Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles

NCT ID: NCT01231984

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 293 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-05-31

Brief 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.

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

4 mm vs. 8 mm

Subjects randomized to this study arm first used either the 4 mm x 32G Pen Needle or the 8mm x 31G Pen Needle for 12 weeks (Period 1), then switched to the alternate pen needle (PN) for another 12 weeks (Period 2). Order of PN use was randomly determined.

Group Type: EXPERIMENTAL

4 mm x 32G Pen Needle

Intervention Type: DEVICE

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.

8mm x 31G Pen Needle

Intervention Type: DEVICE

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.

4 mm vs. 12.7 mm

Subjects randomized to this study arm first used either the 4 mm x 32G Pen Needle or the 12.7mm x 29G Pen Needle (PN) for 12 weeks (Period 1), then switched to the alternate PN for another 12 weeks (Period 2). Order of PN use was randomly determined.

Group Type: EXPERIMENTAL

4 mm x 32G Pen Needle

Intervention Type: DEVICE

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.

12.7mm x 29G Pen Needle

Intervention Type: DEVICE

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).

Interventions

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.

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

BD Ultra-Fine™ Nano pen needle, Catalog number 320122; BD Ultra-Fine™ Short pen needle, Catalog number 320109; BD Ultra-Fine™ Original pen needle, BD Catalog Number 328203

Eligibility Criteria

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 80 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'

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence Hirsch, MD

Role: STUDY_DIRECTOR

BD Medical - Diabetes Care

Locations

AMCR Institute, Inc.

Escondido, California, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Springfield Diabetes and Endocrine Center

Springfield, Illinois, United States

International Diabetes Center (IDC)

Minneapolis, Minnesota, United States

Diabetes and Endocrine Associates

Omaha, Nebraska, United States

The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center

Hackensack, New Jersey, United States

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, United States

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, United States

Clinical Trials of Texas, Inc

San Antonio, Texas, United States

Corporate Lane Internal Medicine and Research Center

Virginia Beach, Virginia, United States

Countries

United States

References

Gibney MA, Arce CH, Byron KJ, Hirsch LJ. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin. 2010 Jun;26(6):1519-30. doi: 10.1185/03007995.2010.481203.

Reference Type: BACKGROUND

PMID: 20429833 (View on PubMed)

Bergenstal RM, Strock ES, Peremislov D, Gibney MA, Parvu V, Hirsch LJ. Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes. Mayo Clin Proc. 2015 Mar;90(3):329-38. doi: 10.1016/j.mayocp.2014.12.014. Epub 2015 Feb 7.

Reference Type: DERIVED

PMID: 25662503 (View on PubMed)

Other Identifiers

DBC-10-SQUIR05

Identifier Type: -

Identifier Source: org_study_id