Trial Outcomes & Findings for Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes (NCT NCT01713348)
NCT ID: NCT01713348
Last Updated: 2016-03-04
Results Overview
Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
Day 86 to 100 compared to Day 1 to 15
Results posted on
2016-03-04
Participant Flow
A total of 105 subjects consented and enrolled into the study. Eighteen of these withdrew before randomisation or failed screening. Eighty-seven (87) subjects were randomised and 79 completed the study.
Participant milestones
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
CGM - Intervention Arm - Type 2 Diabetes
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
13
|
30
|
15
|
|
Overall Study
COMPLETED
|
25
|
11
|
28
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
CGM - Intervention Arm - Type 2 Diabetes
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
Baseline characteristics by cohort
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
n=29 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
n=13 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
CGM - Intervention Arm - Type 2 Diabetes
n=30 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
n=15 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
43.7 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
57.8 years
STANDARD_DEVIATION 8.8 • n=27 Participants
|
55.5 years
STANDARD_DEVIATION 10.9 • n=483 Participants
|
49.0 years
STANDARD_DEVIATION 13.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
51 Participants
n=36 Participants
|
|
Region of Enrollment
United Kingdom
|
29 participants
n=93 Participants
|
13 participants
n=4 Participants
|
30 participants
n=27 Participants
|
15 participants
n=483 Participants
|
87 participants
n=36 Participants
|
|
Baseline HbA1c
|
9.2 %
STANDARD_DEVIATION 1.3 • n=93 Participants
|
9.0 %
STANDARD_DEVIATION 1.3 • n=4 Participants
|
9.2 %
STANDARD_DEVIATION 1.4 • n=27 Participants
|
9.2 %
STANDARD_DEVIATION 1.3 • n=483 Participants
|
9.1 %
STANDARD_DEVIATION 1.3 • n=36 Participants
|
PRIMARY outcome
Timeframe: Day 86 to 100 compared to Day 1 to 15Population: All analyses were performed according to the intention-to-treat principle.
Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.
Outcome measures
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
n=29 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
n=11 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
CGM - Intervention Arm - Type 2 Diabetes
n=28 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
n=15 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
|---|---|---|---|---|
|
Time in Range
Baseline
|
10.9 hours per day
Standard Deviation 3.0
|
11.5 hours per day
Standard Deviation 4.6
|
13.3 hours per day
Standard Deviation 5.2
|
12.3 hours per day
Standard Deviation 7.0
|
|
Time in Range
Final
|
10.8 hours per day
Standard Deviation 3.9
|
11.5 hours per day
Standard Deviation 4.2
|
14.7 hours per day
Standard Deviation 5.8
|
13.3 hours per day
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Days 86 to 100 intervention arm compared to control armPopulation: All analyses were performed according to the intention-to-treat principle.
Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.
Outcome measures
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
n=29 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
n=11 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
CGM - Intervention Arm - Type 2 Diabetes
n=28 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
n=15 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
|---|---|---|---|---|
|
Time in Range
Final
|
10.8 hours per day
Standard Deviation 3.9
|
11.5 hours per day
Standard Deviation 4.2
|
14.7 hours per day
Standard Deviation 5.8
|
13.3 hours per day
Standard Deviation 5.5
|
|
Time in Range
Baseline
|
10.9 hours per day
Standard Deviation 3.0
|
11.5 hours per day
Standard Deviation 4.6
|
13.3 hours per day
Standard Deviation 5.2
|
12.3 hours per day
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Day 86 to 100 compared to day 1 to 15Outcome measures
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
n=29 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
n=11 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
CGM - Intervention Arm - Type 2 Diabetes
n=28 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
n=15 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
|---|---|---|---|---|
|
Glucose Standard Deviation (SD)
Baseline
|
4.0 mmol/L
Standard Deviation 0.8
|
3.7 mmol/L
Standard Deviation 0.8
|
3.0 mmol/L
Standard Deviation 0.7
|
3.1 mmol/L
Standard Deviation 1.0
|
|
Glucose Standard Deviation (SD)
Final
|
3.8 mmol/L
Standard Deviation 0.7
|
3.8 mmol/L
Standard Deviation 0.6
|
2.8 mmol/L
Standard Deviation 0.7
|
3.0 mmol/L
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Day 100 compared to day 1Population: Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier.
