Diabetes management has become more advanced with automated technology that primary care docs need to become familiar with, according to new guidance from the American Diabetes Association (ADA).
The update to the ADA 2019 Standards of Medical Care in Diabetes walks patients and primary care providers through the use of continuous glucose monitors (CGM) and an automated insulin delivery system, explained James Chamberlain, MD, of St. Mark’s Hospital and St. Mark’s Diabetes Center in Salt Lake City, and colleagues in the Annals of Internal Medicine.
“We thought it was extremely important to get this review of the statement on diabetes technology from the American Diabetes Association in the hands of the people that are providing the majority of the diabetes care in America,” said Chamberlain, the lead author of the clinical guideline.
“Diabetes technology is changing at a very rapid pace,” he told MedPage Today. “Patients are asking their providers about insulin delivery systems, continuous glucose monitoring, insulin pumps, and hybrid closed-loop pump products, and we believe primary care providers must have at least a basic understanding of these technologies.”
The guideline group recommends that nearly all patients with diabetes (type 1 or type 2) who are on intensive insulin regimens, monitor blood glucose throughout the day, and particularly before snacks, full meals, physical activity, and at bedtime. Glucose checks should be done by either CGM or through self-monitoring (grade “B” recommendation).
Patients who receive less frequent insulin injections are advised to use self-monitoring of blood glucose (SMBG), which “may help guide treatment decisions” (grade “B” recommendation).
As far as accuracy with glucose meters goes, the guidance advises providers that several factors can play a role in interfering with accuracy of readings.
“The U.S. Food and Drug Administration (FDA) uses the following accuracy standard for glucose monitors intended for home use: 95% of readings need to be within 15% for all blood glucose results in the monitor’s readable range, and 99% must be within 20%,” they noted.
They also warn against patients using counterfeit glucose strips, which may also give inaccurate results. Additionally, Chamberlain’s group advises that monitors that use glucose oxidase in the reaction should only be used in patients whose oxygen saturation levels are normal, as the readings depend on oxygen levels.
The guidance suggests all children, adolescents, and adults can improve glycemic control with sensor-augmented pump therapy without increasing their chances of severe hypoglycemia (grade “A” recommendation).
Along with ongoing use of a CGM, intensive education and support for the patients is required for improved outcomes (grade “E” recommendation). The group also notes that patients who successfully use a CGM should receive continued access across third-party payers for the devices.
Chamberlain highlighted one key point to take away from this guidance is how CGM technology has really “revolutionized” diabetes management, leading to improvements in several outcomes such as glucose averages, less glucose variability, more time spent in range, less hypoglycemia, and less fear of hypoglycemia.
Patients who require very frequent glucose testing should consider using an intermittently scanned CGM instead of self-monitoring of blood glucose, the guide states (grade “C” recommendation).
“Although SMBG is required to make treatment decisions with some CGM systems, the FDA has approved 2 CGM systems (Dexcom G5 and Dexcom G6) for decision making without a confirmatory SMBG check,” notes the guidance.
Additionally, the group recommends that in patients with type 1 diabetes who do not meet their targets, real-time CGM plus an intensive insulin regimen can help to reduce HbA1c levels, and should be used daily for maximum benefit (grade “A” recommendation for both).
Furthermore, adults with type 1 diabetes at particularly high risk for hypoglycemia, such as older adults, should consider using a sensor-augmented pump with automatic suspension of basal insulin technology when glucose is low, or expected to drop below 70 mg/dL within 30 minutes.
Automated Insulin Delivery
Automated insulin delivery that involves an insulin pump, CGM sensor, and a programmed algorithm for insulin delivery can be used in any patient with type 1 diabetes, age ≥7 years, to help improve glycemic control (grade “A” recommendation).
However, as hybrid closed-loop systems become more popular, including an insulin pump with CGM technology, Chamberlain stated that providers should be aware that some patients may choose to build their own off-label, non-FDA approved “artificial pancreas” systems using online training modules, such as OpenAPS and Loop.
“These systems do not have FDA approval, and the FDA recently warned of the risks of using unapproved or unauthorized devices for diabetes management (including CGM systems, insulin pumps, and automated insulin dosing systems) in the United States,” the updated guidance concluded.
Chamberlain disclosed support from Janssen, Merck, Novo Nordisk, Sanofi, and Dexcom. Co-authors disclosed relevant relationships with Tandem Diabetes Care, AstraZeneca, Boehringer Ingelheim, Teva, Lilly, Intarcia, Mylan, and GSK.
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