Diabetes is big business. If you don’t believe me, just Google the term “diabetes is big business” to see the headlines that agree. As of 2012, $245 billion was spent in the United States alone per year, and that has some people believing there will never be a cure—there is too much money in it. Maybe that’s true, maybe not. But there are plenty of companies out there making products intended to help those afflicted.
What Is Diabetes?
Here’s the quick, highly over-simplified primer on the disease if you’re not up to speed. Diabetes mellitus, more often called just diabetes, maybe even DM, or “the diabeetus” if you’re a fan of Wilford Brimley, comes in a few forms.
The first is called Type 1 (aka T1), a chronic autoimmune disorder where the pancreas can no longer effectively produce the insulin hormone needed to manage the glucose (sugar) a person eats, mainly from carbohydrates. If you can’t make insulin, your body gets hyperglycemia—that’s too much sugar (high blood glucose). On the converse, diabetics are also easily prone to hypoglycemia—not enough sugar—caused by taking too much insulin (thus the term “insulin shock”), or even missing a meal or getting too much activity. Type 1 used to be called juvenile diabetes because you can get it as a kid and then you have it the rest of your life. T1s are entirely dependent on insulin from an outside source; and taking the right dosage means constantly monitoring blood glucose level. There is no known cause of T1, but it’s likely a mix of genetics and environment.
Type 2 (T2) diabetes was once considered “adult-onset diabetes,” but can occur in kids. Patient’s bodies can make insulin, typically, but develop a resistance to it; then may stop altogether. Sometimes T2s need insulin injections, sometimes just diet adjustments. Ninety-five percent of people with diabetes have T2 and many can reverse it—it’s usually brought on by a lack of exercise and weight gain.
(And there is also gestational diabetes—where pregnant woman can’t make or use the insulin their body produces. It doesn’t mean they had diabetes before or will have it after, but it can affect the baby.)
The IDF Diabetes Atlas 7th Edition says there are 412 million people with diabetes on Earth today (up from 382 in 2015). That’s one in 11 people (while one in 100 is a T1). That number will rocket up to 642 million by the year 2040. It affects men and women in equal numbers; and 25 percent of those with diabetes don’t even know it. The complications are many, but the worst is that having diabetes doubles the chances of an early death. In the US, it was the seventh leading cause of death in 2010, either as an underlying cause or contributor—and it’s probably well under reported.
Tools for Treatment
Insulin wasn’t discovered until 1921; before that, diabetes was a death sentence for most. In the past, the way to monitor blood glucose levels (BGL) varied. In the 50s people stirred their urine and a reagent tablet into water to see what color they turned. In 1976, the discovery that red blood cells hold glucose, led to the A1C test—using blood directly to test BGL—that’s still used today. Tracking the BGL and injecting insulin as needed is the basis of diabetes treatment. The goal is to keep the levels between 80 and 180 mg/dL (milligrams per deciliter).
In the modern high-tech world, the treatment of diabetes has tried to keep pace. The tools break down into a few major categories, with a lot of overlap between them, depending on the product.
Blood glucose meters (glucometers) are the simplest devices—they may be digital, but still require a reactant test strip that the patient doses with their own blood after performing a finger stick with a sterile lance to squeeze out a drop of blood. That’s a pain diabeticsbecome all too familiar with. An electric current from the meter reacts with the blood and glucose oxidase in the test strip to test the conductivity of the blood and get a pretty accurate BGL reading. You can typically buy a meter over the counter, along with the strips; strips are typically proprietary to their meter. A glucometer tells a patient their BGL at that moment, but can’t predict if it’s going up or down.
There is also some off-brand insulin you can purchase without a doctor’s order, at least in some states—but they’re not known for metabolizing fast, which could be important. Also, patients need training, which usually happens at a doctor’s office.
Then you get into the area of prescription only.
The brand names of rapid-acting insulin like Novolog and Humalog, or basal insulins like Lantus and Levemir, are prescription-only. So is whatever your insulin delivery device may be—even if it’s a syringe. (Diabetics also typically carry a kit with a syringe full of a one-time emergency dose of glucagon, a peptide hormone that is essentially the opposite of insulin. It will raise the BGL when they go low—and since a low BGL can lead to confusion, dizziness, or even delirium, family and friends should know about it, too.)
