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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Other | 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. |
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| Arm B | Other | 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. |
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| Arm C | Other | 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. |
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| Arm D | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD/33G | Device | BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood Sample of Sufficient Volume to Yield a Valid Meter Reading | 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. | Study Day 1 (Visit 1) |
| Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only) | 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. | Approximately Day 3 (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael E Casser, MD | TKL Research, Inc. | Principal Investigator |
| Ronald L Rizer, PhD | Thomas J. Stephens & Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J. Stephens & Associates | Colorado Springs | Colorado | 80915-3540 | United States | ||
| TKL Research, Inc. |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 1 |
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| OTM / 33G | Device | OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) |
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| OTU/28G | Device | OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ BGM) and OneTouch® Ultra® test strips) |
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| ACC/28G | Device | Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip) |
|
| OTM/28G | Device | OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) |
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| Approximately Day 3 (Visit 2) |
| Reported Device Preference Within Lancing Pair at 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. | Approximately Day 3 (Visit 2) |
| Carlstadt |
| New Jersey |
| 07072 |
| United States |
| TKL Research, Inc | Paramus | New Jersey | 07652 | United States |
| TKL Research, Inc. | Ramsey | New Jersey | 07446 | United States |
| FG001 | Arm B | 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. |
| FG002 | Arm C | 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. |
| FG003 | Arm D | 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. |
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| NOT COMPLETED |
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| Visit 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Blood Glucose Meter Brand | Number | participants |
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| Diabetes Type | Number | participants |
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| Years Since Diagnosis | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Sample of Sufficient Volume to Yield a Valid Meter Reading | 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. | 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. | Posted | Number | Participants | Study Day 1 (Visit 1) |
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| Primary | Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only) | 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. | 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. | Posted | Mean | Standard Deviation | mm | Approximately Day 3 (Visit 2) |
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| Secondary | Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only) | 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. | 61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above. | Posted | Mean | Standard Deviation | mm | Approximately Day 3 (Visit 2) |
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| Secondary | Reported Device Preference Within Lancing Pair at 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. | 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. | Posted | Number | lancing pairs | Approximately Day 3 (Visit 2) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G | 0 | 62 | 5 | 62 | ||
| EG001 | Arm B | Visit 1 (V1) Device: BD/33G,OTM/33G,OTU/28G; Visit 2 (V2) Device: BD/33G,OTU/28G | 0 | 63 | 6 | 63 | ||
| EG002 | Arm C | Visit 1 (V1) Device: BD/33G,OTM/33G,ACC/28G; Visit 2 (V2)-BD/33G,ACC/28G | 0 | 62 | 11 | 62 | ||
| EG003 | Arm D | Visit 1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit (V2) Device: OTM/33G,OTM/28G | 0 | 63 | 6 | 63 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Kassler-Taub, VP Medical Affairs | Becton Dickinson | 201-847-7009 | kenneth_kassler_taub@bd.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D010146 | Pain |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BD/Novamax |
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| Bayer |
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| Lifescan |
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| Private Label Walgreens |
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| Reli-on |
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| Roche |
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| Other |
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| 6-10 |
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| >10 |
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| Sufficient Volume - Unsuccessful |
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| 100 |
| 95 |
| 98.79 |
| 100 |
| No |
| Superiority or Other |
| Percentage | 100 | 95 | 97.61 | 100 | No | Superiority or Other |
| Percentage | 100 | 95 | 95.36 | 100 | No | Superiority or Other |
| Percentage | 100 | 95 | 95.13 | 100 | No | Superiority or Other |
| ACC/28G - BD/33G |
Accu-Chek Softclix Device/Accu-Chek Softclix 28G Lancet as compared to BD Lancet Device / BD 33G Lancet |
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Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet - BD Lancet Device / BD 33 gauge Lancet |
| OG003 | OTM/28G - OTM/33G | OneTouch MiniDevice / OneTouch 28g Lancet - OneTouch MiniDevice /BD 33 Gauge Lancet |
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