SBIR-STTR Award

Diabetes has become a growing epidemic, yet treatment goals are seldom achieved, and patients endure detrimental complications. Insulin is the only dose-dependent antidiabetic medication in which most patients can accomplish balanced blood glucose levels when adequate dosages are prescribed. Nonetheless, only when insulin dosage is frequently titrated, is the full benefit of the drug realized. The mismatch between patients' needs and caregivers' availability prohibit frequent insulin dosage titrations. Hygieia INC. is developing a device called the "Private-Doc", intended for use by insulin-requiring diabetic patients. Private-Doc will be a pocket-size device, combining a glucose meter with embedded proprietary algorithmic software that analyzes blood glucose levels recorded in the device's memory, and periodically recommends modifications in insulin dosage. The already developed software algorithms are based on the way an endocrinologist evaluates and frequently adjusts insulin in a diabetic patient. The algorithms utility has been evaluated retrospectively using historical data from an intensive insulin therapy trial. Like other glucose meters on the market, Hygieia intends to distribute Private-Doc without cost to the patient, while the cost of consumable glucose test strips will be covered by the medical insurance. In Phase I, Hygieia seeks to prospectively corroborate Private-Doc's software in a 16-week clinical safety and efficacy study, including 60 Type-1 and Type-2 diabetic patients, who are already on insulin therapy, but have poor metabolic control. During the first 4 weeks of the trial (the control period), daily glucose levels and insulin dosages will be documented by the enrolled patients, without modifying their insulin dosages. During the 12-week experimental period that follows, patients will be provided with weekly insulin dosage modifications as recommended by Private-Doc's software algorithms and communicated by the study-team. Efficacy of the insulin dosage modifications will be assessed by hemoglobin A1C, fructosamine and mean weekly glucose data. Safety will be confirmed by frequency of hypoglycemia. Hygieia hypothesizes that Private-Doc software will effectively and safely optimize glucose control in insulin-requiring type-1 and type-2 diabetic patients. Upon validating feasibility of the concept in Phase I, , a prototype hand-held device containing the proprietary software will be tested for safe and effective use by the patients in the home setting in Phase II. We believe that once Private-Doc becomes widely available to insulin- requiring diabetic patients, the overall medical benefit of the individualized insulin dosage optimizer device will be to reduce the incidence of diabetic complications, to alleviate the health system burden and thus potentially save billions of dollars in national health care costs.

Public Health Relevance:
Despite immense effort to achieve balanced glucose control, millions of insulin-treated diabetic patients have high glucose levels and develop devastating complications at tremendous annual cost. Hygieia Research developed novel software retrospectively proven capable of optimizing patient's insulin dosage in a similar manner to a group of expert endocrinologists. This study will test the software ability to prospectively treat diabetic patients, thus leading to the development of an intelligent glucose meter that will actively help physicians manage patients, reduce complications of the disease, and save billions of tax payer dollars in health care costs.

