Trial Outcomes & Findings for Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus (NCT NCT04599075)

NCT ID: NCT04599075

Last Updated: 2024-07-08

Results Overview

First neonatal blood sugar obtained within 2 hours of birth

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: Within 2 hours of birth
• Results posted on: 2024-07-08

Participant Flow

Participant milestones

Measure	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	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)
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The row summary is the mean age and standard deviation.

Baseline characteristics by cohort

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)	Total n=70 Participants Total of all reporting groups
Age, Continuous	29.2 years STANDARD_DEVIATION 5.4 • n=5 Participants • The row summary is the mean age and standard deviation.	31.6 years STANDARD_DEVIATION 4.7 • n=7 Participants • The row summary is the mean age and standard deviation.	30.4 years STANDARD_DEVIATION 5.2 • n=5 Participants • The row summary is the mean age and standard deviation.
Sex: Female, Male Female	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Nulliparous	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 2 hours of birth

First neonatal blood sugar obtained within 2 hours of birth

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Neonatal Hypoglycemia	49.2 mg/dL Standard Deviation 22.6	50.1 mg/dL Standard Deviation 23.4

SECONDARY outcome

Timeframe: During labor

Number of maternal blood sugars < 60 mg/dL

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Number of Maternal Hypoglycemic Events	5 Participants	1 Participants

SECONDARY outcome

Timeframe: During Labor

Development of Diabetic Ketoacidosis during labor

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Development of Diabetic Ketoacidosis During Labor	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At birth

Mode of Delivery (vaginal versus cesarean)

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Mode of Delivery Cesarean Delivery	17 Participants	23 Participants
Mode of Delivery Vaginal	16 Participants	11 Participants
Mode of Delivery Operative Vaginal	2 Participants	1 Participants

SECONDARY outcome

Timeframe: At Birth

Neonatal Birthweight

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Neonatal Birthweight	3067.8 grams Standard Deviation 1035.8	3293.3 grams Standard Deviation 883.7

SECONDARY outcome

Timeframe: At birth

Number of participants with shoulder dystocia

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Number of Participants With Shoulder Dystocia	4 Participants	1 Participants

SECONDARY outcome

Timeframe: At birth

Number of participants with brachial plexus injury

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Number of Participants With Brachial Plexus Injury	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At delivery (5 minutes)

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.

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
5 Minute Apgar Score < 7	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Within 24 hours of life

Received intervention for hypoglycemia (any oral, IV, or both)

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Received Neonatal Intervention for Hypoglycemia	18 Participants	20 Participants

SECONDARY outcome

Timeframe: At delivery and within first 2 day of life

Admission to level 2 or greater neonatal ICU. This is a marker for additional need for neonatal support and care after delivery.

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Neonatal Intensive Care Unit Admission	16 Participants	17 Participants

SECONDARY outcome

Timeframe: At birth

Gestational age at delivery

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Gestational Age at Delivery	35.6 weeks Standard Deviation 3.6	36.0 weeks Standard Deviation 2.8

SECONDARY outcome

Timeframe: At delivery

Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Number of Participants With Neonatal Respiratory Distress	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Within first 2 days of life

Requiring phototherapy

Outcome measures

Measure	Intravenous Insulin Infusion n=35 Participants Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol. Insulin: IV Insulin Infusion	Continuous Subcutaneous Insulin Infusion (CSII) n=35 Participants 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)
Number of Participants With Neonatal Hyperbilirubinemia	3 Participants	3 Participants

Adverse Events

Intravenous Insulin Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuous Subcutaneous Insulin Infusion (CSII)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gianna Wilkie

University of Massachusetts Chan School of Medicine

Phone: 7743642523

Email: Gianna.Wilkie@umassmemorial.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place