measures to prevent or treat hypoglycemia themselves.

Please visit www.medtronicdiabetes.com/importantsafetyinformation for more details.

Comments

William Kowal

Posted on Thu Oct 03 22:05:22 GMT 2013

I purchased my insulin pump (medtronic Mini Med) in Sept 2012. Am I able to get an upgrade? I am 67 yrs old.

Jeanie werner

Posted on Thu Oct 03 22:11:42 GMT 2013

I was told today by your rep that I cannot order the 'revel' any longer. My insurance indicates that I am eligible for a new pump.....why can't I order the pump I want. Don't want the cgm.....

Brea W.

Posted on Thu Oct 03 22:19:24 GMT 2013

I just received my pump the day you came out with the news about the upgrade. I also purchased the CGM so I am eligible for an upgrade. Can I choose not to upgrade if I want? If so, will I be eligible for an upgrade sometime in the future when you come out with even more advanced technology?

Naomi

Posted on Thu Oct 03 22:42:18 GMT 2013

William, I’ll have a member of my team reach out to you soon to discuss your upgrade options.

Jeanie, we strongly believe that the MiniMed 530G provides the greatest clinical benefit to people with diabetes when used as a system, which is why we’re only offering it to most people as a system. Our new system includes the Enlite sensor which we worked hard to improve compared to previous sensors. In addition, to use the Threshold Suspend technology, CGM is required. Would you be willing to speak to someone about the new system and determine if it is right for you?

Brea, thanks for the question. The New Technology Guarantee program that we offered to allow customers to upgrade to the MiniMed 530G system once approved by the FDA will not extend to current unapproved future technology. I will have a member of my team follow up with you though to discuss your upgrade options.

Marcia

Posted on Thu Oct 03 22:44:13 GMT 2013

So, without the sensor, the pump is just like the others? My insurance does not cover the sensor. So how would this new pump be useful in my case? Anyway, I tried the other sensor long ago and that drove me crazy. It was stressful and inaccurate. How better is this new sensor?

Helen Curtis

Posted on Thu Oct 03 23:16:37 GMT 2013

Question? How long should we wait to hear from Medtronic if I believe I am in the "New Technology Guarantee" program. I know they are probably receiving thousands of calls, but would like contact of some kind myself. What should I do now? or should I just wait a few weeks.

Diane

Posted on Thu Oct 03 23:47:40 GMT 2013

Why is the MySentry which I paid $2,500 for not compatible with the new pump? I can't afford to pay for another one but need to have the MySentry. Also, why can't the new sensors be used with the Revel? Many of your customers are kids who could really use the new shorter, more comfortable, more accurate sensor. Why didn't Medtronic get FDA approval separately for the sensor so it could be marketed to kids as well? Frustrated.

Stephanie

Posted on Fri Oct 04 00:05:00 GMT 2013

I am a mom of a t1d 8 year old daughter, and daughter to a t1d father. They both started their pumps on the same day:) We love the pump, as well as the encouraging advancements, but my question is if those with heart problems can have a pacemaker placed inside them, why can't diabetics have a sensor surgically placed inside? Just a thought...thank you!

Naomi

Posted on Fri Oct 04 00:08:16 GMT 2013

Hi Marcia, we strongly believe that the MiniMed 530G with Enlite provides the greatest clinical benefit to people with diabetes when used as a system, which is why we’re only offering it to most people as a system. We have several programs available to all customers that can help with the out of pocket costs. We have made improvements in both comfort and accuracy with the new Enlite sensor and there are many advantages to the MiniMed 530G, which you can learn about here – http://www.medtronicdiabetes.com/treatment-and-products/enlite-sensor. If you’d like to talk to someone about your options and out of pocket costs, I’d be happy to connect you with someone to help.

Helen, if you purchased your Revel under the New Technology Guarantee program, someone will be in touch with you soon about upgrading to MiniMed 530G. We have quite a number of these upgrades to process, so please bear with us as we work hard to provide new product and training to everyone in the program.

