None listed
Conditions
Brief summary
Gestational diabetes (GDM) is one of the most common medical complications of pregnancy and its incidence is rising. Due to the large population that continually requires this service, the current model of care is inconvenient, inefficient, unsustainable, and expensive for both patients and health care providers. This trial is an unblinded single centre randomized control trial comparing remote blood sugar monitoring solution via a web-based dashboard to conventional clinic based consultations in gestational diabetes. It will compare pregnancy, foetal, neonatal, patient satisfaction and cost outcomes.
Interventions
The interventional arm of this trial will involve twice weekly remote review of blood glucose levels utilizing a Bluetooth enabled glucometer (Roche AccuChek) in combination with a smartphone application/web based portal (MoTHer platform). The Roche AccuCheck Bluetooth glucometers are validated, and Therapeutic Goods Administration (TGA) approved medical devices. They are available under subsidy for women with diabetes in pregnancy under the National Diabetes Support Scheme (NDSS). These glucometers have undergone prior examination and demonstrated efficacy in conjunction with mobile health (MHealth) solutions. The mobile health solution and web portal chosen for this study is the MoTHer application and platform developed by a reputable Australian organization of CSIRO’s Australian e-Health Research Centre (AEHRC). Participants will be provided with a retail Bluetooth enabled meter (Roche Accu-chek Guide). The glucometer has the same functionality as current with Bluetooth capability. The application will replace the traditional paper diary system. In addition to automated blood glucose measures, women will be able to record other health measures such as blood pressure, activity, body weight, and diet. Women will be asked to enter their insulin doses. The smartphone application also includes educational multimedia resources to support women in understanding and management of gestational diabetes. The application will be able to provide visual and textual reports on entered/transferred data. Healthcare practitioners are able to monitor patient progress via cloud based dashboard. Procedure for intervention - The web portal is password protected and provides timely data transmission. - Blood glucose readings will be reviewed twice weekly by a member of the research team. - For participants whose blood glucose levels are within the target range, as per local guidelines, a notification will be sent via the application to the participant stating: “Your blood glucose readings are within target. Please continue your current management. If you have any concerns, please contact your diabetes team using the provided numbers.” - Out-of-target blood glucose levels are defined as follows according to local guidelines, which apply uniformly to all women with gestational diabetes. The threshold to commence or uptitrate pharmacological treatment remain the same as the control arm as per local practice. o Any 3 readings above target for fasting or post prandial (after breakfast/lunch/dinner) in preceding 7 days o No data for 72 hours o Any hypoglycemia defined as BGL < 4 mmol - When blood glucose readings fall outside the target range, a notification will be sent via the dashboard informing participants that a member of the research team will contact them. - Participants are then contacted by phone to initiate or adjust their current treatment plan. - The updated treatment plan is recorded in both the dashboard and the electronic medical records. - 2 X attempts via phone call will be made to arrange intervention in 24 hours o If the woman is unable to be contacted within 24 hours, she will be booked into a clinic review (Telehealth or F2F) within 1 week - All women will be routinely reviewed in an obstetric endocrinology clinic via Telehealth or F2F appointment every 4 weeks - Women will be booked for their usual antenatal obstetric appointments according to their obstetric risk as defined by their maternity model of care - Twice weekly review of blood glucose will continue until delivery - Women can initiate contact with the diabetes team via phone/email at any time in between clinic reviews if required.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults Diagnosis of GDM based on Australian Diabetes in Pregnancy Society - Fasting plasma glucose greater than 5 - Positive 75 mg Oral Glucose Tolerance Test Fasting plasma glucose 5.1–6.9 mmol/l ; 1-h post 75 g oral glucose load greater than or equal to 10.0 mmol/l; 2-h post 75 g oral glucose load 8.5–11.0 mmol/l Gestation > 14 weeks Compatible smartphone with Bluetooth connectivity and internet access Able to give informed consent for participation in the study Singleton pregnancy
Exclusion criteria
Inability to access or operate the Mobile health based system Unable to consent Non English-speaking and language not supported by the mobile application Gestation < 14 weeks Pre existing diabetes Pre-existing active medical disorders Evidence of fetal compromise or other obstetric complications at recruitment Twins or higher order pregnancy