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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-05-02

Brief Summary

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The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.

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Detailed Description

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Intrapartum glucose management is critical to reducing neonatal hypoglycemia shortly after birth. Some providers are comfortable continuing patients on their subcutaneous insulin pump during labor while others transition these patients to intravenous insulin infusions. Previous literature has retrospectively shown this to be both a feasible and safe option.

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

Conditions

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Type 1 Diabetes Pregnancy, High Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, single-center, randomized study evaluating intrapartum insulin delivery management strategies among pregnant women with type 1 diabetes mellitus.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.

Study Groups

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Intravenous Insulin Infusion

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

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

IV Insulin Infusion

Continuous Subcutaneous Insulin Infusion (CSII)

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

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Continuous Subcutaneous Insulin Infusion (Pump)

Interventions

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Insulin

IV Insulin Infusion

Intervention Type DRUG

Insulin

Continuous Subcutaneous Insulin Infusion (Pump)

Intervention Type DRUG

Other Intervention Names

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Insulin via IV Infusion Insulin via Pump

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients who are under the age of 18
* Patients with altered state of consciousness
* Critically ill patient requiring intensive care unit admission
* Patient at risk for suicide
* Patient refuses or is otherwise unable to participate in own care
* Patient without pump supplies
* Patients presenting with diabetic ketoacidosis on admission

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No