Status:
COMPLETED
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Women and Infants Hospital of Rhode Island
Geisinger Clinic
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
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 blo...
Detailed Description
This study is a prospective randomized, non-inferiority clinical trial of pregnant women diagnosed with gestational diabetes. Patients with GDM diagnosed between 20 weeks 0 days and 32 weeks 0 days of...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT01818557
Start Date
May 1 2013
End Date
October 1 2016
Last Update
July 2 2018
Active Locations (3)
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1
Geisinger Health System
Danville, Pennsylvania, United States, 17822
2
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
3
The University of Texas Health Science Center, Houston
Houston, Texas, United States, 77030