Tokyo, July 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062207) titled 'Menstrual Cycle-Related Changes in Insulin Sensitivity in Premenopausal Women with Type 1 Diabetes' on July 10.
Study Type:
Observational
Primary Sponsor:
Institute - Juntendo University
Condition:
Condition - type 1 diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To characterize women with type 1 diabetes who exhibit a luteal phase-associated decline in insulin sensitivity and to elucidate the organ-specific mechanisms underlying this phenomenon, including alterations in insulin clearance
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1) Premenopausal women diagnosed with type 1 diabetes
2) Patients receiving treatment with the MiniMed 780G advanced hybrid closed-loop system
3) Patients who are 18 years of age or older at the time of informed consent who have not reached menopause
4) Patients with regular menstrual cycles
5) Patients who, after receiving a sufficient explanation of the study and fully understanding its contents, provide written informed consent to participate of their own free will
Key exclusion criteria - 1) Patients with type 2 diabetes or secondary diabetes
2) Patients with extremely poor glycemic control, defined as an HbA1c (NGSP) level of 10% or higher
3) Patients not receiving treatment with the MiniMed 780G advanced hybrid closed-loop system
4) Patients who are pregnant, breastfeeding, possibly pregnant, or planning pregnancy
5) Patients receiving hormonal contraception or hormone therapy
6) Patients receiving glucocorticoid therapy
7) Patients with systemic diseases that may affect glycemic profiles
8) Patients considered unsuitable for participation in the study by the investigator
Target Size - 20
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 07 Month 07 Day
Date of IRB - 2026 Year 07 Month 07 Day
Anticipated trial start date - 2026 Year 07 Month 07 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070168
Disclaimer: Curated by HT Syndication.
