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

Type 1 Diabetes Clinical Trial

Official title:

Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599075
• Other study ID #: H00021746
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2021
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Pregnancy, High Risk
• Type 1 Diabetes

Intervention

Drug:
• Insulin
IV Insulin Infusion
• Insulin
Continuous Subcutaneous Insulin Infusion (Pump)

Locations

Country	Name	City	State
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Gianna Wilkie

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Hypoglycemia	First neonatal blood sugar obtained within 2 hours of birth	Within 2 hours of birth
Secondary	Number of maternal intrapartum glucose measurements	Number of maternal intrapartum glucose measurements	During Labor
Secondary	Maternal glucose values	Each maternal glucose values obtained during labor	During labor
Secondary	Number of maternal hypoglycemic events	Number of maternal blood sugars < 60 mg/dL	During labor
Secondary	Development of Diabetic Ketoacidosis during labor	Development of Diabetic Ketoacidosis during labor	During Labor
Secondary	Mode of Delivery	Mode of Delivery (vaginal versus cesarean)	At birth
Secondary	Neonatal Birthweight	Neonatal Birthweight	At Birth
Secondary	Number of participants with shoulder dystocia	Number of participants with shoulder dystocia	At birth
Secondary	Number of participants with brachial plexus injury	Number of participants with brachial plexus injury	At birth
Secondary	Apgar Score	Neonatal Apgar Score	At delivery
Secondary	Neonatal mean glucose level	Neonatal mean glucose level in first 24 hours of life	Within 24 hours of life
Secondary	Received neonatal intervention for hypoglycemia	Received intervention for hypoglycemia (any oral, IV, or both)	Within 24 hours of life
Secondary	Neonatal Intensive Care Unit Admission	Admission to level 2 or greater neonatal ICU and length of stay	At delivery and within first 2 day of life
Secondary	Neonatal Intensive Care Unit Admission for hypoglycemia	Admission to level 2 or greater neonatal ICU for hypoglycemia and length of stay	At delivery and within first 2 day of life
Secondary	Gestational age at delivery	Gestational age at delivery	At birth
Secondary	Number of participants with neonatal respiratory distress	Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis	At delivery
Secondary	Number of participants with neonatal hyperbilirubinemia	Requiring phototherapy	Within first 2 days of life
Secondary	Time from birth to first neonatal glucose measurement	Time from birth to first neonatal glucose measurement	Within first 3 hours of life
Secondary	Maternal Care Satisfaction Survey	Survey assessing satisfaction with healthcare provided	Postpartum, assessed within 4 days of delivery
Secondary	Placental Pathology	Assessing for malperfusion pathology	At birth
Secondary	Umbilical Cord Blood Level of C-peptide	Umbilical Cord Blood Level of C-peptide	At Birth
Secondary	Umbilical Cord Blood Level of Leptin	Umbilical Cord Blood Level of Leptin	At Birth
Secondary	Umbilical Cord Blood Level of Insulin	Umbilical Cord Blood Level of Insulin	At Birth