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

NCT02838147 | Unknown Phase 3 DMC

• 1 other identifier: 0213-16- TLV
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Neonatal hypoglycemia

  Number of Neonatal hypoglycemia(defined as a blood glucose concentration ≤45mg/dL (2.5mmol/L))

  2 weeks.

Secondary Outcomes (2)

• Large-for-gestational age (LGA)

  2 weeks

• Macrosomia

  2 weeks

Study Arms (3)

Normal OGTT (Oral Glucose Tolerance Test)

EXPERIMENTAL

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

Device: FreeStyle sensors.

Pathological OGTT - 1 abnormal value

EXPERIMENTAL

Patients will pathological OGTT (either one or more abnormal values) will be randomly allocated to the antenatal care plus FreeStyle group or the SMBG group by a computer generated random number table

Device: FreeStyle sensors.; Device: Glucometer

Pathological OGTT - 2 abnormal value

EXPERIMENTAL

Patients will pathological OGTT (either one or more abnormal values) will be randomly allocated to the antenatal care plus FreeStyle group or the SMBG group by a computer generated random number table

Device: FreeStyle sensors.; Device: Glucometer

Interventions

FreeStyle sensors. DEVICE

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

Normal OGTT (Oral Glucose Tolerance Test); Pathological OGTT - 1 abnormal value; Pathological OGTT - 2 abnormal value

Glucometer DEVICE

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

Pathological OGTT - 1 abnormal value; Pathological OGTT - 2 abnormal value

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with pathological glucose tolerance test (GCT) are eligible for the study.
• Women with a singleton pregnancy who were diagnosed with GDM between 24 and 28 weeks' gestation.

You may not qualify if:

• Alcohol or substance abuse, pre-gestational diabetes, any hypertensive disorders and chronic diseases requiring medication except for hypothyroidism. Additionally, multiple gestation, known fetal anomaly or chromosomal defects and intrauterine fetal growth restriction (EFW less than the 10th percentile according to local growth charts) will be excluded as well. Written informed consent will be obtained from all study participants.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Officials

• yariv yogev, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yariv yogev, professor

CONTACT

97236925603; yarivy@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: July 20, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 9, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share