Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Mean glucose levels during the early follicular phase |
|
Day 1 to 5 of the menstrual cycle |
|
Primary |
Mean glucose levels during the mid-late follicular phase |
|
Day 6 until 2 days prior to ovulation |
|
Primary |
Mean glucose levels during the periovulation phase |
|
Ovulation plus/minus 1 day |
|
Primary |
Mean glucose levels during the early luteal phase |
|
Day 2 to 4 after ovulation |
|
Primary |
Mean glucose levels during the mid-luteal phase |
|
Day 5 to 9 after ovulation |
|
Primary |
Mean glucose levels during the late luteal phase |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L |
|
Ovulation plus/minus 1 day |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L |
|
Day 2 to 4 after ovulation |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L |
|
Day 5 to 9 after ovulation |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 7.8 mmol/L |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 10.0 mmol/L |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 10.0 mmol/L |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 10.0 mmol/L |
|
Ovulation plus/minus 1 day |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 10.0 mmol/L |
|
Day 2 to 4 after ovulation |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 10.0 mmol/L |
|
Day 5 to 9 after ovulation |
|
Secondary |
Percentage of time of glucose levels between 3.9 and 10.0 mmol/L |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Percentage of time of glucose levels below 3.9 mmol/L |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Percentage of time of glucose levels below 3.9 mmol/L |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Percentage of time of glucose levels below 3.9 mmol/L |
|
Ovulation plus/minus 1 day |
|
Secondary |
Percentage of time of glucose levels below 3.9 mmol/L |
|
Day 2 to 4 after ovulation |
|
Secondary |
Percentage of time of glucose levels below 3.9 mmol/L |
|
Day 5 to 9 after ovulation |
|
Secondary |
Percentage of time of glucose levels below 3.9 mmol/L |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Percentage of time of glucose levels below 3.0 mmol/L |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Percentage of time of glucose levels below 3.0 mmol/L |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Percentage of time of glucose levels below 3.0 mmol/L |
|
Ovulation plus/minus 1 day |
|
Secondary |
Percentage of time of glucose levels below 3.0 mmol/L |
|
Day 2 to 4 after ovulation |
|
Secondary |
Percentage of time of glucose levels below 3.0 mmol/L |
|
Day 5 to 9 after ovulation |
|
Secondary |
Percentage of time of glucose levels below 3.0 mmol/L |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Percentage of time of glucose levels above 10.0 mmol/L |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Percentage of time of glucose levels above 10.0 mmol/L |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Percentage of time of glucose levels above 10.0 mmol/L |
|
Ovulation plus/minus 1 day |
|
Secondary |
Percentage of time of glucose levels above 10.0 mmol/L |
|
Day 2 to 4 after ovulation |
|
Secondary |
Percentage of time of glucose levels above 10.0 mmol/L |
|
Day 5 to 9 after ovulation |
|
Secondary |
Percentage of time of glucose levels above 10.0 mmol/L |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Percentage of time of glucose levels above 13.9 mmol/L |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Percentage of time of glucose levels above 13.9 mmol/L |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Percentage of time of glucose levels above 13.9 mmol/L |
|
Ovulation plus/minus 1 day |
|
Secondary |
Percentage of time of glucose levels above 13.9 mmol/L |
|
Day 2 to 4 after ovulation |
|
Secondary |
Percentage of time of glucose levels above 13.9 mmol/L |
|
Day 5 to 9 after ovulation |
|
Secondary |
Percentage of time of glucose levels above 13.9 mmol/L |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Standard deviation of glucose levels |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Standard deviation of glucose levels |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Standard deviation of glucose levels |
|
Ovulation plus/minus 1 day |
|
Secondary |
Standard deviation of glucose levels |
|
Day 2 to 4 after ovulation |
|
Secondary |
Standard deviation of glucose levels |
|
Day 5 to 9 after ovulation |
|
Secondary |
Standard deviation of glucose levels |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Coefficient of variance of glucose levels |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Coefficient of variance of glucose levels |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Coefficient of variance of glucose levels |
|
Ovulation plus/minus 1 day |
|
Secondary |
Coefficient of variance of glucose levels |
|
Day 2 to 4 after ovulation |
|
Secondary |
Coefficient of variance of glucose levels |
|
Day 5 to 9 after ovulation |
|
Secondary |
Coefficient of variance of glucose levels |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Low blood glucose index |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Low blood glucose index |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Low blood glucose index |
|
Ovulation plus/minus 1 day |
|
Secondary |
Low blood glucose index |
|
Day 2 to 4 after ovulation |
|
Secondary |
Low blood glucose index |
|
Day 5 to 9 after ovulation |
|
Secondary |
Low blood glucose index |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
High blood glucose index |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
High blood glucose index |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
High blood glucose index |
|
Ovulation plus/minus 1 day |
|
Secondary |
High blood glucose index |
|
Day 2 to 4 after ovulation |
|
Secondary |
High blood glucose index |
|
Day 5 to 9 after ovulation |
|
Secondary |
High blood glucose index |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Standard deviation of insulin delivery |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Standard deviation of insulin delivery |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Standard deviation of insulin delivery |
|
Ovulation plus/minus 1 day |
|
Secondary |
Standard deviation of insulin delivery |
|
Day 2 to 4 after ovulation |
|
Secondary |
Standard deviation of insulin delivery |
|
Day 5 to 9 after ovulation |
|
Secondary |
Standard deviation of insulin delivery |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Coefficient of variance of insulin delivery |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Coefficient of variance of insulin delivery |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Coefficient of variance of insulin delivery |
|
Ovulation plus/minus 1 day |
|
Secondary |
Coefficient of variance of insulin delivery |
|
Day 2 to 4 after ovulation |
|
Secondary |
Coefficient of variance of insulin delivery |
|
Day 5 to 9 after ovulation |
|
Secondary |
Coefficient of variance of insulin delivery |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|
Secondary |
Total insulin delivery |
|
Day 1 to 5 of the menstrual cycle |
|
Secondary |
Total insulin delivery |
|
Day 6 until 2 days prior to ovulation |
|
Secondary |
Total insulin delivery |
|
Ovulation plus/minus 1 day |
|
Secondary |
Total insulin delivery |
|
Day 2 to 4 after ovulation |
|
Secondary |
Total insulin delivery |
|
Day 5 to 9 after ovulation |
|
Secondary |
Total insulin delivery |
|
Day 10 after ovulation until the first day of the next menstrual cycle |
|