A continuous glucose monitor (CGM) is what most patients need. It’s a handheld device that tells them what their current BGL is, as often as 288 times a day; the data is received wirelessly on a handheld monitor they can read, from a transmitter on the body, which is attached to an implanted sensor. The sensor is constantly reading the BGL in the interstitial fluid under the skin—it’s the fluid surrounding the cells of all mammals. That’s great—but the problem is, reading a BGL from that fluid is not as accurate as a finger stick test with red blood cells. So for most CGMs, a few finger-sticks a day are still required for calibration. A selling point of the newest CGMs is always higher sensor accuracy leading to fewer finger sticks.
The best insulin delivery device for most is an insulin pump—an automated device filled with a reservoir of insulin that is attached to the patient via an infusion set. An infusion set carries insulin via a tube (usually) to a small needle or a cannula (a “needle” made of plastic) that goes beneath the skin to deliver the drug. Infusion sets must be rotated to a different part of the body, typically somewhere on the abdomen, every three days. They can’t be too close to a sensor, or the BGL readings will be out of whack.
What you get when you combine a CGM with an insulin pump is pretty much the holy grail of diabetes treatment: an automated insulin delivery system—the so-called artificial pancreas. The JDRF—once known as the Juvenile Diabetes Research Foundation—started researching such a device in 2005. This is a big deal for patients who have to deal with highs and lows as they sleep, and at mealtime when an extra insulin injection (called a bolus) can be necessary. Every major maker of diabetic technology is at work on this, and the first partial artificial pancreas devices are only now hitting getting to patients. The market is expected to reach $335.5 million alone in five years.
As noted above, the majority of these products are prescription-only. That’s important, because without training (typically in the doc’s office from a representative of the manufacturer) they can be dangerous to use. And they are very expensive. Few people would or could pay out of pocket for a CGM or pump or especially the combo of the two. Most manufacturers wouldn’t even quote me a price on their devices. Medicaid for younger patients, Medicare for older patients, and personal insurance can play a major factor in the availability to any of these.
The Artificial Pancreas
Medtronic is the 800-pound gorilla of the diabetes world. It doesn’t work much with others, goes its own way…and leads the pack. It’s had pumps (below) for years, but made history in September 2016 by becoming the first partial artificial pancreas system approved for use in the United States by the Food and Drug Administration (FDA). It’s only slowly rolling out to patients now and could get international approval this year. It is for T1s only and holds about 3ml (300 units) of insulin. It’s not for use by kids under 7.
The 670G is technically called a “hybrid closed-loop insulin pump” in that it is not fully automated. The clamshell-like sensor is Medtronic’s own Guardian Sensor 3, the part of the CGM that attaches to the body. It wirelessly sends BGL info based on the interstitial fluid to the MiniMed 670G. But while a CGM is integrated, it still requires regular finger stick tests each day for calibration (that’s the closed-loop part). For that, patients use the included Contour Next Link 2.4 meter, which wirelessly sends the accurate BGL to the 670G. After that, the pump provides the right amount of bolus insulin at a meal; the auto-mode adjusts basal insulin delivery while sleeping. What’s very important is the 670G also has a “suspend before low” option to stop providing insulin 30 minutes before a predicted low BGL.
Continuous Glucose Monitors (CGM)
Medtronic took the lead in the artificial pancreas for now, but Dexcom has long been the other gorilla in the diabetes treatment industry. It’s got a decade of experience making the CGMs used as companion products by almost every other pump manufacturer.
The G5 is the latest and greatest, having received FDA approval in December 2016. It uses a sensor to measure interstitial fluid, but with enough accuracy to be categorized as a “therapeutic CGM” that allow pumps or people to make insulin dosing decisions without a finger stick (however, two finger sticks are required per day to keep it calibrated).
