#DexCom G5 Mobile CGM Approved

DexCom G5

The next generation of DexCom has been approved and is expected to begin shipping in late September. With this system, the need for a dedicated receiver will be eliminated if you use a compatible mobile device. One less thing to carry. Receivers are still a part of the system, but now they are optional.

What’s equally exciting is the enhanced app that will be used with G5. Alerts and the ability to log events right in the app sounds like we may finally have meaningful reports to help us best use all this information for better diabetes management.

More photos and information at dexcom.com.

Forgetting Diabetes | Impact of Dexcom G4 and CGM in the Cloud

IMG_9106Minimizing Caleb’s disruption at school is paramount. Prioritizing this is less about restricting his classroom instruction, although that is an important right of his, but more about preserving his emotional health.

Every time Caleb has to perform a diabetes care task, it’s a reminder that he is different and that he has a burden from which those around him are free. It divides his attention from whatever is happening in his day, that those around him can give full attention. My goal is to minimize those disruptions, aka: reminders at the hope of avoiding burnout.

  • In first grade we minimized visits to the nurse’s office. He checked in class and the nurse came to him.
  • In third grade we removed the need for nurse supervision – he used a classroom phone to contact me when a care decision needed to be made.
  • In fourth grade we utilized the school wifi system to allow him to text with me for added discretion.
  • In sixth grade we introduced CGM in the Cloud.

In general, Caleb is more independent in his care. Where we used to have defined times to check in, now he checks in at his discretion.

There are even days when I don’t hear from him at all and the only diabetes task he has done at school is to bolus for lunch, and at that time, give Dexcom a look. On those days he’s had exactly one interruption to his day because of diabetes. Just one. It’s a taste of normalcy that struck me the first time it happened. It felt luxurious – like being pampered by not having to give this beast attention whenever it demanded it, which is something we’ve grown used to.

Because there are still beastly days, and you never really know when when they will be,  we’re always on guard for it. So when the luxury days occur, they are relishable.

We’ve been able to eliminate the schedule because of Dexcom and CGM in the Cloud. We trust Dexcom. Caleb’s been using it for six years and the G4 has fantastic accuracy. We allow it to watch his blood sugar and let Caleb know when it needs attention. The addition of CGM in the Cloud means I also get alerts when Caleb’s blood sugar needs attention, no matter where he is.

We therefore think less about it. Neither of us wonder what might be happening. I’m not worried that he might be distracted and forgetting to address his blood sugar, Dexcom and Share2 are keeping watch for us.

We are allowed to forget about diabetes, even if it’s just for a little while, and it’s fantastic.

Caleb has used both the Nightscout and Dexcom Share2 CGM in the Cloud systems. 

I am neither a doctor nor certified medical practitioner. How Caleb and I choose to manage his diabetes should not be taken as medical advice. Please consult with your doctor any treatment decisions.

Lilly Diabetes/Disney Books and Backpack Giveaway!

IMG_0317You may have seen these sets around the community in recent weeks. If you’ve missed out on other giveaways, you still have a chance. Lots of great resources targeted toward children with diabetes are included. The Coco books are targeted toward the younger child, but have meaningful messages for all ages. The ESPN books are targeted to a teen audience.

If you’re interested, use the below linkto enter! Good luck and act fast! This giveaway ends this Sunday!

THIS CONTEST IS COMPLETE! WINNERS HAVE BEEN NOTIFIED VIA EMAIL. THANK YOU SO MUCH FOR ENTERING AND CONGRATS TO THE WINNERS! Thanks also to Lilly Diabetes and Disney for making this possible!

a Rafflecopter giveaway

Updated Feb 6 to state: shipments made within the contiguous US only.

WHAT’S IN THE BAG?

(click on the photo to enlarge)

Lilly Diabetes/Disney Books and Backpack Giveaway

FDA Approves #Dexcom G4 Platinum #CGM System with #Share

Fantastic news announced by Dexcom today. Cloud information has been approved for the G4 system. New receivers will be available soon – see below for details.

As posted at MarketWatch

SAN DIEGO, Jan 26, 2015 (BUSINESS WIRE) — DexCom, Inc., DXCM, -0.29% a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4® PLATINUM Continuous Glucose Monitoring System with Share. The Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient’s receiver and an app on the patient’s smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients, or “followers,” without the need for a dedicated docking cradle. These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere, initially via their Apple® iPhone® or iPod® touch and in the future on Android devices, giving them peace of mind and reassurance when they are apart. The “Share” and “Follower” apps will be available on the Apple App Store at no charge.

