Memorandum

DreaMed’s Advisor Pro receives FDA Clearance and CE Mark to Optimize Pump Settings Based on BGM-Only Data – September 17, 2019

~Two-month FDA review follows initial clearance for CGM data in June 2018; interview with CEO Eran Atlas on commercial rollout, plans for MDI, and early launches

Israel-based DreaMed Diabetes just announced FDA clearance and CE Mark for its clinical decision support software, Advisor Pro, to optimize insulin pump settings in BGM-only users. This is an important indication expansion following Advisor Pro’s FDA clearance for pump and CGM users in June 2018 and CE Mark in February 2018. The software provides AI-generated, specific recommendations to help health care providers optimize pump basal rates, insulin:carb ratios (ICR), and correction factors (CF) based on glucose data – see the picture below for an example from Glooko’s web-based Population Tracker. Advisor Pro can also run in standalone mode on DreaMed’s website, pulling in data from Tidepool and delivering the recommendations to the HCP (and then to a patient app). This new version of Advisor Pro will initially launch to clinics using Tidepool in the coming quarter.

Advisor Pro for BGM-only was 510(k) cleared under the same “Insulin Therapy Adjustment Device” classification that was created after the de novo FDA clearance – see the new 510(k) summary, decision summary, and FDA listing. The FDA review was 5x faster this time – a little under two months – a reminder of the advantages of using a previous de novo clearance as a predicate application (e.g., iCGM, ACE Pump pathways should also have this benefit).

To generate pump settings recommendations, Advisor Pro requires a minimum of “12 valid days” for both BGM-only and CGM users. For BGM-only users, this is defined as at least four fingersticks per day, separated from each other by at least 160 minutes. For CGM users, a valid day requires at least 67% of sensor readings per day according to the sample rate (e.g., for a CGM that samples every 5 minutes, Advisor Pro needs 192 out of 288 CGM data points – that seems totally reasonable and is equivalent to 16 hours a day). Notably, Advisor Pro has similar recommendation bounds for BGM-only users – it is not more conservative with less glucose data. Providers can still approve or modify the system’s generated recommendations.

We’re excited to see this clearance, as T1D Exchange data still indicates the population of pump/BGM users (~40% of the Exchange) outnumbers the pump/CGM population (~25%) – even though these patients are seeing leaders in the field, this is still “as expected ” since there is still so much inertia in the field. For HCPs, this expansion will provide welcome clinical decision support, meaning less time analyzing data and tinkering with settings and more time for human touch and/or faster-moving practices.

Read on below for our interview with CEO Eran Atlas, which includes pilot and commercial updates (still early) and plans for MDI users.

Interview with DreaMed CEO Eran Atlas

Close Concerns: How many US clinics are using Advisor Pro? Are all six T1D Exchange Quality Improvement clinics set up, following the announcement in June?

Eran Atlas: We found the sales cycle with clinics to be a bit lengthy. So far, we have a clinic operable in Arizona, we initiated UF Pediatrics last week, and we will onboard AdventHealth Orlando next week. There are more clinics in the process, with most of them already in the contracting phase. We will be able to provide more accurate numbers towards the end of the year. The T1D Exchange QI clinics are part of this cycle, as we still need to get IT and legal review with each clinic. So far, we have more than 100 patients that have used Advisor Pro.

CC: How many European clinics are using Advisor Pro?

EA: We have not launched the product in Europe yet. The next market we are going to enter is Israel. The main thing that was surprising to us is the fact the most clinics still have trouble understanding how to download most of the devices to the diabetes data management system. Most MDs never use data management to review glucose and insulin reports; rather, they review the data on the printout of the reports. In addition, there is a clear need for more education on the use of technology as part of clinic routine, especially for the young MDs who do not come to the big conferences. This is why we initiated the Advisor Academy Project. Last month we had around 100 participants who registered to Professor Tadej Battelino's lecture about Time in Range. This month, Professor Thomas Danne will discuss SGLT-Inhibitors and technology.

We are also launching a limited pilot soon named Advisor Squad – we will provide free help to clinics in understanding how to download data from diabetes devices to the platforms and how to incorporate them efficiently to improve care in clinics.  If this pilot is successful, we will scale it.

CC: What is the plan for a commercial rollout of Advisor Pro? Will you wait one year until the T1D Exchange data comes in from the QI project?

EA: We are moving full speed in rolling out Advisor Pro in the US and Israel. We will have soon the data from the Helmsley Charitable Trust study, which I hope will support us in this rollout. This new version of Advisor Pro will be available this quarter initially only to our customers who will use the Advisor Pro standalone platform that pulls data from Tidepool. We will have additional new features in this rollout, such as the ability to copy the recommendations of Advisor Pro into the EMR. Thus, we intend to launch in the next 1-2 weeks a special program for clinics that use Tidepool to allow them to register in advance for this upgrade. Details on this new program will be available soon.

CC: Can you share more specific timing on extending Advisor Pro to MDI users? To people with type 2 diabetes?

EA: We are working very hard on the MDI T1D version. We plan to roll out the first pilot with this project this month. Our goals are to have Advisor Pro with support of insulin titration for MDI T1D during 2020 and T2D towards end of 2020-beginning of 2021.

 

--by Adam Brown, Albert Cai, and Kelly Close