Status:
COMPLETED
Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus
Lead Sponsor:
University of Oxford
Conditions:
Gestational Diabetes Mellitus
Pregnancy
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems for both mothers-to-be and their babies such as causing a large baby and difficult birth. Gestational diab...
Eligibility Criteria
Inclusion
- Pregnant women with an abnormal 75 gram 2 hour glucose tolerance test as defined by the IADPSG (International Association of Diabetes in Pregnancy Study Group)
- Willingness and able to give informed consent
- Female aged between 18-40 years
- Singleton pregnancy
- Able to travel to hospital independently
Exclusion
- Impaired cognitive function such that she is unable to operate m-health equipment
- Any evidence of fetal compromise
- Known risk factors for obstetric complications, other than obesity and diabetes
- Gestational diabetes requiring immediate pharmacologic treatment
- Twins or higher order pregnancy
- OGTT (Oral Glucose Tolerance Test) suggesting preexisting diabetes (fasting blood glucose \>= 7.0 or 2 hour \>= 11.1 mmol/L
- Gestation greater than 34+6 at the time of potential recruitment
- Unable to speak English well enough to explain or use equipment
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT01916694
Start Date
September 1 2013
End Date
February 1 2016
Last Update
May 20 2016
Active Locations (1)
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1
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU