Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.

It had two arms (groups): Intravenous Insulin Infusion (experimental) and Continuous Subcutaneous Insulin Infusion (CSII) (experimental).

Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol.

Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol.

The registry classes the interventions as drug.

More on the Plan

Some providers are comfortable continuing patients on their subcutaneous insulin pump during labor while others transition these patients to intravenous insulin infusions.

The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to obstetric and neonatal outcomes.

Who Took Part

70 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pregnant women with pre-gestational diagnosis of type 1 diabetes mellitus and managed on an insulin pump in pregnancy. Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center. Patients able to provide written informed consent.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: patients who are under the age of 18; patients with altered state of consciousness; critically ill patient requiring intensive care unit admission.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-03-15 with completion listed for 2023-05-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Neonatal Hypoglycemia (time frame: Within 2 hours of birth).

It also tracked 12 secondary outcomes, for example Number of Maternal Hypoglycemic Events, Development of Diabetic Ketoacidosis During Labor, Mode of Delivery, Neonatal Birthweight, Number of Participants With Shoulder Dystocia and Number of Participants With Brachial Plexus Injury.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 70 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.