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

This study has been completed.
Sponsor:
Information provided by:
NiliMedix
ClinicalTrials.gov Identifier:
NCT00592241
First received: December 17, 2007
Last updated: April 6, 2008
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Device: "Adi" Insulin Pump Usability

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NiliMedix:

Primary Outcome Measures:
  • Validate safety while using the ADI Insulin Pump by intended users. This objective will be assessed by independently and successfully carrying out a list of tasks. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate user's satisfaction. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Subject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years.
 Device: "Adi" Insulin Pump Usability
no intervention
Other Name: "Adi" Insulin Pump

Detailed Description:

This usability study was designed in order to test independent home use and device interface effectiveness of the NiliMedix Adi Insulin Pump, in order to validate safe and effective use by intended users. The study objectives are as following:

  • Validate the safe and effective use while using the ADI Insulin Pump by intended users. This objective will be assessed by carrying out list of tasks (operating the device, programming the appropriate flow rate and volume-to-be-infused parameters, and reacting to hazard massages) independently and successfully.
  • Evaluate user's satisfaction. Study Design Orientation, consent, and pre-test questionnaire Participants will receive a short, scripted verbal orientation explaining the purpose of the usability test.

Prior to any study related procedures participant will provide written informed consent.

Performance evaluation The performance evaluation will consist of a list of tasks that participants will attempt to complete. The tasks were designed to explore the usability concerns. Participants will be provided with the Adi Insulin Pump and the user manual.

All participants will be guided by the investigator how to use the ADI Insulin Pump independently, how to read and interpret the display readings, how to program the device including insulin Basal and Bolus settings as well as how to maintain the device. In addition, participants will be given sufficient time to read carefully the user manual.

After ensuring that the participant has perceived the directions for use he will be asked to operate the Adi Insulin Pump by performing list of tasks.

All tasks will be conducted by the participants independently. The investigator will not guide the subject during this phase- unless the subject asked him to.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/female age 18 years and up.
  • Subject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years.
  • Subject understands the study procedure.
  • Subject is able to read the User Manual.
  • Signed Informed Consent form
  • Compliance with study requirements.

Exclusion Criteria:

  • Major physical, motor, mental, behavioral, or psychiatric limitations.
  • Concurrent additional major illness.
  • Subject objects to the study protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592241

Locations
Israel
RAMBAM Medical center
Haifa, Israel, 34636
Sponsors and Collaborators
NiliMedix
Investigators
Principal Investigator: Naim Shehadah, Prof. RAMBAM Medical Center, Haifa Israel
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, NiliMedix
ClinicalTrials.gov Identifier: NCT00592241     History of Changes
Other Study ID Numbers: NM-UA-01
Study First Received: December 17, 2007
Last Updated: April 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NiliMedix:
Insulin Pump

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013