On targets and staying in range with the MiniMed™ 670G system

Person with MiniMed 670G insulin pump

Almost seven years ago, I became the Chief Medical Officer at Medtronic Diabetes to work with the teams developing the closed loop system.  I knew that it was the right time for this advancement in diabetes technology and I wanted to be part of it despite knowing there would be challenges on many fronts.  But with the help of hundreds of engineers, scientists, clinicians and product development people at Medtronic and as the result of many successful clinical trials and the final pivotal trial, the FDA approved the MiniMedTM 670G system for commercial release.  This was a truly exciting moment, and my Medtronic colleagues and I are proud to be the first to make such an innovative therapy available to those living with type 1 diabetes. 

To gain FDA approval for people with type 1 diabetes, 14 years of age and above, we did our pivotal study and found the following results: 

1. The MiniMedTM 670G system is safe. 

2. The system increased the percent of glucose values in the acceptable target range (between >70 and 180 mg/dL), without increasing lows. 

3. The MiniMedTM 670G system is capable of dynamically delivering basal insulin throughout the day and night. 

But like most clinical trials and new commercial products, numerous questions have also arisen.  I would like to take this opportunity to address one of the most common questions that have been presented to me as I’ve crossed the country talking about the MiniMedTM 670G system – Why 120?

 

Question: “Why was 120 mg/dL chosen as the target for Auto Mode in the MiniMedTM 670G system?”
 

The goal of the MiniMedTM 670G system is to increase the time with glucose values in the target range of 70-180 mg/dL. This is what is most important and what allows you to feel better more of the time, allowing you to focus more on the people and activities that you love. To do that, a single mid-point target of 120 mg/dL is used by the algorithm (the mathematics) to automatically deliver basal insulin.  While many people might think the target should be lower, we showed in the pivotal trial that this target can decrease A1C – the mean A1C of the 124 study subjects went from 7.4% to 6.9%, while also decreasing the amount of time spent with low glucose values.  In addition, over the 12,000 patient days of hybrid closed-loop use by the study subjects, there were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA) – showing that this target is safe and effective in improving glucose control.

 

Question:“If I use the MiniMedTM 670G system, will my glucose always be at 120 mg/dL?”
 

No. The people in the clinical trial and those who are part of the Customer Training Phase of the commercial rollout see many different numbers on the blue shield of their pumps – some higher and some lower. But the important thing is that they’re spending more time in range of 70-180 mg/dL and a lot less time with lows or highs. The 120 mg/dL target just gives the system something to work toward, a mechanism that allows the system to achieve that bigger, more important goal of more time in range.

 

Question:“My personal BG target is lower than 120 mg/dL. Will my A1C go up if I use the Auto Mode feature?”
 

The results of the MiniMedTM 670G pivotal trial showed that study participants decreased their A1C levels with the system using 120 mg/dL as the target.  The average time spent in the range of >70-180 mg/dL also increased to 72% during the day and 75% at night.  Overall, there were fewer highs and fewer lows. This is what we want to see. In addition, an average glucose value of 120 mg/dL equates to an A1C of 6% - showing that targeting 120 mg/dL should lead to the kind of A1C levels that are the suggested goal of the American Diabetes Association. 

 

Question:“Why can’t my endocrinologist and I decide on a target glucose value?” 
 

The MiniMedTM 670G system uses mathematics (a control algorithm) to determine how much basal insulin should be delivered every 5 minutes.  The algorithm determines at 5 minute intervals how much insulin to give by assessing the present glucose value, its rate of change, how much insulin has been given and how much is active, and the sensitivity to insulin.  It does this continual assessment and targets the insulin dosages it gives to get the glucose to as close to 120 mg/dL as possible, and with as many glucose values between 70 to 180 mg/dL as possible. Through all of the studies we have done, the 120 mg/dL target has been effective and safe – and therefore that is a fixed target in the system that cannot be changed.

