5-year-old Kycie Terry’s fight continues to be heard by thousands, even after her death on July 11.

On Saturday July 11, 2015, a post appeared on Facebook that shook the diabetes community and beyond. Five-year-old Kycie Terry, diagnosed with Type 1 diabetes less than six months ago, had passed away. It was the kind of news that you have to read twice and even a third time, hoping that somehow you’re misreading it. Back on January 30, Kycie had suffered severe brain damage after Type 1 diabetes went undiagnosed for roughly five days. Her doctor initially thought that she had strep throat and sent her home with antibiotics. Two days later, her blood sugar had reached 1,148 (normal is 80-120). She experienced seizures and became unresponsive after being life-flighted from a local ER to a better equipped children’s hospital. Doctors informed her parents, Josh and Jamie, that Kycie’s brain had herniated into the brain stem. If she survived, she would be severely handicapped. Little did anyone know how much fight was left in Kycie.

She opened her eyes and would spend a total of 111 days in the hospital, relearning everything from swallowing to sitting up. She could not speak and her parents longed to hear her first words again. Josh and Jamie began to share their daughter’s recovery via the Facebook page Kisses for Kycie, which has amassed over 54,000 followers since its creation. After Kycie was released from the hospital, the local community welcomed her home with a hero’s celebration, lining the street and holding up signs as Josh and Terry fought back tears of gratitude as they carried their daughter inside. Like so many others, I followed Kycie’s rehabilitation, her ups and downs, and her little triumphs that were anything but small, always amazed by her bravery and the courage of her parents.

Click here to view the embedded video.

Our immediate instinct is to ask why. How could God take someone so young? If only we could find a way to turn back the clock and warn them. After all, how could a doctor miss the diagnosis? The tragic truth is that it is not uncommon for Type 1 diabetes to go undiagnosed and be misdiagnosed. I know this because it happened to me. In 2004, after exhibiting extreme thirst, frequent urination, sudden weight loss, and changes to my vision (it temporarily went back to 20/20), I visited my family doctor. I told him that I looked my symptoms up online and thought that I might have diabetes. “First off,” he said, “you can’t believe what you read online, and I really doubt that you have diabetes.” Feeling slightly relieved, they drew blood at the office and sent it out to a lab. I asked if I should change my diet and eat less sugar in the meantime. “No,” he said. “Let’s wait until the bloodwork comes back. It’s unlikely you have diabetes.” A simple finger prick at the office would have shown a much different picture. Instead, like Kycie, they sent me home.

Over the next couple days, my symptoms worsened. My appetite increased and I began to crave sugar. I started to feel strange, lethargic, and at times my body felt like it was on the wrong wavelength, kind of like an appliance that is getting too much juice from an outlet. I don’t know how high my blood sugar got, but after hearing about stories like Kycie’s, I feel very lucky. The doctor’s office eventually called to inform me that the bloodwork indicated diabetes. I went back for another appointment. I then went to see a specialist, a doctor I later found out was on the verge of retiring. A nurse took me back to an exam room to wait. I could hear him down the hall in his office talking on the phone about his golf game. This went on for approximately twenty minutes and then he finally appeared. He wanted to do more blood work, but he was diagnosing it as Type 2 diabetes. He prescribed Metformin and sent me home. More days passed and then the additional blood work came back. The diagnosis was changed to Type 1 diabetes.

It’s been eleven years and the thought of the experience surrounding my diagnosis (or lack thereof) still infuriates me. I can remember the leave-it-to-the-experts smirk on my primary care physician’s face when I told him I tried to self-diagnose online, as if I had done something foolish. Yet, why wasn’t a simple finger prick done to test my blood sugar at the office when all of my symptoms pointed to diabetes? How could a “specialist” then look at a trim, healthy looking 27-year-old and make a diagnosis of Type 2 diabetes? Ultimately, why has there been such a lack of awareness, especially among doctors?

