Commercial Agreement Makes d-Nav Insulin Guidance Service Available to Selected Type 2 Diabetes Population in Michigan

New Data From Clinical Trial Evaluating Hygieia’s d-Nav Insulin Guidance Service Presented Today at the American Diabetes Association Annual Scientific Sessions

Findings Demonstrate d-Nav Service Significantly Improves the Efficacy of Insulin Therapy for People with Type 2 Diabetes as Compared to Enhanced HCP Support —

LIVONIA, Mich., June 25, 2018 – Hygieia, a digital insulin enhancement company dedicated to making insulin therapy easier for everyone involved, announced that expanded and updated results from a clinical trial evaluating its d-Nav® Insulin Guidance Service were presented today at the 78th Scientific Sessions of the American Diabetes Association (ADA), in Orlando, Fla. The new data highlight the efficacy and safety of the d-Nav Service among people with Type 2 diabetes in comparison to close follow-up by diabetes specialists.

“We are excited to share data from the complete analysis of all 181 patients who participated in the
d-Nav Service randomized controlled clinical study,” said Eran Bashan, Ph.D., Hygieia CEO. “Insulin is the most effective therapy available for diabetes, but because it is difficult to use, the majority of users do not achieve the full benefit. These findings provide strong evidence that the d-Nav Service is a simple, effective, and safe way of using insulin that can help enhance insulin dosing and thereby markedly improve the management of Type 2 diabetes.”

The Hygieia d-Nav Insulin Guidance Service combines smart cloud-based technology and a small team of healthcare professionals to support primary care physicians and help people with diabetes achieve improved health. The d-Nav Service provides personalized adjustments to enhance and simplify insulin dosing, maximizing its effectiveness for patients and the physicians who prescribe it.

Data presented today at the ADA are from a multicenter, 1:1 randomized, controlled clinical trial that enrolled 181 patients with Type 2 diabetes. Study participants were divided into two groups (d-Nav = 93; control = 88), both receiving seven healthcare provider (HCP) interactions over the course of six months. The study was designed to determine the additive impact of d-Nav-guided, personalized, automatic insulin titrations across a number of factors, including patient satisfaction, retention, insulin dosage and health outcomes.

Results show that patients in the d-Nav group experienced an average hemoglobin A1c (HbA1c) reduction of 1.0 percent vs. 0.3 percent among the control group (p<0.0001). d-Nav patients reported a high level of satisfaction and comfort with the Service, resulting in a high retention level among d-Nav Service study participants (94.6 percent). In each treatment arm (d-Nav and control), there were two episodes of severe hypoglycemia. Instances of minor hypoglycemia were similar and low for both the
d-Nav and control groups.

Importantly, the average daily insulin dose in the d-Nav group increased from 0.77 units/kg to 1.24 units/kg over the course of the study, and reflected a nearly 64 percent increase over the average daily insulin use among the control group (p<0.0001). This finding suggests that insulin-using patients are typically substantially undertreated, even under close supervision by HCPs.

“Insulin under-treatment can lead to serious health complications,” said Israel Hodish, M.D., Ph.D., associate professor of Internal Medicine at the University of Michigan and Hygieia co-founder, who presented the study data. “The data presented today underscore the potential for substantially better insulin management through validated technologies such as the d-Nav Service, which could lead to significant reductions in diabetes complications and costs of care.”

About the d-Nav Insulin Guidance Service
The Hygieia d-Nav Insulin Guidance Service combines smart cloud-based technology and a small team of healthcare professionals to support primary care physicians and help people with diabetes achieve improved health. The d-Nav Service provides personalized adjustments to enhance and simplify insulin dosing, maximizing its effectiveness for patients and the physicians who prescribe it. The Service has demonstrated ability to sustain hemoglobin A1c (HbA1c) reductions for at least five years.

About Hygieia
Hygieia is a digital insulin enhancement company dedicated to making insulin therapy easier 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

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Michele Parisi
Forward Health Communications, Inc.
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925-864-5028 (cell)
mparisi@forwardhealthinc.com