Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In clinical practice, women living with type 1 diabetes frequently report that insulin requirements change across the menstrual cycle. Consequently, glycemic fluctuations are observed. This phenomenon could be explained by a decrease in insulin sensitivity during the second half of the menstrual cycle (luteal phase).
Overall, despite an important proportion of women reporting glycemic and/or insulin variations across the menstrual cycle, studies to date have involved small sample sizes, and have had inconsistent results. The objective of this study will be to study glycemic fluctuations across the menstrual cycle using CGM data, alongside insulin data, in a large sample of women.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with type 1 diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring | Device | Glucose levels will be measured using continuous glucose monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose levels during the early follicular phase | Day 1 to 5 of the menstrual cycle | |
| Mean glucose levels during the mid-late follicular phase | Day 6 until 2 days prior to ovulation | |
| Mean glucose levels during the periovulation phase | Ovulation plus/minus 1 day | |
| Mean glucose levels during the early luteal phase | Day 2 to 4 after ovulation | |
| Mean glucose levels during the mid-luteal phase | Day 5 to 9 after ovulation | |
| Mean glucose levels during the late luteal phase | Day 10 after ovulation until the first day of the next menstrual cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels between 3.9 and 7.8 mmol/L | Day 1 to 5 of the menstrual cycle | |
| Percentage of time of glucose levels between 3.9 and 7.8 mmol/L | Day 6 until 2 days prior to ovulation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Women aged 18 to 50 living with type 1 diabetes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Bonhoure | Contact | 514-987-5500 | 3238 | anne.bonhoure@ircm.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Rémi Rabasa-Lhoret | Institut de Recherches Cliniques de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherches cliniques de Montréal | Recruiting | Montreal | Quebec | H2W 1R7 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| D007328 | Insulin |
| D008597 | Menstrual Cycle |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin | Drug | Insulin doses will be retrieved from insulin pump reports (for insulin pump users) or journals for (for multiple daily injections users) |
|
| Premenstrual symptoms | Other | Premenstrual symptoms will be assessed using the Premenstrual symptoms screening tool |
|
| Ovulation kits | Other | Ovulation testing will be done using ovulation kits |
|
| Fitbit Inspire 2 | Device | Physical activity will be assessed using the Fitbit Inspire 2 |
|
| Keenoa | Other | Food intake will be assessed using the Keenoa phone application |
|
| Menstrual cycle | Other | The application My Calendar will be used to record information on the menstrual cycle |
|
| Percentage of time of glucose levels between 3.9 and 7.8 mmol/L | Ovulation plus/minus 1 day |
| Percentage of time of glucose levels between 3.9 and 7.8 mmol/L | Day 2 to 4 after ovulation |
| Percentage of time of glucose levels between 3.9 and 7.8 mmol/L | Day 5 to 9 after ovulation |
| 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 |
| Percentage of time of glucose levels between 3.9 and 10.0 mmol/L | Day 1 to 5 of the menstrual cycle |
| Percentage of time of glucose levels between 3.9 and 10.0 mmol/L | Day 6 until 2 days prior to ovulation |
| Percentage of time of glucose levels between 3.9 and 10.0 mmol/L | Ovulation plus/minus 1 day |
| Percentage of time of glucose levels between 3.9 and 10.0 mmol/L | Day 2 to 4 after ovulation |
| Percentage of time of glucose levels between 3.9 and 10.0 mmol/L | Day 5 to 9 after ovulation |
| 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 |
| Percentage of time of glucose levels below 3.9 mmol/L | Day 1 to 5 of the menstrual cycle |
| Percentage of time of glucose levels below 3.9 mmol/L | Day 6 until 2 days prior to ovulation |
| Percentage of time of glucose levels below 3.9 mmol/L | Ovulation plus/minus 1 day |
| Percentage of time of glucose levels below 3.9 mmol/L | Day 2 to 4 after ovulation |
| Percentage of time of glucose levels below 3.9 mmol/L | Day 5 to 9 after ovulation |
| Percentage of time of glucose levels below 3.9 mmol/L | Day 10 after ovulation until the first day of the next menstrual cycle |
| Percentage of time of glucose levels below 3.0 mmol/L | Day 1 to 5 of the menstrual cycle |
| Percentage of time of glucose levels below 3.0 mmol/L | Day 6 until 2 days prior to ovulation |
| Percentage of time of glucose levels below 3.0 mmol/L | Ovulation plus/minus 1 day |
