Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619301
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
RCT Glargine vs NPH for Treatment of DM in Pregnancy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy Currently many hospitals differ among use of insulin for management of DM in pregnancy with NPH glargine and detemir being the most commonly used forms of basal insulin Outside of pregnancy NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients Detemir has been well studied in pregnancy and found to be noninferior to NPH Unfortunately glargine has not been as well studied in pregnancy Thus with this study we want to compare glargine and NPH
The purpose of this study is to compare two different forms of insulin Glargine and NPH that we regularly use to manage diabetes mellitus in pregnancy
The purpose of this study is to compare two different forms of insulin Glargine and NPH that we regularly use to manage diabetes mellitus in pregnancy
Detailed Description:
This is an open-label noninferiority prospective randomized study Patients will be randomized to either be treated with NPH insulin for management of diabetes mellitus in pregnancy or with Glargine insulin We will include all pregnant patients managed by the Maternal Fetal Medicine team at Loyola University of Medical Center that have pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin Our primary outcome is hypoglycemia
We provide patients with insulin teaching a referral to diabetic nutrition education and instructions for hypoglycemic events Patients are instructed to continue monitoring blood glucose 4 times a day fasting and 2 hours after each meal log their blood glucose values in MyLoyola chart continue routine prenatal care with maternal fetal medicinehigh risk obstetric clinic and continue routine ultrasound with serial growth ultrasounds and antenatal fetal surveillance The study is voluntary and the patients will receive the same care and number of visits regardless of whether they choose to participate in the study or not regardless of which arm they are in within the RCT
We provide patients with insulin teaching a referral to diabetic nutrition education and instructions for hypoglycemic events Patients are instructed to continue monitoring blood glucose 4 times a day fasting and 2 hours after each meal log their blood glucose values in MyLoyola chart continue routine prenatal care with maternal fetal medicinehigh risk obstetric clinic and continue routine ultrasound with serial growth ultrasounds and antenatal fetal surveillance The study is voluntary and the patients will receive the same care and number of visits regardless of whether they choose to participate in the study or not regardless of which arm they are in within the RCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None