Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l) |
Intention-to-treat analysis (ITT). |
The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT) |
|
Secondary |
Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l) |
Per protocol analysis (PP) |
Primary intervention period from 06:00h study day 1 - 06:00h study day 6 PP |
|
Secondary |
Percentage of time spent in the alert and clinical hypoglycemic range |
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT) |
Study day 1: The day when the first exercise session is performed and registered. |
|
Secondary |
Percentage of time spent in the alert and clinical hypoglycemic range |
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT) |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Percentage of time spent in the alert and clinical hypoglycemic range |
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT) |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Percentage of time spent in the alert and clinical hypoglycemic range |
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT) |
Day time: 06:00-22:00h from during study day 1 to study day 6. |
|
Secondary |
Percentage of time spent in the alert and clinical hypoglycemic range |
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT) |
Night time: 22:00-06:00h from during study day 1 to study day 6. |
|
Secondary |
Percentage of time spent in the alert and clinical hypoglycemic range |
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT) |
The time the participant has recorded start and end of exercise session during study day 1 to study day 6 |
|
Secondary |
Number of alert and clinical hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Number of alert and clinical hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Number of alert and clinical hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1 - study day 6 |
|
Secondary |
Number of alert and clinical hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 - study day 6 |
|
Secondary |
Number of alert and clinical hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 study day 6 |
|
Secondary |
Number of severe hypoglycemia events during |
Per protocol analysis and intention-to-treat analysis |
Study day 1: The day when the first exercise session is performed and registered |
|
Secondary |
Number of severe hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Number of severe hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Number of severe hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1 - study day 6 |
|
Secondary |
Number of severe hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 - study day 6 |
|
Secondary |
Number of severe hypoglycemia events |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 - study day 6 |
|
Secondary |
Percentage of time in range (3.9-10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Study day 1: The day when the first exercise session is performed and registered |
|
Secondary |
Percentage of time in range (3.9-10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Percentage of time in range (3.9-10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Percentage of time in range (3.9-10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Percentage of time in range (3.9-10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 -study day 6 |
|
Secondary |
Percentage of time in range (3.9-10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Percentage of time in good range (3.9-7.8 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Study day 1: The day when the first exercise session is performed and registered. |
|
Secondary |
Percentage of time in good range (3.9-7.8 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Percentage of time in good range (3.9-7.8 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Percentage of time in good range (3.9-7.8 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h and Night time: 22:00-06:00h during study day 1-study day 6 |
|
Secondary |
Percentage of time in good range (3.9-7.8 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6 |
|
Secondary |
Percentage of time in hyperglycemia (>10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Study day 1: The day when the first exercise session is performed and registered. |
|
Secondary |
Percentage of time in hyperglycemia (>10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Percentage of time in hyperglycemia (>10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Percentage of time in hyperglycemia (>10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 -study day 6 |
|
Secondary |
Percentage of time in hyperglycemia (>10 mmol/l) |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6 |
|
Secondary |
Percentage of time in hyperglycemia (>10 mmol/l) during all the predefined time blocks. Per protocol analysis and intention-to-treat analysis |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Study day 1: The day when the first exercise session is performed and registered. |
|
Secondary |
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 -study day 6 |
|
Secondary |
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Mean CGM glucose level du during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Study day 1: The day when the first exercise session is performed and registered. |
|
Secondary |
Mean CGM glucose level du during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Mean CGM glucose level du during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Mean CGM glucose level du during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Mean CGM glucose level du during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 -study day 6 |
|
Secondary |
Mean CGM glucose level du during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
CGM estimated eA1c during the primary intervention period |
Per protocol analysis and intention-to-treat analysis |
The Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Study day 1: The day when the first exercise session is performed and registered. |
|
Secondary |
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 -study day 6 |
|
Secondary |
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Carbohydrate interventions for prevention and treatment of hypoglycemia registered by the participants in the booklet for the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis c) Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Carbohydrate interventions for prevention and treatment of hypoglycemia registered by the participants in the booklet for the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis c) Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Change in total daily insulin dose (basal and bolus insulin) of 7 days prior to screening day and during the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Change in total daily insulin dose (basal and bolus insulin) of 7 days prior to screening day and during the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Actigraph wrist wear time during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Actigraph wrist wear time during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Actigraph wrist wear time during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Actigraph wrist wear time during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 -study day 6 |
|
Secondary |
Actigraph wrist wear time during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 -study day 6 |
|
Secondary |
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Metabolic expenditure rate for the primary intervention periods |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Metabolic expenditure rate for the primary intervention periods |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Time in sedentary during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Time in sedentary during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Time in sedentary during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Time in sedentary during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Night time: 22:00-06:00h during study day 1 -study day 6 |
|
Secondary |
Time in sedentary during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Time in light physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Time in light physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Time in light physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Time in light physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Time in moderate physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Time in moderate physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). |
|
Secondary |
Time in moderate physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Time in moderate physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Time in vigorous physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Time in vigorous physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Time in vigorous physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Time in vigorous physical activity during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Number of steps during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Number of steps during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Number of steps during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Day time: 06:00-22:00h during study day 1-study day 6 |
|
Secondary |
Number of steps during predefined time blocks |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Heart rate during exercise sessions |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
R-R intervals during exercise sessions (f) |
Per protocol analysis and intention-to-treat analysis |
Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 |
|
Secondary |
Sleep latency (min) during the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Sleep latency (min) during the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Total sleep time (min) during the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Total sleep time (min) during the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Sleep efficiency (%) during the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Sleep efficiency (%) during the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Number of awakening during sleep in the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Number of awakening during sleep in the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Time of awakening during sleep in the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) |
|
Secondary |
Time of awakening during sleep in the primary and total intervention period |
Per protocol analysis and intention-to-treat analysis |
Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) |
|
Secondary |
Question about patient preference regarding the two study arms |
Per protocol analysis and intention-to-treat analysis |
At the end of study. Study day 6 the last interventions period. |
|