Trial Outcomes & Findings for An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes (NCT NCT02082184)
NCT ID: NCT02082184
Last Updated: 2017-05-30
Results Overview
Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
302 participants
Primary outcome timeframe
Baseline and Day 194
Results posted on
2017-05-30
Participant Flow
A total of 302 subjects consented and enrolled into the study. Seventy-eight (78) of these failed screening or withdrew before randomisation. Two hundred and twenty-four (224) subjects were randomised and 201 completed the study.
Participant milestones
| Measure |
Sensor Based Glucose Monitoring System
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
75
|
|
Overall Study
COMPLETED
|
139
|
62
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
| Measure |
Sensor Based Glucose Monitoring System
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Medical diagnosis
|
1
|
2
|
|
Overall Study
Device associated symptoms
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Subject non-compliance
|
0
|
1
|
Baseline Characteristics
An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Sensor Based Glucose Monitoring System
n=149 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=75 Participants
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
59.5 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
59.2 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Screening HbA1c
|
72.0 mmol/mol
STANDARD_DEVIATION 10.6 • n=99 Participants
|
73.5 mmol/mol
STANDARD_DEVIATION 11.3 • n=107 Participants
|
72.5 mmol/mol
STANDARD_DEVIATION 10.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 194Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=149 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=75 Participants
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
HbA1c at 6 Months
Baseline
|
8.65 percentage of Glycated Haemoglobin
Standard Deviation 1.01
|
8.75 percentage of Glycated Haemoglobin
Standard Deviation 0.98
|
|
HbA1c at 6 Months
Day 194
|
8.37 percentage of Glycated Haemoglobin
Standard Deviation 0.83
|
8.34 percentage of Glycated Haemoglobin
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Baseline and Days 194 to 208Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range) using ANCOVA.
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=149 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=75 Participants
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Time in Range
Baseline
|
13.9 hours per day
Standard Deviation 4.5
|
13.5 hours per day
Standard Deviation 5.2
|
|
Time in Range
Days 194-208
|
13.6 hours per day
Standard Deviation 4.6
|
13.2 hours per day
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and Days 194 to 208Difference in time \<70 mg/dL and \<55 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=149 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=75 Participants
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Time Spent <70 mg/dL and <55 mg/dL
Time spent <70 mg/dL, Baseline
|
1.30 hours per day
Standard Deviation 1.78
|
1.08 hours per day
Standard Deviation 1.58
|
|
Time Spent <70 mg/dL and <55 mg/dL
Time spent <70 mg/dL, Days 194-208
|
0.59 hours per day
Standard Deviation 0.82
|
0.99 hours per day
Standard Deviation 1.29
|
|
Time Spent <70 mg/dL and <55 mg/dL
Time spent <55 mg/dL, Baseline
|
0.59 hours per day
Standard Deviation 1.13
|
0.38 hours per day
Standard Deviation 0.83
|
|
Time Spent <70 mg/dL and <55 mg/dL
Time spent <55 mg/dL, Days 194-208
|
0.19 hours per day
Standard Deviation 0.37
|
0.37 hours per day
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Baseline and Days 194 to 208Difference in frequency of episodes \<70 mg/dL and \<55 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=149 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=75 Participants
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Frequency of Episodes <70 mg/dL and <55 mg/dL
Frequency of episodes <70 mg/dL, Baseline
|
0.64 number of episodes per day
Standard Deviation 0.63
|
0.63 number of episodes per day
Standard Deviation 0.66
|
|
Frequency of Episodes <70 mg/dL and <55 mg/dL
Frequency of episodes <70 mg/dL, Days 194-208
|
0.38 number of episodes per day
Standard Deviation 0.45
|
0.53 number of episodes per day
Standard Deviation 0.59
|
|
Frequency of Episodes <70 mg/dL and <55 mg/dL
Frequency of episodes <55 mg/dL, Baseline
|
0.34 number of episodes per day
Standard Deviation 0.50
|
0.27 number of episodes per day
Standard Deviation 0.44
|
|
Frequency of Episodes <70 mg/dL and <55 mg/dL
Frequency of episodes <55 mg/dL, Days 194-208
|
0.14 number of episodes per day
Standard Deviation 0.24
|
0.24 number of episodes per day
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Baseline and Days 194 to 208Difference in time \>180 mg/dL and \>240mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=149 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=75 Participants
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Time Spent >180 mg/dL and >240 mg/dL
Time spent >240 mg/dL, Baseline
|
3.1 hours per day
Standard Deviation 3.3
|
3.9 hours per day
Standard Deviation 4.5
|
|
Time Spent >180 mg/dL and >240 mg/dL
Time spent >240 mg/dL, Days 194-208
|
3.5 hours per day
Standard Deviation 3.7
|
3.9 hours per day
Standard Deviation 4.2
|
|
Time Spent >180 mg/dL and >240 mg/dL
Time spent >180 mg/dL, Baseline
|
8.8 hours per day
Standard Deviation 5.0
|
9.4 hours per day
Standard Deviation 5.8
|
|
Time Spent >180 mg/dL and >240 mg/dL
Time spent >180 mg/dL, Days 194-208
|
9.8 hours per day
Standard Deviation 4.8
|
9.8 hours per day
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Days 15 to 208Number of blood glucose fingerstick tests per day by intervention and control group during days 15 to 208. The number of sensor scans performed by the intervention group during days 15 to 208.
