HQ Team
August 27, 2024: Insulet Corporation, a tubeless insulin pump maker, got clearance from the US Food and Drug Administration to add diabetes type 2 adult patients 18 years or older, to the treatment regime.
Previously, the US drug regulator had approved the Acton, Massachusetts-based company, to market its interoperable automated glycemic controller for type 1 diabetes.
An interoperable automated glycemic controller is software that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.
Previously, insulin therapy options for people with type 2 diabetes were limited to methods such as injection with a syringe, an insulin pen or an insulin pump, all of which require patients to self-administer insulin one or more times a day and check blood glucose frequently to achieve the best results.
“The latest approval provides a new option that can automate many of these manual tasks, potentially reducing the burden of living with this chronic disease,” according to an FDA statement. It is the first such option for people with type 2 diabetes.
Regulating hormone insulin
More than 11% of Americans are diagnosed with diabetes, a condition in which the body does not make enough or properly use the blood glucose-regulating hormone insulin.
In diabetes type 1 the pancreas does not make insulin, because the body’s immune system attacks the islet cells in the pancreas that make insulin.
In diabetes type 2, the pancreas makes less insulin than used to, and your body becomes resistant to insulin. This means your body has insulin, but stops being able to use it.
“Automated insulin dosing technology has previously been available only for people with type 1 diabetes. Today’s action helps expand access to this important diabetes management tool to millions of adults living in the U.S. with type 2 diabetes,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health.
“The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes,” she said.
Insulin therapy
People with type 2 diabetes may take medications that can help increase insulin secretion or improve insulin sensitivity, in addition to following a healthy eating plan and physical activity.
Many patients also need to use insulin therapy to keep their blood sugar in a safe range.
The nod for Insulet’s pump came after the FDA reviewed data from a clinical study in which 289 individuals 18 years and older with type 2 diabetes on insulin used the Insulet SmartAdjust technology for 13 weeks.
This study enrolled a diverse group of subjects from different racial and ethnic backgrounds, with a wide range of ages, education and income levels.
Study participants had varying amounts of experience with diabetes and insulin use, and many subjects were also using common non-insulin diabetes medications like GLP1 agonists.
‘No complications’
Overall, the study showed that subjects’ blood sugar control improved compared to before the study and these improvements were seen across all demographic groups.
“There were no complications or serious adverse events related to using the SmartAdjust technology. Adverse events reported during the study were generally mild to moderate and included high blood sugar, low blood sugar and skin irritation,” according to the FDA statement.
Over 30 million US people are living with type 2 diabetes, with about six million people who require insulin, of which 2.5 million are using multiple daily injections, according to an Insulet statement.
Despite advances in medical therapy over the past 20 years, there has been no significant change in the percentage of adults with type 2 diabetes achieving recommended HbA1c targets.
Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7% or less, and half of this population has an HbA1c greater than 8.0%.
Even with guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified.
Insulet’s Omnipod 5 System eliminates the need for multiple daily injections and automatically adjusts insulin delivery every five minutes. It is a waterproof, discreet, and wearable tubeless device.
