Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus (TREAT-GDM)

University of Oxford

Status: Completed

Conditions: Gestational Diabetes Mellitus; Pregnancy

Treatments: Device: Blue tooth enabled glucose meter with smart phone application; Behavioral: Self home blood glucose monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01916694

13/SC/0176

Details and patient eligibility

About

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 diabetes in the mother may also lead to effects on the long term health of the baby.

Most people today use mobile phones. Our research is looking at using a mobile phone app to help with diabetes care in pregnancy. In particular, the investigators are using phones which connect to the standard blood glucose monitoring machines given to all women with gestational diabetes to see if sending the hospital team blood test results between clinic appointments can result in the need for fewer clinic visits. The investigators are also testing to see how acceptable using mobile phones in this way, is to our patients and that the control of the blood glucose and outcomes for the mother and baby are at least as good as standard care.

The investigators are planning to recruit 200 women who receive care for their gestational diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be randomised so that 100 will receive standard care, and 100 will have a mobile phone "app" linked to the blood glucose machines to send blood glucose readings directly to the diabetes care team to review.

Both groups will be asked to test their blood glucose levels at home regularly with a glucometer. All participants will also be given lifestyle advice to reduce the chance they will need medication. Blood glucose control will be measured also by the percentage of glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before delivery.

Enrollment: 203 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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203 participants in 2 patient groups

Smart phone app glucose monitoring

Experimental group

Description:

Home blood glucose monitoring results directly transmitted via a bluetooth enabled smart phone app to a central database to be reviewed by clinicians

Treatment:

Device: Blue tooth enabled glucose meter with smart phone application

Behavioral: Self home blood glucose monitoring

Standard glucose monitoring

Active Comparator group

Description:

Home blood glucose monitoring results recorded by hand in a paper diary by the patient and reviewed by the clinical team in the outpatient clinic.

Treatment:

Behavioral: Self home blood glucose monitoring