FDA Clears embecta’s Type 2 Diabetes-Inspired Patch Pump

FDA clears type 2 diabetes-inspired patch pump by embecta

People with type 2 diabetes have been using insulin pumps for decades, but the large number of people with type 1 diabetes on pumps has overshadowed the need for insulin pumps in the type 2 diabetes community. Until now.

The FDA recently cleared a new insulin patch pump by embecta developed with the unique needs of people with type 2 diabetes in mind. It’s the first wearable, fully disposable insulin patch pump to come from embecta, and it’s indicated for the management of diabetes in those requiring insulin, for individuals 18 years of age or older, including both type 1 and type 2 diabetes.

One key feature of the patch pump is its 300-unit reservoir, which may be beneficial for people who require a larger amount of daily insulin. A recent embecta-sponsored study showed that a 300-unit insulin reservoir would meet the needs of 64% of adults with type 2 diabetes for its three-day wear.1 There are also people with type 1 diabetes who may require larger amounts of insulin and could benefit from a larger insulin reservoir.

What Is a Patch Pump?

Patch pumps are insulin pumps without any tubing, so they adhere directly to the skin. The entire device, including the insulin reservoir and delivery mechanism, is self-contained within the patch. Patch pumps are also disposable and recyclable, unlike tubed pumps.

What Are the Benefits of a Patch Pump?

Patch pumps are often easier to fill than tubed pumps, and they generally offer full freedom of movement. There’s no tubing to get tangled up on the bedroom door handle or caught on clothes (yours or your significant other’s). Patch pumps can increase your options for insertion sites, and they have a lower risk for occlusions, kinks, or dislocation that can interrupt insulin delivery. Some patch pumps are water resistant and can be used in the shower and even while swimming (even if you do not know how to swim 😉) like the Omnipod 5, which was also recently FDA-cleared for people with type 2 diabetes.

What Are the Key Features of embecta’s Patch Pump?

  • It’s a wearable, fully disposable patch pump that provides adjustable basal and bolus insulin for up to three days.
  • It’s completely tubeless, so the catheter enters your skin from the bottom side of the pump and it sticks to your body with an adhesive.
  • It can be placed on common locations such as the upper arm and abdomen like other insulin patch pumps and sensors.
  • It has a 300-unit insulin reservoir with the goal of accommodating people with higher daily insulin needs.

Why Might embecta’s Patch Pump Be a Good Option for People with Type 2 Diabetes?

Some insulin pumps only give basal insulin (long-acting insulin), which works well for a subset of people with type 2 diabetes whose pancreas still secretes enough insulin when they’re having a meal. Other pumps are bolus-only pumps, which work well as long as the user has some pancreatic function and can produce insulin overnight and in the fasting state (or take an injection of a long-acting basal insulin once a day). embecta’s newly cleared insulin patch pump is a basal/bolus pump that is designed to meet the needs of people with type 2 diabetes who need either or both basal and bolus insulin.

Versatility for New and Advanced Users

This pump was designed to make things simple for new users, but it has the intended capability to allow people to make advanced setting adjustments. embecta has also stated its plans for the development of a closed-loop version including an insulin-dosing algorithm in a potential future FDA submission.

Does the embecta Patch Pump Work with CGMs?

The recently cleared pump will not be an automated insulin delivery (AID) system and will not communicate directly with CGMs. The user will of course be able to look at his or her own CGM and make adjustments themselves. Development plans have been communicated for a closed-loop version that includes an insulin-dosing algorithm to make the system a hybrid closed-loop device.

When Will the embecta Patch Pump Be Available?

No release date has been announced.

In Summary

The team at embecta set out to develop an insulin pump that would address some of the most significant obstacles of adopting pump therapy for people with type 2 diabetes who use insulin based on patient feedback.

 

References:

  1. Eugene E. Wright, Jr., MD, et al, Evaluating Need for Larger Insulin Reservoir in Patch Pumps: Leveraging Retrospective Dose Data for US Adults with T2D on MDI, https://www.embectamedical.com/pdf/ADA-Poster-1902.pdf

 

embecta is a supporting company of TCOYD®

3 Comments
  1. Avatar

    Need to know availability and what the cost will be . I am a retired person and have limited funds. I use a syringe now and use a libra 3. I also use novolog and morning and night a long acting insulin. Having trouble finding how much insulin to use. Will this pump regulate this problem? Running about 7.2 a1c. Please advise

    • Hi William,

      We will update this article as soon as embecta announces the launch of their pump. Communication with a CGM device will help regulate your insulin, but that function will come a little later to this pump. Saying that, just being on a pump with a smooth basal rate and easy-to-administer pre-meal doses of insulin will help in and of itself.

  2. I’m speculating based on Embecta previously announcing a Tidepool ACE pump and the path the Twiist/Sequel Med Tech/Deka Research pump has taken through the FDA, the product that got clearance will never come to market. A full featured Hybrid Closed Loop version will eventually be what is sold. The Twiist pump, also based on Tidepool, has done a FDA review square dance getting the pump reviewed starting in 2021 with a small clinical trial, then the controller with Tidepool reviewed without a clinical trial, then adding the controller to the pump and getting that reviewed without a clinical trial. The Twiist isn’t on the market yet so the dance may continue. Embecta submitted their FDA paperwork in 2023. I hope they aren’t 2 years behind. Thank you for letting us know about the announcement, I’m pumped. Up.

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