NCT06282055

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Nov 2025Sep 2027

First Submitted

Initial submission to the registry

January 23, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

January 23, 2024

Last Update Submit

December 2, 2025

Conditions

Diabetes Mellitus, Type 1

Keywords

Menstrual cycleTrajectoriesWomenInsulin sensitivityGlycaemiaInsulin need

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (3)

  • To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness.

    6 months

  • To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle

    6 months

  • To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints.

    6 months

Study Arms (1)

Women with T1D

Women living with T1D who are willing to share their diabetes management and menstrual cycle data.

Other: No intervention

Interventions

No interventionOTHER

Observational prospective longitudinal data collection

Women with T1D

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system.

You may qualify if:

  • Female sex
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DCB Research AG

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Central Study Contacts

Stefanie Hossmann, MSc

CONTACT

+41794217376stefanie.hossmann@dcberne.com

Martina Rothenbühler, PhD

CONTACT

martina.rothenbuehler@dcberne.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 28, 2024

Study Start

November 20, 2025

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 15, 2027

Last Updated

December 3, 2025

Record last verified: 2025-12

Locations

CH(1)