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Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus

NCT01916694 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2016-05-20

No results posted yet for this study

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 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.

Conditions

  • Gestational Diabetes Mellitus
  • Pregnancy

Interventions

DEVICE

Blue tooth enabled glucose meter with smart phone application

BEHAVIORAL

Self home blood glucose monitoring

Fingerprick testing of blood glucose levels before and 2 hours after meals

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United Kingdom

Study Locations

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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 NCT01916694 on ClinicalTrials.gov