Outcome measures
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
n=28 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
n=13 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
CGM - Intervention Arm - Type 2 Diabetes
n=30 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
n=15 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
|---|---|---|---|---|
|
HbA1c (mmol/Mol)
Baseline
|
75 mmol/mol
Standard Deviation 10
|
75 mmol/mol
Standard Deviation 14
|
77 mmol/mol
Standard Deviation 15
|
77 mmol/mol
Standard Deviation 14
|
|
HbA1c (mmol/Mol)
Final
|
72 mmol/mol
Standard Deviation 8
|
74 mmol/mol
Standard Deviation 14
|
67 mmol/mol
Standard Deviation 13
|
72 mmol/mol
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Day 100 compared to day 1Population: Analysis performed according to the intention-to-treat principle.
Outcome measures
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
n=28 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
n=13 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
CGM - Intervention Arm - Type 2 Diabetes
n=30 Participants
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
n=15 Participants
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
|
|---|---|---|---|---|
|
HbA1c
Baseline
|
9.0 Percent
Standard Deviation 0.9
|
9.0 Percent
Standard Deviation 1.3
|
9.2 Percent
Standard Deviation 1.4
|
9.2 Percent
Standard Deviation 1.3
|
|
HbA1c
Final
|
8.7 Percent
Standard Deviation 0.7
|
8.9 Percent
Standard Deviation 1.3
|
8.3 Percent
Standard Deviation 1.2
|
8.8 Percent
Standard Deviation 0.8
|
Adverse Events
CGM - Intervention Arm - Type 1 Diabetes
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
SMBG - Control Arm - Type 1 Diabetes
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CGM - Intervention Arm - Type 2 Diabetes
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
SMBG - Control Arm - Type 2 Diabetes
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
n=29 participants at risk
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
n=13 participants at risk
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100.
|
CGM - Intervention Arm - Type 2 Diabetes
n=30 participants at risk
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
n=15 participants at risk
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100.
|
|---|---|---|---|---|
|
Endocrine disorders
Severe hypoglycaemia
|
3.4%
1/29 • Number of events 2 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
1/15 • Number of events 1 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
Other adverse events
| Measure |
CGM - Intervention Arm - Type 1 Diabetes
n=29 participants at risk
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 1 Diabetes
n=13 participants at risk
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100.
|
CGM - Intervention Arm - Type 2 Diabetes
n=30 participants at risk
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
|
SMBG - Control Arm - Type 2 Diabetes
n=15 participants at risk
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100.
|
|---|---|---|---|---|
|
Endocrine disorders
Hypoglycaemia
|
10.3%
3/29 • Number of events 10 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
7.7%
1/13 • Number of events 4 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
2/30 • Number of events 5 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
10.0%
3/30 • Number of events 3 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Skin and subcutaneous tissue disorders
Sensor tip
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
2/30 • Number of events 2 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
27.6%
8/29 • Number of events 11 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
30.8%
4/13 • Number of events 6 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
26.7%
8/30 • Number of events 11 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
20.0%
3/15 • Number of events 3 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Respiratory, thoracic and mediastinal disorders
Infection
|
6.9%
2/29 • Number of events 2 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
40.0%
6/15 • Number of events 9 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Gastrointestinal disorders
Sickness
|
13.8%
4/29 • Number of events 4 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
General disorders
Infection - general
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
7.7%
1/13 • Number of events 1 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
2/30 • Number of events 2 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
1/15 • Number of events 1 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
General disorders
Allergic reaction
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
7.7%
1/13 • Number of events 1 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
7.7%
1/13 • Number of events 1 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
2/30 • Number of events 2 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Psychiatric disorders
Depression
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
1/15 • Number of events 1 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
General disorders
Headache
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
1/15 • Number of events 1 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Renal and urinary disorders
Infection - renal
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
6.7%
1/15 • Number of events 1 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/30 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
13.3%
2/15 • Number of events 2 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
|
General disorders
Dental
|
0.00%
0/29 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/13 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
10.0%
3/30 • Number of events 3 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
0.00%
0/15 • Adverse events collected from enrollment to completion by last subject (8 months)
In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.
|
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