Diabetes MellitusNCT00592241
Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study
A study testing "Adi" Insulin Pump Usability in people with Diabetes Mellitus, run by NiliMedix at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- "Adi" Insulin Pump Usability
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Concurrent additional major illness.
- Subject objects to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- "Adi" Insulin Pump Usability
- Keywords
- Insulin Pump
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Adi" Insulin Pump UsabilityDevice
Also called "Adi" Insulin Pump
no intervention
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Subject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years. Receives: Device: "Adi" Insulin Pump Usability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Secondary outcomes (1)
Evaluate user's satisfaction.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NiliMedix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Naim Shehadah, Prof., Principal investigator, RAMBAM Medical Center, Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592241
- Sponsor's protocol ID
- NM-UA-01
- Status last verified
- Dec 2007
- First submitted
- 17 Dec 2007
- Last updated
- 8 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study
- ClinicalTrials.gov ID
- NCT00592241
- Acronym / sponsor ID
- NM-UA-01
- Conditions
- Diabetes Mellitus
- Keywords
- Insulin Pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NiliMedixIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | Device: "Adi" Insulin Pump UsabilitySubject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Concurrent additional major illness.
- Subject objects to the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Adi" Insulin Pump UsabilityAlso: "Adi" Insulin Pumpno intervention | Device | A |
Primary outcome
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
1 secondary outcome
Evaluate user's satisfaction.
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naim Shehadah, Prof. principal investigator
RAMBAM Medical Center, Haifa Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Adi" Insulin Pump Usability in people with Diabetes Mellitus, run by NiliMedix at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2008.