Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297980
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-12
Brief Title:
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-02
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:
MERIT
Brief Summary:
The objectives of this study are to examine how sex hormones use of hormonal birth control menstrual cycle phase impact glycemic control among women with type 1 diabetes T1D and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity
Detailed Description:
The overall goal of this project is to further understand the impact of hormonal status on glycemic metrics and to test personalized changes to insulin dosing through implementing the following specific aims
Specific Aim 1 Using CGM examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability to identify personalized patterns of glycemic control across the menstrual cycle phase and to test glycemic responses to acute bouts of aerobic interval and resistance training
Specific Aim 2 Using the data from the observational period examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with T1D
Specific Aim 3 Test an intervention that includes up to four personalized adjustments to food intake insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group We will also examine responses to daily activity planned exercise activities and acute bouts of aerobic interval and resistance exercise
Specific Aim 1 Using CGM examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability to identify personalized patterns of glycemic control across the menstrual cycle phase and to test glycemic responses to acute bouts of aerobic interval and resistance training
Specific Aim 2 Using the data from the observational period examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with T1D
Specific Aim 3 Test an intervention that includes up to four personalized adjustments to food intake insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group We will also examine responses to daily activity planned exercise activities and acute bouts of aerobic interval and resistance exercise
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None