Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes

Completed · Not applicable

Conditions studied: Gestational Diabetes

In brief

The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to test their blood glucose at least four times daily. The investigators propose to prospectively evaluate blood glucose testing done every day compared to every other day. The primary goal is to establish the most cost-effective modality while still being able to detect patients who require therapy in a timely fashion. The investigators plan to evaluate this new management scheme utilizing a non-inferiority trial design. The investigators primary research question is the following: When managing patients with GDM, is every other day blood glucose testing non-inferior compared to every day blood glucose testing, as measured by the difference of less than 5% in birth weight?

Key facts

Study ID

NCT01818557

Run by

The University of Texas Health Science Center, Houston

People needed

293

Starts

2013-05-01

Expected to finish

2016-10-01

Last updated by the study team

2018-07-02

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age between 20 weeks 0 days and 32 weeks 0 days of gestation.
• Singleton pregnancies
• Maternal age over 18 years
• Patients able to read and write in English or Spanish,
• Diagnosis of gestational diabetes mellitus using criteria supported by the American College of Obstetrics and Gynecology (ACOG).
• Patients identified as not requiring medical therapy (insulin or glyburide) after the first week of initial blood glucose monitoring.

You may not qualify if…

• Diagnosis of GDM made by any method or criteria other than the one outlined above
• Women with pre-existing diabetes mellitus
• Patients under the age of 18 years
• Patients known to be carrying a fetus with a fetal anomaly that requires either prenatal or postnatal surgery, requires early delivery or is at risk for intrauterine growth restriction (IUGR)
• Patients carrying multiple gestations
• Patients with past history of gastric bypass
• Patients with poorly controlled asthma, defined as the need for oral/inhaled corticosteroids to control symptoms
• Patients with chronic hypertension requiring medical therapy
• Patients currently on methadone/suboxone therapy
• Patients currently on any steroid therapy, regardless of the dose or route of administration
• Patients demonstrating poor compliance during the first week of initial blood glucose monitoring, defined as <20% of expected values actually recorded during the one-week period of initial monitoring

Where it is running

• Geisinger Health System — Danville, Pennsylvania, United States
• Women & Infants Hospital — Providence, Rhode Island, United States
• The University of Texas Health Science Center, Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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