Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes, obesity, hypoglycemia, hyperglycemia, pen needle
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.
Interventions
DEVICE4 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.
DEVICE8mm 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.
DEVICE12.7mm 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).
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 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'
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injection Pain Scores (4 mm vs. 12 mm) | At the end of Study Period 2 | 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. |
| Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | 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. | 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. |
| Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle. | During Study Period 1 (12 weeks) and Study Period 2 (12 weeks) | 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. |
| Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle. | During Study Period 1 (12 weeks) and Study Period 2 (12 weeks) | 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). |
| Injection Pain Scores (4 mm vs. 8 mm) | At the end of Study Period 2 | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 380 subjects were screened from the current diabetic patient population at 10 research centers in the US. Of those, 293 subjects met eligibility criteria and were enrolled in the wash-in period.
Pre-assignment details
Subjects who successfully completed the wash-in period and agreed to participate were further randomized into one of the study arms. Specifically, 274 of 293 subjects who were enrolled in the wash-in period completed the wash-in period and were randomized into one of the two study arms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 139 |
| 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. | 135 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Study Period 1 | Adverse Event | 1 | 0 | 0 | 0 |
| Study Period 1 | Did not continue to meet I/E Criteria | 2 | 2 | 2 | 2 |
| Study Period 1 | Lost to Follow-up | 1 | 1 | 1 | 0 |
| Study Period 1 | Non-compliance with study requirements | 5 | 0 | 2 | 1 |
| Study Period 1 | Other | 0 | 0 | 0 | 1 |
| Study Period 1 | Protocol Violation | 3 | 4 | 2 | 3 |
| Study Period 1 | Screen Failure | 0 | 0 | 0 | 1 |
| Study Period 1 | Withdrawal by Subject | 0 | 0 | 0 | 1 |
| Study Period 2 | Did not continue to meet I/E Criteria | 1 | 1 | 0 | 1 |
| Study Period 2 | Lost to Follow-up | 1 | 0 | 0 | 3 |
| Study Period 2 | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 4 mm vs. 8 mm | 4 mm vs. 12.7 mm | Total |
|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 10.6 | 55.9 years STANDARD_DEVIATION 11.3 | 56.7 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 139 participants | 135 participants | 274 participants |
| Sex: Female, Male Female | 66 Participants | 66 Participants | 132 Participants |
| Sex: Female, Male Male | 73 Participants | 69 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 91 / 274 | 36 / 127 | 29 / 147 |
| serious Total, serious adverse events | 9 / 274 | 1 / 127 | 7 / 147 |
Outcome results
Primary
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).
Time frame: Over each 12 week study period
Population: 115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 12.7 primary analysis due to protocol deviations. The total population size evaluated for this analysis is therefore 113.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) | HbA1c Baseline (Visit 3) | 7.57 HbA1c (%) | Standard Deviation 0.96 |
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) | HbA1c end of Period 1 (Visit 5) | 7.58 HbA1c (%) | Standard Deviation 1.03 |
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) | HbA1c end of Period 2 (Visit 7) | 7.73 HbA1c (%) | Standard Deviation 1.18 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) | HbA1c Baseline (Visit 3) | 7.45 HbA1c (%) | Standard Deviation 0.88 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) | HbA1c end of Period 1 (Visit 5) | 7.54 HbA1c (%) | Standard Deviation 0.95 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) | HbA1c end of Period 2 (Visit 7) | 7.51 HbA1c (%) | Standard Deviation 0.97 |
Comparison: General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.95% CI: [-0.19, 0]Two one-sided 95% confidence limit
Primary
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).