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=132 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=52 Participants
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Number of Glucose Measurements Performed
Number of fingerstick tests, Days 194-208
|
0.4 number of measurements per day
Standard Deviation 1.0
|
3.8 number of measurements per day
Standard Deviation 1.9
|
|
Number of Glucose Measurements Performed
Number of sensor scans, Days 15-208
|
8.3 number of measurements per day
Standard Deviation 4.4
|
NA number of measurements per day
Standard Deviation NA
Number of sensor scans does not apply to this group as they did not use the sensor.
|
SECONDARY outcome
Timeframe: Days 15 to 208Population: 138 subjects included in the analysis, 11 were not included due to missing data.
Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=138 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
System Utilisation
|
88.7 percentage of sensor glucose collected
Standard Deviation 9.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 194The 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 (which ranges from -3 (much less satisfied) to +3 (much more satisfied). 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 perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now). The ANCOVA adjusts for baseline DTSQs (status version).
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=121 Participants
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=50 Participants
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.
Treatment Satisfaction
|
13.4 units on a scale
Standard Deviation 4.3
|
9.6 units on a scale
Standard Deviation 5.6
|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.
Hyperglycaemia
|
0.3 units on a scale
Standard Deviation 1.9
|
0.2 units on a scale
Standard Deviation 1.7
|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.
Hypoglycaemia
|
-0.2 units on a scale
Standard Deviation 1.6
|
0.0 units on a scale
Standard Deviation 1.4
|
Adverse Events
Sensor Based Glucose Monitoring System
Serious events: 16 serious events
Other events: 49 other events
Deaths: 0 deaths
Standard Blood Glucose Monitoring
Serious events: 12 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sensor Based Glucose Monitoring System
n=149 participants at risk
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=75 participants at risk
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Cardiac disorders
acute coronary syndrome
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Cardiac disorders
angina pectoris
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
gastrointestinal carcinoma
|
1.3%
2/149 • Number of events 2 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Cardiac disorders
arrhythmia
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Nervous system disorders
cerebellar ischemia
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
2.7%
2/75 • Number of events 2 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
General disorders
chest pain
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Hepatobiliary disorders
cholecystitis
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Psychiatric disorders
confusional state
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Skin and subcutaneous tissue disorders
diabetic foot
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Cardiac disorders
congestive cardiomyopathy
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Gastrointestinal disorders
enteritis
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Injury, poisoning and procedural complications
forearm fracture
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Gastrointestinal disorders
gastric ulcer
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Infections and infestations
gastroenteritis
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Infections and infestations
gastrointestinal infection
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Gastrointestinal disorders
haematemesis
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
1.3%
2/149 • Number of events 2 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Nervous system disorders
hypoglycaemic coma
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Nervous system disorders
intercostal neuralgia
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Infections and infestations
labyrinthitis
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Musculoskeletal and connective tissue disorders
myositis
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Cardiac disorders
acute myocardial infarction
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
oesophagael carcinoma
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic carcinoma
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic neuroendocrine tumor
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Infections and infestations
cellulitis
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Eye disorders
retinal detachment
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Nervous system disorders
transient ischaemic attack
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
0.00%
0/149 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
1.3%
1/75 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
General disorders
death
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
0.00%
0/75 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
Other adverse events
| Measure |
Sensor Based Glucose Monitoring System
n=149 participants at risk
Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
Standard Blood Glucose Monitoring
n=75 participants at risk
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
20.1%
30/149 • Number of events 32 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
13.3%
10/75 • Number of events 13 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
11/149 • Number of events 13 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
8.0%
6/75 • Number of events 7 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
7/149 • Number of events 9 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
8.0%
6/75 • Number of events 6 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
10/149 • Number of events 27 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
9.3%
7/75 • Number of events 30 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Investigations
Low density lipoprotein increased
|
2.0%
3/149 • Number of events 3 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
5.3%
4/75 • Number of events 4 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
|
Investigations
Blood cholesterol increased
|
0.67%
1/149 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
5.3%
4/75 • Number of events 4 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment. No serious adverse events were related to the study device.
|
Additional Information
Snr Director, Clinical Development & Regulatory Affairs
Abbott Diabetes Care
Phone: 01993 863164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60