CeQur Simplicity Wins Two FDA Clearances. Here’s What the Upgrades Mean for Mealtime Insulin

For people living with diabetes who rely on mealtime insulin, dosing is about to get a lot simpler. 

On June 4th, CeQur, a diabetes company dedicated to making mealtime insulin easier, announced two recent Food and Drug Administration (FDA) approvals for its CeQur Simplicity mealtime insulin patch. 

CeQur Simplicity is a wearable insulin patch that simplifies mealtime dosing. The patch is clinically proven to improve blood sugar control, with patients achieving significantly improved A1C (lowering levels by 1.7%) and time-in-range (TiR) goals, by improving TiR by 50 percent.

The new approvals bring major improvements, including:

• An extended wear of up to seven days from the previous four-day wear time
• A new, one-unit device. Their previous device could only dose insulin in 2-unit doses. 

What do these FDA approvals mean for people with diabetes?

These approvals make mealtime insulin delivery easier, more effective and more discreet than ever before for people who do not want to be on an insulin pump.

Let’s look into the improvements to the CeQur system.

Seven-day wear 

Up from four-day wear, now the CeQur mealtime insulin patch can be worn for up to a week. This will lower the number of device changes and needle pricks a person using the system will have to endure. 

It will also reduce the burden of mealtime insulin delivery, giving people a sense of freedom and flexibility in their diabetes management.

One-unit dosing

Previously, the CeQur system could only dose insulin in 2-unit increments. Now, with a one-unit dosing device, mealtime insulin therapy will be more precise for patients. 

This will be revolutionary for people using the device who wish to have tighter glycemic control or for those who are more sensitive to insulin and require less for meals. 

“These clearances address specific clinical feedback we have received from physicians and patients since launch,” said Bradley Paddock, the ceo of CeQur. “Extending wear up to seven days and enabling 1-unit dosing are not incremental updates; they expand who CeQur Simplicity can help and how clinicians can prescribe it. When you couple these clearances with our real-world data and commercial expansion, the picture is clear: CeQur Simplicity is becoming the proven alternative to multiple daily injections.” 

How does the CeQur Simplicity system work?

The CeQur Simplicity system is a tubeless patch mealtime insulin system for people who require mealtime boluses for the food they eat, and an alternative to both multiple daily injections (MDI) and insulin pump therapy. 

People wear the patch continuously, and each click delivers one to two units of insulin. The therapy can be combined with a long-acting (basal) insulin. 

How can people access the CeQur Simplicity system?

People with insulin-dependent type 2 diabetes need and deserve more treatment options for care. These FDA approvals are a step in the right direction and provide more flexibility and freedom to people with insulin-dependent diabetes by offering more flexible mealtime insulin delivery options will improve the quality of life for many. 

Talk with your doctor to find out if the CeQur Simplicity system is a good option. It’s FDA-approved for people 21 and older living with diabetes.