 

Question:  “How can I find out more about the MiniMedTM 670G system clinical trial results?
 

You can learn more about the MiniMed 670G system clinical trial results here: 
http://jamanetwork.com/journals/jama/article-abstract/2552454 
http://online.liebertpub.com/doi/full/10.1089/dia.2016.0421 

I hope this helps you understand why 120 mg/dL is the target and 70-180 mg/dL is the target range.  The most important aspect of the MiniMedTM 670G system is that it should be safe and more effective than what the person with diabetes can do on their own – thereby reducing the burden of managing this disease.  I couldn’t be more excited about the MiniMedTM 670G system and I look forward to entering this new era in diabetes therapy with all of you.

 

Important Safety Information
The Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G system includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. 
The system requires a prescription. The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOUR®NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian Sensor (3).  
Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site (palm) or from a control solution test. Do not calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.  If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode. 
WARNING: Medtronic performed an evaluation of the MiniMed 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day, because the device requires a minimum of 8 units per day to operate safely. 
Only use rapid acting U100 insulin with this system. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed 670G system has not been studied in pregnant women. For complete details, including product and important safety information concerning the system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-670g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library
 

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Blog comments

Submitted by Anna (not verified) on

In reply to by Commenter (not verified)

Are there expected release dates for the 670G in Australia?

Submitted by Karrie Hawbaker (not verified) on

In reply to by Anna (not verified)

Anna - it is best to reach out to your local team for release dates:
Medtronic Australasia Pty Ltd
Diabetes Division

australia.diabetes@medtronic.com

Tel: +61 2 9857 9000
Fax: +61 2 9887 1829
Toll Free: 1800 668 670

www.Medtronic-Diabetes.com.au

Submitted by David (not verified) on

In reply to by Commenter (not verified)

I have the new pump. The only drawback I have, is the clip that is attached to the back of the pump does not allow me to rotate the pump when I wear it on my belt.
The sensor that came with it doesn't meet my expectations. I have to calibrate it way too many times. Also, the sensor was off a couple of times, as much as 40 points.
Any modifications on these issues planned?

Submitted by Karrie Hawbaker (not verified) on

In reply to by David (not verified)

David, thank you for the feedback on the belt clip. I've made sure to share this with my team. In regard to the sensor, I'd like to connect you with our 24 HelpLine. I will have someone reach out to get your contact information.

Submitted by Jeff (not verified) on

In reply to by Karrie Hawbaker (not verified)

I'd like to second the comment on the belt clip. I just upgraded to the 670G recently and am highly disappointed in the lack of a holster. I wear the pump on my belt (with a suit) most days and cannot easily unclip and look at the pump like I used to be able to do with the 530G holster. It used to be so easy (and discreet) to pull the pump from the holster, check my info or bolus, and then put it back. Now it's a much more cumbersome process without the holster. I know I'm not the first to complain about this, but please add my feedback to the growing list of comments.

Submitted by Karrie Hawbaker (not verified) on

In reply to by Jeff (not verified)

We appreciate the feedback, Jeff. You are correct, we have heard this request before. We don't have any updates available, but we have shared this with our design team and look forward to providing more options in the future.

Submitted by Tim (not verified) on

In reply to by Karrie Hawbaker (not verified)

For me, it would be worth the extra expense to have an (optional) watch-style wrist monitor to see your readings while keeping the pump tucked away.

Submitted by Anna (not verified) on

In reply to by David (not verified)

I agree it would be great to be able to rotate the clip on the pump as I wear it on my bra and the tubing always points up which quite often shows and I am always having to tuck the tubing in

Submitted by Wes Craft (not verified) on

In reply to by Commenter (not verified)

Why is there not a cgm that is part of the infusion set? I have been a type 1 diabetic since I was 8 yrs old (36 yrs). I am tired of having multiple sore spots because I have to have 2 injections for this to work.