As these questions continue to frustrate me and many others in the diabetes community, there is one question whose answer has become clearer. Why Kycie? Why did she survive to fight for more than five months, only to be taken from this world? In trying to wrap my head around this, I thought about her more than 50,000 followers on Facebook and the thousands of others who likely saw their “likes,” comments, and “shares.” Then there are the many news articles that have been written about Kycie, and her YouTube videos that have amassed a total of several hundred thousand views and counting. In addition, television news broadcasts have shared Kycie’s story. I soon realized that Kycie Terry, a 5-year-old girl who never regained her speech, had likely been heard by more than a million people and will undoubtedly be heard by millions more.

Even though it’s hard to face at the moment, the purpose of Kycie’s life and her inspiring fight was already being revealed prior to her death, as evidenced by a July 5 Kisses for Kycie post.

“We just received our newest story from a mom of a recently diagnosed child. Her friend shared one of these awareness graphics 2 weeks ago, the mom saw these signs in her 15 yr old son, took him to the ER, and he tested at 600+ blood sugars.”

Type 1 Olympic cross-country skier Kris Freeman graces the February 2014 cover of Diabetes Forecast.

At age 19, the very same year that Kris Freeman was asked to join the U.S. Ski Team, he received the news that he could have let alter his future as a skier.  He was diagnosed with Type 1 diabetes.  The year was 2000 and by then Freeman had already been on a lifelong trajectory to become an Olympic skier.  His parents, who were both cross-country skiers themselves, pulled Kris behind them in a sled before he could even talk.  He competed in his first race by age 5 and by 19, he had competed at the junior world championships three times.

After his Type 1 diagnosis, Freeman says that although his dream of being an Olympic skier didn’t change, he was “very confused about what it all meant.”  He was becoming an adult and would be leaving home for the first time to train full-time with the U.S. Ski Team in Park City, Utah.  Being diagnosed with Type 1 diabetes was not the way Kris Freeman wanted to start his career as a professional cross-country skier.  He now began to question his body’s abilities.  Could he still compete at an Olympic level in an event that requires maximum endurance?  Could he push his body to its limits while still effectively managing his blood glucose?

“The way to not be terrified was to learn as much as I could about [diabetes],” says Freeman.  He began to study his body like a scientist, especially the way food, insulin and exercise affected his blood glucose. Over and over and over, he took to the treadmill to understand how anaerobic exercise affected his blood sugar.  He compared that to the effects of the less intense aerobic exercise.  The first would initially cause his blood sugar to soar, while the latter would have somewhat the opposite effect.  Kris’s discipline and self-education paid off.  He has won 15 national championships and placed fourth in the world championships twice.  Oh, and he’s also making his fourth trip to the Winter Olympics this year in Sochi.

Type 1 Olympic Skier Kris Freeman uses both an insulin pump and a continuous glucose monitor (CGM), and says that he tests his blood glucose three to four times a day on average.  Do to his training routines, he adjusts his insulin dosage on almost a daily basis.  Does Freeman now have perfect control of his diabetes at all times?  No, that wouldn’t be reality.  However, he says that he has only been severely hypoglycemic during a race twice.  Unfortunately, the last time was in 2010 at the Vancouver Winter Olympics.  It significantly affected his overall time in a competition, and in another event his coaches pulled him out, seeing how taxed his body had become.

Kris Freeman’s diabetes doesn’t keep him from striving for Olympic gold. Here, he trains with an OmniPod insulin pump attached to his arm.

Since then, Freeman has further adjusted his insulin levels during competition and is now at the top of his game.  He has also learned to take into account how the mere stress and adrenaline from being on a world stage can affect his blood glucose levels.  “I feel as confident as I ever have in my diabetes management,” says Freeman, who is ready to compete in the Winter Olympics in Sochi.

