Trial Outcomes & Findings for Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study (NCT NCT01519466)
NCT ID: NCT01519466
Last Updated: 2016-04-01
Results Overview
Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)
COMPLETED
NA
55 participants
Day 1-15 compared with Day 60-74
2016-04-01
Participant Flow
A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.
Participant milestones
| Measure |
FreeStyle InsuLinx
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
|
FreeStyle Freedom Lite
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
16
|
|
Overall Study
COMPLETED
|
33
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
Baseline characteristics by cohort
| Measure |
FreeStyle InsuLinx
n=33 Participants
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
|
FreeStyle Freedom Lite
n=16 Participants
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 15.2 • n=93 Participants
|
43.4 years
STANDARD_DEVIATION 16.7 • n=4 Participants
|
44.1 years
STANDARD_DEVIATION 15.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
8 participants
n=93 Participants
|
4 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
25 participants
n=93 Participants
|
12 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
26.6 kg/m²
STANDARD_DEVIATION 3.6 • n=93 Participants
|
26.4 kg/m²
STANDARD_DEVIATION 4.4 • n=4 Participants
|
26.5 kg/m²
STANDARD_DEVIATION 3.8 • n=27 Participants
|
|
Duration of Diabetes
|
18.8 years
STANDARD_DEVIATION 14.1 • n=93 Participants
|
14.6 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
17.4 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
|
Screening HbA1c
|
7.8 Percentage of Glycosylated Haemoglobin
STANDARD_DEVIATION 0.7 • n=93 Participants
|
8.1 Percentage of Glycosylated Haemoglobin
STANDARD_DEVIATION 0.6 • n=4 Participants
|
7.9 Percentage of Glycosylated Haemoglobin
STANDARD_DEVIATION 0.7 • n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1-15 compared with Day 60-74Population: One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)
Outcome measures
| Measure |
FreeStyle InsuLinx
n=32 Participants
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
|
FreeStyle Freedom Lite
n=16 Participants
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter
|
|---|---|---|
|
Time in Target Blood Glucose Range
Baseline
|
15.28 hours per day
Standard Deviation 2.76
|
15.31 hours per day
Standard Deviation 3.15
|
|
Time in Target Blood Glucose Range
Final
|
14.56 hours per day
Standard Deviation 2.99
|
14.14 hours per day
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: Day 1 compared with Day 74Population: One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).
Outcome measures
| Measure |
FreeStyle InsuLinx
n=32 Participants
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
|
FreeStyle Freedom Lite
n=16 Participants
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter
|
|---|---|---|
|
HbA1c
Baseline
|
7.87 Percentage of Glycosylated Haemoglobin
Standard Deviation 0.76
|
8.07 Percentage of Glycosylated Haemoglobin
Standard Deviation 0.76
|
|
HbA1c
Final
|
7.78 Percentage of Glycosylated Haemoglobin
Standard Deviation 0.58
|
7.98 Percentage of Glycosylated Haemoglobin
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Day 60 compared to day 1Population: One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied). The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.
Outcome measures
| Measure |
FreeStyle InsuLinx
n=32 Participants
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
|
FreeStyle Freedom Lite
n=16 Participants
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter
|
|---|---|---|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.
Hyperglycaemia
|
0.13 Units on a scale
Standard Deviation 1.26
|
-0.25 Units on a scale
Standard Deviation 1.53
|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.
Hypoglycaemia
|
-0.31 Units on a scale
Standard Deviation 1.03
|
0.13 Units on a scale
Standard Deviation 1.02
|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.
Treatment Satisfaction
|
4.36 Units on a scale
Standard Deviation 6.53
|
2.94 Units on a scale
Standard Deviation 7.92
|
Adverse Events
FreeStyle InsuLinx
FreeStyle Freedom Lite
Serious adverse events
| Measure |
FreeStyle InsuLinx
n=33 participants at risk
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
|
FreeStyle Freedom Lite
n=16 participants at risk
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter
|
|---|---|---|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/33 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
6.2%
1/16 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
|
Infections and infestations
Gingiva abcess
|
0.00%
0/33 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
6.2%
1/16 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
|
Musculoskeletal and connective tissue disorders
Fractured Metacarpus
|
3.0%
1/33 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
0.00%
0/16 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
|
Skin and subcutaneous tissue disorders
Sensor tip
|
3.0%
1/33 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
0.00%
0/16 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
|
Skin and subcutaneous tissue disorders
Haematoma
|
3.0%
1/33 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
0.00%
0/16 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
Other adverse events
| Measure |
FreeStyle InsuLinx
n=33 participants at risk
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
|
FreeStyle Freedom Lite
n=16 participants at risk
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
12.1%
4/33 • Number of events 5 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
12.5%
2/16 • Number of events 3 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
6.2%
1/16 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
|
Endocrine disorders
Hypoglycaemia
|
9.1%
3/33 • Number of events 3 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
6.2%
1/16 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
|
Infections and infestations
Infection
|
6.1%
2/33 • Number of events 2 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
6.2%
1/16 • Number of events 1 • Adverse events collected from enrolment to completion by last subject (up to 3 months).
|
Additional Information
Snr Director, Clinical Development & Regulatory Affairs
Abbott Diabetes Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60