None listed
Conditions
Brief summary
Gestational diabetes mellitus (GDM) is a condition of poor blood sugar control occurring during pregnancy. The poor sugar control is associated with poorer pregnancy outcomes, such as large babies often leading to caesarean deliveries, other pregnancy complications and diabetes in the future. About half of all women with GDM need insulin to control blood sugars. Special care needs to be provided to this group of women which involves intensive and frequent support for insulin management, adding to increased workloads on limited GDM services. Telemedicine is another way that people can be provided with health services while they are away from the hospital. In this approach patients send their heath monitoring information over the mobile phones or internet to healthcare providers who in turn review the information and provide advice to the patients. This project aims to use telemedicine to support care for women with GDM and it will be carried out at TNH as a major randomised controlled pilot study. Women who agree to be part of this project will monitor their BGL, insulin and symptoms at home. The women will send this information to the hospital via an online system called Online Health Portfolio for review by the GDM care team. If a patient has readings that are outside desired levels, the team at the hospital can then provide advice immediately via text message without the need for the woman to wait for the next hospital appointment. The project will evaluate whether a new new approach (telemedicine) used as part of of usual care, is able to reduce the workload on the GDM service, whether women who receive telemedicine will have better or similar pregnancy outcomes as women who will receive usual care alone and whether telemedicine will result in cost savings.
Interventions
Telemedicine (Intervention)
Telemedicine will be an add-on (adjunct) to usual care and TeleGDM will refer to Telemedicine plus usual care. The duration of the intervention will be from enrollment until delivery of the baby.
Women recruited to this arm will continue monitoring their BGL, insulin dosing and symptoms according to diabetes education and counseling advice. The difference to usual care alone is that the women in the TeleGDM arm will upload their BGL via a USB cable connection of the
Telemedicine (Intervention) Telemedicine will be an add-on (adjunct) to usual care and TeleGDM will refer to Telemedicine plus usual care. The duration of the intervention will be from enrollment until delivery of the baby. Women recruited to this arm will continue monitoring their BGL, insulin dosing and symptoms according to diabetes education and counseling advice. The difference to usual care alone is that the women in the TeleGDM arm will upload their BGL via a USB cable connection of the glucometer to the computer, and manually enter insulin, dietary/meal information and symptoms data to an online personal health record (PHR). Four BGL readings a day (one preprandial, and three postprandial (breakfast, lunch, dinner) readings) are expected as per usual care. The PHR is set up with every second day automatic reminder to upload data. In addition a Credentialed Diabetes Educator Registered Nurse (CDE-RN) can message the patients if data are not uploaded as expected. When new data are upload an alert email is automatically sent to the CDE-RN, who in turn reviews the data, coordinates care with the other GDM clinic team members and provides feedback and/or care advice to the patients via the PHR (email) messaging and SMS system. This approach reduces the need for clinicians to wait for patients to bring data on paper diary to their scheduled appointment at a later time, usually 1-2weeks. That is, the TeleGDM approach will provide the ability for a timely response and action in order to deliver individually tailored GDM management in response to the patient’s needs. It is expected clinicians will still schedule face-to-face appointment as usual and recall patients as they normally would based on their clinical decision making.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
IADPSG criteria based clinical diagnosis of GDM confirmed by OGTT 24-33 weeks of gestation or earlier diagnosis if in high risk group Management of hyperglycaemia with insulin and no more than 35 weeks gestation. Smartphone/tablet with internet access and/or internet connected personal computer Not requiring an interpreter to navigate through the health care system
Exclusion criteria
Adequate blood glucose control without insulin Other pre-existing (pre-pregnancy) diabetes mellitus (T1DM or T2DM) or glucose intolerance. Currently taking or took corticosteroids in the previous 3months. Require an interpreter to navigate the healthcare system.
Outcome results
None listed