Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 1)

May 14, 2024 updated by: Thomas Jefferson University

Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
        • Contact:
          • Kavisha Khanuja, MD
        • Contact:
          • Rodney McLaren, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Strict Arm
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)
Drug: Insulin
Insulin will be used in gestational diabetics to control blood glucose levels
Other Names:
  • Humalog
  • Lantus
  • Levemir
  • Lispro
  • NPH
Active Comparator: Permissive
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).
Drug: Insulin
Insulin will be used in gestational diabetics to control blood glucose levels
Other Names:
  • Humalog
  • Lantus
  • Levemir
  • Lispro
  • NPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Composite Outcome
Time Frame: First 28 days of birth
neonatal composite including the following measures: large for gestational age (LGA) of neonate defined as birth weight >90th percentile for gestational age using the Fenton growth chart, hypoglycemia o defined as glucose <40 mg/dL <48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, birth trauma
First 28 days of birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Outcome: Gestational Age of Birth
Time Frame: Delivery Time
Gestational age at delivery in weeks and days
Delivery Time
Neonatal Outcome: APGAR Score
Time Frame: At 1 minute of life and at 5 min of life
Scoring system provided a standardized assessment for infants after delivery from 0-10
At 1 minute of life and at 5 min of life
Neonatal Outcome: Birthweight
Time Frame: Delivery Time
Birthweight in grams, Macrosomia (birthweight >4000g, Small for gestational age (<10th percentile based on Fenton Growth Charts)
Delivery Time
Neonatal Outcome: Respiratory distress
Time Frame: Within first 24 hours after delivery
Breathing difficulties after birth requiring supplemental oxygen, mask, intubation, and/or surfactant
Within first 24 hours after delivery
Neonatal Outcome: Admission to Neonatal intensive Care Unit
Time Frame: From delivery to discharge from NICU
Admission to neonatal intensive care unit (NICU)
From delivery to discharge from NICU
Maternal Outcomes: Maternal hypoglycemia
Time Frame: Initiation of insulin to delivery
Maternal episode of hypoglycemia < 60 mg/dL throughout the pregnancy
Initiation of insulin to delivery
Maternal Outcomes: Obstetric anal sphincter injury (OASIS)
Time Frame: At Delivery
3rd degree and 4th degree perineal injuries
At Delivery
Maternal Outcomes: Operative Delivery
Time Frame: At Delivery
Vacuum-assisted and Forcep-assisted vaginal Delivery
At Delivery
Maternal Outcomes: Cesarean Delivery
Time Frame: At Delivery
Cesarean birth
At Delivery
Maternal Outcomes: Postpartum hemorrhage
Time Frame: Within 24 hours of delivery
Defined as cumulative blood loss ≥1000 mL, or bleeding associated with signs/symptoms of hypovolemia within 24 hours of the birth process
Within 24 hours of delivery
Maternal Outcomes: Hypertensive Disorders of Pregnancy
Time Frame: From gestational age of 20 weeks during pregnancy to 6 weeks postpartum
Hypertensive disorders of pregnancy: gestational hypertension, Preeclampsia without severe features, Pre-eclampsia with severe features, severe range blood pressures defined as (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 mmHg), symptoms of central nervous dysfunction, thrombocytopenia with Platelet count <100,000 platelets/microL, hepatic abnormalities, kidney impairment, and or pulmonary edema
From gestational age of 20 weeks during pregnancy to 6 weeks postpartum
Neonatal Outcome: Brachial Plexus Injury
Time Frame: Delivery Time
Brachial plexus nerves in neonate are torn, stretched, or compressed at delivery
Delivery Time
Maternal Outcomes: Shoulder Dystocia
Time Frame: At Delivery
An obstetric emergency where the anterior fetal shoulder becomes stuck on the maternal pubic symphysis, delaying the birth of the baby's body.
At Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iRISID-2024-2999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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