Type 1 diabetic Olympian Kris Freeman is an inspiration.  Hearing his story reminded me of what a good friend once told me immediately following my own diagnosis in 2004.  He said that to be on top of your diabetes, you have to learn as much as you can about it.  You need to become an expert, acquiring more knowledge than even your own doctors possess.  After all, most aren’t Type 1s themselves.  Like Kris Freeman, you have to approach the disease like a scientist conducting research.

While I have yet to fully embrace that advice to the extent I know I should, it’s what I believe will give me the chance to live a long and healthy life.  Stories like Kris Freeman’s are sometimes the motivation we need to step up our own game.

Google’s Glucose Sensing Contact Lens Prototype

Yesterday, my wife sent me an article about a contact lens that Google’s secret lab was working on. No, this lens doesn’t overlay a computer screen in your field of vision, nor does it provide a visual map of turn by turn directions as you walk down the street, pointing out the nearest coffee shop or ATM machine. No, this isn’t the next generation of Google Glass.  It’s arguably more life-changing than that, especially for diabetics.  Google’s diabetes contact lens or ‘smart’ contact lens contains a miniature glucose sensor embedded between two layers of soft contact lens material. The sensor is designed to measure glucose levels in tears. And thankfully, it doesn’t mean you have to cry all day in order to know where your blood sugar level is at.  No, you won’t have to spend your days watching Beaches or thinking of puppies being rescued.  The tears that lubricate your eye are enough for it to work, with prototypes being able to test glucose levels once per second.  I’ll admit, that’s way faster than I can test myself and it sounds less painful and much less of a hassle.

As with any news of this type, my excitement is always met with the stark realization that it could be years or even a decade or more until this would be in the hands of diabetics.  Not only does Google have a lot more development to do, telling the Wall Street Journal that “there’s still a lot more work to do to turn this technology into a system that people can use,” the harsh reality is that there are plenty of lobbyists in Washington who will be pushing back to delay this type of technology.  Why?  Because blood glucose test strips generate an enormous amount of money for major pharmaceutical companies and unless they develop similar products (which could violate Google’s patent), they’ll be doing everything they can to protect their profits, at the expense of diabetics like myself.  Still, it is only a matter of time before technology like Google’s diabetic contact lens makes it into our hands.  The demand for an easier way to test blood sugar has been staring researchers in the face for many years.

I’ve written about C8 Medisensors noninvasive CGM in the past, which used a beam of light to measure glucose levels in the interstitial fluid. However, much to my surprise, that company went under in the first half of 2013, less than a year after it had received CE Mark Approval for sale in the European Union (I discovered this after first trying to go to their website, which seemed to have suddenly vanished).

It’s sad to think that the biggest obstacles that often stand in the way of getting this type of technology into our hands are big business and big government.  Whenever government interferes with the natural actions of capitalism, whether it’s the FDA or some other overreaching regulatory committee, the people undoubtedly suffer.  When it takes years just to crawl through all of the government loopholes to get  new technology to market, it’s no wonder so many potential products never see the light of day.  The funding just runs out.  However, Google is no small company.  If anyone can get a technology such as a diabetes contact lens to see the light of day, it’s certainly them (read Google’s official blog post).  Perhaps it’s time I trade in my iPhone for a Google Android based phone.  Well, maybe not just yet, even though the future is once again looking a little brighter.  Thanks Google.

C8 MediSensors’ nCGM approved for sale in Europe. The device sends readings to a smartphone.

A little over a year ago I first wrote about C8 MediSensors HG1-c noninvasive continuous glucose monitor (nCGM).  This week I received word from the company that their device, which uses light to measure glucose in the interstitial fluid, has gained CE Mark Approval for sale in the European Union.  European customers can reserve C8 MediSensors Optical Glucose Monitor System via the company’s website.  In June, Chief Financial Officer Fred Toney said that the company has raised $19 million for its European launch, bringing the investor total to $60 million.  Though most investors remain undisclosed, GE Capital and GE Healthcare, both divisions of General Electric Corp., have put money into the company.

