Meet the newest member of the family: The MiniMed 630G system
Great news, everyone! Today I’m thrilled to share that the FDA has approved the MiniMedTM 630G system with SmartGuard™ technology. This advanced diabetes system provides better glucose control[i], protective action and personalized management so you can focus less on managing highs and lows and more on what matters most to you –whether that’s time with your loved ones, pursuing a big career goal, traveling the world or all of the above!
What’s so exciting about the MiniMedTM 630G system? Let’s find out.
SmartGuardTM technology
MiniMedTM 630G is a new insulin pump combined with our EnliteTM sensor. The system includes SmartGuardTM, our exclusive technology that takes action to reduce the risk of diabetes complications ii. The system automatically stops delivering insulin when your sensor glucose hits a preset low level and you don’t respond to the alarm. SmartGuardTM is available in both MiniMedTM 630G and MiniMedTM 530G systems (you may recognize this as Threshold Suspend.)
A new, improved pump design
The MiniMedTM 630G system also has a brand new (and improved) pump design with many more personalization options to make the system more convenient and tailored to how you manage your diabetes. You can customize alerts and alarms and we’ve introduced more user-friendly menus. The new system also includes that full-color screen and waterproofing you’ve been asking us for! This new design incorporated extensive patient feedback and user testing from people with diabetes, so we can’t wait to hear what you think.
A new meter
The MiniMedTM 630G system exclusively uses the CONTOUR®NEXT LINK 2.4 Meter to provide highly accurate blood glucose testing and to automatically transmit blood glucose results into the pump to eliminate manual entry errors when using the Bolus Wizard® calculator or calibrating the sensor. It’s similar to the CONTOUR NEXT LINK meter that comes with our MiniMedTM 530G system and is the only meter FDA approved for use with the new system. It also allows you to discreetly give a manual or a pre-set bolus of insulin remotely from the meter – another feature that many of you have told us would be beneficial to you.
Just one more step
Here at Medtronic Diabetes, our vision is to transform diabetes care, together for greater freedom and better health. This new system demonstrates Medtronic’s focus on making diabetes devices more convenient and simple to use as well as delivering better clinical outcomes. We’re certainly not done yet. Innovation is a journey and we’re constantly working on improving the products we have today as well developing new ones. In the meantime, we can’t wait to hear what you think of this latest step to help you live your exceptional life.
Part of a family
The MiniMedTM 630G system joins our family of diabetes management products, including our MiniMedTM 530G system which we will continue to provide. The MiniMedTM 530G system is popular for its ability to be used with MiniMedTM Connect mobile accessory, which allows people with diabetes to discreetly view CGM data on their smartphones as well as remote monitoring for their care partners. So, we’re offering both products to meet the different lifestyle needs of people with diabetes. Like the MiniMedTM 530G system, the MiniMedTM 630G system is approved for people age 16 and older. We expect to start shipping in a few weeks and we’ll be sure to keep our community updated. To learn more about the product in the meantime, visit our website.
Important Safety Information
The MiniMed 530G and 630G systems with SmartGuard technology are intended for the delivery of insulin and continuous glucose (CGM) monitoring for the management of diabetes mellitus in persons 16 years of age or older who require insulin. Insulin infusion pumps and associated components of insulin infusion systems 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 of insulin pump therapy.
The systems are 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 Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter.
WARNING: The Threshold Suspend/Suspend on Low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend/Suspend on Low feature, it is important to read the information in the MiniMed System User Guide and discuss proper use of the feature with your healthcare provider.
A confirmatory fingerstick via a CONTOUR®NEXT LINK portfolio meter*, is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK portfolio meter*, to ensure the glucose result shown agrees with the glucose results shown on the meter. Additional, warnings, precautions and contraindications apply. See www.medtronicdiabetes.com/support/download-library/user-guides and www.medtronicdiabetes.com/importantsafetyinformation for details.
*The CONTOUR®NEXT LINK 2.4 Meter is used with the MiniMed 630G system. The CONTOUR®NEXT LINK Meter is used with the MiniMed 530G system.
[i] Bergenstal R, Tamborlane W, Ahmann A, Buse J. Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes. New Engl J Med. 2010;4(363):311-320
[i][i] The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993:977─986.
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Blog comments
Hi Karrie,
Thank you for this article! Do you know the dimensions of the new pump? I'm petite, and I already have a hard time finding a place to wear my 530g pump with dresses, skirts, etc. It's even tricky to fit into small pockets. Thank you for any information you may have!
You bet, Katherine! The dimensions are 2.1”W x 3.78”H x 0.96”D, a 17% volume difference from our MiniMed 530G system. It's slightly larger so it can accommodate a AA battery.
