Trial Outcomes & Findings for Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study (NCT NCT01432275)
NCT ID: NCT01432275
Last Updated: 2017-08-04
Results Overview
Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
179 participants
Primary outcome timeframe
25 days
Results posted on
2017-08-04
Participant Flow
A total of 179 subjects were enrolled on this study, 164 completed the study.
One subject was excluded due to not meeting all inclusion criteria, one subject withdrew before randomisation.
Participant milestones
| Measure |
ADC, Then Comparator, Then ADC With Calculator
Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
|
Comparator, Then ADC, Then ADC With Calculator
Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
|
|---|---|---|
|
First BG Meter System (7 Days)
STARTED
|
90
|
87
|
|
First BG Meter System (7 Days)
COMPLETED
|
90
|
84
|
|
First BG Meter System (7 Days)
NOT COMPLETED
|
0
|
3
|
|
Second BG Meter System (7 Days)
STARTED
|
90
|
84
|
|
Second BG Meter System (7 Days)
COMPLETED
|
88
|
81
|
|
Second BG Meter System (7 Days)
NOT COMPLETED
|
2
|
3
|
|
ADC With Calculator (10 Days)
STARTED
|
88
|
81
|
|
ADC With Calculator (10 Days)
COMPLETED
|
85
|
79
|
|
ADC With Calculator (10 Days)
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
ADC, Then Comparator, Then ADC With Calculator
Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
|
Comparator, Then ADC, Then ADC With Calculator
Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
|
|---|---|---|
|
First BG Meter System (7 Days)
Adverse Event
|
0
|
2
|
|
First BG Meter System (7 Days)
Withdrawal by Subject
|
0
|
1
|
|
Second BG Meter System (7 Days)
Adverse Event
|
1
|
1
|
|
Second BG Meter System (7 Days)
Lost to Follow-up
|
1
|
0
|
|
Second BG Meter System (7 Days)
Physician Decision
|
0
|
1
|
|
Second BG Meter System (7 Days)
Withdrawal by Subject
|
0
|
1
|
|
ADC With Calculator (10 Days)
Physician Decision
|
1
|
1
|
|
ADC With Calculator (10 Days)
Withdrawal by Subject
|
2
|
0
|
|
ADC With Calculator (10 Days)
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
Baseline characteristics by cohort
| Measure |
Per Protocol Population
n=164 Participants
Subjects who completed the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
145 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
164 participants
n=5 Participants
|
|
Type of Diabetes
Type 1
|
128 participants
n=5 Participants
|
|
Type of Diabetes
Type 2
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 25 daysPopulation: A comparator blood glucose meter was used for 7 days and a FreeStyle InsuLinx for 7 days (insulin calculator inactive). For the last 10 days a FreeStyle InsuLinx with the insulin calculator activated was used. Each subject was assigned one of the three competitor systems. Subjects had not previously used any study systems. Analysis per protocol.
Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.
Outcome measures
| Measure |
Per Protocol Population
n=164 Participants
Subjects completing the study using the FreeStyle InsuLinx Blood Glucose Meter and one of the comparator blood glucose meters
|
|---|---|
|
Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.
|
125 participants
|
SECONDARY outcome
Timeframe: 25 days (results recorded after the two 7 day periods)Population: Subjects used a comparator blood glucose meter for 7 days and a FreeStyle InsuLinx meter for 7 days (insulin calculator deactivated). Subjects then completed a preference questionnaire. Each subject was assigned one of the three competitor systems. Subjects had not previously used either study device. Analysis per protocol.
Result for the question: "The meter the subject would change to"
Outcome measures
| Measure |
Per Protocol Population
n=164 Participants
Subjects completing the study using the FreeStyle InsuLinx Blood Glucose Meter and one of the comparator blood glucose meters
|
|---|---|
|
Preference Questionnaire (Insulin Calculator Not Activated)
Subject would change to FreeStyle InsuLinx
|
98 participants
|
|
Preference Questionnaire (Insulin Calculator Not Activated)
Subject would change to a comparison meter
|
32 participants
|
|
Preference Questionnaire (Insulin Calculator Not Activated)
Not likely to change / not sure / missing answer
|
34 participants
|
Adverse Events
ADC Blood Glucose Meter
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparator Blood Glucose Meter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ADC Blood Glucose Meter With Calculator
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADC Blood Glucose Meter
n=178 participants at risk；n=177 participants at risk
ADC blood glucose meter for 7 days with the insulin calculator not activated.
|
Comparator Blood Glucose Meter
n=178 participants at risk；n=177 participants at risk
Comparator blood glucose meter for 7 days.
|
ADC Blood Glucose Meter With Calculator
n=169 participants at risk
ADC blood glucose meter for 10 days with the insulin calculator active.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/177 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
0.00%
0/177 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
0.59%
1/169 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
|
Endocrine disorders
Hypoglycaemia
|
0.56%
1/177 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
0.00%
0/177 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
0.00%
0/169 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.56%
1/177 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
0.00%
0/177 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
0.00%
0/169 • Adverse events collected from enrolment to completion by last subject (up to 2 months).
|
Other adverse events
Adverse event data not reported
Additional Information
Snr Director, Clinical Development & Regulatory Affairs
Abbott Diabetes Care
Phone: 01993863164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60