Mrs. Maryann Salvin

Posted on Fri Oct 04 00:55:53 GMT 2013

greetings! Excited about the new option of preventing hazardous low sugars below 20 where you are unable to help your own-self.
When it reaches 85mg/dl on the sensor it was 59 mg/dl on the meter today (example) today. hypoglycemic unawareness >for years: DIABETIC (53years).
Hearing problem one ear where I have a great deal of difficulty with ALARMS as well.
Sincerely,
Maryann Salvin

Vicki McDonald

Posted on Fri Oct 04 01:34:02 GMT 2013

I purchased my first CGM in the spring of 2012. When I needed to purchase a new pump in January of 2013, I was told that if I purchased a new CGM (my old one was no longer under warranty) I would be eligible for the soon-to-be-released CGM. It's now nine months later, and I hope the upgrade promise is still open.

Gena Todd

Posted on Fri Oct 04 03:47:30 GMT 2013

Like many others, I recently upgraded to the revel and was disappointed that the sensor wasn't new and improved. Who do I contact to inquire about an upgrade to the 530 G?
Thanks!

Amy Gaines

Posted on Fri Oct 04 05:25:37 GMT 2013

how do I trade my pump and sensor

Marion Roth

Posted on Fri Oct 04 10:40:23 GMT 2013

After several months of usage, I am not happy with the CGM. Too many "lost sensor" and "Cal errors". I want to upgrade as soon as possible. I have been loyal to Minimed for over 20 years, but not so happy with the sensor downtime, or accuracy when using.

Martin

Posted on Fri Oct 04 11:43:24 GMT 2013

Can I use the new sensors from the new 530 on my current paradigm revel pump which is already setup with the sensor? Can I use the same transmitter and order the sensors that have been developed? I have been using the current sensors since you developed them and I would really like to switch from the "harpoon" size needle to insert to something better.

Flex

Posted on Fri Oct 04 12:27:27 GMT 2013

Naomi, Both MiniMed Paradigm and CGM were provided by the VA in 2010. Do I have to go through the VA to for upgrade to MiniMed 530G w/ Enlite sensor?
Sharing w/ All Others: The CGM can at times be a “pain” but it is intended to help us realize when our glucose levels have reached levels outside the normal range. The pump w/ CGM has been instrumental in lowering my A1C from before at 13 to 7 and I am still aiming to lower under 7, which will only be able to achieve w/ the pump & CGM combo. During this quest I am constantly experiencing hypoglycemia, reason why I can’t wait to get the upgrade.

Lisa O

Posted on Fri Oct 04 13:17:14 GMT 2013

Hello, I have a quick question. I got the Revel last year and I dont know if I purchased it under the New Technology Guarantee Program. My insurance company pays for the whole thing. Is there away I can find out if they did order it under the New Technology program? I know you are busy so when you get a chance please answer me back. No hurry I can wait. Thank you for your time.

Lisa O.

Maureen Ridings

Posted on Fri Oct 04 14:48:32 GMT 2013

How do I find out if I am eligible for an upgrade to the MiniMed 530G with Elite?

Naomi

Posted on Fri Oct 04 15:30:05 GMT 2013

Diane, we appreciate the feedback and are sorry to hear that you are frustrated. When we received approval, the MiniMed 530G with Enlite was not indicated for use with mySentry. However, we will be seeking approval of mySentry with MiniMed 530G.

Stephanie, that is such a touching story about your daughter and father! And that is an interesting question about the sensor but not my area of expertise. I’m happy to pass the question along to our product development team though.

Maryann, thanks for sharing. Please keep in mind that the MiniMed 530G with Enlite is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm and take measures to prevent or treat hypoglycemia themselves. Also remember that successful operation of the insulin infusion pumps and/or continuous glucose monitoring systems requires adequate vision and hearing to recognize alerts and alarms. If you'd like to learn more, please visit http://www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite.

