Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose
Study Details
Study Description
Brief Summary
The procurement of blood for SMBG, usually via a finger stick, is considered by many patients to be the most painful portion of diabetes therapy. This has led to the marketing of smaller gauge lancets, lancing devices with variable depth settings and blood glucose sensors that require less blood for measurement.
In this study, two main outcomes were evaluated: The first, which was assessed at Visit 1, was whether specific combinations of lancets and lancing devices would yield sufficient blood volume to allow valid assessment of diabetic subjects' glucose levels. The other outcome, assessed at Visit 2, was the level of pain perceived by subjects during lancing with specific combinations of lancets and lancing devices. During Visit 2, pain assessment was done using a Visual Analog Scale and such that for each lancet/lancing device, the lowest lancing device setting that yielded a valid BG reading for each subject during Visit 1 was used. A third outcome measure, overall comfort with lancing, was also assessed at Visit 2.
A total of 5 combinations of lancets and lancing devices were evaluated.
These were as follows:
-
BD/33G = BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
-
OTM/33G =OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
-
OTM/28G =OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
-
OTU/28G = OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
-
ACC/28G= Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip)
After enrollment and qualification, subjects were assigned to one of 4 intervention arms. The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to each arm are shown in the Assigned Interventions Table below.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Arm A In Visit 1 subjects tested BD/33G, OTM/33G, and OTM/28G devices. In Visit 2 subjects tested BD/33G and OTM/28G. See purpose for additional information. |
Device: BD/33G
BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Device: OTM / 33G
OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Device: OTM/28G
OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
|
| Other: Arm B In Visit 1 subjects tested BD/33G, OTM/33G and OTU/28G devices. In Visit 2 subjects tested BD/33G and OTU/28G. See purpose for additional information. |
Device: BD/33G
BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Device: OTM / 33G
OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Device: OTU/28G
OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ BGM) and OneTouch® Ultra® test strips)
|
| Other: Arm C In Visit 1 subjects tested BD/33G, OTM/33G and ACC/28G devices. In Visit 2 subjects tested BD/33G and ACC/28G. See purpose for additional information. |
Device: BD/33G
BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Device: OTM / 33G
OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Device: ACC/28G
Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip)
|
| Other: Arm D In Visit 1 subjects tested BD/33G, OTM/33G and OTM/28G devices. In Visit 2 subjects tested OTM/33G and OTM/28G. See purpose for additional information. |
Device: BD/33G
BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Device: OTM / 33G
OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Device: OTM/28G
OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
|
Outcome Measures
Primary Outcome Measures
- Blood Sample of Sufficient Volume to Yield a Valid Meter Reading [Study Day 1 (Visit 1)]
Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.
- Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only) [Approximately Day 3 (Visit 2)]
In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.
Secondary Outcome Measures
- Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only) [Approximately Day 3 (Visit 2)]
The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second.
- Reported Device Preference Within Lancing Pair at Visit 2 [Approximately Day 3 (Visit 2)]
After each pair of 4 lancings, the subject was asked: "Which of the two devices did you find more comfortable, overall?" The choices were: first lancing, second lancing or equivalent. The "Stated Preference" row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The "No Preference" row includes lancing pairs with preference of "equivalent" or no answer.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Must currently be diagnosed with either Type I or Type II diabetes mellitus.
-
Must currently be performing self monitoring of blood glucose
-
Must be between 18-70 years of age (inclusive).
-
Must be able to read and follow study instructions in English.
Exclusion Criteria:
-
Pregnant (self reported)
-
History of poor blood circulation.
-
Any skin condition on his or her fingers that prevents blood sampling.
-
History of a bleeding disorder.
-
Neuropathy or other condition affecting sensation in the hands.
-
Self-reported blood borne infection (e.g., HIV, hepatitis B or C [non A, non B], syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
-
Currently participating in another study
-
Employed by BD, J&J, Roche or the Clinical Site.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Thomas J. Stephens & Associates | Colorado Springs | Colorado | United States | 80915-3540 |
| 2 | TKL Research, Inc. | Carlstadt | New Jersey | United States | 07072 |
| 3 | TKL Research, Inc | Paramus | New Jersey | United States | 07652 |
| 4 | TKL Research, Inc. | Ramsey | New Jersey | United States | 07446 |
Sponsors and Collaborators
- Becton, Dickinson and Company
Investigators
- Principal Investigator: Michael E Casser, MD, TKL Research, Inc.
