FDA News

Medtronic receives FDA investigational approval for testing of longer-use insulin infusion set

The FDA approved on Friday a proposed trial of an insulin infusion set that can be worn for 7 days, according to a press release from Medtronic.

Satish Garg

An expected longevity of 2 or 3 days is the standard for insulin infusion sets that are currently on the market, which makes for frequent and potentially obtrusive changes of the device and also makes it more difficult to combine with continuous glucose monitoring due to differing adjustment times, according to the press release. Medtronic said its longer-use system will address these issues with “new adhesive technology” and the aim of ensuring that insulin delivery remains stable.

“There have been significant advances made in the three-plus decades with insulin pumps and CGM. However, we are still stuck with having patients change the insulin delivery sets every 2 to 3 days, whereas most CGMs are now used longer,” Satish Garg, MD, professor of medicine and pediatrics and director of the adult diabetes division of the Barbara Davis Center of the University of Colorado, said in the release. “It is time for an infusion set to extend wear to a week and beyond. This is long overdue and will likely improve quality of life for patients on insulin pumps, and many more patients may accept insulin pump as an option.”

The trial will follow a multicenter, non-randomized, prospective study design. Medtronic will compare the efficacy of the device across 7 days with that of standard devices in 150 adults with type 1 diabetes aged 18 to 80 years who use the MiniMed 670G device, according to the press release.

Disclosure: Garg reports he has served on advisory boards for Dexcom, Eli Lilly, Lexicon, Mannkind, Medtronic, Merck, Roche and Sanofi, and received research grants through his institution from Animas, Dario, Dexcom, Eli Lilly, JDRF, Lexicon, Medtronic, Merck, NIDDK, Novo Nordisk, Sanofi and T1D Exchange.

The FDA approved on Friday a proposed trial of an insulin infusion set that can be worn for 7 days, according to a press release from Medtronic.

Satish Garg

An expected longevity of 2 or 3 days is the standard for insulin infusion sets that are currently on the market, which makes for frequent and potentially obtrusive changes of the device and also makes it more difficult to combine with continuous glucose monitoring due to differing adjustment times, according to the press release. Medtronic said its longer-use system will address these issues with “new adhesive technology” and the aim of ensuring that insulin delivery remains stable.

“There have been significant advances made in the three-plus decades with insulin pumps and CGM. However, we are still stuck with having patients change the insulin delivery sets every 2 to 3 days, whereas most CGMs are now used longer,” Satish Garg, MD, professor of medicine and pediatrics and director of the adult diabetes division of the Barbara Davis Center of the University of Colorado, said in the release. “It is time for an infusion set to extend wear to a week and beyond. This is long overdue and will likely improve quality of life for patients on insulin pumps, and many more patients may accept insulin pump as an option.”

The trial will follow a multicenter, non-randomized, prospective study design. Medtronic will compare the efficacy of the device across 7 days with that of standard devices in 150 adults with type 1 diabetes aged 18 to 80 years who use the MiniMed 670G device, according to the press release.

Disclosure: Garg reports he has served on advisory boards for Dexcom, Eli Lilly, Lexicon, Mannkind, Medtronic, Merck, Roche and Sanofi, and received research grants through his institution from Animas, Dario, Dexcom, Eli Lilly, JDRF, Lexicon, Medtronic, Merck, NIDDK, Novo Nordisk, Sanofi and T1D Exchange.