Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management

Phase 4Not Yet RecruitingNCT07224893

Eastern Virginia Medical School200 enrolled

Overview

The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Pregestational Diabetes Pregnancy

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than 18 years of age; * The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study; * Type II diabetes mellitus requiring insulin; * The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists. * Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management Exclusion Criteria: * Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated; * Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance; * Concomitant use of other anti-diabetic medication (such as metformin); use of a short-acting insulin will not be considered an exclusion; * Known or suspected fetal anomaly or aneuploidy; * Prisoners; * Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.

Outcomes

Primary Outcomes

Weekly Time in Range

The mean blood glucose time in range as measured by the continuous glucose monitor

Time frame: From Day 7 to Day 14 after study enrollment

Secondary Outcomes

Hypertensive disorders of pregnancy

Development of hypertensive disorders of pregnancy

Time frame: From time of enrollment until time of delivery, up to 20 weeks following enrollment

Preterm birth <34 weeks

Delivery at less than 34 weeks gestation

Time frame: From time of enrollment to 34 weeks gestation

Preterm birth <37 weeks

Delivery prior to 37 weeks gestation

Time frame: From time of enrollment until 37 weeks gestation

Spontaneous or Indicated Delivery

Whether delivery was spontaneous or there was an indication for induction or cesarean delivery

Time frame: From time of enrollment until time of delivery, up to 20 weeks following enrollment

Operative vaginal delivery

Whether an operative vaginal delivery was indicated

Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment

Cesarean Delivery

Whether a cesarean delivery was indicated

Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment

Estimated blood loss

The estimated blood loss during delivery

Time frame: Duration of labor, up to 24 hours

Quantitative blood loss

The quantified blood loss during delivery

Time frame: Duration of labor, up to 24 hours

Blood transfusion

Whether a blood transfusion was necessary during or following delivery

Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)

Endometritis

Incidence of endometritis (inflammation of uterine lining)

Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)

Chorioamnionitis

Incidence of chorioamnionitis (placental and amniotic membrane infection)

Time frame: From time of enrollment until time of hospital discharge (up to 42 days post-delivery)

Wound infection

Infection of wounds left by labor

Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)

Venous thromboembolism

Incidence of venous thromboembolism

Time frame: From time of enrollment to time of hospital discharge (up to 42 days post-delivery)

Massive transfusion and postpartum hemorrhage

Incidence of massive transfusion and postpartum hemorrhage

Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)

ICU admission

Admission to the ICU

Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)

Maternal death

Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)

Antepartum death

Fetal death

Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment

Intrapartum death

Fetal death during labor and delivery

Time frame: Duration of labor, up to 24 hours

Neonatal Intubation within 72 hours of birth

Time frame: From time of delivery to 72 hours later

Continuous positive airway pressure (CPAP) within 72 hours of birth

Use of CPAP for neonate within 72 hours of birth

Time frame: From time of delivery to 72 hours later

High-flow nasal cannula (HFNC) within 72 hours of birth

Time frame: From time of delivery to 72 hours later

Cardiopulmonary resuscitation within 72 hours of birth

Time frame: From time of delivery to 72 hours later

Neonatal Hypoglycemia (glucose <35 mg/dL) requiring IV glucose therapy