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  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.
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.