Submitted by Karrie Hawbaker (not verified) on

In reply to by Wes Craft (not verified)

Wes, thanks for the feedback. This is something we've heard from the community and, while we can't talk about future products we have a bright team working hard on what's next.

Submitted by Rebecca Kluz (not verified) on

In reply to by Commenter (not verified)

If my endo had gone through the training, are we looking at the beginning of June or later in the month for possible deliveries to start?

Submitted by Karrie Hawbaker (not verified) on

In reply to by Rebecca Kluz (not verified)

Rebecca, we will have more information about the roll out of the MiniMed 670G system in June. Please stay tuned.

Submitted by Elena F (not verified) on

In reply to by Commenter (not verified)

When will the new 670 G be available in Italy? I can buy it now?

Submitted by Karrie Hawbaker (not verified) on

In reply to by Elena F (not verified)

Elena, this is a great conversation to have with your local team. Please find the contact information here:
Customer Services & Ordering
Fax: + 39 02 24138 209
24h HelpLine
Toll free number: 800 20 90 20 (Italy only)
Tel. + 39 02 24137 220 (International dial)

www.parliamodiabete.com
www.medtronic.it

Submitted by MisanthropicScott (not verified) on

In reply to by Commenter (not verified)

Hi.

I have a few questions.

This article says "the mean A1C of the 124 study subjects went from 7.4% to 6.9%, while also decreasing the amount of time spent with low glucose values."

1. How many of the 124 patients had an A1C below 6.9% before the start of the study?

2. How many of those who started with a lower A1C saw their A1C go up?

3. Is the 670G shipping in the U.S. today? I am not finding any recent update. The last post I see said it would be shipping before now. But, I do not see any update to that.

4. Is the 670G available on the Pathways program?

Thanks for any information,
Scott

Submitted by Karrie Hawbaker (not verified) on

In reply to by MisanthropicScott (not verified)

Great questions, Scott! You can learn more about the MiniMed 670G system clinical trial results and download the full text here for more details: http://bit.ly/2nwQtSd. The MiniMed 670G system is shipping in the U.S. today to our Priority Access customers currently. We do have in-warranty upgrade options available for customers who are on our MiniMed 630G system who would like to get on the MiniMed 670G system. We will have more information on this once we get through our Priority Access program.

Submitted by MisanthropicScott (not verified) on

In reply to by Karrie Hawbaker (not verified)

Thanks Karrie. Unfortunately, as I read the study and your reply, it seems my answers are :

1. 0. None of the study participants began with an A1C below 7.1. This may mean the results of the study are entirely irrelevant to me personally and to anyone with an A1C below 7.

2. Unknown. The study report does not give any data at the individual level, even anonymously. One can only suppose that those few who dropped out of the study experienced worse control on the system than off it. But, there is no information about the percent of people whose A1C actually went up on the system.

3. Yes.

4. No.

Please let me know if I've misinterpreted anything.

Submitted by Vic (not verified) on

In reply to by Commenter (not verified)

Can you provide the Math Algorthim, how you compute the insulin delivery amounts based on readings. I am sure FDA looked at this. As you get more data, I am sure the Algorthim will get better. Ml/AI, how will these get down loaded. Eventually the Algorthim will change by weight/Sex/exercise and other varaibles. Algorthim will get tweakes/dynamically

Submitted by Karrie Hawbaker (not verified) on

In reply to by Vic (not verified)

Vic, thank you for reaching out. Our 24-Hour HelpLine may be better able to answer some of your questions and they can be reached at 800.646.4633 option #1.

Submitted by Koen Van Vooren (not verified) on

In reply to by Commenter (not verified)

Dear,
I live in Belgium.
I have know the minimed 640G.
When comes the minimed 670G fot the patient in Belgium?
Greets

Koen

Submitted by Gary (not verified) on

In reply to by Commenter (not verified)

My Endo asked Medtronics to call me. No contact after a week. I tried using your website to get someone to contact me. Would not work on mobile or window pc. I found a contract number and left multiple voice mails for a representative. He only tried to return my calls once. I finally found out Kaiser DME could order it. They sent my order to Medtronics. How long till I contacted by Medtronics? Customer service does not appear to be priority. Thanks for letting me vent.

