Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419777
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-09
Brief Title:
Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus GDM With Glucometer Use - A Randomized Control Trial START1
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
START 1
Brief Summary:
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes GDM Our goal is to compare a strict and permissive threshold The strict threshold is defined as two abnormal values or more over a one-week period two fasting values elevated two of the same post prandial values elevated or 1 fasting and 1 post prandial value elevated whereas the permissive threshold is defined as 50 of values elevated over 1 week 50 of overall fasting values 50 of postprandial values or 50 of overall values
Detailed Description:
Pregnancy is a state of insulin resistance to ensure that the growing fetus has ample nutrition Gestational Diabetes GDM develops in pregnant patients with pancreatic dysfunction that leads to impairment of glucose tolerance
Various studies have examined the benefit of treatment for GDM including the 2005 Australian Carbohydrate Intolerance Study in Pregnant Women ACHOIS and the 2009 Landon et al randomized controlled trials These studies found that treatment was associated with a significant reduction in newborn complications of perinatal death shoulder dystocia large for gestational age infants cesarean delivery and birth trauma The specific threshold value for initiation and up-titration of medical therapy is unknown Lack of evidence leads to a wide variation in clinical practice of pharmacological initiation and titration for GDM A systematic review and meta-analysis by Caissutti in 2019 analyzed criteria for initiating pharmacotherapy for GDM and noted the following 12 of 15 trials initiated pharmacotherapy after 1-2 abnormal values over 1-2 weeks 2 studies initiated pharmacotherapy after 50 of overall values were abnormal and 1 study initiated pharmacotherapy after 30 of overall values were abnormal However there have been no randomized controlled trials of head-to-head comparison of different thresholds
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes Our goal is to compare a strict and relaxed threshold The strict threshold is defined as two abnormal values or more over a one week period two fasting values elevated two of the same post prandial values elevated or 1 fasting and 1 post prandial value elevated whereas the relaxed threshold is defined as 50 of values elevated over 1 week 50 of overall fasting values 50 of postprandial values or 50 of overall values
Various studies have examined the benefit of treatment for GDM including the 2005 Australian Carbohydrate Intolerance Study in Pregnant Women ACHOIS and the 2009 Landon et al randomized controlled trials These studies found that treatment was associated with a significant reduction in newborn complications of perinatal death shoulder dystocia large for gestational age infants cesarean delivery and birth trauma The specific threshold value for initiation and up-titration of medical therapy is unknown Lack of evidence leads to a wide variation in clinical practice of pharmacological initiation and titration for GDM A systematic review and meta-analysis by Caissutti in 2019 analyzed criteria for initiating pharmacotherapy for GDM and noted the following 12 of 15 trials initiated pharmacotherapy after 1-2 abnormal values over 1-2 weeks 2 studies initiated pharmacotherapy after 50 of overall values were abnormal and 1 study initiated pharmacotherapy after 30 of overall values were abnormal However there have been no randomized controlled trials of head-to-head comparison of different thresholds
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes Our goal is to compare a strict and relaxed threshold The strict threshold is defined as two abnormal values or more over a one week period two fasting values elevated two of the same post prandial values elevated or 1 fasting and 1 post prandial value elevated whereas the relaxed threshold is defined as 50 of values elevated over 1 week 50 of overall fasting values 50 of postprandial values or 50 of overall values
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