Pregnancy, High Risk, Type 1 Diabetes
Conditions
Keywords
Pregnancy, Type 1 Diabetes, Intrapartum Insulin, Maternal Outcomes, Neonatal Outcomes
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.
Interventions
DRUGInsulin
IV Insulin Infusion
Sponsors
Gianna Wilkie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Hypoglycemia | Within 2 hours of birth | First neonatal blood sugar obtained within 2 hours of birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of Diabetic Ketoacidosis During Labor | During Labor | Development of Diabetic Ketoacidosis during labor |
| Mode of Delivery | At birth | Mode of Delivery (vaginal versus cesarean) |
| Neonatal Birthweight | At Birth | Neonatal Birthweight |
| Number of Participants With Shoulder Dystocia | At birth | Number of participants with shoulder dystocia |
| Number of Participants With Brachial Plexus Injury | At birth | Number of participants with brachial plexus injury |
| Number of Maternal Hypoglycemic Events | During labor | Number of maternal blood sugars \< 60 mg/dL |
| Received Neonatal Intervention for Hypoglycemia | Within 24 hours of life | Received intervention for hypoglycemia (any oral, IV, or both) |
| Neonatal Intensive Care Unit Admission | 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. |
| Gestational Age at Delivery | At birth | Gestational age at delivery |
| Number of Participants With Neonatal Respiratory Distress | At delivery | Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis |
| Number of Participants With Neonatal Hyperbilirubinemia | Within first 2 days of life | Requiring phototherapy |
| 5 Minute Apgar Score < 7 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| 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) | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Intravenous Insulin Infusion | Continuous Subcutaneous Insulin Infusion (CSII) | Total |
|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 5.4 | 31.6 years STANDARD_DEVIATION 4.7 | 30.4 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 29 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Nulliparous | 17 Participants | 9 Participants | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 29 Participants | 29 Participants | 58 Participants |
| Region of Enrollment United States | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Neonatal Hypoglycemia
First neonatal blood sugar obtained within 2 hours of birth
Time frame: Within 2 hours of birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Insulin Infusion | Neonatal Hypoglycemia | 49.2 mg/dL | Standard Deviation 22.6 |
| Continuous Subcutaneous Insulin Infusion (CSII) | Neonatal Hypoglycemia | 50.1 mg/dL | Standard Deviation 23.4 |
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.
Time frame: At delivery (5 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | 5 Minute Apgar Score < 7 | 7 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | 5 Minute Apgar Score < 7 | 3 Participants |
Secondary
Development of Diabetic Ketoacidosis During Labor
Development of Diabetic Ketoacidosis during labor
Time frame: During Labor
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | Development of Diabetic Ketoacidosis During Labor | 0 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Development of Diabetic Ketoacidosis During Labor | 0 Participants |
Secondary
Gestational Age at Delivery
Gestational age at delivery
Time frame: At birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Insulin Infusion | Gestational Age at Delivery | 35.6 weeks | Standard Deviation 3.6 |
| Continuous Subcutaneous Insulin Infusion (CSII) | Gestational Age at Delivery | 36.0 weeks | Standard Deviation 2.8 |
Secondary
Mode of Delivery
Mode of Delivery (vaginal versus cesarean)
Time frame: At birth
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intravenous Insulin Infusion | Mode of Delivery | Cesarean Delivery | 17 Participants |
| Intravenous Insulin Infusion | Mode of Delivery | Vaginal | 16 Participants |
| Intravenous Insulin Infusion | Mode of Delivery | Operative Vaginal | 2 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Mode of Delivery | Cesarean Delivery | 23 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Mode of Delivery | Vaginal | 11 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Mode of Delivery | Operative Vaginal | 1 Participants |
Secondary
Neonatal Birthweight
Neonatal Birthweight
Time frame: At Birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Insulin Infusion | Neonatal Birthweight | 3067.8 grams | Standard Deviation 1035.8 |
| Continuous Subcutaneous Insulin Infusion (CSII) | Neonatal Birthweight | 3293.3 grams | Standard Deviation 883.7 |
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.
Time frame: At delivery and within first 2 day of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | Neonatal Intensive Care Unit Admission | 16 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Neonatal Intensive Care Unit Admission | 17 Participants |
Secondary
Number of Maternal Hypoglycemic Events
Number of maternal blood sugars \< 60 mg/dL
Time frame: During labor
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | Number of Maternal Hypoglycemic Events | 5 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Number of Maternal Hypoglycemic Events | 1 Participants |
Secondary
Number of Participants With Brachial Plexus Injury
Number of participants with brachial plexus injury
Time frame: At birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | Number of Participants With Brachial Plexus Injury | 0 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Number of Participants With Brachial Plexus Injury | 0 Participants |
Secondary
Number of Participants With Neonatal Hyperbilirubinemia
Requiring phototherapy
Time frame: Within first 2 days of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | Number of Participants With Neonatal Hyperbilirubinemia | 3 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Number of Participants With Neonatal Hyperbilirubinemia | 3 Participants |
Secondary
Number of Participants With Neonatal Respiratory Distress
Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis
Time frame: At delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | Number of Participants With Neonatal Respiratory Distress | 4 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Number of Participants With Neonatal Respiratory Distress | 2 Participants |
Secondary
Number of Participants With Shoulder Dystocia
Number of participants with shoulder dystocia
Time frame: At birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | Number of Participants With Shoulder Dystocia | 4 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Number of Participants With Shoulder Dystocia | 1 Participants |
Secondary
Received Neonatal Intervention for Hypoglycemia
Received intervention for hypoglycemia (any oral, IV, or both)
Time frame: Within 24 hours of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Insulin Infusion | Received Neonatal Intervention for Hypoglycemia | 18 Participants |
| Continuous Subcutaneous Insulin Infusion (CSII) | Received Neonatal Intervention for Hypoglycemia | 20 Participants |