No intervention: Observational prospective longitudinal data collection
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion criteria:
* 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)
* Average menstrual cycle length between 21 and 38 days
* Difference in length between consecutive menstrual cycles of at most 7 days
* Living with type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year
* Actively using an AID system for their diabetes management at least six months prior to study inclusion
Exclusion criteria:
* 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)
* Intake of glucocorticoid medication, agents affecting gastric emptying, oral anti-diabetic agents (Metformin) or SGLT-2 inhibitors or GLP-1-analogs
* Individuals with work patterns involving frequent shifts between night and day work (e.g., alternating night and day shifts on a weekly or similar basis).
* Participation in an interventional study within two months preceding and during the present study
Primary outcome measure(s)
Identify clusters in trajectories across the menstrual cycle — 6 months 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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