- Innovation Health and Sanofi announced a digital health pilot in type 2 diabetes leveraging (i) One Drop’s mobile app, coaching/education, and Bluetooth-enabled BGM; and (ii) Common Sensing’s Gocap for dose capture from insulin pens. The program is already underway and will evaluate the impact of One Drop and Gocap on patient outcomes and medication adherence in individuals ages 18-65 years old.
- Pilot specifics aren’t clear, but One Drop CEO Jeff Dachis noted that both clinical and financial outcomes will be assessed and that the program is taking place in the Greater Northern Virginia region. The population is not limited to MDIs.
- Sanofi is a seed investor in Common Sensing, but this is the first work with One Drop that we know of. We’re glad to see a greater digital health commitment from Sanofi and wonder if an acquisition of either or both companies is possible?
- Innovation Health is a joint enterprise forged by Aetna and the not-for-profit Inova Health System that provides health benefit plans to >200,000 members. We’re very moved to see two digital health technology companies, a pharmaceutical company, and a health plan provider collaborating to improve outcomes and excited to see the results.
This morning, Innovation Health and Sanofi announced a digital health pilot program to study (i) Common Sensing’s long-awaited Gocap, a Bluetooth-enabled cap that captures doses from disposable insulin pens; and (ii) One Drop’s mobile app, Bluetooth-enabled BGM, and coaching/education.
The press release was light on details and the companies involved cannot share much at this point (study size, end date, etc.), but we do know that the pilot is already underway in people with type 2 diabetes ages 18-65 in the greater Northern Virginia Region. Study outcomes will include clinical and financial metrics, medication adherence, and in the words of One Drop CEO Mr. Jeff Dachis, “valuable experience.” The overarching stated goal of the program is for “pharmaceutical companies, technology companies, and plan providers to work more closely together to help improve patient outcomes.”
One Drop and Common Sensing couldn’t share exactly how their offerings are being leveraged. We might guess insulin dosing data from Common Sensing’s Gocap and glucose data from One Drop’s Bluetooth-enabled Chrome meter will flow into a mobile app(s); presumably coaching and education could be layered on top of that data. The study population is not limited to MDI users, though we’re not sure if non-insulin users are also included. As a reminder, Gocap streams insulin dose data to a dedicated patient-facing app and back-end clinician interface (see our deep dive on Common Sensing here). It was compatible with Sanofi’s SoloStar U100 Lantus and Apidra as of June 2016, though it has been tested with all disposable pens in the US, per a February 2017 interview with President Mr. James White. We thought the company’s ADA poster was one of the most important digital health updates – a clear sign of the power of combining insulin dose capture from pens with CGM data.
Innovation Health is a major joint enterprise forged by Aetna and the not-for-profit Inova Health System that provides health benefit plans to >200,000 members in Northern Virginia. Involvement in a payer pilot supported by a large pharmaceutical company is a big victory for startups Common Sensing and One Drop, both of which stand to benefit from the opportunity to demonstrate economic benefit in a more integrated care model. Gocap has yet to launch (it is 510(k) exempt since it only logs doses at this point and doesn’t have a bolus calculator), but is being studied in an ongoing observational study with Joslin (more below), while One Drop has over 350,000 registered app users as of early August.
Sanofi, already a seed investor for Common Sensing, seems to be committed to Gocap, but this is the first indication of interest in One Drop, to our knowledge. Language in the press release (data from this pilot will be “analyzed to gain insights into potential best practices for industry arrangements…”) and from Sanofi VP of Innovative Solutions Mr. Sebastien Coisne (Sanofi trusts the pilot will “provide further insights to [combine innovative medicines with connected devices and solutions]”) suggests a keen interest in continuing to work in digital health. Perhaps an acquisition of Common Sensing and One Drop is possible, should the pilot go well.
We are excited to see this groundbreaking program to integrate two digital health technology startups, a large pharmaceutical company, and a health plan provider (a large payer and a not-for-profit health system rolled into one). This model of bringing relevant stakeholders together to improve outcomes – presumably in a risk-sharing setting (that’s an important question we’d love to get answered) – is one we expect to see more frequently and one that we’re excited to see. Testing individual components is necessary in clinical trials to prove safety and efficacy in isolation, and deploying them in combinations in the real-world setting is where drugs, technology, and patient support will come together to really make strides for diabetes management. The potential is there – we look forward to reporting back with much more about the pilot setup as soon as we hear.
