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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
181
Insulin dosage is adjusted as required
Insulin dosage is adjusted as required
Park Nicollet Institute / International Diabetes Center, Minneapolis, MN
Minneapolis, Minnesota, United States
Reduction in HbA1C
To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
Time frame: 6 months
Comparison Percent Reduction HbA1c
To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c \< 7.0%, \< 8.0%, and \>9.0% at 6 months
Time frame: 6 months
Number of Glucose Readings <70 mg/dl
To determine the difference between the Control and d-Nav group in the number of glucose readings \<70 mg/dl (symptomatic or asymptomatic) utilizing the documented downloaded glucose values.
Time frame: 3 and 6 months
Change in Rate of Hypoglycemia
To determine change (if any) in rate of hypoglycemia, during the study for d-Nav users in the secondary cohort
Time frame: 6 months
Comparison Percent Reduction HbA1c w/out Hypoglycemia
To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c \< 7.0%, \< 8.0% without a severe hypoglycemia event at 6 months.
Time frame: 6 months
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