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A Thirty Year Journey with Medtronic

By Karrie Hawbaker

Public Relations Manager

Posted:  10/17/2013 8:59 PM

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I’ve met a lot of people with diabetes, and Cindy Tenney is one that stands out as one of the most fascinating. She was diagnosed with type 1 diabetes at the age of 13 and has lived a full life with diabetes. When it comes to diabetes technology, she’s seen it all as she wore our very first insulin pump, the MiniMed 502. Cindy currently works as an Administrator of Health Services for a Southern California school district and was able to take part in a clinical trial of a MiniMed pump with Threshold Suspend. Here’s her story!

I was diagnosed with insulin-dependent diabetes at the age of 13, in 1976.  Five years later, my endocrinologist convinced me to try wearing a “pump”. As a high school senior I was sporting the infamous big, “blue brick” on a daily basis. This basic machine had one infusion rate, which meant I had to dilute my insulin into different concentrations in order to create “basal rates”! In addition, the pump required its internal, re-chargeable battery to be plugged into the wall every night while I lay sleeping next to it. The first infusion sets were straight NEEDLES, and taping those down did pinch!  It was an open-faced machine with a large syringe, dials, knobs and a flashing red light openly exposed.

Several years later, I wore Medtronic’s first insulin pump (which was a lot smaller than the brick!) and have been extremely fortunate to move along through the steps of insulin pump medical technology with Medtronic. Insulin pumps are now computerized, capable of multiple basal rates throughout the day, small enough to wear in your pocket or under your clothes.  Infusion sets are merely a teeny tiny catheter left in place for three days, and with the advent of the CGM, insulin pumps are able to display your real time glucose readings.

I have had a successful and rewarding career as a registered nurse; working night shifts, 12-hour shifts.  Now that my children are grown and with my background in cutting edge medical advances, I began to participate in clinical trials associated with Medtronic products.  My endocrinologist encouraged me to look on the internet, that’s how I found the clinical trial for the Minimed  pump with the Enlite Sensor.

When I started this trial, my biggest fear was that I wouldn’t be able to keep all the minute details straight.  There were so many do’s and don’ts to remember to make the data reliable! I was thrilled to have the opportunity to wear the latest technology available.  The Enlite sensor really impressed me with the smaller internal probe, more comfortable to wear, and much easier to insert.  Not only does the Enlite sensor last 6 days, but the glucose readings are noticeably more accurate. I was pleasantly surprised to discover Enlite to be such a fabulous improvement over the Sof-sensors.

Wearing the MiniMed pump during the trial provided me reassurance to sleep through the night.  Like many people with diabetes, I feel most vulnerable while asleep.  During my trial, I slept through the low sensor glucose alarms and the pump went into SUSPEND MODE for two hours.  My blood sugars did not continue to fall.  I was completely amazed at how well this feature worked.  In addition, I utilize the temporary basal rate option whenever I head to the gym or bicycling to help prevent hypoglycemia.

All the clinical trials I have participated in have brought excitement about advances and future treatment for people with diabetes.  I encourage others to check out these opportunities to learn and grow.

Editor’s note: To learn more about enrolling in clinical trials, visit www.clinicaltrials.gov.

Important Safety Information
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. 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.

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

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. Replace the infusion set every 48-72 hours, or more frequently per your healthcare professional’s instructions. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected.

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. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s Health Care Provider. WARNING: The Threshold Suspend 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 feature, it is important to read the Threshold Suspend information in the MiniMed 530G` System User Guide and discuss proper use of the Threshold Suspend feature with your healthcare provider.

Comments

Paul Fuqua

Posted on Fri Oct 18 00:07:42 GMT 2013

I've been a type 1 diabetic for 42 of my 55 years and on a pump for approximately 15. Like Cindy, my biggest fear is having a low blood sugar while I sleep. Living alone now, I tend to let my glucose readings run high at night. The alternate of the big sleep is not acceptable. We could put a man on the moon in 1968, why is the technology to control diabetes so slow to develop. The CGM system and particularly the suspend mode definitely sounds like a leap in the right direction. Hears hoping my doctor and insurance company see it that way.

Naomi

Posted on Fri Oct 18 17:24:26 GMT 2013

Hi Paul. Thanks for the comment. We’re very exciting excited about the new MiniMed 530G system too. If you need any help submitting to your insurance, we do have a team of people here who would love to assist with the process and paperwork. Let me know if there is anything else I can do to help.

Beverly Deffner

Posted on Sun Oct 27 23:08:11 GMT 2013

I am eagerly waiting for my new pump., but continue to be disappointed that Medicare refuses to cover a device that, in the long run, could be a money-saver for the government. Are there any signs of movement by Medicare.
Are those of us who are long time pampers going to have to wait for training to begin with the 530G?

Naomi

Posted on Mon Oct 28 18:53:09 GMT 2013

Hi Beverly. Thanks for your comment. I do not have a timeline on when Medicare will provide CGM coverage, but we are actively exploring coverage processes with Centers for Medicare and Medicaid services. To begin with the MiniMed 530G, you will need to have training to learn how to insert the Enlite sensor, which is different from Sof-sensor. Your training will also cover how to use the new Threshold Suspend feature of the MiniMed 530G system.

Miriam Iossi

Posted on Tue Nov 26 07:08:48 GMT 2013

I have been a diabetic since June of 1952, so have had type 1 diabetes for over 61 yrs.
I finally went on a Medtronic 522 pump about 7 or 8 yrs. ago after becoming tired of having to test my blood sugars and taking insulin up to five times a day. I have found it difficult to find places in my stomach area and below to insert the infusion set and when I do find a spot, I often times hit a blood vessel, which is very painful. After 61 yrs., I feel fortunate to still be on this earth and to still have pretty good vision along with everything else working good, too. To have a machine that checks the sugar levels would be wonderful without having to prick my fingers so many times a day.

