What this study is
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).
What's being tested
- Insulin
Intervention · DRUG
Insulin will be used in gestational diabetics to control blood glucose levels
Study details
- Official title
- Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)
- Sponsor
- Thomas Jefferson University
- Conditions
- Gestational Diabetes · Pregnancy Related
- Enrolling
- 430 people
- Starts
- 2024-09-01
- Est. completion
- 2026-05
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- <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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Rochester Medical Center
Rochester, New York, United States
- Sarah Crimmins, DO · Contact
Not yet recruitingThomas Jefferson University
Philadelphia, Pennsylvania, United States
- Kavisha Khanuja, MD · Contact
- Rodney McLaren, MD · Contact
Recruiting
Study team
Sponsor
Thomas Jefferson University
Study ID iRISID-2024-2999
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.