July/August 2016

6 Ways Technology is Changing Diabetes Care
By Judith C. Thalheimer, RD, LDN
Today's Geriatric Medicine
Vol. 9 No. 4 P. 10

The number of older adults living with diabetes is rising, and this population is at increased risk for serious complications and death. Exciting new technologies and products bring hope for improving care and management.

According to the American Diabetes Association (ADA), diabetes disproportionately affects older adults.1 Already more than 25% of the US population aged 65 and older is living with this disease, and the number is expected to grow rapidly in the coming decades.2 This population has the highest rates of major lower extremity amputation, heart attack, visual impairment, and end-stage renal disease of any age group, and higher rates of premature death, disability, and cardiovascular disease than those without diabetes. Older adults with diabetes also are at greater risk for issues such as polypharmacy, cognitive impairment, urinary incontinence, and falls.2 New tools for treatment and management like those described below could change the way diabetes impacts future generations, potentially decreasing the devastating toll this disease can take in later life.

#6 New Ways to Manage Lows
Hypoglycemia, or extremely low blood glucose, is a major concern for older adults with diabetes. Those aged 75 and older have twice the rate of emergency department visits for hypoglycemia of the general population with diabetes.2 "Members of the geriatric population with compromised kidney function or hypoglycemic unawareness may be more prone to hypoglycemia," says Eileen Sturner, RD, CDE, BC-ADM, MBA, manager of the Abington-Jefferson Health Diabetes Center and Nutrition Counseling Center in Abington, Pennsylvania.

When an individual experiences an episode of severe low blood sugar, a glucagon injection is the only remedy. A bystander must prepare and inject the proper dosage during a crisis situation. In the not-so-distant future, managing a hypoglycemic crisis may be as easy as putting on a patch or puffing a powder.

In October 2015, Zosano Pharma released the results of phase 2 trials of their ZP-Glucagon patch.3 This microneedle patch system allows a dry, stable formulation of rapid-onset glucagon to be delivered more easily by using a handheld device to apply the patch to the skin.4 A small trial designed to test the patch's safety and efficiency found that the patch acted quickly to normalize blood sugar in 100% of subjects, with a response time similar to injections.3 Zosano is currently working with the FDA on further development plans. A phase 3 clinical trial is tentatively scheduled for later this year.4

Another exciting innovation in hypoglycemia recovery is nasal glucagon. This powder that can be sprayed into a patient's nose was developed by Locemia Solutions and recently acquired by Eli Lilly and Company. In February 2016 the companies announced results of phase 3 adult clinical trials showing that nasal delivery is highly effective in treating insulin-induced hypoglycemia in adults with type 1 diabetes.5

#5 There's an App for That
Diabetes management is complicated. Like seemingly everything else today, apps are being developed to help with the integration and management of information. In their 2016 Standards of Medical Care in Diabetes, the American Diabetes Association (ADA) stated that technology-assisted tools such as apps can be useful elements of effective lifestyle modification to prevent diabetes.2

Similarly, apps can be useful to those already living with the disease. "For the smartphone-savvy population, some apps could help with management," Sturner says. "It's great to be able to see trends." There are a number of apps already available that allow users to record blood glucose readings, medications, food, and activity, with features designed to make it easier to spot trends and areas for improvement or change. The newest of these apps seek ways to streamline diabetes management even further.

Rather than having users test their blood sugar and enter the results into a logbook or onto an app, new products such as One Drop and the SugarCube aim to automate this cumbersome recordkeeping, while making diabetes management easier and more user friendly. Like other diabetes apps, One Drop, a free download available in the Apple iOS App Store and expected to be available for Android this year, allows the user to log daily activities including food intake, insulin, and exercise and examine them in relation to their blood glucose readings. The app also interconnects users, who can exchange ideas and information on improving blood glucose levels. What will set this app apart from most others is the One Drop glucose meter, expected to become available as part of a subscription service in 2016. This Bluetooth-enabled meter pairs with the app, automatically sending blood glucose readings to make trend spotting and lifestyle analysis easier.6

The SugarCube bills itself as a "diabetes lifestyle management system." Designed as an all-in-one glucose testing kit with built-in storage space for test strips, lancets, needles, and some brands of insulin pen, the SugarCube aims to help people with diabetes carry in one convenient container all the supplies required for testing blood glucose levels and administering insulin. The SugarCube meter also will be Bluetooth enabled for pairing with the SugarCube app, which will provide a place for test results, food tracking, and activity logs. Like One Drop, the SugarCube app offers an online support community, as well as access to a registered dietitian. The company is currently fundraising and reportedly plans to have the kit, app, and meter available in 2016.7

Meters aren't the only products taking advantage of wireless technology. In May 2015, Companion Medical received significant funding from Eli Lilly to bring to market an insulin pen (a dosing and injection system) with a built-in computer.8 The Bluetooth-enabled InPen and its associated smartphone app will help calculate the appropriate dose, track doses and administration times, and even indicate how much insulin remains active in the body from the last dose. The InPen will be able to send alerts and reminders about missed doses.9 "For people to be able to have all of this information at their fingertips could help with management," Sturner says.

