Clinical trial NCT04599075: Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
Official title: Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Pregnancy, High Risk
Keywords: Pregnancy
Type 1 Diabetes
Intrapartum Insulin
Maternal Outcomes
Neonatal Outcomes
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, single-center, randomized study evaluating intrapartum insulin delivery management strategies among pregnant women with type 1 diabetes mellitus.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Neonatal Hypoglycemia
timeFrame: Within 2 hours of birth
Secondary outcomes:
measure: Number of Maternal Hypoglycemic Events
timeFrame: During labor
measure: Development of Diabetic Ketoacidosis During Labor
timeFrame: During Labor
measure: Mode of Delivery
timeFrame: At birth
measure: Neonatal Birthweight
timeFrame: At Birth
measure: Number of Participants With Shoulder Dystocia
timeFrame: At birth
measure: Number of Participants With Brachial Plexus Injury
timeFrame: At birth
measure: 5 Minute Apgar Score < 7
timeFrame: At delivery (5 minutes)
measure: Received Neonatal Intervention for Hypoglycemia
timeFrame: Within 24 hours of life
measure: Neonatal Intensive Care Unit Admission
timeFrame: At delivery and within first 2 day of life
measure: Gestational Age at Delivery
timeFrame: At birth
measure: Number of Participants With Neonatal Respiratory Distress
timeFrame: At delivery
measure: Number of Participants With Neonatal Hyperbilirubinemia
timeFrame: Within first 2 days of life
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Memorial Health
name: Gianna L Wilkie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feldberg D, Dicker D, Samuel N, Peleg D, Karp M, Goldman JA. Intrapartum management of insulin-dependent diabetes mellitus (IDDM) gestants. A comparative study of constant intravenous insulin infusion and continuous subcutaneous insulin infusion pump (CSIIP). Acta Obstet Gynecol Scand. 1988;67(4):333-8.
citation: Peterson C, Grosse SD, Li R, Sharma AJ, Razzaghi H, Herman WH, Gilboa SM. Preventable health and cost burden of adverse birth outcomes associated with pregestational diabetes in the United States. Am J Obstet Gynecol. 2015 Jan;212(1):74.e1-9. doi: 10.1016/j.ajog.2014.09.009. Epub 2014 Oct 28.
citation: Professional Practice Committee for the Standards of Medical Care in Diabetes-2016. Diabetes Care. 2016 Jan;39 Suppl 1:S107-8. doi: 10.2337/dc16-S018. No abstract available.
citation: Drever E, Tomlinson G, Bai AD, Feig DS. Insulin pump use compared with intravenous insulin during labour and delivery: the INSPIRED observational cohort study. Diabet Med. 2016 Sep;33(9):1253-9. doi: 10.1111/dme.13106. Epub 2016 Mar 20.
citation: Fresa R, Visalli N, Di Blasi V, Cavallaro V, Ansaldi E, Trifoglio O, Abbruzzese S, Bongiovanni M, Agrusta M, Napoli A. Experiences of continuous subcutaneous insulin infusion in pregnant women with type 1 diabetes during delivery from four Italian centers: a retrospective observational study. Diabetes Technol Ther. 2013 Apr;15(4):328-34. doi: 10.1089/dia.2012.0260. Epub 2013 Mar 28.