Ken Smith

Posted on Tue Nov 26 16:33:34 GMT 2013

Diagnosed at age 38 as a type 1, I began wearing my first pump in 1984 (Big as a Bible), until my first Minimed pump in 1987. After several accidents, I was approved by my insurance company to wear the CGM sensors in May, 2013. Now have signed up for the Minimed 530G with Enlite, although under strain to afford copays, I am appealing for relief of copays. At age 81, with 29 years on 'the pump', I am looking forward to being the 'oldest person alive on the pump!' Thanks, Minimed! Ken

Joel

Posted on Tue Nov 26 18:25:17 GMT 2013

Ken, thanks for sharing your story with us and for being our customer for all these years! If you have any questions about your insurance, we have a team of people here who may be able to help. We also offer financial assistance for those who qualify. Please let me know if you’d like to speak to someone and I’d be happy to have a member from my team reach out to you. Please keep us posted on your journey with the new MiniMed 530G system.

Naomi

Posted on Tue Nov 26 19:44:08 GMT 2013

Hi Mariam. Thank you for sharing your story with us, and putting your trust in us for all these years. For information on site rotation and location for your infusion sets, check out our website at http://www.medtronicdiabetes.com/customer-support/insertion-site-management/infusion-placement. I would like to connect you with a member from my team to discuss this with you, so will have someone follow up with you soon. In the meantime, to learn more about the MiniMed 530G system and continuous glucose monitoring, visit our website at http://www.medtronicdiabetes.com/treatment-and-products/continuous-glucose-monitoring.

Mary T Smith

Posted on Tue Nov 26 20:02:12 GMT 2013

Have been on the pump about 11 yrs. Been a diabetic for 46 yrs. Have major problems with hypoglycemia while i sleep even with the sensors. I am excited about the new 530G. I had signed up for the "New Technology Guarantee Program" a while back but i have not heard from anyone. When i called they said they didnt see my name on the list so what do i do now? I should have had them send me a confirmation of that but didnt think about it. Please help!! Mary

Joel

Posted on Tue Nov 26 20:37:22 GMT 2013

Thanks for reaching out, Mary. I will have someone from my team contact you to help answer your questions. Please let me know if there’s anything else I can do for you in the meantime.

Tim Coonahan

Posted on Tue Nov 26 21:22:05 GMT 2013

I have a question that I am sure that many new pumpers have being that their current 723 MiniMed pump and Sof-sensor. Is the new Minimed 530G pump with Enlite sensor that more accurate to be cost justified? Since many of us cannot get this new process approved by our various Insurance companies and Medicare until several years (2016) in many cases. I do understand that there is a program available for a "Trade-in" value etc. with a final net User cost of about $399. Can you help, please.

Jill Meyer

Posted on Tue Nov 26 23:45:28 GMT 2013

I have Cindy beat. I was diagnosed with Type I diabetes on Valentine's Day before I was one year old. I have now been a diabetic for almost 52 years, without too many complications. But those tight blood sugars also come with a few problems. Most of my emergency room visits have been for lows, not highs.

I got my first pump when I was nineteen years old, with plenty resistance on my part, but in the end it was well worth it. It was probably the same kind Cindy started with, rechargeable batteries, adjusted the basil rate with a screw driver several times a day and had to dilute the insulin in the 3cc syringe to get U100 for a full syringe.

I then got my first Mini-Med after my daughter was born a few years later, when Mini-Med's first came out, the same 502. Since that time I have gone thru almost every pump model Mini-Med has made to date. I have a few more months to go on my warranty with my Paradigm 723 System with the CMG. which has been a blessing, but it's still not enough. No matter how much I test and my basil rates have been adjusted, I still have to deal with hypo episodes.

I am hoping that later this next year when I visit my physician again I can talk her into the newest Mini-Med, the one Cindy now has. My HMO no longer wants to give a new pump, every time the warranty is up, while in the past they always did. It would be a better choice as my blood sugars seem to drop unexpectedly at all hours of the day or night with serious consequences. So many times my daughter has had to call 911 because I have been so low and unresponsive, even from 500 miles away. It's been no fun awaking to someone pumping me full of glucose. And you know it's bad when most of the firemen/paramedics where I live know me by name and have been out to my home on more than one occasion.

Naomi

Posted on Wed Nov 27 22:16:39 GMT 2013

Thank you for sharing your story with us, Jill. Great having you as a customer for all these years. I am sorry to hear about your low episodes. I will connect you with someone from my team to discuss your upgrade options with you.

Karrie

Posted on Mon Dec 02 21:06:01 GMT 2013

Hi Tim. The MiniMed 530G with Enlite shows 31% improvement in accuracy over previous generation, Paradigm Revel with Sof-Sensor (According to MiniMed Paradigm REAL-Time Revel User Guide and MiniMed 530G User Guide). And we have several programs available to all customers that can help with the out of pocket costs. I will have someone from my team contact you to discuss your options.

Marcella Jean Meloni

Posted on Thu Dec 19 04:53:34 GMT 2013

I have had Type I since the age of two (almost 63 years.) I wear a pump with a better success of more "normal" blood sugars. My pump is not under warranty. Like other comments, I also have a fear of low blood sugar during the night. At times I lay awake all night afraid to fall asleep. I have Kaiser Medical Insurance and will be elgible for medicare in a few months. Please let me know whats the best way to try the MIN MED 530G with Enlight.

Joel

Posted on Thu Dec 19 20:01:47 GMT 2013

Thanks for reaching out to us, Marcella. I will have a member of my team contact you to discuss your upgrade options. Please let me know if you have any other questions.

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