#4 Continuous Glucose Monitoring
No matter how convenient the package or how "smart" the device, pricking one's finger multiple times per day to check blood glucose levels, calculating insulin doses, and injecting insulin are complicated and cumbersome responsibilities. And intermittent blood testing gives only a glimpse into what is really going on with blood glucose levels throughout the day. In 2005, continuous glucose monitoring (CGM) became available to provide a more complete picture of blood glucose fluctuations.10 CGM uses a sensor inserted under the skin to measure blood glucose levels at regular intervals.11 The ADA supports CGM as a useful tool for patients who are self monitoring, and states that individuals who have been successfully using CGM should have continued access after they reach the age of 65.2

The Dexcom G5 Mobile CGM System, another product that takes advantage of wireless technology, can send CGM data to the users' smartphones. Users can see their data in real time, check for trends, and even share their data with others. Using the Dexcom Follow app, up to five people can remotely follow the wearer's CGM data. According to the company, Dexcom CLARITY software analyzes the user's data to help identify patterns and spot problems so that management can be improved. According to the company's website, the G5 Mobile CGM System is "the only CGM approved for adults and pediatric patients 2 years of age and older."11 Dexcom also plans a product that will require the user to perform a finger stick only once every 24 hours for calibration, devices that can be worn longer than the typical three days before changing, smaller transmitters, and a less-painful application system.4

#3 Perfecting Pumps
Widely available since the 1990s, insulin pumps are worn close to the body and release insulin via a thin catheter placed under the skin. Rather than preparing a syringe or pen, wearers simply set a dose and push a button on the pump.10 Because of the growing number of older adults with insulin-dependent diabetes, the 2016 ADA Standards added the recommendation that people who use insulin pumps should have continued access after they reach the age of 65.2

These pumps are not without problems, however. Users need to check their blood sugar levels by sticking their fingers in order to calibrate the pump. The fine tubes carrying the insulin can become clogged, setting off an alarm. But sometimes the tubes become only partially blocked, which, although it doesn't trigger a warning, slows insulin delivery enough to potentially cause hyperglycemia.12 The FlowSmart infusion set from Becton, Dickinson and Company (BD) is designed to reduce this problem. Approved in April 2015 and scheduled for launch by Medtronic in 2016, this new insulin infusion set has a side-ported catheter designed to improve insulin flow. Both preclinical and clinical data showed that an insulin infusion set with BD FlowSmart technology significantly reduced flow interruptions compared with other commonly used infusion sets, and the FDA has cleared the set for sale in the United States.4,13

In addition to becoming safer with innovations like the new infusion system, pumps are getting "smarter." The existing Medtronic MiniMed 530G uses built-in CGM to stop insulin delivery if glucose levels become too low, but the next-generation MiniMed 640G is designed to predict lows 30 minutes before they occur, stopping delivery before blood glucose dips and starting it again when levels begin to climb. The 640G was approved for use in Australia in early 2015.10

#2 The Artificial Pancreas
Taking the next step toward a more autonomous product, Medtronic in April 2015 signed an exclusive agreement to incorporate DreaMed Diabetes' GlucoSitter artificial pancreas software into future Medtronic insulin pumps.14 While it will require the wearer to input elements such as meal size and upcoming exercise, this hybrid closed-loop pump will use CGM to adjust basal insulin (but not bolus) without input from the wearer.4,10

Add even more complex algorithm software to a pump that has CGM, and you have an artificial pancreas. In theory, the CGM monitors blood glucose levels, the algorithm responds in real time to changes, and the insulin pump releases just the right amount of insulin to correct any highs. These devices will release the proper amount of insulin at the correct time without input from the wearer. While the devices will need to be calibrated regularly using old-fashioned finger sticks, an artificial pancreas would free the user from constant watchfulness, testing, carb counting, measuring, injecting, and worrying about dangerous highs and lows and could dramatically improve blood glucose control around the clock. The May 2016 issue of Discover magazine profiled multiple groups that are working to make an artificial or "bionic" pancreas a reality.10

Research on these exciting devices is being conducted and published. In 2014 The New England Journal of Medicine published a study by Russell et al entitled "Outpatient Glycemic Control With a Bionic Pancreas in Type 1 Diabetes." Two random-order crossover studies tested a bionic pancreas for five days in 20 adults and 32 adolescents with type 1 diabetes. Compared with a regular insulin pump, the artificial pancreas, which delivered both insulin and glucagon as needed, improved mean glycemic levels with less frequent episodes of hypoglycemia.15 Unfortunately, glucagon is currently approved by the FDA for emergency use only, and problems with glucagon's stability and price also may hamper this product's progress.10

With multiple private companies and research/business partnerships supported by public, private, and nonprofit funding all conducting trials in the race to bring this long-sought-after product to market, the artificial pancreas may be a dream whose time is near.10

#1 A New Pancreas?
The ultimate solution to diabetes would be to either prevent the pancreas from malfunctioning or provide a patient with a new pancreas. The possibility of people with insulin-dependent diabetes being able to produce their own insulin may actually be close to reality.

