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6 Not-to-Miss Details from the ADA’s New Guidelines for Diabetes Tech

Chances are good that you work with patients touched by diabetes: About a third of the U.S. adult population — more than 100 million people — is living with either diabetes or pre-diabetes, according to Centers for Disease Control estimates.

The good news? There’s more accessible technology helping people manage diabetes than ever. And for the first time, the American Diabetes Association (ADA) has provided guidelines on these tools to help healthcare providers make confident decisions for patients with diabetes.

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This year’s annual update of the ADA’s Standards of Medical Care in Diabetes includes an entirely new section on diabetes technology. It addresses devices, hardware and software that people with diabetes use to self-manage the condition, such as insulin pumps and continuous glucose monitors. 

“Diabetes tech is such a huge part of treating diabetes with type 1 and type 2 patients,” says Kacie Doyle-Delgado, RN, ARNP, co-author of a review of the 2019 guidelines published in Annals of Internal Medicine. “In the past everything was just based on medication and finger stick blood glucose checks. Now, technology really drives where diabetes care is heading. We feel that any healthcare providers who work with patients with diabetes should be aware of this technology.”

To pull together their guidelines, the team looked at review studies published between October 2017 and November 2018 and sought input from clinicians who work with patients who have diabetes. Here are the most notable recommendations for HCPs working with diabetes patients.

Continuous glucose monitoring (CGM) is the ideal way to measure and manage blood glucose levels

The ADA committee recommends CGM for adults and children who have type 1 diabetes or type 2 diabetes with intensive insulin regimens (i.e. multiple daily injections or insulin pump therapy) to improve glucose control and decrease hypoglycemia. Real-time CGM devices measure glucose with a subcutaneous sensor; alarms notify patients when they become hypoglycemic or hyperglycemic. 

Because most CGM devices measure blood glucose levels every five minutes, they allow patients to see the effect of medications, meals and exercise. Compared to traditional finger prick measurements, which offer a very limited snapshot of blood glucose levels at certain moments of the day, CGM data offers a much more detailed picture. HCPs can benefit from looking at the amount of time that patients’ blood glucose levels are in-range (70 to 180 mg/dL).

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“That brings about a shift in the way HCPs provide care. We now know there’s more important data than HbA1c alone. You can’t get that without CGM,” says Doyle-Delgado. Daily use of real-time CGM has been shown to lower HbA1c levels in adults with type 1 diabetes who aren’t meeting their glycemic targets, and regular use may be helpful for type 2 patients with frequent hypoglycemic episodes.

Sensor-augmented pump therapy combines CGM with an insulin pump. They receive high praise from the committee for improving glycemic control without increasing overall or severe hypoglycemia in children, adolescents and adults. Some devices, recommended only for adults with type 1 diabetes at high risk for hypoglycemia, suspend basal insulin when glucose is currently low or predicted to drop. 

The ADA notes that it’s essential to educate, train and support patients using CGM devices so they can use the data to adjust their eating patterns, exercise and medications.

Intermittently scanned CGMs can be a more affordable and practical option

Intermittently scanned CGM (isCGM) devices, also known as “flash” CGM, were approved by the FDA in 2017 for use in adults. Patients wear a receiver that displays real-time glucose values with trend arrows when scanned over a sensor; data can be uploaded and reports created. The scanners can be worn for up to 14 days. Unlike traditional CGM, they don’t report data continuously, and they don’t have alarms. 

The upside: isCGM is significantly cheaper than traditional CGM, which cost about $700 for the device and transmitter for one month without insurance. Flash CGMs run $70 to $80 at most American pharmacies, says Doyle-Delgado. 

“Patients will sometimes opt to use [flash CGM] even if it’s not covered by their health insurance because it’s affordable,” notes Doyle-Delgado. Other patients prefer that the flash system doesn’t have an alarm, she adds, although the ADA recommends alarms so patients are notified before blood levels become too high or low. 

The accuracy of flash CGM is lower than self-monitoring of blood glucose at high and low glucose levels; evidence is conflicting in comparison with real-time CGM. But overall they have been shown to have excellent accuracy and performance, especially for people with gestational diabetes, type 1 diabetes and hypoglycemia unawareness.

