Phase 4
Completed N=70
Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
Type 1 Diabetes · Pregnancy, High Risk
Source: ClinicalTrials.gov NCT04599075 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Neonatal Hypoglycemia — 49.2; 50.1 mg/dL
◆ Published Evidence
Emerging
11citations · ~4 / year
Intrapartum continuous subcutaneous insulin infusion vs intravenous insulin infusion among pregnant individuals with type 1 diabetes mellitus: a randomized controlled trial.
Summary
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.
Linked Publications
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Intrapartum continuous subcutaneous insulin infusion vs intravenous insulin infusion among pregnant individuals with type 1 diabetes mellitus: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neonatal Hypoglycemia |
49.2; 50.1 | — |
| SECONDARY Number of Maternal Hypoglycemic Events |
5; 1 | — |
| SECONDARY Development of Diabetic Ketoacidosis During Labor |
0; 0 | — |
| SECONDARY Mode of Delivery |
17; 23; 16; 11; 2; 1 | — |
| SECONDARY Neonatal Birthweight |
3067.8; 3293.3 | — |
| SECONDARY Number of Participants With Shoulder Dystocia |
4; 1 | — |
| SECONDARY Number of Participants With Brachial Plexus Injury |
0; 0 | — |
| SECONDARY 5 Minute Apgar Score < 7 |
7; 3 | — |
| SECONDARY Received Neonatal Intervention for Hypoglycemia |
18; 20 | — |
| SECONDARY Neonatal Intensive Care Unit Admission |
16; 17 | — |
| SECONDARY Gestational Age at Delivery |
35.6; 36.0 | — |
| SECONDARY Number of Participants With Neonatal Respiratory Distress |
4; 2 | — |
| SECONDARY Number of Participants With Neonatal Hyperbilirubinemia |
3; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04599075) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.