ADA 2021: Medtronic's smart insulin pen helps control blood sugar levels in study

Medtronic’s smart insulin pen doesn’t merely provide a streamlined method for managing diabetes—according to newly released data, it’s also effective at helping to regulate blood sugar levels and reducing instances of hypoglycemia.

The InPen dispenses short-acting insulins and wirelessly transmits that dosage data to a connected app. The app also takes in data from continuous glucose monitors, allowing diabetes patients to track their insulin intake and resulting glucose levels all in the same place.

In a study of information collected by the app between January 2018 and October 2020, Medtronic found that patients who used the InPen alongside a CGM experienced longer stretches of time inside their target blood sugar ranges.

Patients with glucose management indicators—or the average expected A1c levels of users employing CGM systems—of at least 8% saw about a 2.3% increase in the amount of time they spent in the preferred range, while those with a GMI of at least 9.5% saw their time in range lengthen by about 5% with use of the InPen.

Additionally, no patients in either group experienced incidents of low blood sugar during the study period.

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The InPen was also linked to improvements in overall insulin dosing. While users’ daily dosage of rapid-acting insulin increased on average, the frequency of their daily bolus doses decreased, indicating a drop in the need for regulating insulin at mealtimes.

The study analyzed data collected from 1,736 patients who used the InPen for at least 90 days, and who had also tracked CGM readings for at least 30 days before that period. The findings were presented at the annual scientific sessions of the American Diabetes Association.

The InPen recently received a CE mark, paving the way for a European rollout later this fall, while the device was previously cleared in the U.S. in early 2020 when it was still owned by Companion Medical. Medtronic announced its acquisition of the company in August and soon after announced plans to make the InPen available throughout the U.S. in mid-2021.

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Alongside its InPen study, Medtronic also presented results demonstrating that its extended-use insulin infusion tubing is safe for long-term use. The infusion set can be worn for up to seven days, more than doubling the lifespan of other sets.

A U.S. trial of more than 250 diabetes patients aged 18 to 80 compared their daily insulin dosages when wearing a typical two- or three-day infusion set to those administered while wearing the week-long hardware.

Use of the longer-wear set caused no significant increase in patients’ total daily dose of insulin, according to the trial’s results, and resulted in no adverse events. Trial participants also reported an overall preference for the extended-use tubing, citing its convenience, comfort and ease of use.

Those study results will likely support Medtronic’s bid for FDA clearance of the tubing set. It has already been cleared in Europe, where the company began marketing the technology this spring.