FDA Approves Accu

The Accu-Chek Solo micropump system has been cleared by the FDA. The system includes a tubeless insulin pump and a wireless handheld controller with Bluetooth, which integrates with blood glucose monitoring and provides bolus advice.

Roche announced that its Accu-Chek Solo insulin patch pump and wireless touchscreen handheld device has received FDA approval for people with type 1 diabetes aged 2 years and older. The Solo launched in Europe in 2018 and is now available in 19 markets globally, including Austria, Poland, Switzerland, and the UK.

Like Insulet’s Omnipod, Accu-Chek Solo is a tubeless insulin pump worn as a patch directly on the body and controlled from a wireless handheld device, enabling discreet insulin delivery. The pump does not have a screen and is controlled wirelessly from a touchscreen handheld via Bluetooth.

Solo is “semi-disposable” and the consists of five key parts:

A disposable adhesive pump holder, which is replaced every three days

A disposable adhesive infusion cannula, which is replaced every three days

A disposable 200-unit reservoir, which is replaced every four days

A reusable pump base, which lasts up to four months

A reusable handheld diabetes manager, which includes an integrated Accu-Chek guide glucose meter and a bolus calculator

In all, the patch has five parts, making it slightly larger than the fully disposable Omnipod. The semi-automated insertion device lasts for up to one year.

Other noteworthy features of the Accu-Chek Solo include:

A quick bolus button with three different options (standard, extended, and multi-wave). This allows users to deliver a bolus when the handheld device is out of range.

A transparent reservoir to allow better detection of air bubbles. The reservoir is compatible with the U100 insulins Humalog, NovoLog, NovoRapid, Apidra, Insuman, Infusat, and Fiasp.

A cannula, or insertable tube, available in two different lengths (6 mm and 9 mm) to fit personal needs.

“Pen-therapy mode” to allow for temporary switches to an insulin pen without losing data.

Similar to other insulin pumps, Solo can be worn in different locations on the body, such as the upper arm, upper thigh, and abdomen. To learn more about Solo’s features, download an interactive PDF.

At this time, Solo does not appear to include a smartphone app for uploading data, remote monitoring, or controlling the pump.

Roche offers several resources online to help users navigate Solo:

Roche’s Accu-Chek Solo YouTube playlist covers different aspects of the patch pump, including replacing the pump base and cannula, using the quick bolus feature, and editing a quick bolus in the diary.

Accu-Chek Academy provides all the information needed for initial training as well as ongoing learning and answers to common questions.

Roche has not shared any information regarding launch timelines in the US.

While Solo doesn’t connect with CGM, Roche is researching potential ways to integrate CGM into the micropump system and future generations are likely to include this feature. Plans to integrate Solo with automated insulin delivery (AID) have not been shared.

Roche acquired Solo in 2010 and Solo first came to market in Europe in 2018. The US launch has been five years in the making and marks a major win for people seeking greater flexibility for insulin delivery. Solo is the second tubeless insulin pump available in the US after Omnipod, offering another option for a more discreet way to manage insulin delivery.

Additional reporting by Emma Ryan, Maeve Serino, Brian Levine, and Adam Brown

Photo credits: Roche Diabetes Care