Insulin Infusion versus Rotating Fluids for Diabetes

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to control blood sugar in pregnant women with Type II diabetes or gestational diabetes during labor. One group receives insulin through an IV (Insulin Infusion Protocol), while the other group receives rotating fluids through an IV (Rotating Fluids Protocol) to determine which method is more effective. The trial seeks women who are pregnant with one baby, have diabetes managed with medication, and plan to deliver at a specific medical center. Participants should also plan to deliver at least four hours after joining the trial. As an unphased trial, this study allows participants to contribute to important research that could enhance diabetes management during labor.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that women using an insulin pump or those who have used oral corticosteroids recently are excluded, which might suggest some restrictions on certain medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that using insulin through an IV safely manages blood sugar in women with diabetes during labor. Research indicates that this method effectively controls blood sugar levels and is commonly used in childbirth care. However, safety concerns include very low blood sugar and diabetic ketoacidosis, a serious diabetes complication.

Studies show no significant difference in newborn blood sugar levels when using rotating fluids compared to insulin through an IV. This suggests that rotating fluids might be a safe alternative for managing blood sugar during labor. Both methods appear well-tolerated, with no clear reports of serious side effects for either treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Insulin Infusion versus Rotating Fluids protocols because they offer innovative approaches to managing diabetes during labor and delivery. Unlike the standard insulin therapy that relies on injections, the Insulin Infusion protocol provides a continuous, controlled delivery of insulin directly into the bloodstream, potentially offering better glucose control and stability. The Rotating Fluids protocol is intriguing because it involves the strategic use of different fluids to manage blood sugar levels, possibly reducing the need for insulin administration altogether. These protocols could enhance patient comfort and optimize outcomes by providing more personalized and effective diabetes management during this critical time.

What evidence suggests that this trial's treatments could be effective for controlling blood sugar in laboring women with diabetes?

Research has shown that insulin infusion, one of the treatments in this trial, effectively controls blood sugar in pregnant women with diabetes. Studies have found that insulin infusion helps maintain stable blood sugar levels during labor, with patients reaching target levels about 39% of the time. The trial also examines rotating IV fluids, a newer method. Previous studies comparing these two methods found that both insulin infusion and rotating fluids manage blood sugar similarly during labor. However, slight differences appeared in newborns' blood sugar levels shortly after birth. Overall, both treatments show promise for managing blood sugar in pregnant women with diabetes during labor. ^{2 4 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7808046/

The peripartum management of diabetes - PMC The basal infusion provides continuous delivery of insulin to maintain normoglycaemia and prevent ketogenesis. The insulin bolus is titrated at meal times ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S306/157565/15-Management-of-Diabetes-in-Pregnancy-Standards

15. Management of Diabetes in Pregnancy: Standards of Care ... Continuous subcutaneous insulin infusion was compared with intravenous insulin infusion in an RCT of 70 participants during labor and delivery.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39959521/

Evaluation of a Standardized Obstetrics Insulin Drip ... Time spent within the goal glucose range while on an insulin drip in the pre-group was 1.63% compared with 39.30% in the post-group (P <0.001).

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2303911

Automated Insulin Delivery in Women with Pregnancy ... In this trial, closed-loop therapy was effective during pregnancy complicated by type 1 diabetes, accounting for the marked gestational changes ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S3050915725000748

Continuous Subcutaneous Insulin Infusion Versus Multiple ... MDI patients had higher HbA1C levels but lower cesarean delivery rate, and overall pregnancy outcomes were similar between both groups.

6. diabetesjournals.org diabetesjournals.org/spectrum/article/38/1/68/157254/Evaluation-of-a-Standardized-Obstetrics-Insulin

Evaluation of a Standardized Obstetrics Insulin Drip Protocol ... Implementation of a nursing-driven, obstetrics-specific intravenous insulin drip protocol significantly improved maternal glycemic management.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03273881?cond=%22Diabetes,%20Gestational%22&aggFilters=status:not%20rec&rank=2

Study Details | NCT03273881 | Intrapartum Glucose and ... In this study we will examine the effect of 2 different protocols on glycemic control during labor and the immediate neonatal period. Women in group 1, will ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3220861/

Safety and Efficacy of 24-h Closed-Loop Insulin Delivery in ... Closed-loop insulin delivery was as effective as conventional CSII, with less time spent in extreme hypoglycemia.