Vicki, if you were enrolled in the New Technology Guarantee program then yes it is! For those who purchased a Revel and CGM under the New Technology Guarantee program, someone from my team will be in touch soon about upgrading to MiniMed 530G. We have many upgrades to process, so please be patient with us as we reach out to each of our customers.

Lisa

Posted on Fri Oct 04 18:22:21 GMT 2013

Hi...I purchased a new CGM in September last year as mine I was using was out of warranty and died; I then received a new pump in February of this year. I was told I would be eligible for the new technology guarantee, however, everything I've read says you must purchase both at the same time. I'm not new to pump therapy so the odds of needing both at the same time are fairly slim. Can you please let me know if this is correct? It's quite disapointing having to wait another 4 years for the new/smaller CGM!

Naomi

Posted on Fri Oct 04 18:34:47 GMT 2013

Gena, Amy, and Maureen I will have a member of my team follow up with you to discuss your options. In the meantime, you can find more information about the MiniMed 530G with Enlite on our website at http://www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite.

Marion, I’m sorry you’ve had issues using your current CGM. I’d be happy to have someone from my team reach out to you to try to help. In the meantime, to find more information about the MiniMed 530G with Enlite click here http://www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite.

Martin, the MiniLink transmitter is exactly the same. It can be used with either the Revel insulin pump or the MiniMed 530G insulin pump. However, the Enlite sensor is only approved for use with the new MiniMed 530G insulin pump (and not older models). If you’re interested in learning more I’d be happy to put you in touch with someone who can talk you through your upgrade options.

Flex, thanks so much for sharing your experience using a pump and CGM. I’m so glad to hear that you’re doing well. To answer your question, every insurance works a little differently so I’m not sure but I’ll be sure to have a member of my team contact you to discuss your upgrade options.

Lisa O., if you purchased your Revel under the New Technology Guarantee program, someone will be in touch with you soon about upgrading to MiniMed 530G. We have quite a number of these upgrades to process, so please bear with us as we work hard to provide new product and training to everyone in the program. We appreciate your patience!

Lisa, thanks for reaching out about this. I'm going to pass along your feedback to our Customer Service team and have someone reach out to you to see what upgrade options are available to you.

Jaci

Posted on Sat Oct 05 03:10:37 GMT 2013

I got my latest pump, the Paradigm, last August or September, 2012. How do I find out if I'm included in the new technology guarantee?

Martin

Posted on Sat Oct 05 12:07:53 GMT 2013

Naomi,
Please have someone get in touch with me regarding upgrade options. Please use the email above.
Martin

Naomi

Posted on Sat Oct 05 15:35:41 GMT 2013

Jaci and Martin, I'll have someone from my team reach out to each of you soon to discuss your upgrade options.

Christy T

Posted on Sat Oct 05 21:28:46 GMT 2013

I thought when I purchased my first paradigm (maybe 4 or so years ago, I forget) that I had some kind of new technology upgrade guarantee. that never happened, I forget now what the rationale was. Since my most recent purchase was a year and a half ago I doubt I have it now. But the earlier experience felt like a bait and switch to me- it was heavily stressed when I upgraded. I would certainly need to hear a lot more to understand why this would be better than my current CGM, which, while helpful in showing trends, is frequently GROSSLY inaccurate (as I gather they all are.) I pay a lot for this technology, and now that I have been laid off and underemployed it is a disproportionate share of my income. I am not going to keep upgrading in order for Medtronic to run virtual clinical trials on my dime. but I'm sure enough people will. I once wore the same pump for 12 years, looks like I may need to do that again (if the quality is still good enough- that was a Minimed, pre-Medtronic I believe, 1995 or so. )

Katie

Posted on Sun Oct 06 20:48:42 GMT 2013

Has MM decided on what process will be used to determine which patients will be contacted about upgrades first? I know that I upgraded under the technology upgrade guarantee but would like to get a sense of whether I will be waiting a shorter or longer time. This also leads to the question about whether MM has the 530G's and Enlite sensors already manufactured or if there will be a delay for manufacture before the device upgrades begin.

