Memorandum

Hygieia’s d-Nav Insulin Guidance Service now available through Blue Cross Blue Shield of Michigan for one-year demo project; FDA filing this fall – November 8, 2016

Hygieia just announced that its d-Nav Insulin Guidance Service (blood glucose meter with built-in insulin dose titration algorithm + remote HCP support service) is now available through Blue Cross Blue Shield Michigan (BCBSM). The launch comes six months after the 1,000-patient, 12-month reimbursement study was first announced in April. This pilot will evaluate the cost savings of using the d-Nav service model vs. standard of care in type 2 diabetes, and as we previously noted, BCBSM made a direct investment in Hygieia to support the project cost (size unspecified, but clearly a vote of confidence). BCBSM is the first US health plan to evaluate the d-Nav service, and presumably positive outcomes will drive reimbursement in Michigan and perhaps in other states too. Notably, Hygieia is planning a d-Nav FDA filing this “fall,” the first timing we’ve heard on this front. (A central IRB approved the d-Nav system for this study, as it is not cleared.) Meanwhile, a cellular-enabled docking station and a cellular-enabled d-Nav device will be released by the end of 2016 to current users. (d-Nav currently requires a cable to upload results to computer and then to the cloud.) We’re very glad to see reimbursement pilots of novel technologies, particularly from small companies like Hygieia that don’t have an immediate IN with payers. We wonder how quickly the FDA will clear the insulin titration device, which would be quite differentiated from other BGMs. Outside the US, d-Nav is CE marked and currently used by healthcare systems in Northern Island, UK, with potential for expansion throughout the country.

  • Staff at the new “d-Nav Care Center” in Livonia, Michigan, led by past AADE President Mary Austin, have already begun seeing some of the >2,100 patients who have been referred to Hygieia to date (an “overwhelming” response). The d-Nav Care Center delivers HCP service support, as Hygieia takes responsibility for the patient and does not place additional burden on their primary care physician. We assume the pricing model is pretty favorable for payers, given the number of insulin users that need titration help and the outcomes Hygieia has shown in Europe (2%+ A1c reductions from a 9.4% baseline, sustained for over three years).
  • Insulin dose titration is one of the lowest hanging fruits in diabetes in our view, and we’re glad to see increasing focus on it from companies large and small: Sanofi’s MyStar Dose Coach meter, Glooko’s mobile insulin dosing system, Medtronic’s CareLink, Patients Pending’s Timesulin Dose Capture, and many more. The differentiator for d-Nav, according to Hygieia, is the combination of a care management service enabled with advanced technology.

-- by Brian Levine, Adam Brown, and Kelly Close