Thesaurus Terms:
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According to UnitedHealth14 by 2020 half of all Americans would have either diabetes or pre-diabetes with an annual cost of $500 billion - mainly attributed to diabetes related complications. Diabetes is a growing epidemic yet treatment goals are seldom achieved, and patients endure detrimental complications. In the US, 65% of all insulin takers (most of which have type-2 diabetes) have HbA1c>7% and thus they are susceptible to complications. The challenge is that in reality insulin dosage is rarely titrate between clinic appointments27. Multiple studies with patients with type-2 and type-1 diabetes incorporating different insulin regimens showed frequent titration of insulin dosage is the key element to achieve therapy goal in the majority of patients2-10. Unfortunately, there is no single, patient-friendly, cost-effective, safe and effective intervention that provides frequent insulin titration to patients and maximizes the potential benefits of insulin therapy. Hygieia developed the Diabetes Insulin Guidance System (DIGS") software (formerly called "Private-Doc") to automate the process of insulin dosage titration. The DIGS insulin adjustment software emulates the way clinicians evaluate and adjust dosage. The utility of the DIGS software has been demonstrated in a prospective 16-week clinical trial during the Phase I STTR project12. In the Phase I study, the DIGS software titrated insulin therapy of 38 adults with type-1 and type-2 diabetes, on a weekly basis, resulting in improved glycolic control (lower HbA1c, mean glucose, and frequency of hypoglycemia). Hygieia further developed d-Nav, a handheld device, combining a glucose meter with the DIGS software that analyzes blood glucose patterns and periodically adjust the user's insulin dosage. The goal is to have insulin takers use d-Nav instead of a glucose meter, at a similar cost and requiring no behavioral changes or increased testing frequency, leading to superior glycolic control. The d-Nav DIGS will be given to patients free of charge by their primary care physician (PCP), while the cost of consumable d-Nav glucose test strips is covered by medical insurance. In Phase II, Hygieia seeks to recruit [200] insulin treated patients in a prospective, open-label, randomized, controlled, multi-center, 6- month trial assessing the efficacy and safety of insulin therapy using d-Nav" compared to a [smart] glucose meters in patients with type-2 diabetes. Upon enrollment patients will be randomized to either receive d-Nav or a [smart] glucose meter. Efficacy will be tested by attenuation in HbA1c and safety by the frequency and severity of hypoglycemia. The objectives are to establish clinical indication for registration and convince PCPs insulin therapy combined with d-Nav is safe and effective. We believe once d-Nav becomes widely available to insulin takers, optimization of insulin dosage will reduce incidence of diabetic complications and alleviate the health care system burden, thus saving billions of dollars in national health care costs.

Public Health Relevance Statement:


Public Health Relevance:
Despite immense effort to achieve balanced glucose control, millions of insulin-treated diabetic patients have high glucose levels and develop devastating complications at tremendous annual cost. Hygieia's DIGS" software - now embedded in the d-Nav" device - was previously proven, in a prospective study, capable of optimizing patient's insulin dosage leading to superior glycolic control12. The proposed study will test d-Nav's ability, as a single intervention compared to a [smart] blood glucose meter, to improve glycolic control for insulin takers, establishing it as the companion primary care physicians recommend to their insulin treated patients, thus leading to improved diabetes management, and reduced complications of the disease - saving billions of tax payer dollars in health care costs.

NIH Spending Category:
Clinical Research; Clinical Trials; Diabetes; Prevention

Project Terms:
Adult; American; attenuation; Award; base; Behavioral; Blood Glucose; blood glucose regulation; Caring; Charge; Clinic; Clinic Visits; Clinical; Clinical Research; Clinical Trials; commercial application; Companions; Complications of Diabetes Mellitus; Computer software; cost; cost effective; Devices; diabetes control; diabetes management; Diabetes Mellitus; diabetic patient; Disease; Disease Outcome; dosage; Economics; effective intervention; Elements; Enrollment; Environment; Epidemic; Equilibrium; Event; Exhibits; Federal Government; Frequencies (time pattern); Glucose; glucose monitor; glucose sensor; glycemic control; Glycosylated hemoglobin A; Goals; Health Care Costs; Health Personnel; Healthcare Systems; Home environment; Hypoglycemia; improved; Incidence; Individual; innovation; Insulin; Insurance; Intervention; Israel; Knowledge; Medical; medication compliance; Metabolic Control; meter; Modification; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; open label; Outcome; Patients; Pattern; Pharmaceutical Preparations; Phase; phase 1 study; Positioning Attribute; Prediabetes syndrome; Primary Care Physician; Problem Solving; Process; prospective; Prospective Studies; public health relevance; Randomized; Recommendation; Recruitment Activity; Regimen; Reporting; Research; Safety; Savings; Secondary to; Severities; Small Business Technology Transfer Research; software systems; Solutions; standard of care; success; System; Taxes; technological innovation; Testing; Titrations; tool; type I and type II diabetes; United States National Institutes of Health; virtual