“There is still benefit with isCGM devices because you can see previous data and trends for where blood glucose is predicted to end up,” says Doyle-Delgado.

Glucose meters aren’t always accurate

“This is something that patients commonly complain about. We feel it’s important for them to understand FDA standards,” says Doyle-Delgado. Patients get different results when they either test the same drop of blood on two different meters, or when they test themselves within a few minutes on the same device. This, understandably, causes confusion about what to do. 

Some discrepancy, however, is normal. The FDA’s standard is 95 percent of readings need to be within 15 percent for all blood glucose results in the monitor’s readable range, and 99 percent must be within 20 percent. That means following a reading of 200 mg/dL, a patient could get a reading of 160 or 240—and that’s within the acceptable range.

“There really is a big discrepancy in meter accuracy,” says Doyle-Delgado. “Patients should retest if they’re unsure of accuracy before dosing insulin.”

The recommendations also note that a recent study found that only 6 of the top 18 glucose meters met the FDA’s accuracy standard. If meters are outside of the 20 percent range, a patient should consult his or her HCP.

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Clinicians should also be aware that several factors can interfere with glucose meter accuracy. For example, people who are on oxygen therapy can get falsely low glucose readings when they use glucose oxidase monitors. 

“Providers should be aware of other therapies their patients are using and how those might impact glucose levels. If patients are on oxygen therapy, clinicians should look at meters they’re prescribing to know if it’s an accurate meter for them,” says Doyle-Delgado.

Automated insulin delivery systems may improve glycemic control

Automated insulin delivery systems are an option to improve glycemic control in adults and children over 7 years old with type 1 diabetes. The devices consist of an insulin pump, a continuous glucose sensor and an algorithm that determines insulin delivery. Various configurations are available; sometimes patients prefer a particular system because they’re familiar with its CGM or pump, while other times insurance coverage dictates which pump to prescribe, notes Doyle-Delgado.

Although patients still need to be continuously aware of their blood glucose levels, automated systems give them peace of mind and allow them to be more hands-off about glucose management. “There’s less fear when patients know the pump and sensor are working for them to prevent low blood glucose and give insulin for high glycemia,” says Doyle-Delgado.

While people with type 2 diabetes do use automated insulin delivery systems, the ADA doesn’t currently recommend them for these patients because there haven’t been as many studies to make a strong recommendation, explains Doyle-Delgado. Some health insurance companies don’t cover pumps and/or CGM for patients with type 2 diabetes, she adds. “As this is studied more, as long as the evidence supports the benefits for type 2 insulin-dependent patients, it will drive more insurers to cover these devices and will give stronger recommendation for use.” 

In the meantime, HCPs may still choose to offer automated insulin delivery systems to patients with type 2 diabetes on an intensive insulin regimen based on time spent in hypoglycemia or hyperglycemia, years on insulin and insurance, says Doyle-Delgado.

Patients are hacking their own DIY artificial pancreas 

FDA-approved insulin pumps or Omnipods have glucose targets that can’t be modified; most have base targets of 120 to 150 mg/dL. Patients have been using online communities and tutorials, including OpenAPS and LOOP, to hack FDA-approved devices and create artificial pancreas systems that allow them to customize ranges for own glucose control and set their own glycemic targets. 

“More patients are creating their own artificial pancreas system that is not FDA-approved,” says Doyle-Delgado. “Clinicians cannot recommend these treatments to patients, but they should know it’s out there and available.”

People who create these DIY systems are most often interested in tech and want excellent blood glucose control. “They’re trying to achieve targets that are better than what they can obtain with current available systems,” says Doyle-Delgado. The FDA, however, has warned about the potential dangers of the resulting systems, which haven’t been sufficiently studied to guarantee safety.

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“We thought it was important to draw attention to providers more than patients. So many are not aware that there are these systems or how they work,” says Doyle-Delgado. She adds that these hacks are pushing the pump and CGM makers to adjust their systems, and that ongoing studies are looking into the safety of these DIY systems.

Dual-hormone systems are the future of diabetes tech

Many other automated systems for insulin delivery are under FDA investigation, including dual hormone systems (insulin plus glucagon or pramlintide). These systems aren’t available yet, though Doyle-Delgado expects insulin plus glucagon will be on the market in next three to four years. “This is the future of diabetes tech,” she adds.

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