Phase 4
N=70
Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
Type 1 Diabetes · Pregnancy, High Risk
Bottom Line
View on ClinicalTrials.gov: NCT04599075 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Neonatal Hypoglycemia — 49.2; 50.1 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gianna Wilkie
- Primary completion
- May 2023
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 | — |
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.
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). 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.