NCT00121355

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

July 13, 2005

Last Update Submit

October 17, 2016

Conditions

DiabetesHealthcare ProfessionalsDelivery Systems

Interventions

safety glideDEVICE
autocover needleDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospital nurses with prior injection training without an infectious blood borne disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

July 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

US(1)