Submitted by Karrie Hawbaker (not verified) on

In reply to by Gary (not verified)

Gary, I'm sorry for any delay. I understand you spoke with your device specialist and your order shipped yesterday. If you have any questions, please email us at dhelp@medtronic.com and I'll get you connected with someone who can help.

Submitted by Gary (not verified) on

In reply to by Commenter (not verified)

Comment policy not reachable. Using latest Android chrome browser. I can't comply with a policy that I can't see. I also need better wraparound in this box when in zoom due to visual problems.

Submitted by Karrie Hawbaker (not verified) on

In reply to by Gary (not verified)

I'm sorry you're having trouble, Gary. I took a look and I was able to access our LOOP Blog policies from a mobile device. If you click on the drop-down arrow under our cover photo and click on policies, you should be able to view the information. If you still need help, send us an email to dhelp@medtronic.com and we'll see what we can do for you.

Submitted by Ellen Irvin (not verified) on

In reply to by Commenter (not verified)

I would also like to see a swivel type clip. It would be even better if the screen image could rotate.

Submitted by Ellen Irvin (not verified) on

In reply to by Commenter (not verified)

I would like the rotating belt clip. having a rotating screen view would be even more convenient.

Submitted by Steven (not verified) on

In reply to by Commenter (not verified)

I use the 530G pump with the Enlite sensors ans have used Medtronic pumps and sensors for over 10 years. My A1C is consistently well below 7%. My last A1C was 6.4%. I mention this because this is because I don't rely on the sensor readings alone because they can be unreliable. I finger test my BS 5-7 times a day and only use the sensor data for trending purposes. Having the 670G pump rely solely on the sensor data worries me because I am all to aware how the sensor data can go wonkey at any given minute, and for that reason is unreliable in a closed loop system. It can be rock solid for weeks at a time, then some sensors are far from correct. When the sensor is at the end of its life it tends to trend off in the low range as well, which in this system would lower basil rates and ultimately increase BS. I would have a hard time giving up so much control to this system...add in the fact that this system uses 120 as the target blood sugar. I understand it's a "mathematical algorithm". This algorithm could have used a target value which is inputted from a user instead of a set 120. Algorithms do not need to rely on fixed data.
This would have allowed each individual and their doctor to set the value they want to control to.

I spoke to my doctor about this system and he said he has two patients that have switched to it and both their A1Cs have INCREASED, well above 7% from previously being below 7%.

For these reasons I cant switch to this closed loop system. Hopefully your engineers will listen to this type of feedback and improve the pump/software. I'm sure there are many more with my concerns.

Submitted by Karrie Hawbaker (not verified) on

In reply to by Steven (not verified)

We appreciate the feedback, Steven. Diabetes data management tools from many companies are moving away from estimated A1C based on guidance from the FDA and focusing on time in range. We certainly understand any hesitation, but would love the opportunity to speak with you about our latest products and sensor enhancements, as well as answer any questions you may have. If you'd like to be connected with a therapy specialist, please send your contact info to dhelp@medtronic.com and we'll have a teammate reach out to you.

Submitted by Wam (not verified) on

In reply to by Commenter (not verified)

I have switched after several years on 670 back to manual mode. After three months in manual I averaged 88% in range and often daily in 90%. In auto mode I had a list of issues and my prior pump before 670 had a a1c well below 7. Issues once you go above 150 it takes a very extended approach to recovery and then states in 15o range. It did not aggressively microbolus and of course you don’t have a true basal you can fine tune. Lots of alarms day and night along with sensor issues from way off capillary reading to sensor failure . Sensor issue are almost none existent in manual mode and full 7 days . My view is this was designed with more of a focus on patients that do not actively manage their type one or for type 2 no offense intended


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