Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000547448
Ethics application status
Approved
Date submitted
17/02/2025
Date registered
29/05/2025
Date last updated
29/05/2025
Date data sharing statement initially provided
29/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Smartphone and Internet based interactive glucose management system for women with Gestational Diabetes in Pregnancy
Scientific title
The Effectiveness of a Smartphone and Internet based interactive glucose management system for women with Gestational Diabetes in Pregnancy: An open label randomized control trial
Secondary ID [1] 313985 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 336707 0
Condition category
Condition code
Metabolic and Endocrine 333207 333207 0 0
Diabetes
Reproductive Health and Childbirth 333694 333694 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330571 0
Treatment: Devices
Comparator / control treatment
The control arm will continue usual care consisting of the schedule of appointments in the midwifery and obstetric endocrinology clinics. These appointments may be face to face or telehealth consultations. Initiation or adjustment of pharmacotherapy only occurs at these scheduled appointments at the discretion of the clinician. The frequency of these specialty appointments will be dictated by clinical need, as is current practice, at the discretion of the clinician in the clinic. Women can initiate contact with the diabetes team via phone/email at any time in between clinic reviews if required. The schedule of these appointments range from every 1-4 weekly until delivery.
Control group
Active

Outcomes
Primary outcome [1] 340776 0
Composite primary outcome Proportion of blood glucose readings (expressed as number of values in range/total number of values X 100) within target for the duration of gestation defined as: o Fasting blood glucose levels > 3.9 and < 5.1 mmol/L o Post prandial readings (post breakfast/lunch/dinner) > 3.9 and < 6.8 mmol/L consultations.
Timepoint [1] 340776 0
end of gestation
Secondary outcome [1] 445056 0
Overall mean of fasting readings
Timepoint [1] 445056 0
End of gestation
Secondary outcome [2] 447484 0
Highest weekly mean of fasting readings
Timepoint [2] 447484 0
end of gestation
Secondary outcome [3] 447485 0
Proportion of values (expressed as number of values out of range/total number of values X 100) for fasting readings
Timepoint [3] 447485 0
end of gestation
Secondary outcome [4] 447588 0
Time to treatment in weeks
Timepoint [4] 447588 0
end of gestation
Secondary outcome [5] 447589 0
Number of dose adjustments of treatment (insulin or metformin)
Timepoint [5] 447589 0
end of gestation
Secondary outcome [6] 447593 0
Maximum dose of treatment (insulin or metformin)
Timepoint [6] 447593 0
end of gestation
Secondary outcome [7] 447596 0
Gestational age at delivery
Timepoint [7] 447596 0
end of gestation
Secondary outcome [8] 447597 0
Onset of labour
Timepoint [8] 447597 0
end of gestation
Secondary outcome [9] 447598 0
Mode of delivery
Timepoint [9] 447598 0
end of gestation
Secondary outcome [10] 447599 0
Perineal trauma
Timepoint [10] 447599 0
end of gestation
Secondary outcome [11] 447600 0
Maternal weight gain
Timepoint [11] 447600 0
end of gestation
Secondary outcome [12] 447601 0
Gestational hypertension
Timepoint [12] 447601 0
end of gestation
Secondary outcome [13] 447602 0
Pre-term birth (<37 weeks’ gestation)
Timepoint [13] 447602 0
end of gestation
Secondary outcome [14] 447603 0
Birth weight
Timepoint [14] 447603 0
end of gestation
Secondary outcome [15] 447604 0
Large for gestational age
Timepoint [15] 447604 0
end of gestation
Secondary outcome [16] 447609 0
Small for gestational age
Timepoint [16] 447609 0
end of gestation
Secondary outcome [17] 447610 0
Incidence of should dystocia or birth injury
Timepoint [17] 447610 0
end of gestation
Secondary outcome [18] 447611 0
Incidence of neonatal hypoglycemia
Timepoint [18] 447611 0
end of gestation
Secondary outcome [19] 447612 0
Incidence of neonatal significant hyperbilirubinaemia requiring phototherapy
Timepoint [19] 447612 0
end of gestation
Secondary outcome [20] 447613 0
Respiratory distress
Timepoint [20] 447613 0
end of gestation
Secondary outcome [21] 447616 0
Special care nursery admission
Timepoint [21] 447616 0
end of gestation
Secondary outcome [22] 447619 0
Perinatal death
Timepoint [22] 447619 0
End of gestation and 28 days post partum
Secondary outcome [23] 447620 0
Total number of blood glucose measurements
Timepoint [23] 447620 0
end of gestation
Secondary outcome [24] 447621 0
Compliance
Timepoint [24] 447621 0
end of gestation
Secondary outcome [25] 447622 0
Number of additional clinical appointments required for intervention arm outside of scheduled protocol
Timepoint [25] 447622 0
end of gestation
Secondary outcome [26] 447623 0
Patient satisfaction
Timepoint [26] 447623 0
Sent at 36-38 weeks gestation
Secondary outcome [27] 447628 0
Congenital malformations
Timepoint [27] 447628 0
End of gestation
Secondary outcome [28] 448201 0
Overall mean of post prandial readings
Timepoint [28] 448201 0
End of gestation
Secondary outcome [29] 448202 0
Highest weekly mean of post prandial readings
Timepoint [29] 448202 0
End of gestation
Secondary outcome [30] 448203 0
Proportion of values (expressed as number of values out of range/total number of values X 100) for post prandial readings
Timepoint [30] 448203 0
End of gestation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
2/06/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318486 0
Hospital
Name [1] 318486 0
Western Health
Country [1] 318486 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Country
Australia
Secondary sponsor category [1] 320879 0
Government body
Name [1] 320879 0
CSIRO
Address [1] 320879 0
Country [1] 320879 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317096 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317096 0
Ethics committee country [1] 317096 0
Australia
Date submitted for ethics approval [1] 317096 0
28/10/2024
Approval date [1] 317096 0
28/02/2025
Ethics approval number [1] 317096 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139982 0
Dr Rinky Giri
Address 139982 0
Department of Diabetes and Endocrinology, Sunshine Hospital, Western Health: 176 Furlong Road, Sunshine, Victoria 3021
Country 139982 0
Australia
Phone 139982 0
+61421973056
Fax 139982 0
Email 139982 0
[email protected]
Contact person for public queries
Name 139983 0
Rinky Giri
Address 139983 0
Department of Diabetes and Endocrinology, Sunshine Hospital, Western Health: 176 Furlong Road, Sunshine, Victoria 3021
Country 139983 0
Australia
Phone 139983 0
+61421973056
Fax 139983 0
Email 139983 0
[email protected]
Contact person for scientific queries
Name 139984 0
Rinky Giri
Address 139984 0
Department of Diabetes and Endocrinology, Sunshine Hospital, Western Health: 176 Furlong Road, Sunshine, Victoria 3021
Country 139984 0
Australia
Phone 139984 0
+61421973056
Fax 139984 0
Email 139984 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.