"Lilly is currently exploring commercialization options," Jennifer Hoopingarner, Global Communications Manager for Lilly Diabetes, told MobiHealthNews in an email.
There is at least one, however: Roche's Accu-Check connect app, which launched in 2015. And Eli Lilly's choice of predicate devices - desktop and Palm Pilot software - further suggest very few if any FDA clearances exist for smartphone-based insulin dosage calculators.
Diabetes pilot desktop android#
A 2015 study found 46 such apps on iOS and Android stores and reported that "none of the apps included in this study appear to have completed registration, labeling, or other general controls which are the minimal requirements for products in both regimes".ĭiabetes management app mySugr offers a bolus calculator to European customers but hasn't introduced it to the US because of the regulatory burden. While there are a number of insulin dosage calculator apps available, not many are FDA-cleared despite clear guidance from the FDA that insulin dosage apps require premarket approval. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose values entered by the patient." "The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. "The Go Dose System, comprised of the Go Dose and Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management," the company writes in the submission document. The clearance is for prescription use, but includes two versions of the app: Go Dose, for patients, and Go Dose Pro, for healthcare providers. Indianapolis-based pharma company Eli Lilly recently recieved FDA 510K clearance for a new mobile app called Go Dose, a diabetes management and insulin dosing app for users of Humalog, Lilly's rapid-acting insulin.
0 kommentar(er)
