Medtronic’s MiniMed 670G FDA Approved

screen-shot-2016-09-29-at-1-00-51-pmIt was a big news day yesterday for FDA approval of diabetes devices.

The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.

Read yesterday’s full news release here.

I’m excited about this announcement for two reasons. First, this approval was received about six months before it was expected. I’m used to news coming later than predictions, not sooner. This is at least the second time the FDA has impressed me. The first time is when it approved the DexCom Share Receiver much sooner than expected. I’m optimistic that this is indicative of a great trend with the FDA.

Secondly, it’s another great step closer to a fully closed loop artificial pancreas system.

The 670G is a hybrid closed loop system. It will monitor glucose levels and adjust basal insulin to keep blood sugar as close to 120 as possible. Using this pump will still require carb counting, manually initiating meal boluses and corrections, and manually adjusting basal insulin to compensate for activity. This system is mono-hormonal: it uses only insulin, no glucagon. To me, the greatest benefit of this system may be for managing overnight basals.

For more information about this exciting announcement, here are some articles I found useful:

Updated 10/1/2016 to include this link to Diabetes Mine article describing what this pump is and what it is not. NEWSFLASH: FDA Approves First-Ever Pre-Artificial Pancreas from Medtronic!

diaTribe: Abbott’s FreeStyle Libre Pro AND Medtronic’s MiniMed 670G Get FDA Approval

diaTribe: Medtronic MiniMed 670G Trial Results: 44% Reduction in Hypoglycemia, 0.5% A1c Improvement 

A Sweet Life: How the Medtronic 670G Artificial Pancreas Works: FAQ

Heath Day: FDA Approves 1st ‘Artificial Pancreas’ for Type 1 Diabetes

and also a lively discussion over at TuDiabetes.





Freestyle Libre Pro FDA Approved

screen-shot-2016-09-28-at-11-59-57-amAnother option for managing continuous glucose data is now available in the United States. Abbott’s Freestyle Libre Pro has been FDA approved. This is the Pro version – not the consumer version. This will allow medical professionals to work with their patients to get and analyze data and make therapy decisions. The consumer version has been submitted to the FDA for approval. Hopefully it won’t take too long.

There are some specific differences of the Libre system, including the consumer version, to other CGMs currently available.

– It requires no calibration.

– Information is not displayed continuously. In the consumer version, you scan the reader device over the sensor at your discretion to get a reading. Fingersticks are eliminated.

-The cost is significantly less, thereby making it available to a consumer group to which the more expensive products are out of reach.

Click here for the complete press release.

Visit Abbott’s website for more information.



Investor Bit | Insulet Q4 2015 Call

Screen Shot 2016-02-26 at 9.03.10 AMFull transcript on Seeking Alpha.

In Insulet’s earnings call for the fourth quarter of 2015 yesterday, positive financial results with several performance records were heralded, and strong growth is expected for 2016.

– We were reminded of the divestiture of Neighborhood Diabetes to Liberty Medical to allow for focus on OmniPod and Drug Delivery (think using the Pod for cancer drugs) products.

– They are working with Eli Lilly to gain approval for use of concentrated insulins which would effectively increase (double or more) the capacity of the Pods for users with higher insulin needs. This is expected to hit the market in the next two to three years.

– Digital Insulet is the term used for all things mobile and artificial pancreas. In the first half of 2016, they expect to launch their first app which will allow for product ordering and accessing training tools. Further, quoting directing from the transcript:

In addition, later this year we will submit a 510(k) for our Bluetooth PDM and mobile app that will display key real-time data on a customer’s mobile device, including CGM integration with Dexcom’s G5 sensor. In fact, this will enable CGM integration in a manner that ensures that our users will always have the latest and greatest CGM sensor with the latest and greatest OmniPod.

-Insulet has entered into a licensing agreement with Mode AGC for an Artificial Pancreas algorithm. Clinical trials are expected later this year.

There was much discussion about the robust market opportunities in both type 1 and type 2 markets and why OmniPod is believed by management to be a superior choice for insulin delivery, as well as big improvements in customer retention and customer service. I will leave it to you to read those details in the full transcript.

Investor Bit | Dexcom Q4 2015 Call

Screen Shot 2016-02-24 at 10.30.31 AMFor the full transcript, please go to Seeking Alpha.

Dexcom had an encouraging earnings call yesterday from both a historical financial perspective as well its prospective outlook. In addition to record-breaking financial results for 2015, I found the following noteworthy:

  1. A new G5 receiver and insertion device are expected for the second half of this year. Not mentioned on this call, but heard from a key exec from an interview conducted on Discuss Diabetes – the insertion device is expected to be MUCH simplified, and with automation will eliminate hand shake at insertion and reduce pain.
  2. Gen 6 will require 1 calibration per day, an advanced algorithm and be labeled for 10 day sensor use. Gen 6 IDE will be submitted in the next two weeks and there will be more information on the next investor call.
  3. Dexcom expects an FDA approved insulin dosing claim during the later half of 2016. G5 in Europe is currently thus approved – fingersticks are not required for dosing decisions; 2 daily calibrations are required.
  4. G5 Android app is expected for later this year; Follow app is already available on Android.
  5. A note in the financial overview that struck me references a charge recorded in Q4 relating to a potential increase in warranty expense for an issue with the speaker on the receiver. We’ve had two receivers whose audible alerts completely stopped and had to be replaced.
    • We also note that we recorded a charge in Q4 relating to a potential increase in warranty expense resulting from an important customer notification we have issued related to the speaker component in our hand-held receiver.

  6. The Life Sciences Google partnership is now the Life Sciences Verify partnership and is moving forward according to plan.

There’s lots more in the transcript including discussion of pump partners, international expansion plans, and a more detailed financial review. Find it at Seeking Alpha.





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.

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 by navigating to “Our Company,” then “Investor Relations,” and then “Events and Webcasts,” and will be archived there for future reference.

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.

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

#Nightscout | The New Rig #WeAreNotWaiting #CGMinTheCloud

IMG_7213The Grid-It works well for the “rig” (the dexcom and uploader combination that feeds the data to the cloud). It fits precisely in Cal’s CMC Urban Day pack. There is some vulnerability to the DexCom receiver’s usb port. To avoid damage, it’s important to keep the connection of the cable to the receiver immobile and intact. The Grid-It does that well.

There is a 3D printable case developed by two men who are members of the CGM in the Cloud Facebook group. The case holds the Moto G, the DexCom receiver and a special cable very snugly to limit any movement. You can either buy the case from them or download the file for free to print a case yourself, if you prefer. They also offer a DexCom only case which keeps the cable secure if you are using a different uploader but still want added strength to the DexCom usb connection.

Here is their video which shows how you put the DexCom/Moto rig together:

I got our case that you see pictured here through a local printer I found on 3D Hubs. The case was $24 and the cable was $26. IMG_7218Everything is snug. Very snug. I’m not sure I’ll ever be taking the receiver out of this case. I am getting used to taking the phone in and out of it to charge. It’s a tighter fit than what is shown on the video. Could be due to the printer, speed of printing or some other 3D print variable I’m not familiar with that results in variability in the product. It’s not l light. So although it can be worn as a lanyard with a case, it might be a little uncomfortable, but people are doing it.

The people contributing to this project are simply amazing. Such heart and soul are being given freely to make the lives of people with diabetes better. An update to the NightScout website, called Brownie, was rolled out yesterday. It allows for a Care Portal where care decisions can be documented and shared easily. We started using it this morning. I’ll post more about it soon!