NCT07004504

Brief Summary

This study evaluates the impact of menstrual cycle phases on insulin sensitivity, glycaemic control, and insulin requirements in women with type 1 diabetes (T1D). It aims to quantify differences between the follicular and luteal phases using data from the Tidepool Data Platform. Key endpoints include modelled insulin sensitivity, mean glucose, Time in Range (TIR), and total insulin dose. Secondary objectives include assessing phase-specific variability in the endpoints and differences between participants. The study follows a decentralized, anonymized data collection approach, with participants using continuous glucose monitors (CGMs) and insulin pumps or smart pens. Glycaemic outcomes and insulin requirements will be compared across menstrual cycle phases using linear mixed-effects models to account for repeated measures within individuals. Cycle phase-specific variation in insulin sensitivity will be quantified using a hierarchical Bayesian state-space model, which estimates a latent insulin sensitivity parameter from CGM time series data while accounting for measurement noise and temporal dynamics. The findings are expected to improve understanding of glycaemic dynamics across the menstrual cycle and inform future diabetes management strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 14, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 27, 2025

Last Update Submit

March 22, 2026

Conditions

Type 1 Diabetes Mellitus

Keywords

Insulin sensitivityMenstrual cycleDiabetes management

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Insulin sensitivity quantified by using a hierarchical Bayesian state-space model that estimates a latent insulin sensitivity parameter from CGM time series data.

    Between 1 and 12 months

Secondary Outcomes (7)

  • Mean glucose

    Between 1 and 12 months

  • Time in range (TIR)

    Between 1 and 12 months

  • Time above range (TAR)

    Between 1 and 12 months

  • Time belwo range (TBR)

    Between 1 and 12 months

  • Total daily insulin

    Between 1 and 12 months

  • +2 more secondary outcomes

Study Arms (1)

Single Arm

The study cohort consists of women with type 1 diabetes (T1D) who use continuous glucose monitoring (CGM) and insulin pumps to manage their diabetes. Participants will anonymously upload their diabetes management data, along with self-reported menstrual cycle information.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study includes adults (18+) living with type 1 diabetes (T1D) who use a continuous glucose monitoring (CGM) system and either an insulin pump or a smart pen for insulin delivery. Participants must be willing to upload diabetes-related data to the Tidepool Data Platform, track and share their menstrual cycle data, and provide consent for their anonymized data to be used in research.

You may qualify if:

  • People are eligible to participate in the study if they:
  • are living with T1D;
  • are willing to upload diabetes-related data to the Tidepool Data Platform;
  • are using a continuous glucose monitoring (CGM) system;
  • are using an insulin pump or a smart pen for most of their insulin delivery;
  • are willing to track and share their menstrual cycle data;
  • are 18 years old or older;
  • give consent to share their anonymized data for research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DCB Research AG

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Schiavon M, Dalla Man C, Kudva YC, Basu A, Cobelli C. Quantitative estimation of insulin sensitivity in type 1 diabetic subjects wearing a sensor-augmented insulin pump. Diabetes Care. 2014;37(5):1216-23. doi: 10.2337/dc13-1120. Epub 2013 Dec 6.

    PMID: 24319120BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

  • Martina Rothenbühler, PhD

    DCB Research AG

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 27, 2025

First Posted

June 4, 2025

Study Start

December 14, 2023

Primary Completion

December 29, 2024

Study Completion

December 29, 2024

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

CH(1)