With diabetes affecting around 1 in 10 people globally, it is not surprising that the management of the disease is the focus of many innovators in the DTx space, ranging from start-ups to big pharma. Noteworthy is that diabetes was already one of the target indications of the front-runners in DTx.
Broadly, these DTx facilitate the self-testing of glucose levels and the optimization of insulin doses.
The innovators obtained FDA clearance by following the 510(k) pathway, commonly building upon each other’s DTx, which in turn can often be traced back to very early innovations such as the Accu-Chek Simplicity Test Strips. The FDA submissions mainly contained non-clinical evidence, with a focus on software verification and validation testing. On average, it took the FDA 227 days to reach a decision, which is below the average of 238 days for all DTx.
Let’s have a closer look at the DTx currently cleared by the FDA:
- ACCU-CHEK Connect Diabetes Management App: Support in the treatment of diabetes by allowing for downloading blood glucose meters, manual data entry, storage, display, transfer, and self-management of blood glucose and other related health indicators
- Dario Blood Glucose Monitoring System: Monitoring of the effectiveness of diabetes control by patients through self-testing of glucose levels in blood samples drawn from fingertips
- Gmate Smart Blood Glucose Monitoring System & App: Monitoring and tracking of the effectiveness of patients’ diabetes management by measuring glucose in blood samples drawn from fingertips, forearm, upper arm, palm, thigh, or calf by patients at home
- Go Dose System: Aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes management for adult patients (Go Dose) and HCPs (Go Dose Pro) in an at home and clinical setting
- iBGStar System & Diabetes Manager App: Monitoring of the effectiveness of patients’ diabetes control by measuring blood glucose levels in samples drawn from fingertips, palms, or forearms by patients at home
- One Drop Blood Glucose Monitoring System: Monitoring of the effectiveness of diabetes control by measuring blood glucose levels in blood samples drawn from fingertip by patients at home
- WellDoc BlueStar: Provision of blood glucose data and information to aid in diabetes self-management to HCP’s and adult type 2 diabetes patients aged 21 years and older; the system analyzes and reports blood glucose test results, supports medication adherence, and provides coaching messages
- d-Nav System: Optimization of insulin management by calculating and recommending the next dose of insulin through user interface software, set up by the patient’s HCP
- Glooko Mobile Insulin Dosing System: Support in management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on patient-specific parameters configured by a physician or healthcare provider
- Insulia Diabetes Management Companion: Supporting effective diabetes management by HCP’s and their adult diabetes patients with long-acting insulin, along with providing aid in the review, analysis, and evaluation of patient data
- iSage Rx: Software to titrate basal insulin by type 2 diabetes patients aged 21 and above and their healthcare providers
- My Dose Coach: Provision of dose suggestions to type 2 diabetes patients, who have been prescribed a once-daily long-acting basal insulin, based on dose plan instructions configured by their HCP, which in turn are based on Fasting Blood Glucose as well as hypoglycemia occurrence
For more a more detailed overview, check out our report (download pdf below) in which we discuss the approval timeline, indications for use, and supporting evidence that enabled the FDA to clear the currently available DTx in the diabetes space.
Any questions? Would you like to discuss DTx with us in more detail? Don’t hesitate to reach out to our team!