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Insulin
Insulin Infusion versus Rotating Fluids for Diabetes
N/A
Waitlist Available
Led By Michael J Paglia, MD, PhD
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2)
Be younger than 65 years old
Must not have
Active infection or immunocompromised state (e.g., HIV/AIDS, active malignancy, use of immunosuppressant medication) at time of admission for delivery
Women with Type 1 diabetes mellitus or use of insulin pump
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one hour of delivery
Awards & highlights
Summary
This trialwill compare IV fluid vs. insulin to control baby's blood sugar in laboring women with diabetes. A computer chooses the method.
Who is the study for?
This trial is for pregnant women with Type II diabetes or gestational diabetes controlled with insulin/medication, expecting to deliver at a Geisinger Medical Center between 37 and 40 weeks of gestation. They should be able to communicate in English or Spanish and not expected to deliver within 4 hours of joining the study.
What is being tested?
The study is testing if rotating IV fluids can better manage a baby's blood sugar after birth compared to using insulin infusion during labor. Women will be randomly assigned one of these two methods when they go into labor.
What are the potential side effects?
Potential side effects may include variations in blood sugar levels which could affect both mother and baby. The specifics will depend on individual reactions to either the rotating fluids protocol or the insulin infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am pregnant with Type II diabetes or gestational diabetes managed with insulin or medication.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have an active infection or a condition that weakens my immune system.
Select...
I am a woman with Type 1 diabetes or I use an insulin pump.
Select...
I am expected to give birth within 4 hours of joining the study.
Select...
My unborn baby has been diagnosed with a life-threatening condition.
Select...
I have taken oral corticosteroids within 48 hours before delivery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first 24 hours of life until discharge (average time 21 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 24 hours of life until discharge (average time 21 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neonatal blood glucose value
Secondary study objectives
Incidence of composite neonatal outcome
Hypoglycemia
Maternal blood glucose value before delivery
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Rotating fluidsActive Control1 Intervention
Rotating fluids protocol will be initiated at the time of admission to Labor and Delivery.
Group II: Insulin infusionActive Control1 Intervention
Insulin infusion protocol will be initiated at the time of admission to Labor and Delivery.
Find a Location
Who is running the clinical trial?
Geisinger ClinicLead Sponsor
153 Previous Clinical Trials
1,974,042 Total Patients Enrolled
Michael J Paglia, MD, PhDPrincipal InvestigatorGeisinger Clinic
1 Previous Clinical Trials
150 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are in the final weeks of pregnancy, between 37 and 40 weeks.You are pregnant with more than one baby.I do not have an active infection or a condition that weakens my immune system.You are carrying only one baby.I am a woman with Type 1 diabetes or I use an insulin pump.You received corticosteroid treatment during the week before your delivery.You are pregnant and your due date is less than 37 weeks or more than 40 weeks.I am expected to give birth within 4 hours of joining the study.My unborn baby has been diagnosed with a life-threatening condition.You are not expected to give birth within the next 4 hours. For example, if your cervix is less than 7 cm dilated at the time of the study.You have a condition called diabetic ketoacidosis when you were admitted for delivery.I have taken oral corticosteroids within 48 hours before delivery.The baby has passed away before birth.I speak English or Spanish.I am pregnant with Type II diabetes or gestational diabetes managed with insulin or medication.
Research Study Groups:
This trial has the following groups:- Group 1: Rotating fluids
- Group 2: Insulin infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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