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Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study

NCT00592241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-04-08

No results posted yet for this study

Summary

Diabetes mellitus (DM) is a multisystem disease with both biochemical and anatomical consequences. Insulin pump therapy (continuous subcutaneous insulin infusion \[CSII\]) is an attractive way of treating patients with diabetes. The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin.

Insulin pumps require extensive user interaction because it is critical for treatment. Avoidance of use-related risks that could harm the patient or impact the quality of the treatment is important. Testing for ease and accuracy of use is the only way to ensure that users can safely and effectively operate, install, and program and maintain the insulin pump device.

Conditions

Interventions

DEVICE

"Adi" Insulin Pump Usability

no intervention

Sponsors & Collaborators

  • NiliMedix

    lead INDUSTRY

Principal Investigators

  • Naim Shehadah, Prof. · RAMBAM Medical Center, Haifa Israel

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Israel

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 NCT00592241 on ClinicalTrials.gov