Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes
Recruiting
Observational Study
Diabetes Mellitus, Type 1
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 40
Sex
Female
Study type
Observational
Participants needed
350 (estimated)
Sponsor
DCB Research AG · Other
Who this trial is looking for
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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.
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Eligibility Criteria
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 consecuti…
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
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