Dive Brief:

• Medtronic's InPen smart insulin pen device kept patients in their target blood glucose range for longer periods of time compared to previous treatment without the pen, according to results presented at the 81st American Diabetes Association Scientific Sessions. The study analyzed patient data of 1,736 individuals between January 2018 and October 2020.
• After 90 days of use with a continuous glucose monitor, patients with a glucose management indicator of greater than 9.5%, which the study referred to as patients with the poorest glycemic control, saw time spent in range of their target blood glucose level increase by 5%, or about 1.2 hours per day. Patients with glucose management indicators of greater than 8% saw time in range increase by 2.3%, or about .6 hours per day. The results also showed that both patient groups did not experience an instance of hypoglycemia, when blood sugar dropped below targeted levels.
• The medtech giant's trial results come as competition in the smart insulin pens space is intensifying. Eli Lilly and Bigfoot Biomedical, which is partnered with Medtronic rival Abbott Laboratories, are also prioritizing the technology.

Dive Insight:

Smart insulin pens can link with smartphone applications and use data gathered by CGMs to help inform insulin dosage decisions or alert if a dosage has possibly been missed.

Medtronic bought into the submarket with its acquisition of Companion Medical in August 2020. Now, other large medical device and healthcare companies are focusing on the technology as patients further embrace wearables, particularly in diabetes management.

Bigfoot Biomedical received FDA 510(k) clearance in May for its smart insulin pen system, Bigfoot Unity system. The company's smart insulin pen system is cleared to work with Abbott's FreeStyle Libre 2 CGM.

The Bigfoot Unity system consists of smart insulin pen caps that can link with Abbott's CGM and gather data about a patient's glucose levels. Dosing recommendations are then displayed on the pen cap. The system can also link with a smartphone app and alert patients about very low glucose levels or for possible missed doses.

The pen caps and system work with disposable insulin pens made by companies like Eli Lilly, Novo Nordisk and Sanofi.

Meanwhile, insulin pen maker Eli Lilly is developing a smart-pen attachment of their own, called the Tempo Smart Button, which can be used with the company's Tempo Pen. The Tempo Smart Button is currently in late-stage clinical development and Eli Lilly is pursuing a CE mark for European markets in 2021.

Eli Lilly announced in May that the smart pen system will be compatible with other companies' diabetes technology, including top CGM maker Dexcom.

In a Tuesday note, SVB Leerink analysts wrote that a nurse practitioner/diabetes nurse educator in its consultancy network was encouraged by the proliferation of available smart insulin pens as it offers more treatment options for patients with diabetes. However, the analysts wrote the nurse practitioner views the devices "as a 'entry way' to integrated insulin pumps vs. directly competitive with integrated insulin pumps."