Tandem Diabetes Care hopes newly published data will persuade insurers to cover automated insulin delivery systems for more people with Type 2 diabetes.
AID systems, which pair a glucose sensor with a pump to automate insulin dosing, are covered by Medicare and many private insurers in the U.S. for people with Type 1 diabetes.
Tandem currently has thousands of users with Type 2 diabetes, said Jordan Pinsker, Tandem’s chief medical officer, adding that there is “a lot of coverage” with private insurance.
However, Medicare requires a C-peptide test to assess insulin production, and some private insurers have followed suit, Pinsker said.
Pinsker intends to change that with pivotal trial results used to gain Food and Drug Administration clearance for Tandem’s Control-IQ+ algorithm, which is used in its insulin pumps. The label expansion allows two of Tandem’s pumps to be used by people with Type 2 diabetes as part of an AID system.
“Currently, at least for Medicare, they require you to almost look like you have Type 1. … You’re not making much insulin,” Pinsker said in an interview with MedTech Dive. “We show that has no bearing on outcomes at all.”
In pivotal trial results published March 19 in the New England Journal of Medicine, researchers found that people with Type 2 diabetes using an AID system saw improvements in hemoglobin A1c levels compared to a control group, who used glucose sensors with their usual method of administering insulin. There was one severe hypoglycemia event among the interventional group. The study, which was funded by Tandem, took place over 13 weeks and enrolled 319 people.
“This study potentially could really open up policy changes and really help move things forward to make pumps a lot more accessible,” Pinsker said.
The study design was also important for convincing the FDA of the label expansion, Pinsker added. The study was structured as a randomized controlled trial, while competitor Insulet’s pivotal trial, which led to a Type 2 indication for its AID system last year, was done as a single-arm study.
The study included a racially and socioeconomically diverse group of participants and people who were taking GLP-1 and SGLT-2 medications. It also included a wide variety of insulin regimens, with the study open to people with Type 2 diabetes taking any sort of mealtime insulin.
“For a long time, insulin pumps were considered complex,” Pinsker said. “This study really shows that not only do patients with Type 2 want this therapy, but they can do very, very well.”