What’s more, the G5 trumpets itself as a “mobile CGM” because it sends data every five minutes via Bluetooth to your smart device, either iOS or Android, even smart watches, received in the Dexcom G5 Moble App (the G4 required a receiver, which is still an option on G5 for those without a smart device). Patients headed to a high or low BGL can get push notifications, or get warnings sent via text for privacy. The waterproof G5 has a battery that supposedly lasts three months; you still need to change its location on the body about every seven days. This video by Andrew Ohara gives a great overview.
Dexcom also provides a cloud-based service called Clarity for reporting on your tracked BGL. Dexcom Share is a service that lets up to five followers also keep tabs on your BGL on their own devices via an app called Dexcom Follow—perfect for parents worried about diabetic kids.
While not quite at artificial pancreas levels yet, Dexcom CGMs integrate or work with many pumps from manufacturers you’ll see below like Tandem, Animas, and Insulet. As new products come out, more will probably integrate with the G5.
This wearable isn’t exactly like other CGMs. It’s a disposable, nickel-sized patch holding on a 0.2-inch flexible sensor a little thicker than a hair. It stores BGL data from interstitial fluid for up to two weeks, and conducts a new test every 15 minutes for 1,340 results. Those get uploaded to the doctor at your next visit. The doctor must subscribe to the Libre Pro system, which includes a touch-screen wireless reader used to scan the sensor. The video below makes it look like you can use the reader at home, but that’s not how it’s going to work in the US, at least not for a while.
You just wear the sensor and forget it, though you have to be a little more careful when showering and exercising. It’s not exactly doing you much good until you get to the doctor to see the trends, but it does keep you very ambulatory. Abbott, which makes the device, makes it very clear in the documentation this isn’t a replacement for your regular BGL monitor using finger sticks—or a completely different CGM for that matter—but you don’t need a finger-stick to calibrate this sensor, since you’re not even using the data to prep insulin doses.
Insulin Pump with CGM
Johnson & Johnson owns a host of diabetes-related companies, including Animas and the OneTouch brand, as well as LifeScan meters and Calibra Medical (and might be looking to sell all of them). For now, Animas Vibe is its top insulin pump that also integrates a CGM, specifically the last-generation Dexcom G4 as pictured. (The latest Dexcom G5 will definitely integrate with the OneTouch Vibe Plus pump, which is coming soon; it only got FDA and Health Canada approval in Dec. 2016.
The big selling point on the Vibe (and the coming Vibe Plus) is the approval to be used for diabetic children ages two and up. The screen is in full-color, showing off a pattern of your BGL over the previous 12 hours, not just the current hour’s reading from the sensor. The pump itself is waterproof so you can take it swimming or in the shower. There is an integrated food database to help you determine the right bolus dose when eating. It holds only about 200 units of insulin, which is on the low side.
Tubing—dealing with a tube running from a carried pump to an infusion set—may be one of the hardest things for a diabetic to get used to. The Omnipod doesn’t have tubes—it’s a pump you mount right on your body, essentially becoming its own infusion set. The cannula is built right in and inserts under the skin automatically. The pump sticks to your skin and can be used just about anywhere—arms, legs, abdomen, back, etc. It might be the absolute best option for active, athletic diabetics. It holds up to three days’ worth of insulin for delivery; a typical delivery is probably about 30 Omnipods, so enough for three months. A pod holds about 200 units max.
Omnipod doesn’t integrate directly with any CGM, but it does suggest the Dexcom G4 on its website—use the CGM to check if you’re high or low, double check with a finger-stick, using the the Ominipod wireless Personal Diabetes Manager (PDM) device, which integrates a FreeStyle-brand blood glucose meter and strips you carry around. The PDM has a big color screen that shows you plenty of info, and sends BGL to the Ominpod pump itself to give you the right dose of insulin.
People who use an Omnipod pump call themselves “podders.” Insulet has apps for iOS and Android called My Omnipod, but it’s not for getting any digital info from the device itself nor from CGMs. It’s more of a help app that assists with ordering things like more test strips and pods full of insulin. There is also the option to use the Freestyle CoPilot Health Management system for Windows—it has an Omnipod extension, so when you hook the PDM to the PC, it downloads the data and gives you an overview. (That software works with all Freestyle-branded meters.)
