Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes (TIMES)

DCB Research

Status

Enrolling

Conditions

Diabetes Mellitus, Type 1

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06282055

TIMES

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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