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

February 20, 2024 updated by: DCB Research AG

Trajectories in Insulin Sensitivity Across Menstrual Cycles in Women With Type 1 Diabetes

Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements (insulin pump or smart pen data), glucose variability (CGM data), nutritional information, and menstrual cycle information (cycle tracking app, LH tests, and premenstrual symptoms)) to identify categories of cycle trajectories.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Living with Type 1 Diabetes
  • Perimenopausal people with menstrual cycle
  • Using a hybrid closed-loop system
  • Signed digital informed consent

Exclusion Criteria:

  • Using hormonal therapy or contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with T1D
Women living with T1D who are willing to share their diabetes management and menstrual cycle data.
Other: No intervention
Observational prospective longitudinal data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify different trajectories of insulin sensitivity throughout the menstrual cycle
Time Frame: 6 months
Insulin sensitivity factor based on data from continuous glucose measurements, insulin administration throughout the menstrual cycle
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total daily Insulin dose throughout the menstrual cycle
Time Frame: 6 months
Data from the insulin administration devices
6 months
Coefficient of glucose variability throughout the menstrual cycle
Time Frame: 6 months
Data from continuous glucose monitoring systems
6 months
Estimated insulin sensitivity throughout the menstrual cycle
Time Frame: 6 months
Modeling insulin sensitivity using data from the insulin administering devices, nutrition data, and CGM data.
6 months
Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle
Time Frame: 6 months
Data from continuous glucose monitoring systems
6 months
Correlations between insulin sensitivity trajectories and confounders
Time Frame: 6 months
Data on carbohydrate estimations, activity, and insulin application profiles
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DCB Research AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Estimated)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIMES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We plan to share the data but haven't specified the details yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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