Sandy

Posted on Sun Oct 06 22:59:39 GMT 2013

When will you start shipping the new pump?

Brian

Posted on Mon Oct 07 13:38:37 GMT 2013

I was notified in December about upgrading my pump and was told I would be eligible for the upgrade when it was approved. They were also going to send my a new CGM but mine was working fine so I told them I did not need a new one at this time. Am I still eligible under the New Technology Guarantee Program since I only received the Revel pump and did not get a new CGM? I was never told I wouldn't be otherwise I would have just done it.

Naomi

Posted on Mon Oct 07 16:19:53 GMT 2013

Christy, I apologize if you had a negative experience during your previous upgrade. If you’d like to talk to someone I’d be happy to connect you with a member of my team. Also, the new Enlite sensor features both improved comfort and accuracy over previous generations. If you’d like to learn more, please visit our website here: http://www.medtronicdiabetes.com/treatment-and-products/enlite-sensor

Katie and Sandy, we should begin shipping the new MiniMed 530G system within the next couple of weeks. Our team is working diligently with our current inventory and training schedules to make sure that both new and longtime customers receive their MiniMed 530G system as soon as possible. Thanks so much for your patience!

Brian, thanks for asking. I’ll have a member of my team reach out to you to discuss your upgrade options.

Cheryl

Posted on Mon Oct 07 16:41:45 GMT 2013

My 23-year-old son uses a Paradigm pump and is eligible to upgrade to the 530G. He has very unpredictable and varying overnight blood glucose levels. He was wondering whether, if he is still low (below threshold) even after insulin delivery is suspended for two hours, will the pump just start giving him insulin again - or will it notice he's still low and suspend again? Also, must a physician set the threshold level himself/herself, or can the patient do it with physician input? Thank you.

Nancy

Posted on Mon Oct 07 22:04:19 GMT 2013

I am a little upset. I received a call that I am up to get a new pump because it has been over 4 years. WELL, I do not need to use a sensor my A1C is 6.6. When I received my 1st pump the sales person came to my home and talked me into buying a sensor. Guess what I didn't have to use it at all because the pump worked period.

My question is why do I have to buy a sensor in order to get a new pump. Sales person said that is the ONLY way I can get a new pump is with a sensor. Medtronics was good for the 4 + years I have had this pump but it looks like I probably will have to look/do something else once this pump fails. BUMMER. Not good business to make someone buy extra medical equipment when they only need the pump.

You really need to look into this more and see if people that do not need the sensor and still be able to get a insulin pump only.

Naomi

Posted on Tue Oct 08 16:56:19 GMT 2013

Nancy, we strongly believe that the MiniMed 530G with Enlite provides the greatest clinical benefit to people with diabetes when used as a system, which is why we’re only offering it to most people as a system. In addition, to use the Threshold Suspend automation of the MiniMed 530G, CGM is required. Would you be willing to speak to someone about the new system and determine if it is right for you?

jean vidas

Posted on Thu Oct 10 08:56:53 GMT 2013

I need to have some answers to some questions and need some more info where can I email to find out I am living out of the country right now and would like to fine out more for when I come back to the states. only why is email for me

jean vidas

Posted on Thu Oct 10 09:01:43 GMT 2013

I read that it takes AAA batteries. is there any thing else that has to be changed when using this and how often would that be.

Naomi

Posted on Thu Oct 10 17:55:21 GMT 2013

Cheryl, this is a good question. If the Threshold Suspend feature suspends insulin delivery for two hours and the patient does not respond, insulin delivery will automatically resume for 4 hours regardless of sensor glucose value. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. As for setting the threshold level, we always recommend that diabetes management decisions be made with a healthcare team. If you have any more questions about how the Threshold Suspend feature works I'd be happy to connect you with someone from my team.