Tandem Diabetes Care makes a number of pumps, the top-of-the-line being the thin (only 0.6 inches thick), waterproof, rechargeable t:slimX2. It’s discrete but can still hold 300 units of insulin, which is pretty amazing for its size—that’s 100 units more than the Omnipod and the same as the larger Medtronic MiniMed 670g.
Being rechargeable is controversial with some—most pumps run on AA batteries, and if you can’t plug in you’re hosed insulin-wise—but it has its fans. Use a micro-USB cable to power it up nightly and to transfer data to a PC (or get updates from the PC).
The touch-screen controls are easy to set for both basal and bolus dosing, though you’ll want to work with a separate CGM and a meter to get the right amount programmed. (The older t:slim G4 actually does sell with the Dexcom G4 CGM. There is also the t:Flex, which is also very similar in appearance, but has a massive reservoir of 480 units of fast-acting insulin.)
T:slim X2 is the only Tandem pump that has Bluetooth. You’d think would mean sharing data with phones, but the Bluetooth isn’t really used much, it’s more of a future-proofing to work with devices in the future. X2 and its brethren are for touch-screen-capable ages six and up only.
Similar looking to its sibling the Animas Vibe, the OneTouch Ping is a pump that doesn’t have a CGM; it only communicates with the companion wireless blood glucose meter, the kind that uses test strips. After a finger stick, the data collected about BGL is sent to the pump, so it knows how much insulin to deliver. No need for a separate syringe.
It’s waterproof and the pump itself comes in five highlight colors (black, gray, green, blue, and pink). The data collected can be shared with an online management platform and in turn shared with healthcare providers. The OneTouch Ping has one bit of infamy—it was the first such diabetes device to be subject to a recall because of a cyber-security bug that, had it been exploited (no report says it was), hackers could have overdosed someone with insulin.
The precursor to Medtronic’s artificial pancreas above, this pump came with the same Contour Next Link 2.4 meter to help prepare bolus doses of insulin. It was the first it had that went waterproof and also added a color screen. It was only for ages 16 and up.
As a pump, the 630G is pretty much identical to the 670G above, but the differences are the CGM (it used the older Enlite CGM) and that it doesn’t stop insulin on a predictive basis—it would only stop after a registered low blood sugar, which in some cases could come too late. Sadly, the 630G is not in any way upgradable to become a 670G closed-loop system despite the hardware being practically identical. This is one of the few where the upgrade cost was spelled out in that a 630G would cost users of older MiniMed products around $3,100! If you’re curious what its all about without trying it personally, Medtronic made free 630G simulator apps for iOS and Android.
Blood Glucose Meters
The glucometers you use when performing a finger-stick are still ubiquitous for diabetics: the accuracy of measuring BGL with actual hemoglobin is what’s used to calibrate CGMs, after all. But even glucometers can vary wildly in reading the same drop of blood. No one ever said diabetes was an exact science.
Remember if you settle on a meter of choice, you have to get the right strips to go with it. Get the wrong kind and you risk getting faulty readings, and using bad readings to dose yourself with insulin could cause trouble.
There are plenty of over-the-counter meters available with big monochrome screens to show you the BGL the minute the blood hits the test strip. They’re that good, but some are more accurate than others. And accuracy is all important in this area. Getting a device that then talks to your other devices—be they smartphones or other diabetes treatment devices—almost has to take a back seat. If you can get all of that, you’re going to be the most satisfied. Here are a few we found that rated best in reviews around the web plus have a slight high-tech factor.
Fora Test N’Go $29.99
A small, accurate, and Bluetooth-enabled meter, the Test N’ Go works with apps for iOS and Android to give you a continues graph of your BGL results. The screen on the device itself is a little LCD backlight. The whole thing weighs 27 grams—it looks like a USB flash drive. You can recharge it via USB. Fora naturally also sells lances for finger sticks, and the test strips are about $19.99 for 50 of them (which isn’t a bad price yet still adds up fast if you stick a lot).
