DiabetesPhase 4NCT00121355
Novofine Autocover Safety Needle Versus BD Safety Glide
A Phase 4 study testing safety glide and autocover needle in people with Diabetes and Healthcare Professionals, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this trial is to examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide (TM) Syringe (only) in a hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Healthcare Professionals, Delivery Systems
- What is being tested?
- safety glide and autocover needle
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2006
- Phase
- Phase 4
- 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
- Hospital nurses with prior injection training without an infectious blood borne disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Plainsboro, New Jersey, 08536
About this study
Official title: An Open-Label, Multi-Center, Prospective Cross-Over Study of Preference and Safety of NovoFine® Autocover(TM) Needles Compared to BD Safety Glide (TM) Syringes in the Hospital Setting
This trial is conducted in the United States of America (USA). The aim of this trial is to examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide (TM) Syringe (only) in a hospital setting. The number of needle stick injuries will also be evaluated and whether these hospital nurses prefer the safety features of the NovoFine® Autocover Needle versus those of the BD Safety Glide (TM) Syringe. The identified hospital nurses will evaluate the two types of needles during standard administration of insulin to patients being treated for diabetes.
- Conditions
- Diabetes, Healthcare Professionals, Delivery Systems
- Being tested
- safety glide, autocover needle
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safety glideDevice
autocover needleDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121355
- Sponsor's protocol ID
- MS241-1674
- Status last verified
- Oct 2016
- First submitted
- 13 Jul 2005
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Prospective Cross-Over Study of Preference and Safety of NovoFine® Autocover(TM) Needles Compared to BD Safety Glide (TM) Syringes in the Hospital Setting
- ClinicalTrials.gov ID
- NCT00121355
- Acronym / sponsor ID
- MS241-1674
- Conditions
- Diabetes, Healthcare Professionals, Delivery Systems
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 21 Jul 2005 (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.
This trial is conducted in the United States of America (USA). The aim of this trial is to examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide (TM) Syringe (only) in a hospital setting. The number of needle stick injuries will also be evaluated and whether these hospital nurses prefer the safety features of the NovoFine® Autocover Needle versus those of the BD Safety Glide (TM) Syringe. The identified hospital nurses will evaluate the two types of needles during standard administration of insulin to patients being treated for diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospital nurses with prior injection training without an infectious blood borne disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| safety glide | Device | – |
| autocover needle | Device | – |
Primary outcome
Not reported in the source record.
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 18 Oct 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing safety glide and autocover needle in people with Diabetes and Healthcare Professionals, run by Novo Nordisk A/S at 1 site in United States.
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 1 inclusion and 0 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 18 Oct 2016. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 18 Oct 2016.