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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Insulin Infusion | Experimental | Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. |
|
| Continuous Subcutaneous Insulin Infusion (CSII) | Experimental | Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | IV Insulin Infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Hypoglycemia | First neonatal blood sugar obtained within 2 hours of birth | Within 2 hours of birth |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Maternal Hypoglycemic Events | Number of maternal blood sugars < 60 mg/dL | During labor |
| Development of Diabetic Ketoacidosis During Labor | Development of Diabetic Ketoacidosis during labor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianna L Wilkie, MD | UMass Memorial Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3051881 | Background | 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. | |
| 25439811 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Insulin Infusion | Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion |
| FG001 | 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. Insulin: Continuous Subcutaneous Insulin Infusion (Pump) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Insulin Infusion | Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion |
| BG001 | Continuous Subcutaneous Insulin Infusion (CSII) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The row summary is the mean age and standard deviation. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neonatal Hypoglycemia | First neonatal blood sugar obtained within 2 hours of birth | Posted | Mean | Standard Deviation | mg/dL | Within 2 hours of birth |
|
Intrapartum (on admission to labor and delivery) and for 24 hours postpartum)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Insulin Infusion | Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gianna Wilkie | University of Massachusetts Chan School of Medicine | 7743642523 | Gianna.Wilkie@umassmemorial.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2024 | Jun 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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This is a prospective, single-center, randomized study evaluating intrapartum insulin delivery management strategies among pregnant women with type 1 diabetes mellitus.
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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.
| Insulin | Drug | Continuous Subcutaneous Insulin Infusion (Pump) |
|
|
| During Labor |
| Mode of Delivery | Mode of Delivery (vaginal versus cesarean) | At birth |
| Neonatal Birthweight | Neonatal Birthweight | At Birth |
| Number of Participants With Shoulder Dystocia | Number of participants with shoulder dystocia | At birth |
| Number of Participants With Brachial Plexus Injury | Number of participants with brachial plexus injury | At birth |
| 5 Minute Apgar Score < 7 | Neonatal Apgar Score: The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. | At delivery (5 minutes) |
| Received Neonatal Intervention for Hypoglycemia | Received intervention for hypoglycemia (any oral, IV, or both) | Within 24 hours of life |
| Neonatal Intensive Care Unit Admission | Admission to level 2 or greater neonatal ICU. This is a marker for additional need for neonatal support and care after delivery. | At delivery and within first 2 day of life |
| Gestational Age at Delivery | Gestational age at delivery | At birth |
| Number of Participants With Neonatal Respiratory Distress | Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis | At delivery |
| Number of Participants With Neonatal Hyperbilirubinemia | Requiring phototherapy | Within first 2 days of life |
| 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. |
| 26696673 | Background | 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. |
| 26927202 | Background | 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. |
| 23537417 | Background | 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. |
| 37429432 | Derived | Wilkie GL, Delpapa E, Leftwich HK. Intrapartum continuous subcutaneous insulin infusion vs intravenous insulin infusion among pregnant individuals with type 1 diabetes mellitus: a randomized controlled trial. Am J Obstet Gynecol. 2023 Dec;229(6):680.e1-680.e8. doi: 10.1016/j.ajog.2023.07.003. Epub 2023 Jul 8. |
Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol. Insulin: Continuous Subcutaneous Insulin Infusion (Pump) |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Nulliparous | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Maternal Hypoglycemic Events | Number of maternal blood sugars < 60 mg/dL | Posted | Count of Participants | Participants | During labor |
|
|
|
| Secondary | Development of Diabetic Ketoacidosis During Labor | Development of Diabetic Ketoacidosis during labor | Posted | Count of Participants | Participants | During Labor |
|
|
|
| Secondary | Mode of Delivery | Mode of Delivery (vaginal versus cesarean) | Posted | Count of Participants | Participants | At birth |
|
|
|
| Secondary | Neonatal Birthweight | Neonatal Birthweight | Posted | Mean | Standard Deviation | grams | At Birth |
|
|
|
| Secondary | Number of Participants With Shoulder Dystocia | Number of participants with shoulder dystocia | Posted | Count of Participants | Participants | At birth |
|
|
|
| Secondary | Number of Participants With Brachial Plexus Injury | Number of participants with brachial plexus injury | Posted | Count of Participants | Participants | At birth |
|
|
|
| Secondary | 5 Minute Apgar Score < 7 | Neonatal Apgar Score: The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. | Posted | Count of Participants | Participants | At delivery (5 minutes) |
|
|
|
| Secondary | Received Neonatal Intervention for Hypoglycemia | Received intervention for hypoglycemia (any oral, IV, or both) | Posted | Count of Participants | Participants | Within 24 hours of life |
|
|
|
| Secondary | Neonatal Intensive Care Unit Admission | Admission to level 2 or greater neonatal ICU. This is a marker for additional need for neonatal support and care after delivery. | Posted | Count of Participants | Participants | At delivery and within first 2 day of life |
|
|
|
| Secondary | Gestational Age at Delivery | Gestational age at delivery | Posted | Mean | Standard Deviation | weeks | At birth |
|
|
|
| Secondary | Number of Participants With Neonatal Respiratory Distress | Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis | Posted | Count of Participants | Participants | At delivery |
|
|
|
| Secondary | Number of Participants With Neonatal Hyperbilirubinemia | Requiring phototherapy | Posted | Count of Participants | Participants | Within first 2 days of life |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | 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. Insulin: Continuous Subcutaneous Insulin Infusion (Pump) | 0 | 35 | 0 | 35 | 0 | 35 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Operative Vaginal |
|