“The Dexcom Share receiver represents a significant step forward for our company and our mobile strategy, but more importantly, it will provide a huge improvement for people managing their diabetes and for those parents and caregivers who help them each and every day,” said Kevin Sayer, President and Chief Executive Officer of Dexcom. “The FDA understands the importance of this type of innovation and the need to regulate it appropriately, and we could not be more pleased with the speed at which they reviewed and approved this important innovation.”

About Dexcom G4 Platinum with Share:

The Share receiver is anticipated to ship to new patients in early March 2015.

All patients who purchased a Share cradle will receive a free upgrade to the Share receiver.

All purchasers of a G4 Platinum receiver from January 1, 2015, until the Share receiver is shipped, will receive a free upgrade to the Share receiver.

There will be a low cost cash upgrade to the Share receiver for those patients who are still under warranty with their existing receiver.

The Share receiver will be compatible with future generation Dexcom sensor systems.

About the De Novo Classification Process:

The FDA reviewed the mobile app software used with the Dexcom Share receiver (both the “Share” app on the patient’s phone and the “Follow” app on the caregiver’s phone) through its de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. The FDA has specifically classified the apps which communicate with the Share receiver as a secondary display device and has noted that similar devices which provide only secondary display for passive monitoring, but which do not replace the primary real-time display device, will be subject to the same classification, subject to compliance with certain special controls established by the Agency with respect to this secondary display. This means that devices which comply with appropriate FDA regulations, including the special controls, will not be required to submit a premarket notification to the FDA before marketing a secondary display device for continuous glucose monitoring. The Share receiver was still evaluated as a Class III medical device.

Management will hold a conference call to review this approval starting at 9:00 a.m. (Eastern Time) on Monday, January 26, 2015. The conference call will be concurrently webcast. The link to the webcast will be available on the Dexcom website at http://www.dexcom.com by navigating to “Our Company,” then “Investor Relations,” and then “Events and Webcasts,” and will be archived there for future reference.

#Nightscout | Harboring Autonomy #WeAreNotWaiting #CGMintheCloud

IMG_8890My number one reservation about starting Nightscout was the size and weight of the rig. It’s a definite price to pay. It’s not ideal, but Caleb’s been able to manage, and the benefits are currently worth the price.

My next concern was taking a step backward in the progress we had made in Caleb’s self-care.

Since he was in preschool, Caleb has always had some level of responsibility in his care, and it has advanced both organically and with careful planning each year. In third grade, we (his school nurse at the time, Caleb and I) started to take steps to prepare him for middle school. We targeted specific milestones for each of the next three years. Caleb was caring for himself as I expected a middle schooler would by the beginning of his last year in elementary school.

Given this success in autonomy, and on the verge of starting middle school, I didn’t want to compromise his progress. If I started watching his bgs, would the torch come back to me? That was absolutely not the goal. Why would we need remote access to his CGM data if he was now running the show? I didn’t have the answers to these questions, but I started seeing successes with the Nightscout Project, got over the hurdle of the rig size,  and figured with a limited financial investment, why not give it a try.

The role Nighscout played in Caleb’s autonomy was not one I anticipated. Knowing that he was no longer “alone” when I dropped him off somewhere, gave him security. This increased the opportunities to be places by himself because he was comfortable. The more he did this and saw that he could care for himself by himself, the more confidence he gained. Increased confidence added more security, which led to more confidence, and before we knew it, things had changed dramatically.

We had gone from discussing a careful plan of “what ifs” each time he was dropped somewhere, to no longer even thinking about it. This was a change in Caleb. Where he was once anxious, he was now assured. School days became easier as well. A middle school schedule is pretty hectic; he never seems to have a spare moment. He has greater flexibility to go throughout his day as he pleases, without being a slave to a diabetes care schedule. We probably would have gotten to that point because of Dexcom alone, but Nightscout got us there immediately upon starting school.

Does Caleb care for himself entirely independently? I’d say he does 90% of the work when he and I are apart. When he’s home, we’re definitely a team. He makes decisions, I make decisions, we make decisions together. When he’s at school or elsewhere, he’s in the driver’s seat. We consult throughout the day if needed. There are times when I see something on Nightscout that he hasn’t noticed yet and I will prompt him. I don’t feel like I’ve taken back control though. I feel like I’m helping him at a level that is appropriate for someone his age. He’s continued to move forward in his level of self-care. He hasn’t taken any steps back, which was my concern.

The biggest issue we were having when we starting using Nightscout, was Caleb’s self-confidence in his diabetes care. I knew he was capable, he wasn’t as sure. Nightscout propelled his confidence forward, the exact opposite outcome I had anticipated.

