Trial Outcomes & Findings for 24/7 Closed-loop in Older Subjects With Type 1 Diabetes (NCT NCT04025762)
NCT ID: NCT04025762
Last Updated: 2024-12-06
Results Overview
Proportion of time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on continuous glucose monitoring (CGM)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
16 weeks
Results posted on
2024-12-06
Participant Flow
One participant withdrew during the run-in period
Participant milestones
| Measure |
Initial Use of Day and Night Hybrid Closed Loop Control Followed by Sensor Augmented Pump Therapy
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Initial Use of Sensor Augmented Pump Therapy Followed by Day and Night Hybrid Closed-loop Control
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Run-in (3-4 Weeks)
STARTED
|
20
|
17
|
|
Run-in (3-4 Weeks)
COMPLETED
|
20
|
17
|
|
Run-in (3-4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Crossover Study Period 1 (16 Weeks)
STARTED
|
20
|
17
|
|
Crossover Study Period 1 (16 Weeks)
COMPLETED
|
20
|
16
|
|
Crossover Study Period 1 (16 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout Period (4 Weeks)
STARTED
|
20
|
16
|
|
Washout Period (4 Weeks)
COMPLETED
|
20
|
16
|
|
Washout Period (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Crossover Study Period 2 (16 Weeks)
STARTED
|
20
|
16
|
|
Crossover Study Period 2 (16 Weeks)
COMPLETED
|
20
|
16
|
|
Crossover Study Period 2 (16 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Initial Use of Day and Night Hybrid Closed Loop Control Followed by Sensor Augmented Pump Therapy
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Initial Use of Sensor Augmented Pump Therapy Followed by Day and Night Hybrid Closed-loop Control
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Crossover Study Period 1 (16 Weeks)
Death
|
0
|
1
|
Baseline Characteristics
24/7 Closed-loop in Older Subjects With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Initial Use of Day and Night Hybrid Closed Loop Control Followed by Sensor Augmented Pump Therapy
n=20 Participants
Run-in period (3-4 weeks)
16 weeks of day and night hybrid closed-loop system (CamAPS FX) consisting of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
Washout period (4 weeks)
|
Initial Use of Sensor Augmented Pump Therapy Followed by Day and Night Hybrid Closed Loop Control
n=17 Participants
Run-in period (3-4 weeks)
16 weeks of the comparator consisting of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
Washout period (4 weeks)
16 weeks of day and night hybrid closed-loop system (CamAPS FX) consisting of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
67 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Duration of diabetes
|
38 years
n=5 Participants
|
38 years
n=7 Participants
|
38 years
n=5 Participants
|
|
Duration of pump therapy
|
11 years
n=5 Participants
|
9 years
n=7 Participants
|
10 years
n=5 Participants
|
|
Charlson comorbidity index (lower value indicates less comorbidity burden)
|
4 points on a scale (minimum 0 maximum 37)
STANDARD_DEVIATION 2 • n=5 Participants
|
4 points on a scale (minimum 0 maximum 37)
STANDARD_DEVIATION 1 • n=7 Participants
|
4 points on a scale (minimum 0 maximum 37)
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Continuous glucose monitor user
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
HbA1c, mmol/mol
|
58 mmol/mol
STANDARD_DEVIATION 10 • n=5 Participants
|
57 mmol/mol
STANDARD_DEVIATION 9 • n=7 Participants
|
57 mmol/mol
STANDARD_DEVIATION 10 • n=5 Participants
|
|
HbA1c, %
|
7.5 % of glycated hemoglobin
STANDARD_DEVIATION 1.0 • n=5 Participants
|
7.4 % of glycated hemoglobin
STANDARD_DEVIATION 0.9 • n=7 Participants
|
7.4 % of glycated hemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Total daily insulin, units per day
|
45.8 units/day
n=5 Participants
|
40.0 units/day
n=7 Participants
|
45.1 units/day
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Proportion of time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on continuous glucose monitoring (CGM)
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Proportion of Time Spent in the Target Sensor Glucose Range During the 16 Week Intervention Period (%)
|
79.9 % of time
Standard Deviation 7.9
|
71.4 % of time
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
HbA1c at the End of the 16 Week Intervention Period (mmol/Mol)
|
49.3 mmol/mol
Standard Deviation 7.9
|
52.1 mmol/mol
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Proportion of Time Spent Below Target Glucose (3.9mmol/l) (70mg/dl) Based on CGM During the 16 Week Intervention Period (%)
|
1.7 % of time
Interval 1.3 to 2.4
|
1.7 % of time
Interval 0.9 to 2.7
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Proportion of Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl) Based on CGM During the 16 Week Intervention Period (%)
|
16.7 % of time
Interval 11.4 to 23.9
|
21.4 % of time
Interval 16.9 to 36.5
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Average (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
|
7.8 mmol/L
Standard Deviation 0.7
|
8.5 mmol/L
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Proportion of Time With Glucose Levels < 3.5 mmol/l (63mg/dl) Based on CGM During the 16 Week Intervention Period (%)
|
0.7 % of time
Interval 0.5 to 1.1
|
0.7 % of time
Interval 0.4 to 1.2
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Proportion of Time With Glucose Levels in the Significant Hyperglycaemia (Glucose Levels > 16.7 mmol/l) (300mg/dl) Based on CGM During the 16 Week Intervention Period (%)
|
0.5 % of time
Interval 0.2 to 0.8
|
0.8 % of time
Interval 0.2 to 2.8
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Total Daily Insulin Dose During the 16 Week Intervention Period (Units/Day)
|
46.3 units/day
Interval 36.9 to 53.5
|
42.9 units/day
Interval 36.6 to 53.0
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Standard Deviation (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
|
2.6 mmol/L
Standard Deviation 0.5
|
2.8 mmol/L
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Crossover study design
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
n=37 Participants
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
Proportion of Time With Glucose Levels < 3.0 mmol/l (54mg/dl) Based on CGM During the 16 Week Intervention Period (%)
|
0.2 % of time
Interval 0.1 to 0.3
|
0.2 % of time
Interval 0.1 to 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Closed-loop use was only measured during the closed-loop period.
Utility evaluation
Outcome measures
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 Participants
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Hybrid closed-loop system (CamAPS FX): Hybrid closed-loop system
|
Sensor Augmented Pump Therapy
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Sensor augmented pump therapy: Sensor augmented pump therapy
|
|---|---|---|
|
The Proportion of Time of Use of the Closed-loop System at Home During the 16 Week Intervention Period (%)
|
96.7 % of time
Interval 95.1 to 98.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5-7 daysHolter monitor data at the fourth month in the two treatment groups
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysSleep quality assessment using data collected by Actiwatch
Outcome measures
Outcome data not reported
Adverse Events
Day and Night Hybrid Closed Loop Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sensor Augmented Pump Therapy
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Run-in Period
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Washout Period
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 participants at risk
16 weeks of the day and night hybrid closed-loop system (CamAPS FX) which consists of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
|
Sensor Augmented Pump Therapy
n=37 participants at risk
16 weeks of the comparator which consists of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
|
Run-in Period
n=37 participants at risk
3-4 week run-in period with Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
|
Washout Period
n=36 participants at risk
4 week washout period between treatment periods when participants could continue to use the study devices with auto mode disabled or they could continue to use their pre-study devices
|
|---|---|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/36 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
2.7%
1/37 • Number of events 1 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
0.00%
0/37 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
0.00%
0/36 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
|
Endocrine disorders
Unplanned hospital admission
|
0.00%
0/36 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
0.00%
0/37 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
2.7%
1/37 • Number of events 1 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
0.00%
0/36 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
Other adverse events
| Measure |
Day and Night Hybrid Closed Loop Control
n=36 participants at risk
16 weeks of the day and night hybrid closed-loop system (CamAPS FX) which consists of:
* Dana RS insulin pump (Sooil)
* G6 real-time CGM sensor (Dexcom)
* An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
|
Sensor Augmented Pump Therapy
n=37 participants at risk
16 weeks of the comparator which consists of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
|
Run-in Period
n=37 participants at risk
3-4 week run-in period with Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
|
Washout Period
n=36 participants at risk
4 week washout period between treatment periods when participants could continue to use the study devices with auto mode disabled or they could continue to use their pre-study devices
|
|---|---|---|---|---|
|
General disorders
Other
|
11.1%
4/36 • Number of events 6 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
18.9%
7/37 • Number of events 9 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
5.4%
2/37 • Number of events 2 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
2.8%
1/36 • Number of events 1 • Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.
Crossover study design Adverse events reported during the run-in period (pre-randomization) are reported for the whole study cohort and not by group as this was not determined at the time of the adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place