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NCT00928057 · ClinicalTrials.gov registry record · NA
Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
A NA study, sponsored by Becton, Dickinson and Company.
- Completed
- Registry status
- NA
- Development phase
- 173
- Enrollment target
NCT00928057: Completed NA study, sponsored by Becton, Dickinson and Company.
NCT00928057 is a NA study that has completed, run by Becton, Dickinson and Company. The registered enrollment target is 173 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00928057, a NA study, has completed, sponsored by Becton, Dickinson and Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 173 participants
- Enrollment target
Study Summary
Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and more comfortable. Currently marketed pen needles range in length from 5 to 12.7 millimeters (mm). The primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.
Primary Outcome
Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula: Percent
Interventions
- DEVICE 4mm x 32G pen needle
- DEVICE 8mm x 31G pen needle
- DEVICE 5mm x 31G pen needle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2009-06 |
| Est. Completion | 2009-11 |
| Phase | NA |
What the finished NCT00928057 record still lists
NCT00928057 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which 4mm x 32G pen needle is the first listed.
NCT00928057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00928057 about?
NCT00928057 is a clinical study titled "Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles". Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as le...
What is the current status of trial NCT00928057?
This trial is currently completed. It is a NA study. The enrollment target is 173 participants. The study started on 2009-06. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00928057?
The interventions under investigation include: 4mm x 32G pen needle (DEVICE), 8mm x 31G pen needle (DEVICE), 5mm x 31G pen needle (DEVICE).
Who is sponsoring clinical trial NCT00928057?
This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00928057's enrollment target sits among peer trials
173 611th of 2000 higher than 1,389 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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