- Principal Investigator: Ronald L Rizer, PhD, Thomas J. Stephens & Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BDDC-08-001
Study Results
Participant Flow
| Recruitment Details | A total of 250 subjects were enrolled in this study between 8/4/2008 (first subject visit) and 9/5/2008 (last subject visit) at two study centers. |
|---|---|
| Pre-assignment Detail | After enrollment, baseline characteristics such as demography, diabetes history, and current lancets were recorded for each subject. No additional baseline measures were taken. Thereafter, subjects were assigned to one of the 4 intervention arms. Subjects were able to complete the enrollment visit and Study Visit 1 activities on the first day. |
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D |
|---|---|---|---|---|
| Arm/Group Description | Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G. The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm A are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips. For Visit 2 only the BD/33G and OTM/28G were used. | Visit 1 (V1):BD/33G,OTM/33G,OTU/28G; Visit 2 (V2):BD/33G, OTU/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing).The lancet/lancing device combinations assigned to Arm B are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTU/28G (OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the BD/33G and OTU/28G were used. | Visit 1 (V1): BD/33G, OTM/33G,ACC/28G Visit 2 (V2): BD/33G, ACC/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm C are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: ACC/28G (Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip). For Visit 2 only the BD/33G and ACC/28G were used. | Visit1 (V1): BD/33G,OTM/33G,OTM/28G; V2: OTM/33G, OTM/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm D are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the OTM/33G and OTM/28G were used. |
| Period Title: Visit 1 | ||||
| STARTED | 62 | 63 | 62 | 63 |
| COMPLETED | 60 | 63 | 55 | 62 |
| NOT COMPLETED | 2 | 0 | 7 | 1 |
| Period Title: Visit 1 | ||||
| STARTED | 59 | 61 | 55 | 61 |
| COMPLETED | 59 | 61 | 54 | 60 |
| NOT COMPLETED | 0 | 0 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Entire Study Population |
|---|---|
| Arm/Group Description | |
| Overall Participants | 250 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52.1
(12.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
151
60.4%
|
| Male |
99
39.6%
|
| Region of Enrollment (participants) [Number] | |
| United States |
250
100%
|
| Blood Glucose Meter Brand (participants) [Number] | |
| Abbott |
45
18%
|
| Agamatrix |
1
0.4%
|
| BD/Novamax |
17
6.8%
|
| Bayer |
20
8%
|
| Lifescan |
106
42.4%
|
| Private Label Walgreens |
2
0.8%
|
| Reli-on |
2
0.8%
|
| Roche |
41
16.4%
|
| Other |
16
6.4%
|
| Diabetes Type (participants) [Number] | |
| Type 1 |
95
38%
|
| Type 2 |
155
62%
|
| Years Since Diagnosis (participants) [Number] | |
| <1 |
12
4.8%
|
| 1-5 |
46
18.4%
|
| 6-10 |
46
18.4%
|
| >10 |
146
58.4%
|
Outcome Measures
| Title | Blood Sample of Sufficient Volume to Yield a Valid Meter Reading |
|---|---|
| Description | Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading. |
| Time Frame | Study Day 1 (Visit 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| BD/BD33g and Mini/BD33g were included in 4 arms,the Mini/OT28g in 2 arms,and Ultra/OT28g and AC/AC28g in 1 arm. Thus the # of subj evaluated for each device was 246, 246, 124, 63, and 60, resp. Subj were analyzed for blood volume adequacy if they completed the depth setting/volume testing for at least 1 device w/o significant protocol deviation. |
| Arm/Group Title | BD/33G | OTM/33G | OTM/28G | OTU/28G | ACC/28G |
|---|---|---|---|---|---|
| Arm/Group Description | BD Lancet Device / BD 33 Gauge Lancet. In Study Visit 1 each subject was randomly assigned to one of four groups, each subject evaluated three different lancet device/lancet combinations. The order of evaluation of the three systems was randomly assigned for each subject. Subjects started at the middle depth setting of each lancet device. The lowest depth setting for each system yielding sufficient volume for each system was recorded for that subject and used during Visit 2. All subjects whom obtained adequate sample volumes were selected to participate in Study Visit 2. | OneTouch Mini Device / BD 33 Gauge Lancet See description for BD/33G. | OneTouch Mini Device / OneTouch UltraSoft 28G Lancet See description for BD/33G. | OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet See description for BD/33G. | Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet See description for BD/33G. |
| Measure Participants | 246 | 246 | 124 | 63 | 60 |
| Sufficient Volume - Success |
245
98%
|
246
NaN
|
124
NaN
|
63
NaN
|
60
NaN
|
| Sufficient Volume - Unsuccessful |
1
0.4%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BD/33G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage |
| Estimated Value | 99.59 | |
| Confidence Interval |
() 95% 98.09 to 99.59 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OTM/33G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage |
| Estimated Value | 100 | |
| Confidence Interval |
() 95% 98.79 to 100 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OTM/28G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage |
| Estimated Value | 100 | |
| Confidence Interval |
() 95% 97.61 to 100 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | OTU/28G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage |
| Estimated Value | 100 | |
| Confidence Interval |
() 95% 95.36 to 100 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | ACC/28G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage |
| Estimated Value | 100 | |
| Confidence Interval |
() 95% 95.13 to 100 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only) |
|---|---|
| Description | In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second. |
