Combined glucose sensor and infusion set

Diabetes Technology Insulin Pumps
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<< Back Medtronic Begins Initial European Market Launch of World's First Combined Glucose Sensor and Insulin Infusion Set for People with Diabetes
Medtronic, Inc.

MiniMed® Duo(TM) Enhances Simplicity and Comfort of Sensor Augmented Insulin Pump Therapy

TOLOCHENAZ, SWITZERLAND - June 3, 2014 - Medtronic, Inc. (NYSE:MDT) today announced the European launch of MiniMed® Duo(TM), the world's first two-in-one breakthrough that combines a glucose sensor and insulin infusion set into one on-body device, simplifying integrated insulin pump therapy and continuous glucose monitoring (CGM). MiniMed Duo, which is used with the MiniMed® Veo(TM) system, makes it easier for more people with diabetes to benefit from CGM. The product received CE (Conformité Européenne) mark this week.

Insulin pumps provide precise insulin delivery and lifestyle flexibility for people with diabetes by delivering small amounts of insulin around-the-clock. Insulin pumps integrated with CGM are clinically proven to provide better glucose control than multiple daily injections[1] or pump therapy alone[2]. Better glucose control reduces the risk of diabetes complications such as eye disease, kidney disease and nerve damage.[3] Insulin pumps with built-in CGM provide people with diabetes with real-time glucose values and customizable alerts that give warning before glucose levels go too high or too low, prompting the person with diabetes to take action. The MiniMed® Veo(TM) is the only integrated system with an automatic insulin shut-off mechanism if glucose levels fall too low, providing protection against hypoglycemia (low blood glucose). Traditional finger stick tests alone often miss up to 78% of potentially dangerous highs and lows[4], resulting in a higher risk for diabetes complications.

"CGM provides people with diabetes with real-time information about their glucose levels that is invaluable in helping them optimize their diabetes management. However, in the past, many people have been reluctant to use a system that requires them to wear two separate devices on their bodies. By integrating a glucose sensor and infusion set into one device, MiniMed Duo will make it easier and more comfortable for these patients to adopt and experience the benefits of CGM technology," said Dr. Francine Kaufman, Chief Medical Officer and Vice President of Global Clinical Affairs for Medtronic Diabetes.

Benefits of the MiniMed Duo include:

Enhanced simplicity:
Both the glucose sensor and cannula (the tiny tube that goes into the body to deliver the insulin) are inserted with one easy-to-use insertion device.
People with diabetes only have to remember to change one device every 3-days.
There's no need to manage two different sites on the body while bathing, exercising or being active.

Greater comfort:
A smaller footprint on the body (compared to a separate CGM sensor and infusion set) means less skin covered by adhesive tape.
A single-button insertion and automatic needle retraction (so patients don't have to see the needle) were specifically designed for greater comfort.
In a study, 95.8% of people using MiniMed Duo rated pain at the time of insertion at 0 or 1 out of 10[5].
An improved adhesive pad accommodates movement without compromising adhesion.
"For over 30 years, Medtronic has been dedicated to developing world-class technologies to provide better outcomes and simplify diabetes management," said Greg Meehan, Vice President and General Manager of the Continuous Glucose Monitoring business at Medtronic Diabetes. "MiniMed Duo is the latest breakthrough designed in response to the needs of insulin pumpers who don't want to wear two separate devices on their bodies, addressing one of the most common barriers to CGM technology."

The MiniMed Duo received CE (Conformité Européenne) Mark approval and, as the first stage of a progressive rollout across Europe, will be available in select countries in the next few months, pending local approvals. The device is not available in the United States.

About the Diabetes Business at Medtronic
The Diabetes business at Medtronic (www.medtronicdiabetes.com) is the world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software, as well as world-class, 24/7 expert consumer and professional service and support.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

- end -

[1] Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med.2010;363:311-320.

[2] Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial. Diabetologia. 2012;55:3155-3162.

[3] The Diabetes Control and Complication Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. J Pediatr 1994; 125: 177-88

[4] Kaufman FR, Gibson LC, Halvorson M, Carpenter S, Fisher LK, Pitukcheewanont P. A pilot study of continuous glucose monitoring system. Diabetes Care. 2001;24:2030-2034.

