Trial Outcomes & Findings for An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) (NCT NCT02232698)
NCT ID: NCT02232698
Last Updated: 2017-04-10
Results Overview
Difference in time \<70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
328 participants
Primary outcome timeframe
Baseline and Days 194 to 208
Results posted on
2017-04-10
Participant Flow
A total of 328 subjects consented and enrolled into the study. Eighty-seven (87) of these failed screening or withdrew before randomisation. Two hundred and forty-one (241) subjects were randomised and 211 completed the study.
Participant milestones
| Measure |
Sensor Based Glucose Monitoring System
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
121
|
|
Overall Study
COMPLETED
|
110
|
101
|
|
Overall Study
NOT COMPLETED
|
10
|
20
|
Reasons for withdrawal
| Measure |
Sensor Based Glucose Monitoring System
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Met exclusion criteria
|
1
|
1
|
|
Overall Study
Had device-associated symptoms
|
7
|
0
|
|
Overall Study
Non-compliance with study device
|
1
|
4
|
|
Overall Study
Allocated to control group
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
11
|
Baseline Characteristics
An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)
Baseline characteristics by cohort
| Measure |
Sensor Based Glucose Monitoring System
n=119 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=120 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Screening HbA1c
|
50.1 mmol/mol
STANDARD_DEVIATION 5.7 • n=5 Participants
|
50.2 mmol/mol
STANDARD_DEVIATION 6.5 • n=7 Participants
|
50.1 mmol/mol
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Days 194 to 208Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Difference in time \<70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=119 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=119 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Time Spent <70 mg/dL
Baseline
|
3.38 hours per day
Standard Deviation 2.31
|
3.44 hours per day
Standard Deviation 2.62
|
|
Time Spent <70 mg/dL
Days 194-208
|
2.03 hours per day
Standard Deviation 1.93
|
3.27 hours per day
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline and Day 208Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=119 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=120 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
HbA1c at 6 Months
Baseline
|
6.79 percentage of Glycated Haemoglobin
Standard Deviation 0.52
|
6.78 percentage of Glycated Haemoglobin
Standard Deviation 0.64
|
|
HbA1c at 6 Months
Day 208
|
6.94 percentage of Glycated Haemoglobin
Standard Deviation 0.65
|
6.95 percentage of Glycated Haemoglobin
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline and Days 194 to 208Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Difference in time \<55 mg/dL \& \<40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=119 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=119 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Time Spent <55 mg/dL and <40 mg/dL
Time spent <55 mg/dL, Baseline
|
1.59 hours per day
Standard Deviation 1.42
|
1.77 hours per day
Standard Deviation 1.86
|
|
Time Spent <55 mg/dL and <40 mg/dL
Time spent <55 mg/dL, Days 194-208
|
0.80 hours per day
Standard Deviation 0.96
|
1.65 hours per day
Standard Deviation 1.97
|
|
Time Spent <55 mg/dL and <40 mg/dL
Time spent <40 mg/dL, Baseline
|
0.59 hours per day
Standard Deviation 0.85
|
0.75 hours per day
Standard Deviation 1.11
|
|
Time Spent <55 mg/dL and <40 mg/dL
Time spent <40 mg/dL, Days 194-208
|
0.26 hours per day
Standard Deviation 0.47
|
0.73 hours per day
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline and Days 194-208Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Difference in frequency of episodes \<70 mg/dL, \<55 mg/dL and \<40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=119 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=119 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Frequency of episodes <70 mg/dL, Baseline
|
1.81 number of episodes per day
Standard Deviation 0.90
|
1.67 number of episodes per day
Standard Deviation 0.80
|
|
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Frequency of episodes <70 mg/dL, Days 194-208
|
1.32 number of episodes per day
Standard Deviation 0.81
|
1.69 number of episodes per day
Standard Deviation 0.83
|
|
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Frequency of episodes <55 mg/dL, Baseline
|
0.96 number of episodes per day
Standard Deviation 0.65
|
0.92 number of episodes per day
Standard Deviation 0.73
|
|
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Frequency of episodes <55 mg/dL, Days 194-208
|
0.56 number of episodes per day
Standard Deviation 0.55
|
0.92 number of episodes per day
Standard Deviation 0.74
|
|
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Frequency of episodes <40 mg/dL, Baseline
|
0.39 number of episodes per day
Standard Deviation 0.43
|
0.44 number of episodes per day
Standard Deviation 0.51
|
|
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Frequency of episodes <40 mg/dL, Days 194-208
|
0.19 number of episodes per day
Standard Deviation 0.29
|
0.43 number of episodes per day
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline and Days 194 to 208Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Difference in time \>180 mg/dL and \>240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=119 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=119 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Time Spent >180 mg/dL and >240 mg/dL
Time spent >180 mg/dL, Baseline
|
5.62 hours per day
Standard Deviation 2.48
|
5.80 hours per day
Standard Deviation 3.11
|
|
Time Spent >180 mg/dL and >240 mg/dL
Time spent >180 mg/dL, Days 194-208
|
6.16 hours per day
Standard Deviation 3.05
|
6.08 hours per day
Standard Deviation 3.20
|
|
Time Spent >180 mg/dL and >240 mg/dL
Time spent >240 mg/dL, Baseline
|
1.85 hours per day
Standard Deviation 1.44
|
1.91 hours per day
Standard Deviation 1.70
|
|
Time Spent >180 mg/dL and >240 mg/dL
Time spent >240 mg/dL, Days 194-208
|
1.67 hours per day
Standard Deviation 1.36
|
2.06 hours per day
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Baseline and Days 194 to 208Population: 1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Difference 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).