Fora Test N’Go Voice $24.99
If you’re a diabetic with vision problems, consider the Test N’Go Voice. It has most of the same features as the basic Test N’Go, but it’s a little bigger and will speak aloud the steps you have to take, as well as announce the final BLG reading.
One Drop Chrome
One Drop wants to be a one-stop shop: it provides an app for iOS, watchOS, and Android; unlimited test strips via subscription at $39.95/month; a bullet-like lancet for finger sticks, and the One Drop Chrome that does the test and delivers the data to your phone. It’s not cheap, but it looks dope. One Drop promises accuracy similar to most: 99 percent BGL within 20 percent of lab results.
If you want cheap commodity glucometers with easy-to-find test strips in just about any drug store in the country, stick with the LifeScan OneTouch, Abbott Freestyle, or Ascensia (formerly Bayer) Contour Next brands.
Ultimately, the best glucometer for you will probably be the one your insurance pays for, especially for the test strips.
Diabetes Apps for Smartphones
It’s nice when the pumps and monitors and meters work with the screen you look at more than any other, your smartphone. But there are plenty of apps out there that you can use even without automation. You have to do some work to make it happen, but they could be worth it.
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Log everything having to do with your diabetes: A1C results, BGL, doses of insulin. Log through your iPhone and you can still access the data via the website.
Officially the most downloaded, if not most popular, diabetes app worldwide. Austria-based mySugr passed one million users in May 2017. It lets T1 and T2 diabetics keep track of everything. It’s free, but add-ons include $20-a-month coaching with certified diabetes educators. Pay $2.99 a month to upgrade to the pro version and get options like smart search, blood sugar reminders, and export of reports.
This costly app says it’s the “easiest and most comprehensive diabetes tracker app” and has the reviews to back it up. It’s suitable for T1, T1, pre-diabetes and even gestational diabetes patients. The Android version is as much a diet tracker as it is a diabetes tracker, if you’re also looking to lose weight.
Future Diabetes Tech on the Horizon
Now that you know what’s available, what new tech is coming for T1 and T2 patients? For those of us in the US, so much depends on FDA approval that delays or scrapping of plans should be expected of some of these, but here are a few items we dug up.
Bigfoot Biomedical is a startup that has the attention of the big players. It’s well-funded by the likes of the JDRF and T1D Exchange, among others, enough so it just bought Timesulin, the maker of a smart pen cap to go on insulin injectors. Its plan is to create an entire smart ecosystem of pumps, sensors, and more that work together better, and with your smart devices, to combat diabetes.
- The iLet from startup Beta Bionics is being billed as a “bionic pancreas.” It’s a standalone platform that would not require a smartphone; it would work with a CGM like the Dexcom G5 and then administer not only insulin but also glucagon to keep diabetics—of almost any age—healthy. As of June 7, it has already passed some critical trials.
- The OneTouch Via was hailed last year as the product that could revive the doldrums of Johnson & Johnson’s various diabetes treatment properties. It looks a little like the Omnipod at first glance, but here’s the gist: this “patch” holds 200 unites of insulin on your body for up to three days and instantly administer a bolus at mealtime with full discretion—there is no handheld or smartphone needed. (It’s not going to help people who also need all-day/night basal insulin injections though.) In that way it’s not entirely unlike the Unilife Imperium patch pump that hasn’t been heard from in a while.
- Alphabet—the parent company is Google—is heavy into a couple of research projects for diabetics, all via is Verily Life Sciencesdivision. First was the “smart contact lenses” plan from 2014 in conjunction with Novartis that would measure BGL from tears; that one seems to be on the wane. Dexcom confirmed it is still working with Verily on a project to make a miniaturized CGM specifically for T2s.
- Apple may have a secret dream-team of biomedical engineers working on a non-invasive sensor and CGM. Instead of a hair-sized metal sensor poking into you, it would, in theory, use optics to measure glucose levels right through the skin. Supposedly Apple is doing tests in the Bay Area, and even Tim Cook has reportedly been seen wearing one.