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Blood Glucose Variability and Insulin Action During Menstrual Cycle in Females With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:
Investigating Blood Glucose Variability and Insulin Action During Menstrual Cycle in Females With Type 1 Diabetes to Design Innovative Therapies

Clinical Trial Summary

This research study is designed to look at differences in responsiveness to the subcutaneous injection of a standardized dose of rapid-acting insulin analog and blood glucose variability during different phases of the menstrual cycle in females with type 1 diabetes (T1D).

Clinical Trial Description

Type 1 Diabetes (T1D) is a chronic disease that leads to disability and premature death if not well treated. While females and males are equally affected by T1D, diabetes places additional burdens of care on females. Characteristically, females with T1D have worse glycemic control, a higher incidence of diabetic ketoacidosis, and a greater risk of cardiovascular complications as compared to their male peers. It has been hypothesized that variations in responsiveness to pre-meal bolus doses of insulin during menstrual cycling is an important underlying cause for increased management problems in females with T1D, but the hypothesis has not been adequately tested. Consequently, insulin treatment of females during the different cycles of menstruation remains a guessing game that often results in major swings in blood glucose from high to low levels. The unfavorable impact of this gap in knowledge extends to the efficiency and accuracy of artificial pancreas closed-loop (CL) system insulin delivery algorithms designed based on insulin action parameters. The proposed study addresses this unmet need in diabetes management for females both in open-loop (OL) and CL therapies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02693938
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date November 13, 2019
Completion date February 7, 2020
View Details
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