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=119 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=119 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Time in Range
Baseline
|
15.0 hours per day
Standard Deviation 2.5
|
14.8 hours per day
Standard Deviation 2.8
|
|
Time in Range
Days 194-208
|
15.8 hours per day
Standard Deviation 2.9
|
14.6 hours per day
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Days 1 to 208Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=106 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=93 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Number of Glucose Measurements Performed
Number of fingerstick tests, Baseline
|
5.5 number of measurements per day
Standard Deviation 2.0
|
5.8 number of measurements per day
Standard Deviation 1.7
|
|
Number of Glucose Measurements Performed
Number of fingerstick tests, Days 194-208
|
0.6 number of measurements per day
Standard Deviation 1.0
|
5.6 number of measurements per day
Standard Deviation 2.2
|
|
Number of Glucose Measurements Performed
Number of sensor scans, Days 15-208
|
15.1 number of measurements per day
Standard Deviation 6.9
|
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 to self-manage their glucose levels.
|
SECONDARY outcome
Timeframe: Days 15 to 208Population: 112 subjects included in the analysis, 7 were not included due to missing data.
System utilisation assessed by percentage of sensor glucose data collected by the intervention group
Outcome measures
| Measure |
Sensor Based Glucose Monitoring System
n=112 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
System Utilisation
|
92.8 percentage of sensor glucose collected
Standard Deviation 7.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 208The 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=103 Participants
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=86 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
Hyperglycaemia
|
-0.6 units on a scale
Standard Deviation 1.6
|
0.5 units on a scale
Standard Deviation 1.2
|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
Hypoglycaemia
|
-0.3 units on a scale
Standard Deviation 1.6
|
0.1 units on a scale
Standard Deviation 1.1
|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
Treatment Satisfaction
|
13.4 units on a scale
Standard Deviation 5.5
|
7.2 units on a scale
Standard Deviation 6.2
|
Adverse Events
Sensor Based Glucose Monitoring System
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Standard Blood Glucose Monitoring
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sensor Based Glucose Monitoring System
n=120 participants at risk
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=121 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
0.83%
1/120 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
0.00%
0/121 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
|
Gastrointestinal disorders
retroperitoneal haematoma
|
0.83%
1/120 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
0.00%
0/121 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/120 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
0.83%
1/121 • Number of events 1 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
1.7%
2/120 • Number of events 2 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
2.5%
3/121 • Number of events 4 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
Other adverse events
| Measure |
Sensor Based Glucose Monitoring System
n=120 participants at risk
Standard sensing system use 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.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
Standard Blood Glucose Monitoring
n=121 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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
|
|---|---|---|
|
General disorders
medical device site reaction
|
8.3%
10/120 • Number of events 13 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
0.00%
0/121 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
|
Infections and infestations
influenza
|
5.8%
7/120 • Number of events 7 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
5.8%
7/121 • Number of events 7 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
|
Infections and infestations
nasopharyngitis
|
15.8%
19/120 • Number of events 20 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. No serious adverse events were related to the study device.
|
14.0%
17/121 • Number of events 19 • Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group. 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