[5] Data on File.

Contacts:
Amanda Sheldon
Public Relations
+1-818-576-4826

Jeff Warren
Investor Relations
+1-763-505-2696

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Cool!

Now, if the cost is comparable to the combined cost of changing a G4 sensor every 7 days and an infusion set every 3, they've got something.

OTOH, if the cost now goes up by roughly a factor of 7/3 (2 1/3) time the recurring G4 sensor costs, it'll be a dead product. No insurance will cover it when you can simply wear two devices and achieve the exact same result.

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I was just at a training class for my mini-med 530g last week and was complaining about the size of the transmitter on the Enlite to their regional therapy rep(she is also T1). She mentioned that this product was coming, I just didn't expect to see it this soon in the EU. She also mentioned she was going to be trying out some "new" gadgets very soon that will be coming to the US. I'd assume she meant this product.

I have a feeling it will be driven through the FDA pretty aggressively since the 530g is Medtronics current flagship pump. Having a single attachment point would be a HUGE boon to product sales. Is there any way to look on the FDA site to see what Medtronics has in the pipeline there?

I remember her stating that this still has two needles for insertion(one for cgm and one for the cannula) but still has a single point of adhesion.

As far as price, I'm sure it will be more expensive, but to be honest I'd think insurance companies will cover this from the get go. Diabetics not having to spend time in the ER or having as many complications is a huge savings for them.

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If they have improved the sensor accuracy that would be great, but I still wouldn't trade my G4 and pod for this. My current sensor is very accurate and will be 2 weeks old tomorrow.

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As far as price, I'm sure it will be more expensive, but to be honest I'd think insurance companies will cover this from the get go. Diabetics not having to spend time in the ER or having as many complications is a huge savings for them
Count me skeptical. Very.

Combining infusion and sensor sites will not affect trips to the ER at all. It's a matter of convenience for the user, nothing more. If there is no reduced price for the sensors over the 7-day version, then we can do a pretty fair cost difference approximation taking the cost of the G4.

8 sensors cost $1,200US. This lasts 8 weeks, nominally. If these sensors will have to be changed every 3 days instead of 7 with the new all-in-one, sensor cost for the same 8 week period rises to 2.33*1200 = ~$3,000, a difference of $1,800, or $900 a month.

I can all but guarantee you that every insurance company, in the current cost structure the ACA has implemented, will not support this device at these costs under any circumstances. There is no medically necessary justification. The patient can just put two devices on themselves, and save $900 a month.

Of course, this is likely the very decision all of us would make if having to cover these supplies 100% out of our own pocket. Or, suppose insurance said, "sure, we'll allow that -- but we are only paying for non-combined price... you're on the hook for the other $900/mo". Would anyone here pay that $900?

Doesn't seem fair to demand insurers cover what amounts to a luxury, when none of us would make that foolish financial decision, (those with funds that are, in practice, unlimited, are exempt from this discussion :-)).

So, the only way I see this getting insurance approval is if the cost is on par, or maybe a little more, than the cost to achieve the exact same diagnostic/treatment effect with existing, seperate attachments.

Finally, in the real world, most people wear their sensors well beyond the 7-day official expiration. Judging by anecdotal data from postings here, I'd estimate that across the G4 population sensors are used on average about twice as long. Given that, the cost issue only gets uglier.

6

My concern beyond cost and insurance coverage would be how do they seperate and or account for the local insulin infusions effect on the interstitial glucose reading at the same site.
Without adequate separation of sensor and insulin absorption site this is a disaster in the making. Depending on the amount of and or strength of the insulin dispensed for individual needs for both basal and bolus insulin requirements, there has to be a huge range of variation effect on the adjacent sensor.
Not sure I would want the "convenience" of a single site insertion if the CGM readings did not match what I get with my DexG4. Would not want to be the guinea pig for proof of the algorithm, especially since I use U50 insulin and expect my CGM to help me to achieve tight control.

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I agree with Clare. But next year I'll be on Medicare, and right now Medicare doesn't cover the Dex or OmniPod, so if my retiree insurance won't cover them, I'll have to transition to a tubed pump. Ugh.

