Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000934640
Ethics application status
Approved
Date submitted
26/08/2014
Date registered
1/09/2014
Date last updated
16/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Telemedicine for Insulin Treated Gestational Diabetes Mellitus (TeleGDM)
Scientific title
Effectiveness of Telemedicine plus Usual Care for Insulin Treated Women with Gestational Diabetes Mellitus (TeleGDM): An Exploratory Pilot Randomised Controlled Trial and Qualitative Evaluation
Secondary ID [1] 285002 0
None
Universal Trial Number (UTN)
U1111-1159-4007
Trial acronym
TeleGDM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 292508 0
Condition category
Condition code
Metabolic and Endocrine 292815 292815 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289835 0
Other interventions
Comparator / control treatment
Standard treatment (Usual Care)
Usual care is as described above with the exception of telemedicine. Under usual care patients record self monitoring data on a paper diary which they bring to their scheduled clinic appointment. Care advice or change to treatment plans may be given during the appointment or via telephone.
Control group
Active

Outcomes
Primary outcome [1] 292723 0
Patient service utilisation: Assessed as a composite of scheduled face-to-face consultations, unscheduled face-to-face consultations, and telephone consultations

GDM consultation encounters data will be collated from hospital medical records.
Timepoint [1] 292723 0
From enrollment to baby delivery.

Secondary outcome [1] 309551 0
Glycaemic control. This will be assessed using BGL data. For women in the intervention group BGL data will be obtained from readings they upload to personal health record (Telemedicine system). BGL data for women in the usual care arm will be obtained from their paper based diary.
Timepoint [1] 309551 0
From enrollment to baby delivery
Secondary outcome [2] 309552 0
Macrosomia assessed using foetal ultrasound
Timepoint [2] 309552 0
2nd and 3rd trimester
Secondary outcome [3] 309553 0
Diabetes self efficacy using the Diabetes self Empowerment Scale Short Form (DES-SF) questionnaire.
Timepoint [3] 309553 0
Study enrollment and at 6 weeks from study entry.
Secondary outcome [4] 309937 0
Patient satisfaction assessed using the Client Satisfaction Questionnaire (CSQ-8).
Timepoint [4] 309937 0
6 weeks from study entry.
Secondary outcome [5] 309938 0
Clinician satisfaction using the Canada Health Infoway System And Use Assessment Survey questionnaire.
Timepoint [5] 309938 0
6 months from study commencement.
Secondary outcome [6] 309939 0
Service provision costs. This will be estimated from billable service provision per care episode and will be obtained from hospital administrative data and subscription to use the online personal health record.
Timepoint [6] 309939 0
Collated at participant's completion of study activities at delivery.
Secondary outcome [7] 309940 0
Technology capability and capacity assessed a composite of measures of volume of system usage: login encounters, frequency of data uploads, volume of messages between patients and clinicians over the system, volume of technical glitches or queries.

The data will be collated from the online personal health record logs.
Timepoint [7] 309940 0
Completion of study activities (delivery by the last enrolled woman, approximately 12 months from the start of recruitment).
Secondary outcome [8] 310279 0
Number of neonate admissions to special care nursery. Information will be obtained from hospital medical records.
Timepoint [8] 310279 0
At baby delivery
Secondary outcome [9] 310280 0
Type of delivery (normal vaginal delivery, caesarean delivery or instrument deliveries). Data will be collated form medical records.
Timepoint [9] 310280 0
Baby delivery
Secondary outcome [10] 310281 0
Insulin adjustments assessed as the frequency of insulin adjustments and the number of days between adjustments and information will be collated form medical records.
Timepoint [10] 310281 0
From enrollment to baby delivery
Secondary outcome [11] 310282 0
Large for gestational age (LGA) assessed as weight greater than 90th percentile. Weight will be obtained from medical records.
Timepoint [11] 310282 0
Baby delivery

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

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)
The GDM clinicians, primarily the credentialed diabetes educators will identify eligible patient participants and notify them of the study. The CDE-RNs then direct the prospective participants to the lead member of the researcher team. This member will conduct screening, provide detailed briefing about the project and seek informed consent from eligible prospective participants.

Following informed consent, a participant is then randomly allocated the study arm/group (TeleGDM or Usual Care) by revealing this from a concealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified randomisation list of TeleGDM and Usual Care will be generated by a statistician who is independent of the study. The list will be generated using Stata 13 statistical analysis software. The strata will be high risk of GDM based on previous history of GDM or any of the known risk factors of GDM.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
In addition to summary descriptive and univariate statistics, TeleGDM will be compared to usual care using the following:

i) Ordinal regression for clinic/service utilisation
ii) Logistic regression for categorical outcomes: caesareans, macrosomia, SCN admission
iii) Linear regression for continuous variables: glycaemic control, baby birthweight, costs, glycaemic variability (MAGE)
iv) Survival analysis of BGL data: time to glycaemic stability, time to insulin adjustment
v) T-test or non-parametric equivalent: satisfaction surveys scores

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2014
Actual
8/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2852 0
The Northern Hospital - Epping
Recruitment hospital [2] 2853 0
Craigieburn Health Service - Craigieburn
Recruitment hospital [3] 2854 0
Broadmeadows Health Service - Broadmeadows
Recruitment postcode(s) [1] 8541 0
3076 - Epping
Recruitment postcode(s) [2] 8542 0
3064 - Craigieburn
Recruitment postcode(s) [3] 8543 0
3047 - Broadmeadows

Funding & Sponsors
Funding source category [1] 289778 0
Hospital
Name [1] 289778 0
Northern Health (Small Research Project Grant 2014)
Country [1] 289778 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
General Practice and Primary Health Care Academic Centre
School of Medicine,The University of Melbourne
200 Berkeley Street
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 288531 0
None
Name [1] 288531 0
Address [1] 288531 0
Country [1] 288531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291508 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 291508 0
The Northern Hospital
185 Cooper Street
Epping
Victoria 3076
Ethics committee country [1] 291508 0
Australia
Date submitted for ethics approval [1] 291508 0
Approval date [1] 291508 0
20/06/2014
Ethics approval number [1] 291508 0
PO11/14

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50018 0
Mr Tshepo Rasekaba
Address 50018 0
General Practice and Primary Health Care Academic Centre
School of Medicine,The University of Melbourne
200 Berkeley Street, Carlton VIC 3053
Country 50018 0
Australia
Phone 50018 0
+613 9035 5018
Fax 50018 0
Email 50018 0
[email protected]
Contact person for public queries
Name 50019 0
Mr Tshepo Rasekaba
Address 50019 0
Northern Clinical Research Centre (NCRC)
Northern Health

185 Cooper Street
EPPING VIC 3076
Country 50019 0
Australia
Phone 50019 0
+613 8405 8399
Fax 50019 0
Email 50019 0
[email protected]
Contact person for scientific queries
Name 50020 0
Mr Tshepo Rasekaba
Address 50020 0
General Practice and Primary Health Care Academic Centre
School of Medicine,The University of Melbourne
200 Berkeley Street, Carlton VIC 3053
Country 50020 0
Australia
Phone 50020 0
+613 8405 8399
Fax 50020 0
Email 50020 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseUsing technology to support care in gestational diabetes mellitus: Quantitative outcomes of an exploratory randomised control trial of adjunct telemedicine for gestational diabetes mellitus (TeleGDM).2018https://dx.doi.org/10.1016/j.diabres.2018.05.049
N.B. These documents automatically identified may not have been verified by the study sponsor.