Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001047189
Ethics application status
Approved
Date submitted
15/07/2019
Date registered
24/07/2019
Date last updated
11/03/2021
Date data sharing statement initially provided
24/07/2019
Date results information initially provided
11/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of Blood glucose monitoring Via a Mobile Application in Women with Gestational Diabetes Mellitus
Scientific title
Pilot Study to Investigate the Use of a Smartphone-Based, Interactive Blood Glucose Management System in Women with Gestational Diabetes Mellitus
Secondary ID [1] 297608 0
None
Universal Trial Number (UTN)
U1111-1229-5440
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 311869 0
Pregnancy 311870 0
Condition category
Condition code
Metabolic and Endocrine 310461 310461 0 0
Diabetes
Reproductive Health and Childbirth 310462 310462 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study of women diagnosed with Gestational Diabetes Mellitis (GDM) will investigate the feasibility, acceptability and patient satisfaction with the use of the Net-Health smartphone application (app).
The app will collect baseline information at time of registration including age, ethnicity, family history of type 2 diabetes, height, pre pregnancy weight, gestational weight gain, gestation, number of previous pregnancies and previous GDM (including type of treatment).
After registration, the mobile app will be linked via bluetooth to the blood glucose meter and used to transfer fingerprick BGLs automatically to a secure central server for remote monitoring by the treating team.
The app contains some instructions about its use and women will have direct contact details for the diabetes educators if there are any questions about its use. It has the capacity to transfer blood pressure (BP) results from linked home BP machines.
The Net-Health server will notify the treating team if 3 or more BGLs are out of range within 1 week via an automatically generated email to prompt expedited phone or clinic review.
Duration of the intervention will be from time of consent (after diagnosis between 24-30 weeks gestation) to and will cease after delivery.
Adherence will be assessed at clinic appointments with the number of BGL's reviewed and at completion of the study with number of BGL's submitted (compared with expected 4 per day from consent to delivery). Text reminders may be sent at routine follow up of BGL's at prespecified time points in care.
Intervention code [1] 314919 0
Treatment: Devices
Comparator / control treatment
We will generate a historical control group containing 100 women with GDM matched for type of treatment required. These will be identified from hospital records of women attending the group education session in January 2017 to January 2018 and may incorporate data from a current database of women with GDM.
Control group
Historical

Outcomes
Primary outcome [1] 320722 0
To assess the feasibility of the Net-Health software application for blood glucose monitoring in a group of patients with gestational diabetes mellitus (GDM) in a tertiary hospital setting.
Feasibility for the diabetes service will be assessed by the occasions of service to determine workload on the diabetes service. These include clinic, phone or email reviews as well as messages sent to or received from the participant via the app.
Timepoint [1] 320722 0
Four months post enrollment (post delivery - maximum of 18 weeks post enrollment given earliest gestation of inclusion 24 weeks and latest delivery 42 weeks).
Primary outcome [2] 320723 0
To assess the acceptability and patient satisfaction with the Net-Health software application using a validated questionnaire to be completed in the peri/post-partum period. The questionnaire is 'The Oxford Maternity Diabetes Treatment Satisfaction Questionnaire '(OMDTSQ) which has been developed to assess satisfaction of women with GDM care, technology and the perceived relationship with their diabetes team and validated in this population.
Timepoint [2] 320723 0
Four months post enrollment (post delivery - maximum of 18 weeks post enrollment given earliest gestation of inclusion 24 weeks and latest delivery 42 weeks).
Primary outcome [3] 320724 0
To determine the health resource utilisation as assessed by data linkage to medical records including occasions of service by the diabetes team.
Timepoint [3] 320724 0
Four months post enrollment (post delivery - maximum of 18 weeks post enrollment given earliest gestation of inclusion 24 weeks and latest delivery 42 weeks).
Secondary outcome [1] 372615 0
To determine mean weekly blood glucose level as assessed by app analytics.
Timepoint [1] 372615 0
Four months post enrollment (post delivery - maximum of 18 weeks post enrollment given earliest gestation of inclusion 24 weeks and latest delivery 42 weeks).
Secondary outcome [2] 372616 0
To assess a composite of neonatal outcomes (assessed by data linkage to medical records and perinatal data collection application) including:
- gestation at and mode of delivery
- birthweight
- neonatal complications (including shoulder dystocia, neonatal hypoglycaemia, jaundice and requirement for higher level nursery care)
Timepoint [2] 372616 0
Six months post enrollment

Eligibility
Key inclusion criteria
1. Women with confirmed GDM on routine screening between 24-30 weeks gestation.
2. Singleton pregnancy.
3. Own or have the use of a smartphone.
4. Demonstrate willingness and ability to use a linked glucose meter and mobile phone application.
5. Willing and able to give informed consent.

Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. High risk pregnancies not suitable for reduced frequency of review including:
• Twins or higher gestation
• Known risk factors for obstetric complications (other than obesity or GDM)
• Any evidence of fetal compromise
2. GDM diagnosed earlier or later than time period for routine screening (24-30 weeks gestation) that may represent a higher risk of pre-existing diabetes or normal late gestation insulin resistance.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/10/2019
Actual
9/10/2019
Date of last participant enrolment
Anticipated
2/10/2020
Actual
1/04/2020
Date of last data collection
Anticipated
30/11/2020
Actual
15/09/2020
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 27216 0
4551 - Caloundra
Recruitment postcode(s) [2] 27215 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 302151 0
Charities/Societies/Foundations
Name [1] 302151 0
Wishlist
Country [1] 302151 0
Australia
Primary sponsor type
Individual
Name
Dr Sophie Poulter
Address
Endocrine Department
Sunshine Coast University Hospital
6 Doherty St
Birtinya
QLD
4575
Country
Australia
Secondary sponsor category [1] 301990 0
Hospital
Name [1] 301990 0
Sunshine Coast Hospital and Health Service
Address [1] 301990 0
6 Doherty St
Birtinya
QLD
4575
Country [1] 301990 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302833 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 302833 0
The Prince Charles Hospital
Building 14
Rode Road
Chermside
QLD 4032
Ethics committee country [1] 302833 0
Australia
Date submitted for ethics approval [1] 302833 0
18/02/2019
Approval date [1] 302833 0
07/03/2019
Ethics approval number [1] 302833 0
HREC/2019/QPCH/48414

Summary
Brief summary
Women with Gestational Diabetes (GDM) are recommended to monitor their blood glucose levels (BGLs) aiming at tight control to improve the risk of adverse outcomes. After initial review, our service undertakes weekly phone or email contact with women for surveillance of glycaemia. This creates a significant treatment burden for the patient and clinician.

We are investigating the use of the Net-Health mobile phone application (app) and linked glucose meter, as part of a blood glucose management system in women with GDM. This app:
1) Automatically uploads BGLs in real time to a secure server for review remotely by the treating team;
2) Automatically generates an email alert to the treating team if BGLs are out of target range;
3) Allows messaging via the app for dose titration if required.

We plan to undertake a pilot study of 100 women, recruited from our GDM group education session. Data will be collected to assess feasibility, patient satisfaction and resource utilisation. We will also gather data to explore patterns of glycaemia, maternal and neonatal outcomes.

We hypothesize this management system will be feasible and will lead to a more efficient and responsive model of care and use of resources.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91546 0
Dr Sophie Poulter
Address 91546 0
Endocrinology Department
SCUH
6 Doherty St
Birtinya
QLD
4575
Country 91546 0
Australia
Phone 91546 0
+61 7 5202 0000
Fax 91546 0
Email 91546 0
Sophie.Poulter@health.qld.gov.au
Contact person for public queries
Name 91547 0
Dr Sophie Poulter
Address 91547 0
Endocrinology Department
SCUH
6 Doherty St
Birtinya
QLD
4575
Country 91547 0
Australia
Phone 91547 0
+61 7 5202 0000
Fax 91547 0
Email 91547 0
Sophie.Poulter@health.qld.gov.au
Contact person for scientific queries
Name 91548 0
Dr Sophie Poulter
Address 91548 0
Endocrinology Department
SCUH
6 Doherty St
Birtinya
QLD
4575
Country 91548 0
Australia
Phone 91548 0
+61 7 5202 0000
Fax 91548 0
Email 91548 0
Sophie.Poulter@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
This has not been included in our approved patient information and consent form.


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.