Related Posts:

Nightscout | Getting Started

Nightscout | The First Two Weeks

Nightscout | The New Rig

Exuding Coolness | Adam Lasher from American Idol

Hanging his “robotic pancreas” from his guitar strap, Adam Lasher auditions for American Idol. I haven’t watched in years. This is an incentive to start again.

World Diabetes Day Image Update |#wdd

For the past couple or maybe few years I’ve created a World Diabetes Day image to use as a profile picture for World Diabetes Day (or here’s one that works for a Facebook cover photo). I’ve shared it publicly if others would like to use it. Here are a couple updates for this year. You are welcome to use them and although not necessary, it would be nice if you could give a nod to the creator! My best to you all this diabetes awareness month in any and all advocacy efforts, big or small.wdd2014wddnov14

FDA Approves #Dexcom Software with Artificial Pancreas Algorithm

Screen Shot 2014-11-06 at 2.01.00 PMDexcom announced today the availability of updated software that will improve the accuracy of the system.

We are Nightscout users and use two receivers. One is approved only for adult use and the other is approved for pediatric use. Because this software update is approved for users 18 years and older, the pediatric receiver can not be updated with this new software.

We will therefore be using both receivers, each with a different algorithm. We should be in a good position to compare and assess the improvement in accuracy, even though we’d prefer just to update both with the new software.

If you are planning to update, please note that the update will require a restart of the sensor and will clear out all historical data. So download your data first if you want to keep it. Also, the update cannot be done from a Mac.

Visit Dexcom to access the software update.

Here’s the press release:

New Dexcom software achieves critical milestone in measured accuracy for continuous glucose monitoring

SAN DIEGO, Nov 06, 2014 (BUSINESS WIRE) — Dexcom, Inc., DXCM, +0.45% a leader in continuous glucose monitoring (CGM), announced today that the U.S. Food and Drug Administration (FDA) has approved new software for the Dexcom G4® PLATINUM CGM. The new Software 505 features the same advanced algorithm as used in artificial pancreas research around the world. The software will impact the performance of the Dexcom G4 PLATINUM, already considered the most accurate CGM system on the market today. The software will be made available free of charge to adult patients using the Dexcom G4 PLATINUM.

“Patients will be able to go online and download the software, or they will receive the software preloaded onto their Dexcom receiver with new orders,” said Terrence Gregg, CEO, Dexcom. “This latest software enhancement to the Dexcom G4 Platinum will make the performance level comparable to episodic blood glucose finger sticks; this is a significant step in the evolution of CGM becoming the standard-of-care over blood glucose meters for people with diabetes.”

Now, Dexcom G4 PLATINUM is the first and only CGM system on the market with a single-digit MARD (Mean Absolute Relative Difference) measurement, below 10 percent. MARD is the standard industry measurement of accuracy, where a lower MARD reflects higher accuracy. With the new software, healthcare providers, patients and caregivers will now have glucose readings from a sensor that are closest yet to lab accuracy. The combination of the new software with the CGM advantages of real-time trends, speed and direction provides a complete picture of the patient’s glucose activity.

Diabetes affects 29.1 million Americans and is the 7th leading cause of death in the United States.3 With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. It is estimated that approximately 79 million Americans over the age of 20 are at risk for developing diabetes, largely due to obesity, physical inactivity and poor diet.2 People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.

 

#FDA Approves #DexCom #Share | DexCom Share

Shipments will begin October 22nd and price is $299. Prescription is not needed.

Screen Shot 2014-10-20 at 10.07.07 AMFrom CNBC:

SAN DIEGO–(BUSINESS WIRE)– Dexcom, Inc. (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its CGM remote mobile communications device: Dexcom SHARE. Dexcom SHARE, an accessory to the Dexcom G4® PLATINUM Continuous Glucose Monitoring System, uses a secure wireless connection to transmit the glucose levels of a person with diabetes to the smartphones of up to five designated recipients, or “followers.” These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere via their Apple® iPhone® or iPod® touch. With Dexcom SHARE, parents and personal caregivers can monitor a child’s or loved one’s glucose data from a remote location, giving them peace of mind and reassurance when they are apart. “Dexcom SHARE represents a significant advance in diabetes care by allowing people with diabetes to share important glucose information with their loved ones from afar,” said Terrance H. Gregg, Chief Executive Office of Dexcom. “With Dexcom SHARE, users, parents and personal caregivers now have a new tool to dramatically improve how they communicate about their diabetes.”

See full article here Prior Post DexCom Share

From the DexCom Store:

Screen Shot 2014-10-20 at 10.39.34 AM