The Latest on Common Sensing
- As of January, Common Sensing had raised $4.5 million and had 10 employees. President Mr. James White informed our team at that time that his company was hoping to build a coaching service and was talking with potential glucose monitoring partners (Dexcom seemed like a likely partner, as the G4 CGM is being used in Joslin study evaluating Gocap). In the coaching vein, just over a month after we spoke to Mr. White, Common Sensing and Welkin Health partnered to launch a CDE-driven insulin adherence program – a broad release to insurers and self-insured employers is planned for 2018, and we’re not sure if some form of it is included in this program. In January, Mr. White also shared the company’s plans to explore insulin dosing advice, in which an algorithm uses fingerstick or CGM data to titrate basal and/or bolus insulin – perhaps One Drop Chrome BGM data could be used for this purpose beyond this pilot. In correspondence with our team today, Mr. White emphasized his excitement to be working with One Drop, Innovation Health, and Sanofi.
- An ADA poster detailing preliminary results from a Joslin observational study (n=31) of Gocap paired with Dexcom’s G4 CGM data identified gaps in adherence to insulin dosing, demonstrating the power of making invisible data on injections available to providers. We were blown away by the results and thought this poster was one of the most important technology abstracts from the whole conference. The Sanofi-funded, four-week trial identified that 12% of insulin injections were missed/under-bolused over one month, 20% of injections were extra/over-bolused, and 29% of basal doses were taken outside the one-hour schedule time window for Lantus. Importantly, this data – paired with CGM traces – seemed to be extremely actionable for providers, offering critical insight into patient adherence and suboptimal dosing. The study is currently listed on Clinicaltrials.gov as “recruiting participants” and is expected to be complete by August 2018. We can’t wait to find out how this rich data on adherence and dosing trends, in concert with glucose information, translates to improved outcomes in this pilot.
- Common Sensing appears to be moving along on the partnership front, as planned. In June, the company reported an interest in moving forward with outcomes trials and payer pilots. It has its outcomes trial with Joslin, and this will be a major payer pilot that could demonstrate benefit in a small segment of the real world.
The Latest on One Drop
- The efficacy of the One Drop mobile app and coaching platform has been reported in a number of single-arm (uncontrolled) real-world studies. Recent results from an Evidation Health study (n=144 type 2s) demonstrated a 35 mg/dl drop in mean glucose over three months (estimated ~1.2% A1c decline from baseline ~8.7%). This particular study evaluated the impact of One Drop when delivered with an iPhone and Apple Watch, but ADA posters (63-LB and 885-P) demonstrated similar results using the iPhone alone. The company still lacks a robust RCT (particularly the ‘C’ – none of the studies we’ve seen have a control group), but these data are encouraging at this point.
- As a reminder, One Drop is also involved in a clinical trial with Mannkind. The A-ONE RCT will study the effect of integrating Afrezza inhaled insulin and the One Drop digital diabetes care platform. This trial is the first step of the companies’ collaboration, first announced back in May. In the study, 400 people with type 2 (who are not currently enrolled in a diabetes education/coaching program and have never taken Afrezza) will be randomized to either Afrezza+One Drop Premium or One Drop Premium alone. Outcomes metrics will include changes in A1c, quality of life, self-care, and treatment satisfaction.
Big Picture Thoughts
- The three big insulin manufacturers are all investing more into digital health and insulin pen dose capture. These are big steps for pharma and likely challenging ones – technology moves at a different speed than pharma, and the core competencies are far different. Which company will launch a compelling connected solution?
- Sanofi is piloting Common Sensing’s Gocap after an initial seed investment; it also has its partnership with Verily (Onduo; though there has been no news in over a year);
- Lilly has invested in Companion Medical (Bluetooth-enabled, reusable pen; FDA cleared, expected to launch this year);
- Novo Nordisk is currently piloting a disposable pen at a limited number of clinics in Sweden, and has partnerships with Glooko and IBM Watson.
- MySugr recently became a diabetes digital health poster child with its exit at the hands of Roche – might One Drop become the second? It is too early to speculate at this point, but One Drop has grown its user base quickly, published a number of interesting real-world outcomes, and has a steady stream of innovation momentum. If this pilot suggests that One Drop improves outcomes and the use of Sanofi’s insulin, then an acquisition could make sense. Lots still to see here.
Close Concerns Questions
Q: What outcomes is Sanofi looking for? What would prompt it to acquire Common Sensing and/or One Drop after the pilot?
Q: How long will this pilot last? How many people are enrolled?
Q: Will participants only use BGM, or is CGM an option too?
Q: Is the pilot predicated on a value-based framework – i.e., do Sanofi, Common Sensing, and One Drop get paid for lowering A1c, increasing time-in-range, or reducing cost?
Q: Will One Drop incorporate insulin pen dose data from Gocap into its app?
Q: With respect to insulin dose capture, which will contribute more to improved outcomes (if at all): Patient behavior change or therapeutic adjustment on the provider’s part?
Q: Sanofi is partnered with Verily (Onduo) – will this joint venture come into play in the pilot in any form?
Q: When will we actually see smart pen/caps commercialized in a meaningful way? Which insulin company will be the first?
-- by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close