| Time Frame | Approximately Day 3 (Visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 234 subjects that completed Visit 2, 229 had evaluable pairs and were included in the analysis for Visit 2. Some of the lancing pairs from several subjects were excluded due to protocol deviations, subject discontinuation or adverse events. Of these 175 subjects were analyzed for this primary outcome. |
| Arm/Group Title | OTM/28G - BD/33G | OTU/28G - BD/33G | ACC/28G - BD/33G |
|---|---|---|---|
| Arm/Group Description | OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet | OneTouch UltraSoft Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet | Accu-Chek Softclix Device/Accu-Chek Softclix 28G Lancet as compared to BD Lancet Device / BD 33G Lancet |
| Measure Participants | 59 | 61 | 55 |
| Mean (Standard Deviation) [mm] |
10.86
(34.07)
|
8.71
(36.69)
|
-0.03
(31.83)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BD/33G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 10.84 | |
| Confidence Interval |
() 95% 6.80 to 10.84 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OTM/33G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANOVA | |
| Comments | A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 8.55 | |
| Confidence Interval |
() 95% 3.63 to 8.55 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OTM/28G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.460 |
| Comments | ||
| Method | ANOVA | |
| Comments | A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.23 | |
| Confidence Interval |
() 95% -3.57 to 0.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only) |
|---|---|
| Description | The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second. |
| Time Frame | Approximately Day 3 (Visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above. |
| Arm/Group Title | OTM/28G - OTM/33G |
|---|---|
| Arm/Group Description | OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to OneTouch Mini Device / BD 33G Lancet |
| Measure Participants | 61 |
| Mean (Standard Deviation) [mm] |
4.86
(33.75)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BD/33G |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | ||
| Method | ANOVA | |
| Comments | A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 4.90 | |
| Confidence Interval |
() 95% 1.14 to 4.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Reported Device Preference Within Lancing Pair at Visit 2 |
|---|---|
| Description | After each pair of 4 lancings, the subject was asked: "Which of the two devices did you find more comfortable, overall?" The choices were: first lancing, second lancing or equivalent. The "Stated Preference" row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The "No Preference" row includes lancing pairs with preference of "equivalent" or no answer. |
| Time Frame | Approximately Day 3 (Visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Comfort was analyzed per lancing pairs. 236 subjects performed up to 4 lancing pairs. 869 pairs were evaluated across the 4 arms. Pairs were excluded if they did not result in a valid meter reading or associated with protocol deviations or had missing comfort data. |
| Arm/Group Title | OTM/28G - BD/33G | OTU/28G - BD/33G | ACC/28G - BD/33G | OTM/28G - OTM/33G |
|---|---|---|---|---|
| Arm/Group Description | OneTouch Mini Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet | OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet | Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet - BD Lancet Device / BD 33 gauge Lancet | OneTouch MiniDevice / OneTouch 28g Lancet - OneTouch MiniDevice /BD 33 Gauge Lancet |
| Measure Participants | 59 | 61 | 55 | 61 |
| # of pairs in which participants stated preference |
180
|
183
|
173
|
186
|
| First device in pair preferred |
67
|
70
|
84
|
73
|
| Second device in pair preferred |
113
|
113
|
89
|
113
|
| # of pairs in which no preference was stated |
43
|
26
|
32
|
46
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BD/33G |
|---|---|---|
| Comments | Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | One proportion two-sided test; p=50% | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OTM/33G |
|---|---|---|
| Comments | Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | One proportion two-sided test; p=50% | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OTM/28G |
|---|---|---|
| Comments | Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.761 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | One proportion two-sided test; p=50% | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | OTU/28G |
|---|---|---|
| Comments | Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | One proportion two-sided test; p=50% | |
Adverse Events
| Time Frame | Up to 1 month. At each study contact, subjects were questioned in an open-ended manner regarding any new or worsening undesirable effects that may have occurred since the previous contact. All findings were documented and evaluated by the PI or designee. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D | ||||
| Arm/Group Description | Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G | Visit 1 (V1) Device: BD/33G,OTM/33G,OTU/28G; Visit 2 (V2) Device: BD/33G,OTU/28G | Visit 1 (V1) Device: BD/33G,OTM/33G,ACC/28G; Visit 2 (V2)-BD/33G,ACC/28G | Visit 1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit (V2) Device: OTM/33G,OTM/28G | ||||
All Cause Mortality |
||||||||
| Arm A | Arm B | Arm C | Arm D | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Arm A | Arm B | Arm C | Arm D | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 0/63 (0%) | 0/62 (0%) | 0/63 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Arm A | Arm B | Arm C | Arm D | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/62 (8.1%) | 6/63 (9.5%) | 11/62 (17.7%) | 6/63 (9.5%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hyperglycemia | 1/62 (1.6%) | 1 | 1/63 (1.6%) | 1 | 7/62 (11.3%) | 7 | 2/63 (3.2%) | 2 |
| hypoglycemia | 4/62 (6.5%) | 6 | 5/63 (7.9%) | 6 | 4/62 (6.5%) | 5 | 4/63 (6.3%) | 8 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Kenneth Kassler-Taub, VP Medical Affairs |
|---|---|
| Organization | Becton Dickinson |
| Phone | 201-847-7009 |
| kenneth_kassler_taub@bd.com |
- BDDC-08-001