Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490874
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-17
Brief Title:
Continuous Glucose Monitoring CGM Substudy of the DECIDE RCT
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Continuous Glucose Monitoring Among Individuals With Gestational Diabetes Treated With Metformin Versus Insulin Protocol for a Nested Prospective Cohort in the DECIDE RCT DECIDE CGM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
DECIDE CGM
Brief Summary:
This is a nested multicenter prospective cohort conducted concurrently and in conjunction with the DECIDE two-arm pragmatic non-inferiority comparative effectiveness Randomized Controlled Trial RCT NCT06445946 of metformin versus insulin among individuals with Gestational diabetes mellitus GDM requiring pharmacotherapy for glycemic control Continuous Glucose Monitoring CGM-derived glycemic metric in pregnancy and postpartum will be compared between individuals randomized to metformin versus insulin In addition the association between CGM metrics and adverse pregnancy outcomes will be examined Finally whether CGM metrics can accurately identify diabetes postpartum compared with an oral glucose tolerance test and hemoglobin A1c will be determined A total of 300 150 metformin 150 insulin pregnant individuals will be recruited with GDM who require pharmacotherapy to use a blinded CGM device Dexcom Inc San Diego CA at two pregnancy medication randomization late third trimester and three postpartum timepoints delivery 6 weeks and 2 years
Detailed Description:
Gestational diabetes mellitus GDM is the most frequent metabolic complication of pregnancy and affects nearly 1 in 10 pregnant individuals in the US annually GDM increases the risks of both adverse pregnancy and postpartum outcomes for the affected individual and exposed offspring Following a diagnosis of GDM individuals are instructed to achieve glycemic control to decrease the risk of adverse pregnancy outcomes through monitoring of blood glucose dietary modifications and increased physical activity However 1 in 4 individuals with GDM will not achieve targeted glycemic control with diet and behavior changes alone and require pharmacotherapy
This is a multicenter prospective observational cohort nested in the DECIDE randomized controlled trial NCT06445946 DECIDE is a two-arm pragmatic non-inferiority comparative effectiveness RCT of metformin versus insulin to prevent adverse pregnancy outcomes and to confirm postpartum safety among individuals with GDM who require pharmacotherapy to achieve glycemic control This trial will determine whether metformin is not inferior to insulin in reducing adverse pregnancy outcomes and is comparably safe for exposed pregnant individuals and their children This substudy will be conducted concurrently and in conjunction with the parent study A subset of 300 individuals 150 metformin 150 insulin will be enrolled in this substudy from the 1572 individuals from the parent trial
Primary aim
To compare CGM-derived glycemic profiles primary outcome time in range of 63 to 140 mgdL secondary outcomes mean glucose coefficient of variation and percentage of time below the target glucose range or above the target glucose range in pregnancy between individuals with GDM randomized to metformin versus insulin
Secondary aims
To examine the association between CGM metrics and adverse pregnancy outcomes large-for-gestational-age at birth neonatal hypoglycemia and hyperbilirubinemia hypertensive disorder of pregnancy preterm birth 37 weeks NICU admission neonatal mechanical ventilation neonatal oxygen support neonatal respiratory distress syndrome
To examine whether CGM metrics can identify diabetes and postpartum cardiometabolic outcomes prediabetes type 2 diabetes impaired glucose tolerance impaired fasting glucose hypertension obesity and cholesterol abnormalities compared with an oral glucose tolerance test or hemoglobin A1c
This is a multicenter prospective observational cohort nested in the DECIDE randomized controlled trial NCT06445946 DECIDE is a two-arm pragmatic non-inferiority comparative effectiveness RCT of metformin versus insulin to prevent adverse pregnancy outcomes and to confirm postpartum safety among individuals with GDM who require pharmacotherapy to achieve glycemic control This trial will determine whether metformin is not inferior to insulin in reducing adverse pregnancy outcomes and is comparably safe for exposed pregnant individuals and their children This substudy will be conducted concurrently and in conjunction with the parent study A subset of 300 individuals 150 metformin 150 insulin will be enrolled in this substudy from the 1572 individuals from the parent trial
Primary aim
To compare CGM-derived glycemic profiles primary outcome time in range of 63 to 140 mgdL secondary outcomes mean glucose coefficient of variation and percentage of time below the target glucose range or above the target glucose range in pregnancy between individuals with GDM randomized to metformin versus insulin
Secondary aims
To examine the association between CGM metrics and adverse pregnancy outcomes large-for-gestational-age at birth neonatal hypoglycemia and hyperbilirubinemia hypertensive disorder of pregnancy preterm birth 37 weeks NICU admission neonatal mechanical ventilation neonatal oxygen support neonatal respiratory distress syndrome
To examine whether CGM metrics can identify diabetes and postpartum cardiometabolic outcomes prediabetes type 2 diabetes impaired glucose tolerance impaired fasting glucose hypertension obesity and cholesterol abnormalities compared with an oral glucose tolerance test or hemoglobin A1c
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None