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Costs aside, accuracy and dependability remain my highest values. I find that my Dex sensors take about 24 hours to settle in and produce reliable results. I've never worn a Medtronics sensor but I've read many complaints here. The only reviews that hold water for me are actual PWDs wearing and using the hardware/software.

Swapping out an infusion/sensor site every three days is nowhere near gaining my interest. Medtronics sees much more perceived value in this integration than me. It's of dubious value at best.

I wear the G4 because of it's reasonable level of accuracy over a 7-21 day sensor life. No way will I be interested in trading that for an alternative of three days. This device would make my D-life harder. I'm not sure I'm even interested in combining the infusion and sensor sites. It's still two punctures!

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Interesting devices. I am getting around 11-12 days out of my Enlite sensors, almost twice the 6-day limit they are supposed to have, as Dave noted above about "real-world" usage. If this device combo were to be proven to be both affordable and accurate, I would change to it. I agree that most insurances are not going to pay for a more expensive treatments/technologies.
Thanks for posting this discussion, Lloyd

God Bless,
Brunetta

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Without adequate separation of sensor and insulin absorption site...there has to be a huge range of variation effect on the adjacent sensor
I thought this too pondering it last year when I learned about the Pancreum device.

Turns out there has been (and is on-going) a lot of research on this, and apparently it isn't an issue so long as the sensor is 1" or more away from the infusion site, something not hard to do.

Haven't pursued the question too deeply, so I'm not up on what the theory is. My guess would be that there is very little mobility of injected fluids beyond the immediate site via interstitial diffusion. Capillary bloodflow picks up and sweeps away insulin molecules well before they can migrate very far due to a concentration flux.

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I wear the Enlite currently and your point of "warm-up" time is what has me wondering. Currently I find that you need ~12 hours before the readings are reliable(occasionally ~6 hours). If the same is true of these sensors, we are talking one full 24 hour period a week that you wouldn't have "trustworthy" data to analyze.
If you look at the picture on Diabetesmine it looks pretty much like the same sensor I'm wearing right now. I had really hoped they would make the clam shaped battery/transmitter smaller, it's pretty large.
How big is the Dexcom transmitter?

12

I have been a VEO and Enlite user since Feb 2011 ...love my pump , hate my Enlites .I use Sure-T's and change those about every 48-54 hours ...new gadget could become rather expensive with out of pocket cost ...as is the present .As far as I know , no private insurance in Canada covers GCMS ...hubby and I will get another ASK letter off to our Pacific Blue Cross ! Wish more work was done on a one tool of insulin and glucagon delivery :)

13

Kevin - Here's a photo to give you an idea of the G4 transmitter size. It is about the thickness of a stack of five US quarters.


The G4 transmitter is larger than the 7+ transmitter but the range of this transmitter is much longer than the 7+'s transmitter. It's only guaranteed for 6 months. Most people get more than 6 months, some more than a year. My first one lasted 9 months. It's the transmitter battery that wears out.
14

nel - Couldn't you just as easily purchase the Dexcom G4? I know it's not integrated with your pump. Does the VEO stop basal insulin if you hit a certain low value BG?

I think that would be great if it was accurate and dependable but it could be a real nuisance if not. I will probably have to pay out of pocket for my CGM costs unless Medicare policy changes in the US in the next 4 years.

15

I'm on month 11 with my first one, and it's showing no signs of running out of juice yet.

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Let's hope Dexcom doesn't engineer some way for the sensors to start limiting performance to the official 7 days...

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Knock on wood- July will be 12 months. Have the replacement in the cabinet waiting.

Would not want to go one day without the info my dex gives me!
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Yeah, I've got my spare transmitter squirreled away, too. Once you get that low transmitter battery warning, you may only have one week of service left. And when it fails, it fails quickly. I don't like living without that data stream, either.

I decided that I will initiate an order for a new transmitter every six months so that I'm never at the mercy of the Dexcom/doctor/insurance company kludge!

19

My first transmitter lasted 13 months. The second one is now 7 months old, so I ordered a new one to have for when this one craps out. I have come to rely on it heavily and I don't think it would be any fun to be without.

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crossing my fingers they don't, I have managed to get a combined 80 days out of my last 3 sensors. It would really suck to only get 21 out of the same 3.