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

Diabetes Mellitus, Type 1 Clinical Trial

— TIMES  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06282055
• Other study ID #: TIMES
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: DCB Research AG
• Contact: Stefanie Hossmann, MSc
• Phone: +41794217376
• Email: stefanie.hossmann[@]dcberne.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin Resistance

Intervention

Other:
• No intervention
Observational prospective longitudinal data collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DCB Research AG

Outcome

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