Jean, thanks for your comment. You’re correct, the pump requires one AAA alkaline battery. Use of the MiniMed 530G system requires users to change their infusion set every 2-3 days and the Enlite sensor every 6 days. You can learn more here: http://www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite. If you have any more questions I’d be happy to connect you with someone from my team.

Herman Miller

Posted on Mon Oct 14 15:41:45 GMT 2013

I don,t know if I have the New Technology Guarantee or not. Your website used to include our personal reps and email, but you did away with them. Why can't we get that information back? Thank You

Hunt Allard

Posted on Mon Oct 14 19:55:02 GMT 2013

Can I use the new Enlite sensor with my 723 pump? I need the larger insulin reservoir size of the 723 but like the benefits of the Enlite.

Naomi

Posted on Mon Oct 14 22:07:03 GMT 2013

Herman, thanks for your comment. I’m sorry we do not have that information available for you on our website but I will have a member of my team contact you to walk you through your upgrade options.

Hunt, the Enlite sensor is only approved for use with the MiniMed 530G system. The MiniMed 530G system does come in both 180 and 300u reservoir sizes. If you’d like, I can connect you with a member of my team to discuss your upgrade options.

Herman Miller

Posted on Tue Oct 15 13:28:53 GMT 2013

Thanks for the response and email. I have noticed a lot of people do not know if they are eligible for the.new technology guarantee. That is the only question I really have. Why can't it just be answered? Why does someone have to contact me? I'm sure your records indicate it. I am on vacation, so the email or this blog is the only way to contact me presently. Thank You

Hunt Allard

Posted on Tue Oct 15 19:09:33 GMT 2013

Thanks for your fast reply to my comment on 10/14. FYI, your phone representative was unaware that the 530g offered a 300u size reservoir. The representative did know, however, that Medicare does not offer ANY CGM insurance coverage, which could be deciding factor for some.

Naomi

Posted on Tue Oct 15 21:44:45 GMT 2013

Herman, per HIPAA regulations, customer account information is restricted to those who need that information to perform their job on a daily basis. Because I am on the PR team and do not need customer’s personal information on a daily basis, I do not have direct access to customer account information. I do apologize for the extra step, but it is to protect the privacy of all of our customers. I’ll have a member of my team email you the information you’re looking for, enjoy your vacation!

Hunt, you’re welcome and I apologize if you were not given correct information over the phone. I will look in to it. In the meantime, if you have any other questions please let me know.

Jeff Davis

Posted on Thu Oct 17 14:28:05 GMT 2013

I purchased my insulin pump (medtronic Mini Med) in June 2012. Am I able to get an upgrade? I also have the sensor's for it but currently do not use them. I could never get them to stay in for more then 2days before falling out.

Thai You

Naomi

Posted on Thu Oct 17 23:41:58 GMT 2013

Hi Jeff. Thanks for reaching out! I will have one of my colleagues give you a call to explore your upgrade options and share some information about our new Enlite sensor. In the meantime, you can learn more about MiniMed 530G with Enlite, including some of the improvements we have made in both comfort and accuracy with the this new sensor, here: http://www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite

Pam

Posted on Wed Oct 30 06:01:21 GMT 2013

does the new 530 pump use a different reservoir than the paradigm 723 and different infusion sets?

Naomi

Posted on Wed Oct 30 06:13:01 GMT 2013

Hi Pam, like our Paradigm REAL-Time Revel system, the MiniMed 530G system does come in 2 reservoir sizes, 180U and 300U. Your infusion set options also remain the same with this new system. If you have any other questions I can help with, just let me know.

Kent DuBois

Posted on Thu Oct 31 14:34:14 GMT 2013

I understand the Threshold Suspend idea. My question is will the basal start up again on it own or is intervention required to start up the basal again when the blood sugars are high enough?

