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

NCT02424500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2019-02-27

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

d-Nav

Insulin dosage is adjusted as required

DEVICE

Blood Glucose Monitoring System

Insulin dosage is adjusted as required

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Hygieia Research LLC

    lead OTHER

Principal Investigators

  • Richard M Bergenstal, MD · Executive Director International Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02424500 on ClinicalTrials.gov