Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Prospective, Open-Label, Randomized, Controlled, Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device
Hygieia Research seeks to conduct a prospective randomized clinical study involving adult subjects with uncontrolled Type-2 diabetes requiring insulin. The study seeks to demonstrate that the clinical application of the d-Nav will achieve metabolic control in a safe and effective manner.
The purpose of this study is to demonstrate that the use of d-Nav (d-Nav group) is superior
to titration of insulin dosage relying on data from glucose meters with health care provider
support (Control) in the management of insulin treated diabetes, by randomizing 200 insulin
treated subjects with type 2 diabetes.
Primary Objective: To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users
compared to control patients in the primary cohort.
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