Insulin Infusion versus Rotating Fluids for Diabetes

Recruiting at 1 trial location

Overseen By Michael J Paglia, MD, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Geisinger Clinic

Must be taking: Insulin, Hypoglycemics

Must not be taking: Oral corticosteroids, Immunosuppressants

Disqualifiers: Type 1 diabetes, Multifetal gestation, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 24 hours

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.

Who Is on the Research Team?

Michael J Paglia, MD, PhD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are in the final weeks of pregnancy, between 37 and 40 weeks.

Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV)

You are carrying only one baby.

Exclusion Criteria

You are pregnant with more than one baby.

Non-English or Non-Spanish speaking

I do not have an active infection or a condition that weakens my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either rotating IV fluids or insulin infusion for intrapartum glycemic control during labor

24 hours

Continuous monitoring during labor

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neonatal blood glucose levels

24 hours

Monitoring of neonatal outcomes within the first 24 hours of life

Extended Follow-up

Monitoring of neonatal outcomes such as hypoglycemia, NICU admission, and respiratory distress until discharge

21 days

What Are the Treatments Tested in This Trial?

Interventions

• Insulin Infusion Protocol
• Rotating Fluids Protocol

Trial Overview 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.

How Is the Trial Designed?

Group I: Rotating fluids Active Control 1 Intervention

Rotating fluids protocol will be initiated at the time of admission to Labor and Delivery.

Group II: Insulin infusion Active Control 1 Intervention

Insulin infusion protocol will be initiated at the time of admission to Labor and Delivery.

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+