Clinical trial NCT06419777: Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
Official title: Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Pregnancy Related
Keywords: gestational diabetes
pregnancy
insulin
Initiation of medication
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: University of Rochester
First posted: 2024-05-17
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).

Detailed description: Pregnancy is a state of insulin resistance to ensure that the growing fetus has ample nutrition. Gestational Diabetes (GDM) develops in pregnant patients with pancreatic dysfunction that leads to impairment of glucose tolerance.

Various studies have examined the benefit of treatment for GDM, including the 2005 Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) and the 2009 Landon et al randomized controlled trials. These studies found that treatment was associated with a significant reduction in newborn complications of perinatal death, shoulder dystocia, large for gestational age infants, cesarean delivery, and birth trauma. The specific threshold value for initiation and up-titration of medical therapy is unknown. Lack of evidence leads to a wide variation in clinical practice of pharmacological initiation and titration for GDM. A systematic review and meta-analysis by Caissutti in 2019 analyzed criteria for initiating pharmacotherapy for GDM and noted the following: 12 of 15 trials initiated pharmacotherapy after 1-2 abnormal values over 1-2 weeks, 2 studies initiated pharmacotherapy after 50% of overall values were abnormal, and 1 study initiated pharmacotherapy after 30% of overall values were abnormal. However, there have been no randomized controlled trials of head-to-head comparison of different thresholds.

The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes. Our goal is to compare a strict and relaxed threshold. The strict threshold is defined as two abnormal values or more over a one week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the relaxed threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).

Eligibility criteria: Inclusion Criteria:

* Live, non-anomalous fetus
* Literacy in English, Spanish, Mandarin, or Arabic
* Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.

Exclusion Criteria:

* \<18 years at EDD
* pre-existing diabetes or diagnosis of GDM before 24 weeks
* multi-fetal gestation
* known major fetal anomaly
* known allergy to insulin
* chronic maternal corticosteroid use
* diagnosis of GDM based on finger sticks alone
* patients who have contraindication to oral glucose tolerance test
* a primary language other than English, Spanish, Mandarin, or Arabic

Primary outcomes:
measure: Neonatal Composite Outcome
timeFrame: First 28 days of birth
Secondary outcomes:
measure: Neonatal Outcome: Gestational Age of Birth
timeFrame: Delivery Time
measure: Neonatal Outcome: APGAR Score
timeFrame: At 1 minute of life and at 5 min of life
measure: Neonatal Outcome: Birthweight
timeFrame: Delivery Time
measure: Neonatal Outcome: Brachial Plexus Injury
timeFrame: Delivery Time
measure: Neonatal Outcome: Respiratory distress
timeFrame: Within first 24 hours after delivery
measure: Neonatal Outcome: Admission to Neonatal intensive Care Unit
timeFrame: From delivery to discharge from NICU
measure: Maternal Outcomes: Maternal hypoglycemia
timeFrame: Initiation of insulin to delivery
measure: Maternal Outcomes: Shoulder Dystocia
timeFrame: At Delivery
measure: Maternal Outcomes: Obstetric anal sphincter injury (OASIS)
timeFrame: At Delivery
measure: Maternal Outcomes: Operative Delivery
timeFrame: At Delivery
measure: Maternal Outcomes: Cesarean Delivery
timeFrame: At Delivery
measure: Maternal Outcomes: Postpartum hemorrhage
timeFrame: Within 24 hours of delivery
measure: Maternal Outcomes: Hypertensive Disorders of Pregnancy
timeFrame: From gestational age of 20 weeks during pregnancy to 6 weeks postpartum
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
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