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Effect of a Continuous Glucose Monitoring on Maternal and Neonatal Outcomes in Gestational Diabetes Mellitus

NCT02838147 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-08-09

No results posted yet for this study

Summary

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance first diagnosed during pregnancy \[1\]. It is associated with adverse pregnancy outcome for the mother, and the fetus with consequences regarding future health and development of the neonate. Maternal consequences include increased rate of operative and cesarean delivery, hypertensive disorders during pregnancy and future risk for type 2 diabetes mellitus (T2DM) as well as other aspects of the metabolic syndrome, such as obesity, cardiovascular morbidities and recurrent GDM \[2-4\]. Also, children born to mothers affected by gestational hypertension have been found to have higher body mass index (BMI), systolic blood pressure, glucose and insulin levels \[5\]; this risk extends into adulthood, with an 8-fold increased risk of type 2 diabetes among young adults exposed to gestational diabetes during fetal life \[6\].

Of all types of diabetes, GDM accounts for approximately 90-95% of all cases \[4, 7\]. It complicates up to 14% of all pregnancies. Its prevalence is increasing and parallels the rising incidence of type 2 diabetes mellitus worldwide \[3,4\]. Risk factors for developing GDM in pregnancy include obesity, previously GDM, glycosuria, family history, ethnicity and hypertension \[5,6\].

Conditions

  • GDM

Interventions

DEVICE

FreeStyle sensors.

Patients with normal OGTT (4 normal values) - will be allocated to 2-week period to FreeStyle sensors.

DEVICE

Glucometer

Patients with pathological OGTT - 1 abnormal value Patients with pathological OGTT - 2 abnormal value

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • yariv yogev, professor · Tel Aviv Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-07-31
Completion
2019-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02838147 on ClinicalTrials.gov