CompletedNot Applicable

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

United States293 participantsStarted 2010-10

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Contr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)

Timeframe: Over each 12 week study period

Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)

Timeframe: Over each 12 week study period

Trial details

NCT IDNCT01231984

SponsorBecton, Dickinson and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-05

Results submitted2013-10-24

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials