Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 7:18 AM
Study NCT ID:
NCT07004504
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MEnstrual Cycle pHase ANd dIabeteS Management
Sponsor:
DCB Research AG
Organization:
Study Overview
Official Title:
MEnstrual Cycle pHase ANd dIabeteS Management
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MECHANISM
Brief Summary:
This study examines how menstrual cycle phases affect glycemic control and insulin requirements in women with type 1 diabetes (T1D). It aims to analyze differences in insulin needs and glucose levels between follicular and luteal phases using data from the Tidepool Data Platform. Key parameters include mean glucose, Time in Range (TIR), and total insulin administration. Secondary objectives involve assessing phase-specific glucose fluctuations, aggregated differences, and insulin adjustment strategies. The study follows a decentralized, anonymous data collection approach with participants using CGMs and insulin pumps or smart pens. Statistical analysis includes linear mixed-effects modeling to compare glycemic variability across cycle phases. Findings aim to enhance our understanding of diabetes management during the menstrual cycle and potentially inform future treatment strategies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: