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NCT01231984 · ClinicalTrials.gov registry record · NA
Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
A NA study, sponsored by Becton, Dickinson and Company.
- Completed
- Registry status
- NA
- Development phase
- 293
- Enrollment target
NCT01231984 is a NA study that has completed, run by Becton, Dickinson and Company. The registered enrollment target is 293 participants.
The verdict
NCT01231984, a NA study, has completed, sponsored by Becton, Dickinson and Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 293 participants
- Enrollment target
Study Summary
Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of longer pen needles may appeal to many diabetic patients as the shorter needle may be perceived as less intimidating and more comfortable. While pen needles of 4 to 8 mm in length are generally used for insulin injection in patients considered thin or normal weight, longer (12.7 mm) needles are still often prescribed for overweight or obese patients with diabetes. Since skin thickness is nearly constant across a range of body mass index (BMI), a clear rationale exists for the use of shorter needles in obese patients. (Gibney et al., CMRO 2010) The primary purpose of this study is to evaluate whether the BD Ultra-Fine™ Nano 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by hemoglobin A1c levels) as the BD Ultra-Fine™ 8mm x 31G and the BD Ultra-Fine™ 12.7mm x 29G pen needles in obese subjects with diabetes.
Interventions
- DEVICE 4 mm x 32G Pen Needle
- DEVICE 8mm x 31G Pen Needle
- DEVICE 12.7mm x 29G Pen Needle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01231984
The ClinicalTrials.gov registry entry for NCT01231984 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 293 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Becton, Dickinson and Company, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 4 mm x 32G Pen Needle is the first listed.
NCT01231984 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01231984 about?
NCT01231984 is a clinical study titled "Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles". Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of longer pen needles may appeal to many diabetic patients as the shorter needle may be perceived as less intimi...
What is the current status of trial NCT01231984?
This trial is currently completed. It is a NA study. The enrollment target is 293 participants. The study started on 2010-10. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01231984?
The interventions under investigation include: 4 mm x 32G Pen Needle (DEVICE), 8mm x 31G Pen Needle (DEVICE), 12.7mm x 29G Pen Needle (DEVICE).
Who is sponsoring clinical trial NCT01231984?
This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.
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