In 2015, ViaCyte, Inc, a California company working in the emerging field of regenerative medicine, began testing beta cell replacement therapy in a group of people with diabetes.4 Two small strips are implanted under the skin of the subject's lower back.16 Inside these strips are pancreatic beta cell precursors. Once implanted, the beta cells are expected to mature into endocrine cells capable of excreting insulin and other hormones to control blood glucose levels. ViaCyte's hope is that these strips will protect the cells from triggering the body's immune system, while allowing in glucose and other nutrients and releasing insulin and other hormones as necessary.17 If all goes well, perhaps all of the other innovations mentioned in this article will become unnecessary in the future.

Moving Forward
Recognizing that older adults living with diabetes have unique issues that have not been adequately addressed in research and recommendations, the ADA's 2016 Standards of Medical Care in Diabetes include a new and more comprehensive section on diabetes care in older adult populations.2 The recommendations, covering issues such as neurocognitive function, hypoglycemia, treatment goals, care in skilled nursing facilities/nursing homes, and end-of-life considerations, underscore the need for a comprehensive patient-centered team approach to care.2 "Even with these technologies," Sturner says, "diabetes care needs the human touch. The patient is the center of the team, but needs that team to customize the approach to care, educate, ensure proficiency, and support the use of technology." Sturner cautions that as exciting as these innovations are, technology is only as good as the person using it. "If technology allows better control with increased safety, that's a great thing," Sturner says. "But it's important users are educated on the correct use of these technologies."

The aging of the US population is one of the drivers of the diabetes epidemic. This disease shortens lives, decreases functional status, and increases the risk of institutionalization for older patients.1 But management that improves blood glucose control can reduce the long-term consequences such as amputations, loss of vision, kidney failure, heart disease, and nerve damage often seen in older adults who have been living with diabetes. While the innovations mentioned in this article will not cure diabetes, they will hopefully ensure that future generations live longer, healthier, and easier lives. As Sturner says, "Our goal in working with older adults is to increase not only the quantity of their days but [also] the quality of those days."

— Judith C. Thalheimer, RD, LDN, is a registered dietitian and principal of JTRD Nutrition Education Services, LLC, outside Philadelphia.

References
1. Older adults. American Diabetes Association website. http://www.diabetes.org/in-my-community/awareness-programs/older-adults/. Updated April 9, 2015. Accessed May 2016.

2. American Diabetes Association. Standards of Medical Care in Diabetes — 2016. Diabetes Care. 2016;39(Suppl 1):S1-112.

3. Zosano Pharma announces positive Phase 2 results for its ZP-Glucagon patch program for treatment of severe hypoglycemia. Zosano Pharma website. http://ir.zosanopharma.com/releasedetail.cfm?ReleaseID=936338. Published October 13, 2015.

4. Neithercott T. 12 products in the diabetes pipeline. Diabetes Forecast website. http://www.diabetesforecast.org/2016/mar-apr/12-products-in-diabetes-pipeline.html. Published March 2016.

5. Rickels MR, Ruedy KJ, Foster NC, et al. Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes: a randomized crossover noninferiority study. Diabetes Care. 2016;39(2):264-270.

6. Navigating diabetes, together. One Drop website. http://onedrop.today

7. How the SugarCube works. SugarCube website. http://thesugarcubeapp.com/#how-it-works

8. Companion Medical announces completion of Series B financing. Companion Medical website. http://www.companion-medical.com/news.html. Published May 20, 2015.

9. Tenderich A. Companion's new smart insulin pen will mimic a pump. Healthline website. http://www.healthline.com/diabetesmine/companions-new-smart-insulin-pen-will-mimic-pump. Published July 28, 2015.

10. Hurley D. Priming the pump. Discover. May 2016.

11. Introducing the Dexcom G5® Mobile CGM System. Dexcom website. http://www.dexcom.com/g5-mobile-cgm

12. A ground-breaking innovation in diabetes management. BD website. http://www.bd.com/infusionset/

13. BD and Medtronic collaborate to introduce a new infusion set with BD FlowSmart™ technology designed to improve insulin pump therapy. BD website. https://www.bd.com/press-details/20112/BD-and-Medtronic-Collaborate-to-Introduce-a-New-Infusion-Set-with--BD-FlowSmart™-Technology-Designed-to-Improve-Insulin-Pump-Therapy. Published June 8, 2015.

14. Medtronic to use GlucoSitter artificial pancreas software in future insulin pumps - a big deal! diaTribe website. http://diatribe.org/drugdevice-name/medtronic-minimed-640g#sthash.16MhYTBv.dpuf. Published April 6, 2015.

15. Russell SJ, El-Khatib FH, Sinha M, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014;371(4):313-325.

16. Curry A. Beta cell breakthroughs. Diabetes Forecast website. http://www.diabetesforecast.org/2015/may-jun/beta-cell-breakthroughs.html. Published May 2015.

17. Transforming the lives of patients with diabetes. ViaCyte website. http://viacyte.com