About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female sex
Between 18 and 40 years at inclusion
Menarche at least one year prior to study inclusion
Regular menstrual cycle (at least one menstrual cycle in the last 40 days)
Disqualifiers
Regular hormonal intake (e.g. corticosteroids), except: insulin, stable thyroid substitution, and hormonal contraception
Pregnancy until two months postpartum (ongoing or planned)
Current breastfeeding (including pumping), as well as two months following complete cessation of breastfeeding and pumping
Known Polycystic Ovary Syndrome (PCOS)
Trial population
People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system.
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionObservational prospective longitudinal data collection
Treatment groups
Trial outcomes
Primary outcomes
Identify 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
Secondary outcomes
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.
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)
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.
Sponsors and contacts
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DCB Research AG
Lead sponsor
The Danish Diabetes Association
Collaborator
Heart and Diabetes Center North Rhine-Westphalia
Collaborator
University of Bristol
Collaborator
Emory University
Collaborator