Memorandum
This morning, Glooko announced topline results from a three-week feasibility study of its Mobile Insulin Dosing System (MIDS) in people with type 2 diabetes on basal insulin. The insulin titration app increased the proportion of in-range blood glucose readings (80-180 mg/dl) from 64% to 73% (p=0.048), reduced mean blood glucose by 18 mg/dl (baseline: 164 mg/dl; p=.046), and dramatically dropped the percentage of glucose values >250 mg/dl (from 14% to 3% of readings; p=0.03). The press release did not report hypoglycemia, presumably because this group was not experiencing it (many people with type 2 have insulin resistance that reduces hypoglycemia). Fingerstick frequency was also not reported. As would be expected, the recommended insulin dose increased by 19% from the initial dosage, in line with the under-insulinization at baseline. The press release did not provide further study details, but we’ll see the full results in poster form at DTM later this week (read our conference preview here). As a reminder, in MIDS, a provider configures the treatment plan, and the patient-facing app generates continually-updated basal dosing guidance based on fasting blood glucose levels. Last week at the Novo Nordisk-sponsored HITLAB symposium, we learned that MIDS is still under FDA review – it was in the FDA process in mid-May, implying there has been some back-and-forth with the Agency, presumably on human factors. A larger clinical trial, “Insulin Degludec Titration Using Mobile Insulin Dosing System” is currently recruiting (per CT.gov), and aims to randomize 240 type 2 patients to usual care (STEP WISE degludec algorithm) or MIDS, with a primary outcome of A1c change at 16 weeks. It is slated to complete in November 2018. This fits in nicely with the dose titration goal of the Glooko/Novo Nordisk partnership – see our January coverage. Glooko obviously has a huge advantage over other players in this area, given the 1.5 million patients in its database and reach to 7,000+ providers.
- We’re very excited for this fourth basal insulin titration app to receive clearance, following Voluntis’ Insulia, Sanofi’s My Dose Coach, and Amalgam Rx’s iSageRx. Based on the app download metrics and lack of reviews on the app stores, these products are still not “launched” in a meaningful way. Like many digital health efforts, business models will be key here – who will pay and what’s the go-to market approach? We also wonder how the insulin titration app market will segment going ahead.
-- by Maeve Serino, Brian Levine, Adam Brown and Kelly Close