Is there an eta in the approval for those under 16? My daughter is almost 6 and this seems like a really great system for small children whose diabetes is being managed by others.
Melissa, the clinical trial only had people with diabetes who were aged 16+. We are pursuing the clinical evidence to support an indication for children 15 and under, but we do not have a timetable for when this will happen.
It would be really nice if Medicaid would cover continuous glucose monitoring. I have had issues with my last pump and this new pump. Low blood sugars that I almost died from when I have never had any issues like that before and I've been a diabetic for 29 years. Any time frame on when Medicaid may start covering?
Tiffany, we're actively involved in a coalition advocating for Federal legislation on just this topic. To find out more and learn how you can get involved visit: http://www.loop-blog.com/update-expanding-access-cgm-medicare/
I have been waiting for this to come out. I know it has been available overseas for a while and has had some good reviews. I have been on a Medtronic pump now for 10 years, currently a 523 which was purchased 5 years ago. I did give the Tslim a try but I had some major issues as did my wife. We both shelved the Tslim after 3 months. I am anxious to get my hands on one of these and see what new features are on this. I have read all about it but its always a different story once in your hands and using it. Are they available now?
Gordon - this system is different from the one available outside the US. It has the same SmartGuard technology to what is in the MiniMed 530G system but in a new, more consumer-friendly design with more convenient features -- based on feedback from people like you! You can order now. Start by filling out the form here http://bit.ly/2aNu0dK We'll be able to ship in another 6-7 weeks or so.
Hello, would this 630G model be able to be used if a person didn't want to use the CGM sensors and just the pump?
We strongly believe the way to get the best value out of the system is to use it as a system. But if you fill out the form someone can help you look into your options. http://bit.ly/2aNu0dK
I just got the 530? Pump with the cgm. About a month ago. What are the chances I could upgrade to this new one. I had no idea it was coming out .
We'll have several different programs available once we begin shipping in 6-7 weeks or so. If you want to go ahead and fill out the form here http://bit.ly/2aNu0dK someone will be in touch with your options.
Ahmed, I'm sorry but we can only sell you the pumps that are approved for use in the country where you live.
Is the Enlite Sensor that is integrated into the new 630G system the same as the one that is used with the 530G? What is the "Guardian Link" transmitter? Is the one-press serter that is used for the 630G able to be used with the enlites from the 530G system?
Yes Sandy, the MiniMed 630G system includes the Enlite sensor, which is the same sensor available in the MiniMed 530G system. The Guardian Link transmitter that connects with the Enlite sensor is new. The previous CGM transmitter is not compatible because it operates on a different radio frequency. The MiniMed 630G system uses the new One-press serter, which can be used with the Enlite sensor on either system but it isn't available for purchase yet.
Any idea when the new one-press serter will be available for purchase?
Sandy, you will be able to purchase it online by the end of this month on the online store.
My daughter complains about how slow the bolus is on her 530 G. Does the 630 G deliver insulin at the same rate?
Tara, great question. There are two bolus speeds, Standard and Quick. The Standard rate delivers an average of 1.5 units per minute and the Quick rate delivers an average of 15 units per minute.
Hi Karrie,
I am both excited and upset at this development.
I was contacted in mid-June that my insulin pump was out of warranty, so it would be wise to get a new one. I specifically asked over the phone if there were any new pumps in the pipeline with screens that were easier to read, since as a Type 1 diabetic for 51 years, my eyesight was not the best. I was told that no, there weren't, and so the end of June I ordered the Minimed 530g, which I received on June 30th. As you know, it has the same poor screen as the previous pumps.
Now, only a month later, Minimed reveals a pump with exactly the upgrade in the display that I sorely needed. Is there any recourse to this, or possibility of exchanging pumps with a minimal cost for me? The pump is barely one month old.
Thanks!
Todd
Thanks for your feedback, Todd. I’m sorry but we aren’t able to speak to future products until they are FDA approved. We accept returns within 30 days for our products and will have upgrade options available for our customers in November. We're still sorting out details and ramping up inventory.
I am due for a replacement, as my current pump is five years old. Is there literature available for this pump, and will it be available for trial?
Brian, we will be adding more information on our website in the near future but feel free to get started here http://bit.ly/2aNu0dK. We're currently finalizing our upgrade programs and ramping up inventory so I recommend that you check back with us in November. We will have an upgrade program available to you but free trials will be for new Medtronic customers only.
As i read all the info of the 650g. I think it is great. I was just pushed into getting tge 530g by getting a call saying the info tgey gave me for new pump was not going to be available, so i ryahed to get it and a week later i was being shown how to use my new pump and tge next day guess what this new pump was approved. I was so mad. But this 530g it really nice. It has more buttons to push then the old one. The only things i cant stand is the thresh suspend going off in the middle of the night. And here today it would stop which is great but once my sugar was normal it was still off. The other thing i wish this one and the new one had was this when the sugar is high it would automatically give insulin instead of waiting for a check.
