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NCT06282055Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
350 (estimated)
First submitted
23 Jan 2024
Start date
20 Nov 2025
Primary completion date
15 Sept 2027
Lead sponsor
DCB Research AG
NCT number
NCT06282055

What you commit to

  • Study type: Observational
  • Planned participants: 350
  • From 20 Nov 2025 to the primary completion date, 15 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Regular hormonal intake (e.g. corticosteroids), except: insulin, stable thyroid substitution, and hormonal contraception
  • Intake of glucocorticoid medication, agents affecting gastric emptying, oral anti-diabetic agents (Metformin) or SGLT-2 inhibitors or GLP-1-analogs

Other illness

  • Known Polycystic Ovary Syndrome (PCOS)

Other

  • Pregnancy until two months postpartum (ongoing or planned)
  • Current breastfeeding (including pumping), as well as two months following complete cessation of breastfeeding and pumping
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
DCB Research AG
Coordinator of this site? Confirm its status
BernSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.