Diabetes Mellitus, Type 1NCT01231984
Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
A study testing 4 mm x 32G Pen Needle, 8mm x 31G Pen Needle and 12.7mm x 29G Pen Needle in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- 4 mm x 32G Pen Needle, 8mm x 31G Pen Needle and 12.7mm x 29G Pen Needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2010to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- 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'
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37403
AMCR Institute, Inc.
Escondido, California, 92026
The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center
Hackensack, New Jersey, 07601
International Diabetes Center (IDC)
Minneapolis, Minnesota, 55416
Diabetes and Endocrine Associates
Omaha, Nebraska, 68131
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229
Springfield Diabetes and Endocrine Center
Springfield, Illinois, 62704
Corporate Lane Internal Medicine and Research Center
Virginia Beach, Virginia, 23462
About this study
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
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.
Read the 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.
- Being tested
- 4 mm x 32G Pen Needle, 8mm x 31G Pen Needle, 12.7mm x 29G Pen Needle
- Keywords
- diabetes, obesity, hypoglycemia, hyperglycemia, pen needle
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mm x 32G Pen NeedleDevice
Also called BD Ultra-Fine™ Nano pen needle, Catalog number 320122
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 NeedleDevice
Also called BD Ultra-Fine™ Short pen needle, Catalog number 320109
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.
12.7mm x 29G Pen NeedleDevice
Also called BD Ultra-Fine™ Original pen needle, BD Catalog Number 328203
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).
| Study group | Role | What they receive |
|---|---|---|
| 4 mm vs. 8 mm | Experimental | 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. Receives: Device: 4 mm x 32G Pen Needle; Device: 8mm x 31G Pen Needle |
| 4 mm vs. 12.7 mm | Experimental | 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. Receives: Device: 4 mm x 32G Pen Needle; Device: 12.7mm x 29G Pen Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)
Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.
Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7).
Measured: Over each 12 week study period
Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)
Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.
Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7).
Measured: Over each 12 week study period
Secondary outcomes (5)
Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users
Glycemic control was assessed as by difference between the subjects' HbA1c (%) at baseline (randomization, Visit 3) and at the end of each 12 week study period,in the same manner as for the primary outcome measures. The 95% confidence interval for the mean difference in HbA1c values between the 4mm PN and the longer PN will be estimated based on general linear models adjusting for baseline HbA1c.
Measured: Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period.
Injection Pain Scores (4 mm vs. 8 mm)
At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using 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 in Period 1. 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); therefore a pain rating < 0 indicates that the Period 2 needle was perceived as less painful than the Period 1 needle.
Measured: At the end of Study Period 2
Injection Pain Scores (4 mm vs. 12 mm)
At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using 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); therefore a negative pain rating means the period 2 needle was perceived as less painful than the period 1 needle.
Measured: At the end of Study Period 2
Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle.
Subjects were asked to record hypoglycemic events in his/her diary anytime his/her blood glucose (BG) was below 50mg/dL, s/he had signs/symptoms of hypoglycemia, or s/he required medical attention for treatment.
Hypoglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hypoglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject skipped a meal or exercised vigorously).
Measured: During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)
Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle.
Subjects were asked to record hyperglycemic events in his/her diary anytime his/her blood glucose (BG) was above 400mg/dL, or s/he required medical attention for treatment for hyperglycemia.
Hyperglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hyperglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject missed an insulin dose). Subjects were asked to record these events in a diary.
Measured: During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence Hirsch, MD, Study director, BD Medical - Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231984
- Sponsor's protocol ID
- DBC-10-SQUIR05
- Status last verified
- Aug 2024
- First submitted
- 29 Oct 2010
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20429833Bergenstal 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.
PubMed 25662503
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01231984
- Acronym / sponsor ID
- DBC-10-SQUIR05
- Keywords
- diabetes, obesity, hypoglycemia, hyperglycemia, pen needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 27 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 mm vs. 8 mm | Experimental | Device: 4 mm x 32G Pen Needle, Device: 8mm x 31G Pen NeedleSubjects 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. |
| 4 mm vs. 12.7 mm | Experimental | Device: 4 mm x 32G Pen Needle, Device: 12.7mm x 29G Pen NeedleSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 mm x 32G Pen NeedleAlso: BD Ultra-Fine™ Nano pen needle, Catalog number 320122During 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. | Device | 4 mm vs. 12.7 mm, 4 mm vs. 8 mm |
| 8mm x 31G Pen NeedleAlso: BD Ultra-Fine™ Short pen needle, Catalog number 320109During 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. | Device | 4 mm vs. 8 mm |
| 12.7mm x 29G Pen NeedleAlso: BD Ultra-Fine™ Original pen needle, BD Catalog Number 328203During 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). | Device | 4 mm vs. 12.7 mm |
Primary outcome
Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)
Time frame: Over each 12 week study period
Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2. Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7).
Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)
Time frame: Over each 12 week study period
Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2. Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7).
5 secondary outcomes
Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users
Time frame: Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period.
Injection Pain Scores (4 mm vs. 8 mm)
Time frame: At the end of Study Period 2
Injection Pain Scores (4 mm vs. 12 mm)
Time frame: At the end of Study Period 2
Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle.
Time frame: During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)
Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle.
Time frame: During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20429833Gibney 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.
- Derived from this study: PubMed 25662503Bergenstal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Hirsch, MD study director
BD Medical - Diabetes Care
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 mm x 32G Pen Needle, 8mm x 31G Pen Needle and 12.7mm x 29G Pen Needle in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) (time frame: Over each 12 week study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231984, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.