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.
Study Type
OBSERVATIONAL
Enrollment
350
Observational prospective longitudinal data collection
DCB Research AG
Bern, Switzerland
RECRUITINGIdentify clusters in trajectories across the menstrual cycle
1. Insulin sensitivity across the menstrual cycle/menstrual cycle phases (see Table 1 for definitions relevant to the clinical endpoints). 2. Glycemia measures across the menstrual cycle/menstrual cycle phases: * Percentage in Time In Range (TIR), Rime In Tight Range (TITR), Time Below Range (TBR), Time Above Range (TAR), Coefficient of Variation (CV) * Mean glucose and mean fasted glucose * High and Low Blood Glucose Index (HBGI and LBGI) and Glucose Management Indicator (GMI) 3. Insulin administration measures across the menstrual cycle/menstrual cycle phases: * Basal and bolus insulin dosage * Total daily dose (TDD) * Basal/bolus ratio
Time frame: 6 months
To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness.
2\. Manual Insulin Adjustment Techniques: * Frequency and classification (e.g., timing, magnitude) of manual insulin adjustments. * Impact of adjustment techniques on glycemic outcomes.
Time frame: 6 months
To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle
Identification and characterization of distinct clusters in glycemic metrics, insulin administration and insulin sensitivity representing unique patterns across distinct menstrual cycle phases (early follicular phase, late follicular phase, peri-ovulation, early luteal, mid luteal and late luteal phase)
Time frame: 6 months
To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints.
Predictive Factors: o Identification of demographic, clinical, or physiological predictors (e.g., premenstrual cycle syndrome (PMS) score or age group) that significantly correlate with primary outcomes.
Time frame: 6 months
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