Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
Key facts
- Who runs it
- Thomas Jefferson University
- Where
- Philadelphia and Rochester, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 430 people, planned
- Started
- 1 Sept 2024
- Planned end
- May 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Insulin
- Record updated
- 21 November 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- chronic maternal corticosteroid use
- pre-existing diabetes or diagnosis of GDM before 24 weeks
- known allergy to insulin
- patients who have contraindication to oral glucose tolerance test
- <18 years at EDD
- multi-fetal gestation
- known major fetal anomaly
- diagnosis of GDM based on finger sticks alone
- a primary language other than English, Spanish, Mandarin, or Arabic
Where in United States
- Thomas Jefferson UniversityPhiladelphia, United StatesContact: Kavisha Khanuja, MDTaking people
- University of Rochester Medical CenterRochester, United StatesContact: Sarah Crimmins, DONot yet recruiting
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Strict ArmExisting treatment, for comparison
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)
Treatment: Insulin
- PermissiveExisting treatment, for comparison
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).
Treatment: Insulin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)
- Record updated
- 21 November 2024