Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 |
Device: 4 mm x 32G Pen Needle Device: 8mm x 31G Pen Needle Device: 12.7mm x 29G Pen Needle |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
- Glycemic Control as measured by HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Glycemic control will be assessed by the subjects' HbA1c (%) at baseline (randomization visit) and at the end of each 12 week study period. The 90% confidence interval for the mean difference in HbA1c values between two pen needles will be estimated based on general linear models adjusting for baseline HbA1c.
- Number of Subjects with Serious, Unexplained Hypoglycemic Events [ Time Frame: During 12 week study period ] [ Designated as safety issue: Yes ]Hypoglycemia is defined as serious when the subject requires the assistance of another person to be treated, or when the hypoglycemic event meets the per-protocol definition of a Serious Adverse Event. An unexplained episode is defined as one with no known cause (for example, the subject skipped a meal or exercised vigorously). Subjects will be asked to record these events in a diary.
- Number of Subjects with Serious, Unexplained Hyperglycemic Events [ Time Frame: During 12 week study period ] [ Designated as safety issue: Yes ]Hyperglycemia is defined as serious when the subject requires the assistance of another person to be treated, or when the hyperglycemic event meets the per-protocol definition of a Serious Adverse Event. An unexplained episode is defined as one with no known cause (for example, the subject missed an insulin dose). Subjects will be asked to record these events in a diary.
- Relative Injection Pain [ Time Frame: End of study period 2 ] [ Designated as safety issue: No ]Subjects will complete a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with "as painful" and at each extreme with "much less painful (-75mm) and "much more painful (+75mm). VAS scores will be adjusted for the order of pen needle (PN) use, such that a positive score (> 0 mm) means that the 4mm PN was less painful than the reference PN (8mm or 12.7 mm).
| Enrollment: | 293 |
| Study Start Date: | October 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 4 mm vs. 8 mm
Subjects randomized to this study arm first use either the 4mm PN or the 8mm PN for 12 weeks, then switched to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
|
Device: 4 mm x 32G Pen Needle
During the 12 week study period, subjects use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are advised to inject straight in when using the 4mm PN, with no pinch up.
Other Name: BD Ultra-Fine™ Nano pen needle, Catalog number 320122
Device: 8mm x 31G Pen Needle
During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.
Other Name: BD Ultra-Fine™ Short pen needle, Catalog number 320109
|
|
Experimental: 4 mm vs. 12.7 mm
Subjects randomized to this study arm first use either the 4mm PN or the 12.7mm PN for 12 weeks, then switch to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
|
Device: 4 mm x 32G Pen Needle
During the 12 week study period, subjects use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are advised to inject straight in when using the 4mm PN, with no pinch up.
Other Name: BD Ultra-Fine™ Nano pen needle, Catalog number 320122
Device: 12.7mm x 29G Pen Needle
During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. When using the 12.7mm PN, subjects are instructed to insert either at an angle of 45 degrees, or to pinch up and hold the pen device at a 90 degree angle (straight in).
Other Name: BD Ultra-Fine™ Original pen needle, BD Catalog Number 328203
|
Detailed Description:
Each subject's participation is expected to last a total of 7 months and includes a screening visit, a three-week wash-in period (one week with each of the three different size pen needles) followed by two consecutive 12 week study periods. The purpose of the three week wash-in period is to minimize the number of dropouts during the following study periods by ensuring that subjects have experience using each of the three study needles and find them generally acceptable for use during the study.
Only subjects who complete the wash-in period and confirm their agreement to continue participating will be randomized into one of the two study arms. Subjects will be randomly assigned to use the BD Ultra-Fine™ 4mm pen needle and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle. The randomization will also specify which of the two study pen needles to be used first. Half of the study subjects will use the BD Ultra-Fine™ 4mm and BD Ultra-Fine™ 8mm pen needles (4mm/8mm arm) and the other half will use the BD Ultra-Fine™ 4mm and the BD Ultra-Fine™ 12.7mm pen needles (4mm/12.7mm arm). At the end of the first 12 week study period subjects will switch to the other assigned pen needle for the second and final study period.
Glycemic control (based on HbA1c concentrations) will be assessed at baseline and at the end of each 12 week study period.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Insulin requiring diabetics (type 1 or type 2)
- Using a pen device for self-injection of all diabetes-related medications for at least two months prior to screening.
- 18 to 75 years of age, inclusive.
- Body Mass Index of at least 30 kg/m².
- Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
- Self-monitor blood glucose at least twice per day with a memory blood glucose meter, and willing to do so at least twice per day for the duration of the study
- On a stable diabetes treatment regimen (for example, no change to non-insulin therapies)for at least 2 months prior to screening
- Able to read, write and follow instructions in English or Spanish.
Exclusion Criteria:
- Administer insulin with a pump.
- Currently use a syringe to inject insulin or any other diabetes-related medication.
- Pregnancy.
- History of intravenous drug abuse.
- Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.)
Participated in any one of the following clinical studies:
- BDDC-08-011, 'Comparison of Glycemic Control among Diabetics using the 4mm x 32G BD Pen Needle versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle'.
- DBC-10-SQUIR04, 'Evaluation of Glycemic Control and User Acceptability of the BD Ultrafine Nano 4mm x 32G Pen Needle for Injection of Long-Acting or Basal Insulin Doses Above 40 Units'
- DBC-10-EMRLD01, 'Design Validation of BD 5-bevel Pen Needles (4,5 and 8mm) in Subjects with Diabetes'
Contacts and Locations| United States, California | |
| AMCR Institute, Inc. | |
| Escondido, California, United States, 92026 | |
| United States, Georgia | |
| Atlanta Diabetes Associates | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Springfield Diabetes and Endocrine Center | |
| Springfield, Illinois, United States, 62704 | |
| United States, Minnesota | |
| International Diabetes Center (IDC) | |
| Minneapolis, Minnesota, United States, 55416 | |
| United States, Nebraska | |
| Diabetes and Endocrine Associates | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, North Carolina | |
| Mountain Diabetes and Endocrine Center | |
| Asheville, North Carolina, United States, 28803 | |
| United States, Tennessee | |
| University Diabetes and Endocrine Consultants | |
| Chattanooga, Tennessee, United States, 37403 | |
| United States, Texas | |
| Clinical Trials of Texas, Inc | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Corporate Lane Internal Medicine and Research Center | |
| Virgina Beach, Virginia, United States, 23462 | |
| Study Director: | Laurence Hirsch, MD | BD Medical - Diabetes Care |
More Information
Publications:
| Responsible Party: | Becton, Dickinson and Company |
| ClinicalTrials.gov Identifier: | NCT01231984 History of Changes |
| Other Study ID Numbers: | BDC-10-SQUIR05 |
| Study First Received: | October 29, 2010 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Becton, Dickinson and Company:
|
diabetes obesity hypoglycemia hyperglycemia pen needle |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013