Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
Public ClinicalTrials.gov record NCT01231984. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparison of Glycemic Control in Obese Subjects With Diabetes Using the BD Ultra-Fine™ Nano 4mm x 32G Pen Needle, and Either the BD Ultra-Fine™ Short 8mm x 31G Pen Needle or the BD Ultra Fine™ 12.7mm x 29G Pen Needle
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01231984
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 293 participants
Conditions and interventions
Interventions
- 4 mm x 32G Pen Needle Device
- 8mm x 31G Pen Needle Device
- 12.7mm x 29G Pen Needle Device
Device
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Apr 30, 2012
- Completion
- Apr 30, 2012
- Last update posted
- Sep 18, 2024
2010 – 2012
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AMCR Institute, Inc. | Escondido | California | 92026 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | — |
| Springfield Diabetes and Endocrine Center | Springfield | Illinois | 62704 | — |
| International Diabetes Center (IDC) | Minneapolis | Minnesota | 55416 | — |
| Diabetes and Endocrine Associates | Omaha | Nebraska | 68131 | — |
| The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Mountain Diabetes and Endocrine Center | Asheville | North Carolina | 28803 | — |
| University Diabetes and Endocrine Consultants | Chattanooga | Tennessee | 37403 | — |
| Clinical Trials of Texas, Inc | San Antonio | Texas | 78229 | — |
| Corporate Lane Internal Medicine and Research Center | Virginia Beach | Virginia | 23462 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01231984, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01231984 live on ClinicalTrials.gov.