Travis

Posted on Fri Nov 01 16:36:34 GMT 2013

I am in a training program at work, often in the classroom. The training program is for a critical-type job for which low-threshold suspend features will be immensely useful (imagine kind of like a space shuttle pilot/ fire fighter combo... But no... I won't be the first diabetic in space).

Usually, important pump and sensor alarms will vibrate, then proceed to beep and alarm if not acknowledged. Normally, this is great. However, in a classroom, the interruption is undesirable (although my company has agreed to put up with it for ADA reasons).

I'm really curious to find out if a low glucose suspend alarm can be silenced without lifting the suspension (which I want to happen -- stay suspended but be quiet).
In other words, will acknowledging the alarm lift the threshold suspend (which I don't want to happen)?

Naomi

Posted on Fri Nov 01 20:21:05 GMT 2013

Hi Travis, when your sensor glucose reaches or drops below your preset low threshold, the pump will sound an alarm, stop all insulin delivery, and then display THRESH SUSPEND on the screen. When this occurs, you will have two options. You can clear the Threshold Suspend alarm and select to continue to suspend all insulin delivery for two hours from the time that the alarm first occurred or you can clear the Threshold Suspend alarm and restart basal insulin delivery. Keep in mind that if you do not respond to the Threshold Suspend alarm, the alarm will continue to siren and insulin delivery will remain suspended for two hours. If there is anything else I can help you with, just let me know.

Patricia

Posted on Mon Nov 04 20:57:25 GMT 2013

I have stopped using my CGM due to frustrating gross inaccuracy's, in BG levels & alarms such as Cal Error, etc.. The new system advertises 31% better accuracy. That doesn't sound overwhelmingly convincing that the new system will work much better, therefore I am hesitant to go with the new system. My concern is I will invest in the new system & end up not using the CGM, as I am doing now.

With the CGM, does it become inaccurate over time or when it "goes bad", does it just stop working, entirely? It seemed to be accurate when I first got it...or was it my imagination?

I did briefly speak with a rep today (after 1.5 hrs on hold) & was told there is a program to assist in the out of pocket cost, since my MM is still within the 4 yr warranty period. Will this offer stand up until the 4 yr period (Apr 2016) is up & my insurance would then cover? Or does the amount I would pay, increase/decrease as my 4 yr date approaches? Or is there a limited time this is program is in effect?

If you feel my questions are better addressed over the phone, I would be glad to provide my number, via email.

Thank you!

Naomi

Posted on Wed Nov 06 16:10:08 GMT 2013

Hi Patricia. I am sorry you’ve had a frustrating experience using your current CGM. Our new Enlite sensor includes many advances compared to our previous sensor, such as improved comfort and accuracy, which could enhance your experience. You can also find information about Enlite accuracy here: http://www.medtronicdiabetes.com/treatment-and-products/enlite-sensor. I will have a member of my team reach out to you soon to discuss your concerns and insurance coverage options.

Travis

Posted on Sat Nov 09 03:46:01 GMT 2013

Naomi,
Thanks for the reply, and sounds great!
So to confirm:
Hypothertically, on a low bg alarm, if I were to use the option to "clear the Threshold Suspend alarm and select to continue to suspend all insulin delivery for two hours from the time that the alarm first occurred," then:
1. Acknowledging the alarm with the suspend option would cause the "Low Threshold Suspend" alarm audio/beeps to be silenced, and would not continue for that particular alarm, and
2. Any other future low, rate, prediction alarms, or the like, would continue to alarm as usual.

Is that roughly correct? If so, sounds like a perfect fit...

Thanks again!

Naomi

Posted on Mon Nov 11 17:44:54 GMT 2013

Travis, thanks for your questions! I’d like to connect with a member of my team to discuss this in more detail to make sure you completely understand the new Threshold Suspend feature. I will have someone email you soon.

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