Assuming this pump is marketed for CGM users only? So no point in moving from Revel if we are not CGM folk?!?
We strongly believe that the MiniMed 630G with SmartGuard technology 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. If you're interested in learning more, feel free to give us a call.
So the only real differences between the current 530g and the new 630g are the waterproofing feature and the updated physical design?
Ben, there are additional new features including customizable options, user-friendly menus and a remote bolus function. This system was created with feedback from our customers that we’ve heard over the years.
I would rather stick with my old pump. I am not a fan of the contour next meter. I would rather input the results of my meter that costs 40 cents per strip then one that costs 80 cents per strip
When will this be available in Canada?
Sarah, I'm sorry but I can't provide any details on product availability in other countries. This system was approved for use in the U.S. and I recommend that you reach out to your local team in Canada for products that are available there.
Honestly I am not impressed, why are you still using RF technology? Bluetooth communication would be so much better and compatible with so many more devices. Also Medtronic CGM is terrible. Used it for a month and it was the worst experience I had with my current pump. When my insurance lets me get a new pump in 2 years I know I will steer clear of any Medtronic product.
I literally just got a new pump setup(730G with Elite sensor) on Monday this week and now this has been released. Can I change out the new pump I just got to this one?
Lacey, we have a 30-day exchange policy. Reach out to your Diabetes Therapy Consultant to review the options available to you, or you can email dhelp@medtronic.com.
Can I exchange the old one with the new one.
Pepo - it depends on when you purchased your last one insurance etc. We have a variety of programs. If you fill out the form here http://bit.ly/2aNu0dK someone will call you to discuss
This new pump sounds so great I can't tell you how many times I've passed out from low blood sugar and how many times I've turned down events that evolve water sports the only thing I think could help is if their were some way to make everything in bigger numbers an words so people with poor eyesight could see it better I can't wait to get the new pump
My son got a brand new 530 pump in July. I specifically asked if a newer pump was coming, I had heard that one was in development, but the sales rep could not confirm that. I was told it would be some time before it would be available, but he could upgrade before he ages off my insurance. Had I known it would be released 6 weeks later, I would have waited. It took nearly a month to get a pump trainer to his home, he has only been wearing it for 2-3 weeks. Yes, I know, there is no way to know when the FDA does its approval. I will fill out the form.
Thanks for understanding, Susan. I know it's frustrating. But our U.S. team is not permitted to talk about products until they are approved for use by the FDA.
Thank you
What if I do not use the CGM ? Am I wasting my time with the 630G? Would be no better than my Paradigm 722? Can the CGM feature be turned off? Thanks
Yes, the CGM feature can be turnoff, you don't <em>have</em> to use it. But we strongly believe that CGM provides a lot of value and the best value you can get out of the MiniMed 630G system is to use it as a system.
I currently have a 523 which uses the 1.8ml reservoirs, is there going to be a 1.8 ml version of the 630g? If no, will the 1.8 ml reservoirs fit? I have quite the stockpile of supplies that I would hate to see go to waste........
I'm sorry, John. The MiniMed 630G only comes in one size and only the 3.0 ml reservoirs are approved for use with it.
Heloo, I have a 13 years old daughter with diabetes. We have a problem with the transmitter. She thinks that it is verry big and ugly and she does not want to use it. I would like ti ask do you think about changing the design of the sensor and transmitter, because it doesn`t matter what extras have the new pump when the teenagers don`t want to use it.
This is a revolting development!!! I've only had the 530g for 5 months-AFTER a 2 year struggle to get it. Now what. Those of us who were not told a newer pump was coming should have some recourse to obtain the 630g. I know you don't know WHEN FDA will approve, but you certainly knew 1 was in the works and approval had been requested. I'm stuck in the Medicare not paying; switched to a supplemental insurance plan which I cannot afford; and now this. Not a good feeling, Mr. Israk...
I'm sorry you're upset Patricia. We are absolutely not permitted to talk about future products before they are approved for use by the FDA. We do have several different upgrade options available, depending on your situation. If you'd like to fill out the form here http://bit.ly/2aNu0dK someone will be in touch to discuss your situation.
When you say "we" , who do you mean?
A member of the Medtronic team.
Hi Karrie,
I have an unusual situation here. My 530G failed over the weekend. I have been Out of Warranty since March and was waiting for the 630G to be released. The Minimed sales rep sent me a 530G and I received it yesterday. The new pump is still unopened. Considering I am on a loaner at the moment (good for 83 more days), do you know if I can return the 530G and request the 630G?
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