Memorandum

Telcare at the mHealth summit: Bluetooth device connectivity with pump, CGM, smart pen; reduced healthcare spending data – December 22, 2013

Executive Highlights

  • At the mHealth Summit, Telcare showed its prototype Total Diabetes Management solution, which features Bluetooth connectivity to the Qualcomm 2-Net hub, a DANA insulin pump, a SanMediTech CGM sensor, a smart prescription bottle cap (CleverCap), and a smart insulin pen cap (GoCap).
  • Telcare’s mobile health solution program (cellular-enabled meter + analytics + coaching) has been associated with a $3,300 per employee per year reduction in healthcare costs, more than five times the cost of implementing the monitoring program.

On December 9 and 10, Telcare shared three exciting developments at the mHealth Summit in Washington, DC. Most notable was the unveiling of Telcare’s Total Diabetes Management (TDM) solution, a prototype system that connects the company’s cellular-enabled meter to the San MediTech CGM (available in China; details below) and a DANA insulin pump via Bluetooth. Additionally, it’s great to see that TDM connects Telcare’s meter to devices for patients not on a pump and/or sensor: a Bluetooth-enabled insulin pen cap (Common Sensing’s GoCap), as well as a Bluetooth-enabled prescription bottle cap (CleverCap); these two devices record insulin doses and medication adherence, respectively. Given that most people with diabetes (and very few with type 2) aren’t on a pump or a CGM, it’s notable to see this focus on device connectivity and cross-device, seamless data collection, which has historically been challenging for those taking oral medications or using insulin pens (at best, manual logging on a paper logbook or perhaps in a mobile app).

The press release made it very clear that TDM is a “concept prototype and has not yet entered human testing” (much less been granted FDA approval, which is also acknowledged). However, there is certainly an opportunity here, as the need for hassle-free data collection is so great, for both patients on and not on CGMs or pumps. We particularly appreciated Telcare CEO Dr. Jonathan Javitt’s quote on the system’s rationale: “We take for granted that our fire alarms, vehicles, and other everyday devices are monitored for emergency conditions. Yet we expect patients with life-threatening conditions to monitor themselves after only a few minutes of education and some written instructions.” Very well said. TDM will also connect to Qualcomm’s 2net hub, an FDA approved device that can collect and integrate data from different medical devices into a single cloud-based platform – the multi-data-source integration would be particularly valuable for physicians looking to make therapy changes.

Telcare also shared impressive news on the payer front – Telcare presented data that associated the company’s “mobile health solution for monitoring diabetes” with a $3,300 per employee annual reduction in healthcare costs. Notably, those savings pay back the cost of implementing the program five times over. Telcare attributed these savings to reduced hospital and emergency care costs among employees who participated in the program, compared to similar employees who did not participate. The diabetes monitoring solution has three components: (i) Telcare’s cellular-enabled blood glucose meter; (ii) ActiveCare’s proprietary data analytics, real-time biometrics analysis, and 24/7 monitoring and care services; and (iii) telephone-based diabetes coaches that can target patients who need help or encouragement. On that last – wow!

Kudos to Telcare for moving so smartly on the device and data connectivity front – as healthcare delivery changes, we have confidence that the right solutions delivered in the proper way – especially those that prevent expensive severe events from happening – can really move patient care forward in a cost-effective way. Ultimately, connected solutions should enable proactive, preventative care, which will could big savings for our healthcare system.

  • We last covered Telcare in the AADE exhibit hall (page 144) where the focus was on the new Gluco-Share rewards program. The Gluco-Share app is a free download available on the iTunes store and as a Facebook web app. Gluco-Share has three functions: “Check,” “Share,” and “Reward.” Readings from Telcare’s system are automatically uploaded to Gluco-Share, which are then used to motivate people towards better adherence and glucose control through social gaming.
    • We wonder how many patients are using the system and if it does indeed motivate them to test more often – it’s certainly an innovative approach to encouraging more glucose testing, though we wonder if extrinsic rewards will be enough to maintain heightened adherence over time. Telcare also made an appearance at the ADA exhibit hall (page 428) in June.
  • We look forward to seeing Telcare again at the 2014 Consumer Electronics Show on January 7-10, where the company is an exhibitor along with Dexcom, iHealthLab, Misfit Wearables, Telcare, Yofimeter, and many others.
  • As a reminder, the Telcare meter is the first FDA-approved, cellular-enabled BGM. For more information, read our Closer Look coverage of the Telcare meter’s approval, as well as our diaTribe test drive.

