FDA clears insulin dose calculator that's connected to a smartphone app

  • The FDA has cleared Glooko's Mobile Insulin Dosing System.
  • Glooko's new system calculates long-acting insulin dosages and sends Type 2 diabetes patients reminders on their cellphones.
  • Long-acting insulin maker Novo Nordisk already has a partnership with Glooko and is watching the development of the new product "with great interest."
A man with diabetes takes a blood sugar level test.
BSIP | UIG | Getty Images
A man with diabetes takes a blood sugar level test.

The Food and Drug Administration has cleared a mobile system that could simplify diabetes management for some patients.

Doctors treating Type 2 diabetes patients with long-acting insulin usually prescribe them a daily dose to take, and adjust the dose at follow-up visits based on how well the treatment is working. Some doctors, mostly diabetes specialists, provide patients instructions on how the adjust the insulin dose between visits to bring blood sugar levels into an appropriate range.

Glooko's Mobile Insulin Dosing System allows doctors to set a dosage and pulls data from the patient's glucose monitor to recalculate levels based on the reading. It's integrated into Glooko's existing mobile app and sends reminders to patients' cellphones when it's time to take another dose.

"There's an enormous unmet need for both [clinicians and patients] — clinicians who aren't comfortable with dosing and therefore don't put people on long-acting insulin," said Glooko CEO Rick Altinger. "It's a wonderful drug if taken in the right amount at the right time in the right way. This overcomes a big need for clinicians and saves them time. For patients, math is hard."

Altinger said the company decided to develop the system after learning some doctors and patients struggle with manual calculations and ensuring patients are following their treatment plan. The insight also came from analyzing data from Glooko's existing diabetes management platform.

To test whether the system improved outcomes, Glooko conducted a study of 14 patients for between 7 and 23 days. The system increased adherence to the treatment plan, which was related to positive outcomes, according to the results.

However, the study was conducted over a short period of time and was not blind nor randomized, so it's possible that some patients were more mindful of their diabetes management because they knew they were being tracked, said Dr. Tom Donner, director of the Johns Hopkins Comprehensive Diabetes Center.

Still, he believes the benefits were due to the app, since the subjects were prompted to increase their long-acting insulin dose, which he said doctors know will lower fasting glucose levels.

"If you had a device that got somebody to their ultimate insulin dose more rapidly without causing low blood sugars, that would help speeding up getting somebody's diabetes under control," Donner said.

Now that the system is approved, Glooko will start commercializing it and work through reimbursement. One strategy could be to partner with pharmaceutical companies and offer Glooko's mobile insulin dosing system as a bundle with long-acting insulin products, Altinger said.

Michelle de Haaff, Glooko's vice president of marketing and customer success, said drugmakers could be interested because the system has the potential to keep patients on a particular brand.

"Once a clinician puts a patient on (a brand of long-acting insulin) and something's not right, they will change that patient to another brand if it seems like this brand is not working," she said. "That's a big frustration with pharmaceutical companies."

She said all major long-acting insulin makers have shown interest. Glooko already has a partnership with Novo Nordisk, which produces Levemir and Tresiba. The two launched its Cornerstones4Care Powered by Glooko app last year.

In response to CNBC's request for comment on Glooko's new system, a Novo Nordisk spokesman said the company "is continuing to follow the development and progress of this platform with great interest."