NCT02424500

Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy

Prospective, Open-Label, Randomized, Controlled, Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Hygieia Research LLC · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2
• Hypoglycemia

Interventions

Type	Name	Description
DEVICE	d-Nav	Insulin dosage is adjusted as required
DEVICE	Blood Glucose Monitoring System	Insulin dosage is adjusted as required

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2015-04-23
• Last updated: 2019-02-27

Locations

1 site across 1 country: United States