LIVONIA, Mich., Feb. 23, 2019 /PRNewswire/ -- Hygieia, a digital insulin enhancement company dedicated to making insulin therapy easier and more effective for everyone involved, announced that data demonstrating the efficacy and safety of the d-Nav® Insulin Guidance System combined with support from healthcare professionals (HCP) have been published online today in The Lancet. The data, from a multi-site, randomized, controlled clinical study conducted at three leading national diabetes centers, show that personalized, automated insulin titration provided by the d-Nav System along with dedicated HCP support generates superior glycemic control as compared to HCP support alone. Data from the study will be discussed today during a session at the 12th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2019) in Berlin.
The d-Nav Insulin Guidance Service combines smart cloud-based technology and a small team of dedicated healthcare professionals to support primary care physicians and help people with diabetes achieve improved health. Using proprietary insulin-titration algorithms and patients' individual blood glucose readings, d-Nav provides personalized insulin adjustments to enhance and simplify dosing.
"Insulin therapy is most effective if individual dosage titrations are ongoing and frequent, which is rarely possible in today's healthcare environment given the time it requires from busy physicians," said Richard M. Bergenstal, M.D., executive director of the International Diabetes Center (IDC) at Park Nicollet and principal investigator for the study. "Accordingly, most people with Type 2 diabetes who use insulin do not achieve optimal glycemic goals, putting them at greater risk for complications and increasing healthcare costs. This study suggests that the combination of automated insulin-titration guidance from d-Nav plus HCP support could provide a very practical solution to this intractable problem, helping patients better manage their disease while reducing the day-to-day burden on physicians."
The findings published today in The Lancet are from a six-month, prospective, open-label, randomized controlled clinical study that evaluated the use of d-Nav plus HCP support delivered according to the d-Nav Service protocol (intervention) as compared to HCP support alone (control) among adult insulin users with sub-optimally controlled Type 2 diabetes. Researchers randomized the 181 study participants 1:1 to the two groups, and then compared the average change in hemoglobin A1c (HbA1c) from baseline as well as the percent of patients in each group who achieved HbA1c <7 percent, <8 percent and >9 percent at study end. Clinical practice guidelines generally point to HbA1c levels below 7 percent as reasonable targets to help prevent diabetes complications.
Investigators also evaluated safety, particularly frequency of hypoglycemia, among the two groups.
For participants in the intervention group, average HbA1c decreased by 1.0%±1.0% compared to 0.3%±0.9% for participants in the control group. At baseline, 22.6 percent of the participants in the d-Nav (intervention) group and 31.8 percent in the control group had HbA1c <8 percent. By the end of the study, 62.4 percent of d-Nav participants achieved HbA1c <8 percent, as compared to 33.0 percent in the HCP-only group. The percent of participants who achieve HbA1c <7 percent without severe hypoglycemia was 21.5 percent in the d-Nav group and 3.4 percent in the control group. The frequency of both mild and severe hypoglycemia was similar between the two groups.
"The publication of these findings in The Lancet, a leading scientific journal, reinforces the strong potential for the d-Nav Service to improve the health of people with Type 2 diabetes," said Eran Bashan, Hygeia CEO. "We are grateful for the support and expertise of the IDC, a leading national diabetes center, and to the National Institutes of Health for their generous support through the Small Business Technology Transfer program, both of which enabled us to vet and validate our groundbreaking technology. The resulting data strongly reinforce our earlier findings suggesting that the d-Nav Service offers a scalable, safe and less cumbersome approach to making insulin therapy easier and more effective for everyone involved."
The d-Nav Insulin Guidance Service has previously demonstrated the ability to help patients attain and sustain HbA1c reductions for at least six years while generating substantial cost savings.1,2
Hygieia is a digital insulin enhancement company dedicated to making insulin therapy easier and more effective for everyone involved. The company is based in Livonia, Mich. and has a wholly owned subsidiary in Northern Ireland. More information is available at www.hygieia.com
1 South Eastern Health and Care Trust (SEHCT). April 2016.
2 Harper R, et. al. Temporary Reductions in Insulin Requirements Are Associated with Hypoglycemia in Type 2 Diabetes. Diabetes Tech & Ther. 2018 https://doi.org/10.1089/dia.2018.0266