Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes
Not yet recruiting
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT06282055
- Lead Sponsor
- DCB Research AG
- Brief Summary
Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 250
Inclusion Criteria
- Living with Type 1 Diabetes
- Perimenopausal people with menstrual cycle
- Using a hybrid closed-loop system
- Signed digital informed consent
Exclusion Criteria
- Using hormonal therapy or contraception
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identify different trajectories of insulin sensitivity throughout the menstrual cycle 6 months Insulin sensitivity factor based on data from continuous glucose measurements, insulin administration throughout the menstrual cycle
- Secondary Outcome Measures
Name Time Method Estimated insulin sensitivity throughout the menstrual cycle 6 months Modeling insulin sensitivity using data from the insulin administering devices, nutrition data, and CGM data.
Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle 6 months Data from continuous glucose monitoring systems
Total daily Insulin dose throughout the menstrual cycle 6 months Data from the insulin administration devices
Correlations between insulin sensitivity trajectories and confounders 6 months Data on carbohydrate estimations, activity, and insulin application profiles
Coefficient of glucose variability throughout the menstrual cycle 6 months Data from continuous glucose monitoring systems