After launching in Europe, the next step will be to begin the regulatory process with the U.S. Food and Drug Administration.  The FDA could prove to be a bit of a challenge, given its reputation for playing politics.  However, approval in Europe is the starting point that C8 MediSensors needed in order to get their noninvasive optical glucose monitor passed the FDA.  The device will sell for around $4,000, which is less than the cost of invasive continuous glucose monitors (CGMs).

According to the FDA, computer glitches, device problems and issues with the insulin used have kept them from moving forward. The FDA has approved more than 20 clinical studies surrounding the artificial pancreas. Until now, the approval of these studies has perhaps been the most positive development in seeing that the device gets into the hands of the three million Americans suffering from type 1 diabetes.

What prompted the FDA to offer its approval guidelines for the device? In early November, the JDRF (Juvenile Diabetes Research Foundation), along with health professionals and lawmakers, including Senator Susan Collins (R-ME) who is the co-chair of the Senate Diabetes Caucus, went to Washington, D.C. to urge the FDA to take the necessary action to see that the device becomes a reality.

If you are not familiar with what exactly an artificial pancreas is, it is not an internal device. Like an insulin pump, it is a portable device that closes the loop between blood sugar testing and insulin delivery (or suspension). The artificial pancreas reacts to a patient’s current blood sugar levels and adjusts insulin delivery as needed.

C8 MediSensors HG1-c noninvasive CGM (left) next to its external battery (right).

Can you offer more information regarding a potential time frame for FDA approval and subsequent availability in the US?

“As you mentioned in your posting, we expect CE Mark regulatory approval early next year [2012] and we anticipate making our non-invasive glucose monitor available in Europe by April. After that, we will pursue FDA approval for the US. We can’t say when we expect FDA approval, because that is up to the FDA, not us, but we hope to be able to make the product available in the US by early 2013.”

Although I’m aware that the HG1-c works with smartphones, another blogger posted that the device would be able to call an emergency contact number if the wearer wasn’t responding to the device’s alarms.  Is this true?  It would be a great feature to have.

“Yes, our glucose monitor will be able to ‘call for help’. Our display device is the user’s smartphone, initially Android and then we will add iPhone (but we do not sell the phone). Using the phone opens up new functionality, like being able to set the phone to alert anyone the user specifies, and that functionality is being built into our new non-invasive glucose monitor. If that functionality is not available when we ship the first product, it will be available a few months later, via a software update. I can give you an update on that as we get closer to final EU regulatory approval and shipping dates early next year.”

I like the idea of the device interacting with my iPhone (particularly because my Minimed alarm is often difficult to hear), but will there be a solution for users who don’t own smartphones?

“Our current plans are for smartphones only as the display device. Using a smartphone means new functionality and one less device to carry around, which is something diabetics told us would be nice.  If we see a demand for alternatives, we can develop a non-smartphone display option.”

I understand that the HG1-c comes pre-calibrated from the factory.   Does this mean that the wearer will NEVER have to calibrate the device?

“Yes, the monitor comes pre-calibrated. When the user gets the device, she/he should do a finger stick to validate that the device is working properly and giving accurate readings (in case of damage in shipping etc). As our device is considered an adjunct device, a user should do a finger stick before making any medical decision. But the user need not do finger sticks to calibrate or recalibrate the device. It arrives pre-calibrated and stays that way. It is important to note that our device measures glucose optically, not chemically, and this is one of the innovations that makes a universal calibration possible. It also means the device works just as well in cold weather and hot weather, at altitude, and is not affected by any other chemicals in the bloodstream, like medications.”

Diagram of an individual wearing the belt that holds the nCGM device (external battery not shown).

“Yes, the device is worn on a belt, usually around the abdomen. The belt material is flexible and breathable, suitable for a variety of activities, including working out. When worn under a shirt, the belt is difficult to notice. The belt can be quickly removed to take a shower or go for a swim and put back on as the user needs. Once the device is again in contact with skin, it will start taking readings in about five minutes. We looked at adhesives as an option but the belt seemed more convenient and practical, plus it avoids the added expense of a consumable like tape.”

With regard to the HG1-c device itself, it is stated that there are no ongoing consumables, but is there a lifespan on the laser?  Will it and/or the whole device eventually need replaced?  If so, how long will the device last and will users need to incur the cost of a whole new device when it dies?

“Yes, the device has no consumables except for some inexpensive gel, a year’s supply of which comes with the product. Users can buy more gel online for less than $5 for a year’s supply. No lancets. No disposable sensors. No test strips. No tape. The device has no moving parts and is expected to last at least four years.  We do not expect a user will need to replace it sooner than that unless they want to upgrade to a newer version.”

How does the HG1-c receive its power?  Is it rechargeable itself, or does it use batteries?  How long will the charge/batteries last?

“The device is powered by two re-chargeable lithium-ion batteries, which come with the product.  The charge will vary depending on how frequently the user sets the device to take a reading. If the user sets the device to take a reading every four minutes (it can read as frequently as every three minutes), the battery will last about 10 hours. If the user sets the device to take a reading every ten minutes, the battery will last about 20 hours. In general, we expect users will wear one battery when at work, then come home and swap to the fresh battery.”

After Doug Raymond returned to the office, he responded to me and included a link to the video embedded below that shows C8 MediSensors HG1-c nCGM device and its battery, which he confirmed is worn separately on the belt, external to the device itself.

Click here to view the embedded video.

“The ‘white rectangular thing’ you asked about in the Dr. Marcio Krakauer video [above] is the rechargeable battery. The external battery uses current cell phone battery technology. The benefit of using an external battery allows one to swap out batteries without having to remove the HG1-c from the body. The battery is carried in a soft cloth pouch in the HG1-c belt and is very easy to remove and replace. We plan to supply two batteries with every HG1-c, providing the user the ability to have one on charge while the other is being used. The run time per battery is dependent on the measurement frequency. The user will be able to set the measurement frequency from every 3 minutes, 10 minutes, or 15 minutes. Run time per battery is 10 hrs, 20 hrs, 28 hrs, respectively. Also, we felt that having the battery external gives us the opportunity to take advantage of new battery development moving forward.”

After I apologized for asking so many questions, which in turn can take legitimate amount time to answer, in closing, Paul Connolly shared the following remarks.

“Kevin, no need to apologize about asking questions.  I welcome them.  Ask more. It helps us understand how to introduce this new innovation to you and your peers.

Thanks for sharing your experience with the invasive CGM sensors [I had described to him a recent uncomfortable and bloody experience that I had inserting a conventional invasive CGM sensor].  We are well aware of how archaic and barbaric some of those sensors can be, and we are happy that we can now provide a better way of getting continuous glucose measurements to improve the lives of diabetics.”

At this point, I am optimistic about C8 MediSensors Noninvasive Continuous Glucose Monitor.  The company plans to present its latest clinical data at the Diabetes Technology Meeting in San Francisco at the end of October.

“As for accuracy,” says Connolly, “we are finishing another set of clinical trials and the data is promising, indicating accuracy that is better than invasive CGM and about equal to finger sticks.”

If that data holds true, it could mean a significant leap forward for diabetes self-management.  The next challenge for the company will be obtaining FDA approval for the HG1-c.  For me to expect that process to be swift may be foolhardy.  Then again, unnecessarily continuing to send a spring-loaded piece of metal into my abdomen on a regular basis seems a bit ridiculous as well.

C8 MediSensors HG1-c noninvasive CGM could make living with Type 1 Diabetes a little less painful.

Each year more than 30,000 Americans, half of them children, are diagnosed with Type 1 diabetes.  They join the nearly three million Americans already suffering from the disease, who, like me, are faced with multiple daily finger pricks to test the amount of glucose in their blood.  In order to cover the period of time when we’re not pricking our fingers, many Type 1 diabetics use a continuous glucose monitor (CGM).  Up until this point, the most successful and reliable of these devices are all invasive, requiring the user to inject a metallic filament under the skin, which analyzes the amount of glucose in the body’s interstitial fluid.  This measurement is not reliable on its own and needs to be calibrated with traditional finger pricks several times a day.  In addition, the insertion of this type of CGM is both discomforting and at times painful.  Just last week I bled so much from my insertion site that I had to remove the CGM sensor and start over (not to mention clean up the blood that dripped onto my shoes and clothing).

Yesterday, my wife sent me a link to a blog post that mentioned the invention of a new nCGM (noninvasive Continuous Glucose Monitor) that is being manufactured by C8 MediSensors, Inc.  The device uses a laser beam of light to measure the amount of glucose under the skin.  A small amount of the incident light from the beam causes the glucose molecules (as well as other molecules) to vibrate.  The light that is reflected off of these vibrating molecules will have different colors than the original incident light.  This effect is known as Raman scattering.  The C8 MediSenors nCGM device analyzes these colors, looking for a unique Raman spectra that can be used to identify the chemical structure of the glucose molecules.  More details regarding the technology behind the C8 MediSensors noninvasive CGM can be found on the company’s web site.  For a brief overview of the device, watch the C8 MediSensors video below.

Click here to view the embedded video.

From what I have learned so far, C8 MediSensors’ nCGM device, labeled the HG1-c , is promising for a number of reasons:

• It is noninvasive and the company claims that it is completely pain free since it uses only optical light.
• It comes pre-calibrated from the factory and does not require constant finger stick calibrations (although, like current CGMs it measures the glucose in the body’s interstitial fluid and not in the blood, so it does not replace the need for the more accurate finger stick tests).
• It begins working after five minutes instead of several hours like current CGMs.
• It transmits glucose readings via Bluetooth to the user’s smartphone (a huge plus), and it is also rumored to be able to call an emergency number if the user hasn’t responded to the device’s alarms (another potential huge plus).
• It does not require the need for costly disposable sensors or other consumables in order to function.
• It can be worn all day or taken off at the user’s convenience.

The company is claiming that the cost of the C8 MediSensors nCGM, the HG1-c, is equivalent to the price of three finger stick tests performed daily over the course of four years.  So, if we can assume that a test strip costs on average fifty cents, the equation becomes 365 x 4 x $1.50 = $2,190.  If we add in the minimal cost of lancets, we can expect to pay somewhere above that total, before factoring in insurance coverage.

Of course, the big question is, how accurate is the HG1-c?  The C8 MediSensors company website claims that it is “comparable in accuracy to currently available CGMs.”  However, most of us who use CGMs know that the accuracy is relative to our levels during calibration, and if our glucose levels are rising or falling too much when we calibrate, it can corrupt the accuracy of the CGM.  Since the HG1-c doesn’t require constant calibration, does this mean its accuracy is more consistent?

In conclusion, the C8 MediSensors noninvasive continuous glucose monitor looks to be a promising tool for Type 1 diabetics.  The device is expected to be available overseas in late 2011 for countries that accept CE Mark approval.  With regard to the US, the company expects FDA approval sometime during the 2012 calendar year.  I’ve contacted the company for more information on a possible approval timeframe for 2012.

Has insulin become a prime suspect for the TSA?

Apparently, the TSA agent confiscated a vial of insulin and ice packs, claiming that they were an explosives risk.  The expecting mother-to-be says that she had a doctor’s note and that the insulin was labeled correctly.  However, it is not clear if “labeled correctly” means that the vial of insulin was in its prescription box or if it was only the loose vial that was present.

In any case, it’s certainly a situation that needs to be investigated.  After all, any of us who travel and are diabetic could end up at that same airport being screened by the same agent, not to mention other TSA agents who will hopefully take note of the potential mistake made by their coworker.