Time frame: Over each 12 week study period
Population: 115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 8 primary analysis due to protocol deviations. The total population size evaluated for the primary objective (4 vs. 8) is therefore 113.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | HbA1c at baseline (Visit 3) | 7.59 HbA1c (%) | Standard Deviation 0.86 |
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | HbA1c end of Period 1 (Visit 5) | 7.63 HbA1c (%) | Standard Deviation 0.92 |
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | HbA1c end of Period 2 (Visit 7) | 7.78 HbA1c (%) | Standard Deviation 1.23 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | HbA1c at baseline (Visit 3) | 7.46 HbA1c (%) | Standard Deviation 1.01 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | HbA1c end of Period 1 (Visit 5) | 7.59 HbA1c (%) | Standard Deviation 1.28 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | HbA1c end of Period 2 (Visit 7) | 7.59 HbA1c (%) | Standard Deviation 1.23 |
Comparison: General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.95% CI: [-0.209, 0.058]Two one-sided 95% confidence limits
Secondary
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.
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.
Population: Of the 226 subjects who were considered for the Primary analysis, 107 subjects had at least one dose of insulin that was at least 40 units. The glycemic control of this sub-group of subjects was analyzed as in the Primary Analysis.The same analysis was performed for the high insulin dose subjects, with the two longer PN study arms pooled together.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | HbA1c at Baseline (Visit 3) | 7.77 HbA1C (%) | Standard Deviation 0.92 |
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | HbA1c end Period 1 (Visit 5) | 7.76 HbA1C (%) | Standard Deviation 1.03 |
| 4 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | HbA1c end Period 2 (Visit 7) | 7.98 HbA1C (%) | Standard Deviation 1.35 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | HbA1c at Baseline (Visit 3) | 7.57 HbA1C (%) | Standard Deviation 0.9 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | HbA1c end Period 1 (Visit 5) | 7.62 HbA1C (%) | Standard Deviation 0.97 |
| 8 mm First (4 vs. 8) | Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | HbA1c end Period 2 (Visit 7) | 7.66 HbA1C (%) | Standard Deviation 0.99 |
Comparison: General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.95% CI: [-0.23, 0.051]Two one-sided 95% confidence limits
Secondary
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.
Time frame: At the end of Study Period 2
Population: 115 subjects in the 4mm vs. 12 mm study arm completed all main study visits. One of the subjects was excluded from all primary and secondary analyses due to protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 mm First (4 vs. 8) | Injection Pain Scores (4 mm vs. 12 mm) | -27.72 mm | Standard Error 5.47 |
| 8 mm First (4 vs. 8) | Injection Pain Scores (4 mm vs. 12 mm) | 3.10 mm | Standard Error 5.01 |
p-value: <0.05t-test, 1 sided
Secondary
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.
Time frame: At the end of Study Period 2
Population: 115 subjects in the 4mm vs. 8 mm study arm completed all main study visits. Two of the 115 subjects were excluded from all primary and secondary analyses due to protocol deviations. The total number of subjects analyzed for perceived pain for this study was therefore 113.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 mm First (4 vs. 8) | Injection Pain Scores (4 mm vs. 8 mm) | -31.53 mm | Standard Error 5.3 |
| 8 mm First (4 vs. 8) | Injection Pain Scores (4 mm vs. 8 mm) | -19.17 mm | Standard Error 4.85 |
Comparison: Subjects rated the level of pain experienced when using the PN assigned for use during Study Period 2 compared to the PN assigned for use in Study Period 1. By placing a mark on a line, whose midpoint(anchor) was designated as 0, and represented equivalent pain with assigned PNs, ratings on the continuum represented the degree to which the PN used in the second Study Period was less than or greater than the PN used during the first Study Period.p-value: <0.05t-test, 1 sided
Secondary
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.
Time frame: During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)
Population: Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hyperglycemic events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4 mm First (4 vs. 8) | Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle. | 0 Adverse Events |
| 8 mm First (4 vs. 8) | Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle. | 0 Adverse Events |
| 12.7mm Needle | Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle. | 0 Adverse Events |
Secondary
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).
Time frame: During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)
Population: Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hypoglycemic events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4 mm First (4 vs. 8) | Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle. | 1 Adverse Events |
| 8 mm First (4 vs. 8) | Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle. | 2 Adverse Events |
| 12.7mm Needle | Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle. | 0 Adverse Events |