| Percentage of time of glucose levels below 3.0 mmol/L | Day 2 to 4 after ovulation |
| Percentage of time of glucose levels below 3.0 mmol/L | Day 5 to 9 after ovulation |
| Percentage of time of glucose levels below 3.0 mmol/L | Day 10 after ovulation until the first day of the next menstrual cycle |
| Percentage of time of glucose levels above 10.0 mmol/L | Day 1 to 5 of the menstrual cycle |
| Percentage of time of glucose levels above 10.0 mmol/L | Day 6 until 2 days prior to ovulation |
| Percentage of time of glucose levels above 10.0 mmol/L | Ovulation plus/minus 1 day |
| Percentage of time of glucose levels above 10.0 mmol/L | Day 2 to 4 after ovulation |
| Percentage of time of glucose levels above 10.0 mmol/L | Day 5 to 9 after ovulation |
| Percentage of time of glucose levels above 10.0 mmol/L | Day 10 after ovulation until the first day of the next menstrual cycle |
| Percentage of time of glucose levels above 13.9 mmol/L | Day 1 to 5 of the menstrual cycle |
| Percentage of time of glucose levels above 13.9 mmol/L | Day 6 until 2 days prior to ovulation |
| Percentage of time of glucose levels above 13.9 mmol/L | Ovulation plus/minus 1 day |
| Percentage of time of glucose levels above 13.9 mmol/L | Day 2 to 4 after ovulation |
| Percentage of time of glucose levels above 13.9 mmol/L | Day 5 to 9 after ovulation |
| Percentage of time of glucose levels above 13.9 mmol/L | Day 10 after ovulation until the first day of the next menstrual cycle |
| Standard deviation of glucose levels | Day 1 to 5 of the menstrual cycle |
| Standard deviation of glucose levels | Day 6 until 2 days prior to ovulation |
| Standard deviation of glucose levels | Ovulation plus/minus 1 day |
| Standard deviation of glucose levels | Day 2 to 4 after ovulation |
| Standard deviation of glucose levels | Day 5 to 9 after ovulation |
| Standard deviation of glucose levels | Day 10 after ovulation until the first day of the next menstrual cycle |
| Coefficient of variance of glucose levels | Day 1 to 5 of the menstrual cycle |
| Coefficient of variance of glucose levels | Day 6 until 2 days prior to ovulation |
| Coefficient of variance of glucose levels | Ovulation plus/minus 1 day |
| Coefficient of variance of glucose levels | Day 2 to 4 after ovulation |
| Coefficient of variance of glucose levels | Day 5 to 9 after ovulation |
| Coefficient of variance of glucose levels | Day 10 after ovulation until the first day of the next menstrual cycle |
| Low blood glucose index | Day 1 to 5 of the menstrual cycle |
| Low blood glucose index | Day 6 until 2 days prior to ovulation |
| Low blood glucose index | Ovulation plus/minus 1 day |
| Low blood glucose index | Day 2 to 4 after ovulation |
| Low blood glucose index | Day 5 to 9 after ovulation |
| Low blood glucose index | Day 10 after ovulation until the first day of the next menstrual cycle |
| High blood glucose index | Day 1 to 5 of the menstrual cycle |
| High blood glucose index | Day 6 until 2 days prior to ovulation |
| High blood glucose index | Ovulation plus/minus 1 day |
| High blood glucose index | Day 2 to 4 after ovulation |
| High blood glucose index | Day 5 to 9 after ovulation |
| High blood glucose index | Day 10 after ovulation until the first day of the next menstrual cycle |
| Standard deviation of insulin delivery | Day 1 to 5 of the menstrual cycle |
| Standard deviation of insulin delivery | Day 6 until 2 days prior to ovulation |
| Standard deviation of insulin delivery | Ovulation plus/minus 1 day |
| Standard deviation of insulin delivery | Day 2 to 4 after ovulation |
| Standard deviation of insulin delivery | Day 5 to 9 after ovulation |
| Standard deviation of insulin delivery | Day 10 after ovulation until the first day of the next menstrual cycle |
| Coefficient of variance of insulin delivery | Day 1 to 5 of the menstrual cycle |
| Coefficient of variance of insulin delivery | Day 6 until 2 days prior to ovulation |
| Coefficient of variance of insulin delivery | Ovulation plus/minus 1 day |
| Coefficient of variance of insulin delivery | Day 2 to 4 after ovulation |
| Coefficient of variance of insulin delivery | Day 5 to 9 after ovulation |
| Coefficient of variance of insulin delivery | Day 10 after ovulation until the first day of the next menstrual cycle |
| Total insulin delivery | Day 1 to 5 of the menstrual cycle |
| Total insulin delivery | Day 6 until 2 days prior to ovulation |
| Total insulin delivery | Ovulation plus/minus 1 day |
| Total insulin delivery | Day 2 to 4 after ovulation |
| Total insulin delivery | Day 5 to 9 after ovulation |
| Total insulin delivery | Day 10 after ovulation until the first day of the next menstrual cycle |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |