Trial Outcomes & Findings for Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose (NCT NCT00741390)
NCT ID: NCT00741390
Last Updated: 2010-03-10
Results Overview
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.
COMPLETED
NA
250 participants
Study Day 1 (Visit 1)
2010-03-10
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Visit 1
STARTED
|
62
|
63
|
62
|
63
|
|
Visit 1
COMPLETED
|
60
|
63
|
55
|
62
|
|
Visit 1
NOT COMPLETED
|
2
|
0
|
7
|
1
|
|
Visit 2
STARTED
|
59
|
61
|
55
|
61
|
|
Visit 2
COMPLETED
|
59
|
61
|
54
|
60
|
|
Visit 2
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=250 Participants
|
|---|---|
|
Age Continuous
|
52.1 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
250 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
Abbott
|
45 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
Agamatrix
|
1 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
BD/Novamax
|
17 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
Bayer
|
20 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
Lifescan
|
106 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
Private Label Walgreens
|
2 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
Reli-on
|
2 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
Roche
|
41 participants
n=5 Participants
|
|
Blood Glucose Meter Brand
Other
|
16 participants
n=5 Participants
|
|
Diabetes Type
Type 1
|
95 participants
n=5 Participants
|
|
Diabetes Type
Type 2
|
155 participants
n=5 Participants
|
|
Years Since Diagnosis
<1
|
12 participants
n=5 Participants
|
|
Years Since Diagnosis
1-5
|
46 participants
n=5 Participants
|
|
Years Since Diagnosis
6-10
|
46 participants
n=5 Participants
|
|
Years Since Diagnosis
>10
|
146 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 (Visit 1)Population: 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.
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.
Outcome measures
| Measure |
BD/33G
n=246 Participants
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.
|
OTM/33G
n=246 Participants
OneTouch Mini Device / BD 33 Gauge Lancet
See description for BD/33G.
|
OTM/28G
n=124 Participants
OneTouch Mini Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G.
|
OTU/28G
n=63 Participants
OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G.
|
ACC/28G
n=60 Participants
Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet
See description for BD/33G.
|
|---|---|---|---|---|---|
|
Blood Sample of Sufficient Volume to Yield a Valid Meter Reading
Sufficient Volume - Success
|
245 Participants
|
246 Participants
|
124 Participants
|
63 Participants
|
60 Participants
|
|
Blood Sample of Sufficient Volume to Yield a Valid Meter Reading
Sufficient Volume - Unsuccessful
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Approximately Day 3 (Visit 2)Population: 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.
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.
Outcome measures
| Measure |
BD/33G
n=59 Participants
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.
|
OTM/33G
n=61 Participants
OneTouch Mini Device / BD 33 Gauge Lancet
See description for BD/33G.
|
OTM/28G
n=55 Participants
OneTouch Mini Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G.
|
OTU/28G
OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G.
|
ACC/28G
Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet
See description for BD/33G.
|
|---|---|---|---|---|---|
|
Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)
|
10.86 mm
Standard Deviation 34.07
|
8.71 mm
Standard Deviation 36.69
|
-0.03 mm
Standard Deviation 31.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately Day 3 (Visit 2)Population: 61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above.
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.
Outcome measures
| Measure |
BD/33G
n=61 Participants
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.
|
OTM/33G
OneTouch Mini Device / BD 33 Gauge Lancet
See description for BD/33G.
|
OTM/28G
OneTouch Mini Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G.
|
OTU/28G
OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G.
|
ACC/28G
Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet
See description for BD/33G.
|
|---|---|---|---|---|---|
|
Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)
|
4.86 mm
Standard Deviation 33.75
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately Day 3 (Visit 2)Population: 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.
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.
Outcome measures
| Measure |
BD/33G
n=59 Participants
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.
|
OTM/33G
n=61 Participants
OneTouch Mini Device / BD 33 Gauge Lancet
See description for BD/33G.
|
OTM/28G
n=55 Participants
OneTouch Mini Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G.
|
OTU/28G
n=61 Participants
OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G.
|
ACC/28G
Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet
See description for BD/33G.
|
|---|---|---|---|---|---|
|
Reported Device Preference Within Lancing Pair at Visit 2
# of pairs in which participants stated preference
|
180 lancing pairs
|
183 lancing pairs
|
173 lancing pairs
|
186 lancing pairs
|
—
|
|
Reported Device Preference Within Lancing Pair at Visit 2
First device in pair preferred
|
67 lancing pairs
|
70 lancing pairs
|
84 lancing pairs
|
73 lancing pairs
|
—
|
|
Reported Device Preference Within Lancing Pair at Visit 2
Second device in pair preferred
|
113 lancing pairs
|
113 lancing pairs
|
89 lancing pairs
|
113 lancing pairs
|
—
|
|
Reported Device Preference Within Lancing Pair at Visit 2
# of pairs in which no preference was stated
|
43 lancing pairs
|
26 lancing pairs
|
32 lancing pairs
|
46 lancing pairs
|
—
|
Adverse Events
Arm A
Arm B
Arm C
Arm D
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A
n=62 participants at risk
Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G
|
Arm B
n=63 participants at risk
Visit 1 (V1) Device: BD/33G,OTM/33G,OTU/28G; Visit 2 (V2) Device: BD/33G,OTU/28G
|
Arm C
n=62 participants at risk
Visit 1 (V1) Device: BD/33G,OTM/33G,ACC/28G; Visit 2 (V2)-BD/33G,ACC/28G
|
Arm D
n=63 participants at risk
Visit 1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit (V2) Device: OTM/33G,OTM/28G
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.6%
1/62 • Number of events 1 • 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.
|
1.6%
1/63 • Number of events 1 • 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.
|
11.3%
7/62 • Number of events 7 • 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.
|
3.2%
2/63 • Number of events 2 • 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.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
6.5%
4/62 • Number of events 6 • 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.
|
7.9%
5/63 • Number of events 6 • 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.
|
6.5%
4/62 • Number of events 5 • 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.
|
6.3%
4/63 • Number of events 8 • 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.
|
Additional Information
Kenneth Kassler-Taub, VP Medical Affairs
Becton Dickinson
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60