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Trial registered on ANZCTR


Registration number
ACTRN12620000127909p
Ethics application status
Submitted, not yet approved
Date submitted
10/01/2020
Date registered
11/02/2020
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A smartphone-and Internet-based app to allow for the remote management of patients with a diagnosis of gestational diabetes.
Scientific title
A smartphone-and Internet-based interactive system to support the management of women with Gestational Diabetes Mellitus – Multisite, real world implementation study to evaluate feasibility and acceptability
Secondary ID [1] 300217 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus (GDM) 315777 0
Condition category
Condition code
Reproductive Health and Childbirth 314062 314062 0 0
Antenatal care
Metabolic and Endocrine 314207 314207 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The specific intervention for this trial is in the use of a smart phone and internet based app. The app will enable women with a diagnosis of gestational diabetes mellitus to enter their recorded blood sugar levels into the app on their smart phone. This will be used in lieu of a paper diary. Clinicians providing care to the patient will be able to view the blood sugar levels on a regular basis through an online portal. This reduces the number of time the woman is required to present to the hospital to provider her blood sugar levels to the clinicians. Any intervention required based on the levels are still able to be made through direct contact with the patient and the Diabetes Educator. Intervention will be determined by the patients individual blood sugar levels and care tailored as required. Women will be required to use the app each time their blood sugar levels are taken through the course of a day. On average for a woman diagnosed with GDM blood sugar level readings are taken 3-4 times per day. Each patient is provided a plan for the monitoring of her blood sugar levels with the Diabetes Educator. Frequency is dependent on a number of contributors.
The app usage is monitored by the treating clinician and blood sugar levels reviewed weekly. Should the patient not enter their blood sugar levels into the app, she will be phoned by the diabetes Educator and regular outpatient visits to the antenatal clinic will be required.
Intervention code [1] 316605 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322458 0
The composite primary endpoints include:
i. Uptake and usage of the M?THer App. This is monitored through the clinician portal.
ii. Acceptance of the App by women, and clinical portal by treating clinicians. Focus groups will be held with the patients and clinical staff to ascertain the benefits of the app and if it reached its primary outcomes.
iii. Perceptions on the impact of using M?THer on multidisciplinary care co-ordination by healthcare practitioners. This will be assessed through the abovementioned focus groups and participation questionnaires for patients and staff.
Timepoint [1] 322458 0
From time of diagnosis and recruitment to birth.
Secondary outcome [1] 378603 0
Number of BGL clinical reviews by individual clinicians or multidisciplinary team using app data;

Timepoint [1] 378603 0
From diagnosis and recruitment to birth.
Secondary outcome [2] 379004 0
Percentage of BGL’s within target 4 weeks after commencement using app data
Timepoint [2] 379004 0
From diagnosis to birth
Secondary outcome [3] 379005 0
Frequency of antenatal contact and occasions of service attended by women, related to GDM. This is assessed by the number of physical hospital appointments attended. Appointments are scheduled in the integrated electronic medical record (ieMR) and clinical notes recorded for each visit. Clinical notes will also be recorded by the reviewing clinician in the ieMR when reviewing sugar levels in the app.
Timepoint [3] 379005 0
From diagnosis to birth

Eligibility
Key inclusion criteria
The inclusion criteria to be used for recruiting participants for this study are:
i. a confirmed diagnosis of GDM at any time during pregnancy;
ii. at least 16 years of age;
iii. referred from general practitioner for antenatal care at Redland, Logan or Beaudesert maternity services, or Mater Mother’s Public Hospital
iv. owning and ability to use smart mobile phone (both Androids and Apple phones);
v. ability (and willingness) to upload data either via WiFi or Mobile Data or manual entry and upload
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria include women who have:
i. type 1 or type 2 diabetes;
ii. other illnesses that will limit participation e.g. chronic kidney disease (stage3-4);
iii. a current, acute and major, episode of psychiatric illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Women recruited into the study who opt to use the M?THer app will receive usual care as well as access to the M?THer App. Usual care varies at the different study sites and local procedures will be considered during recruitment, patient monitoring and follow-up. The women will be assisted on downloading the App from the Apple App Store or the Google Play Store and automatically receive login details as soon as they are registered through the Clinician Portal. A video embedded in the App will guide the women on the use of all its features. In addition, all participants will be provided with an illustrated user manual.
All women who consent to participate in the study will be provided with a link to the research trial software, RedCap, and through the software be invited to complete a short satisfaction survey at 4 weeks after commencement on the M?THer App and again within two weeks post their gestational period. All women will be advised to regularly test their BGL’s as per clinical guidelines.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
7/09/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15587 0
Redland Hospital - Cleveland
Recruitment hospital [2] 15588 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 15589 0
Beaudesert Hospital - Beaudesert
Recruitment hospital [4] 15590 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 28985 0
4163 - Cleveland
Recruitment postcode(s) [2] 28986 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 28987 0
4285 - Beaudesert
Recruitment postcode(s) [4] 28988 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304649 0
Government body
Name [1] 304649 0
Metro South Hospital and Health Service
Country [1] 304649 0
Australia
Primary sponsor type
Government body
Name
Metro South Hospital and Health Service
Address
Building 5 Garden City Office Park, 2404 Logan Rd, Eight Mile Plains QLD 4113
Country
Australia
Secondary sponsor category [1] 304951 0
None
Name [1] 304951 0
None
Address [1] 304951 0
None
Country [1] 304951 0
Other collaborator category [1] 281128 0
Commercial sector/Industry
Name [1] 281128 0
Commonwealth Scientific and Industrial Research Organisation
Address [1] 281128 0
Level 5 UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston QLD 4029
Country [1] 281128 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305069 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 305069 0
Ethics committee country [1] 305069 0
Australia
Date submitted for ethics approval [1] 305069 0
14/11/2019
Approval date [1] 305069 0
Ethics approval number [1] 305069 0

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

Contacts
Principal investigator
Name 99162 0
Dr Wendy Dutton
Address 99162 0
Redland Hospital 21 Weippin Street Cleveland Qld 4163
Country 99162 0
Australia
Phone 99162 0
+61 07 3488 3572
Fax 99162 0
Email 99162 0
wendy.dutton@health.qld.gov.au
Contact person for public queries
Name 99163 0
Wendy Dutton
Address 99163 0
Redland Hospital 21 Weippin Street Cleveland Qld 4163
Country 99163 0
Australia
Phone 99163 0
+61 07 3488 3572
Fax 99163 0
Email 99163 0
wendy.dutton@health.qld.gov.au
Contact person for scientific queries
Name 99164 0
Wendy Dutton
Address 99164 0
Redland Hospital 21 Weippin Street Cleveland Qld 4163
Country 99164 0
Australia
Phone 99164 0
+61 07 3488 3572
Fax 99164 0
Email 99164 0
wendy.dutton@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.