The Total Diabetes Management (TDM) Solution

  • The TDM platform connects to San Meditech’s CGM – the “world’s only Bluetooth-enabled CGM sensor” is approved for use in China but not the US. According to a study presented at ADA 2013, San MediTech’s CGM has a MARD of 17%. The MARD posted on San MediTech’s website is a lower 14%. For context, the Dexcom G4 Platinum and Medtronic Enlite have FDA-labeled MARDs of 13% and 14%, respectively. However, we would emphasize that cross-study device accuracy comparisons are extremely difficult given the massive number of variables that go into CGM accuracy studies (calibration procedures, reference standard, number of samples, glucose ranges, sensor lot, etc.).
    • The San Meditech CGM receiver is a square, wrist-worn device with a color screen that displays the trend wave, real-time glucose value, and trend icon. The monitor has both hyper- and hypoglycemic alerts, as well as a trend analysis that “helps with real-time treatment adjustment” – we’re not sure what the latter entails. The CGM updates every three seconds, more frequent than we’ve ever seen.
    • San Meditech’s website notes that the sensor has “no needle injection,” implying it could be minimally/non-invasive. The picture shows a round transmitter sitting on top of an adhesive patch. It is not clear whether the sensor itself is glucose oxidase, optically-based, or some other measurement technology. The sensor’s working life is a reported five to eight days. The company’s website is unfortunately empty of details, though we are following up for more information.
  • Telcare’s platform is also compatible with a Bluetooth-enabled insulin pen cap (Common Sensing’s GoCap) and a Bluetooth-enabled prescription bottle cap (Compliance Meds Technologies’ CleverCap). The GoCap tracks the amount of insulin used in a pen and wirelessly transfers the value to a mobile phone. CleverCap fits on standard prescription bottles and gives patients reminders when to take their medication, tracks when doses were taken, and uploads data to the cloud via the Qualcomm 2net Hub.
  • The TDM platform also includes the DANA Diabecare R insulin pump. Like the Animas OneTouch Ping, the DANA pump is waterproof and also features a blood glucose monitor integrated into a wireless controller handheld. The company’s site claims that this is the “smallest and lightest insulin pump offering a 300-unit insulin capacity.” The pump is about 1.8 in. x 3.0 in. x 0.74 in. and about 2.2 oz. – a hair smaller than Tandem’s t:slim pump (2.0 in. x 3.1 in. x 0.6 in.) and slightly lighter (the t:slim weighs 4 oz. with a full cartridge; however, we’re not sure if the Dana pump’s weight of 2.2 oz is measured with a full cartridge).
    • The Bluetooth connectivity of the Diabecare R is certainly an advantage for artificial pancreas research – we’ve heard many investigators express frustration with the challenges of device connectivity, as propriety wireless protocols are a hassle to work with. Dr. Roman Hovorka is currently using the Dana Diabecare R insulin pump in his 21-day outpatient artificial pancreas studies (more details here). Tandem’s special version of the t:slim also has Bluetooth connectivity, a feature Dr. Ed Damiano (BU) and Dr. Steven Russell (Mass General) have put to good use in his trials (read our coverage here). Roche’s Accu-Chek Combo also has Bluetooth connectivity, and we believe future diabetes devices will increasingly move in this direction.
  • The Qualcomm 2net hub can connect to and integrate data from different devices (CGM, pump, insulin pen cap, and prescription bottle cap) into a single web-based platform. The 2net Mobile meets all HIPPA requirements.
    • Dexcom also has a partnership with Qualcomm’s 2net Hub, which focuses on developing a remote cloud-computing platform through a home gateway system. As of the last update, the platform was expected to launch in 2013-2014, though we have not heard an update on it in some time. In a case study posted on Qualcomm’s website, the 2net Hub and Dexcom G4 Platinum are mostly discussed in the context of clinical trials, as the system could allow for streamlined data collection in the research setting. From a patient perspective, we expect the Gen 5 mobile system will be the real advance on cloud-based data collection, so we would be surprised if Dexcom started making the 2net hub available to consumers. We’d note that Qualcomm’s vice chairman, Mr. Steve Altman, recently joined Dexcom’s board of directors, a major win that we detailed in the company’s 3Q13 financial update.

Healthcare cost reduction

  • Patients using the diabetes mobile health solution saved on healthcare costs across a variety of different sites, including traditional medical practices, employer-sponsored health plans, large Health Maintenance Organizations (HMOs), and Medicare- and Medicaid-managed care plans. We hope to hear more details on the compelling cost savings, which should build the case for strong reimbursement.
    • The Telcare program reminds us of WellDoc mobile prescription therapy software for type 2 diabetes, BlueStar. As a reminder, the BlueStar software uses patients’ own inputted data (e.g., medications, blood sugar readings, diet, and exercise) to provide real-time coaching, educational content, and motivational support to people with type 2 diabetes. The system offers personalized messaging to patients and will be reimbursed and adjudicated as a pharmacy benefit. A key difference is that WellDoc’s BlueStar does not have live coaches, while the Telcare program does. Coaches are certainly more expensive, but also have the advantage of human contact and the possibility for more persuasive and tailored recommendations that software may not be able to accommodate.
  • Telcare’s program also led to increased blood glucose testing and increased glucose control; no specific details were shared on these fronts. We believe this demonstrates again just how pivotal technology is becoming as healthcare looks to trim its costs; new technology allows instantaneous feedback to the patient and thus more opportunities for education and therapeutic interventions.

Telcare and Health Dialog partnership

  • On December 9, Telcare also announced a partnership with Health Dialog to incorporate the live data from Telcare’s cellular-enabled meter into Health Dialog’s diabetes management program. Coaches and HCPs from the Health Dialog program will be able to provide feedback and support to patients in real time. We believe such interactions could help patients in four ways: 1) close the feedback loop between BGM results and therapeutic change (quite difficult to accomplish in the current best-case scenario of four clinic visits a year); 2) quickly identify and reach out to patients that are in trouble; 3) educate patients in real time on best practices for managing glucose (critical to long-term change); and 4) reduce healthcare costs, which Telcare has already started to show with the aforementioned data.
  • Health Dialog aims to improve healthcare quality while reducing costs through health coaching and popular analytic solutions and consulting.

Close Concerns’ Questions

Q: Will Telcare pursue clinical testing and FDA submission of the TDM system?

Q: How was the San MediTech CGM chosen? Did you consider partnering with Dexcom?

Q: Regarding the healthcare savings, how many patients were evaluated in the control and intervention groups? How many sites were included? Can you say which health plans/employers participated? Did the control group receive any extra care or access?

Q: How is the Gluco-Share program going? Can you share any specifics on how many patients are using it, whether they are testing more, etc. ?

Q: Can you share any specifics on what the Health Dialog diabetes care management program looks like? How often are patients in contact with their HCPs?

--by Hannah Martin, Adam Brown, and Kelly Close