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A smartphone-and Internet-based app to allow for the remote management of patients with a diagnosis of gestational diabetes.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000127909
Enrollment
1000
Registered
2020-02-11
Start date
2020-03-02
Completion date
2020-09-07
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Gestational Diabetes mellitus (GDM) is becoming more common in Australia, affecting thousands of pregnant women. Between 12% and 14% of pregnant women will develop GDM, with diagnosis usually occurring around the 24th to 28th week of pregnancy. Scientific evidence shows that controlling glucose levels can result in reduced risk of foetal complications (such as macrosomia) and increased maternal quality of life. However, due to increasing rates, and earlier diagnosis of GDM, and a number of systemic (associated increased health care costs, finite economic and staffing resources;) and patient barriers (non-adherence to blood glucose level (BGL) testing as per clinical guidelines; inconvenience in attending clinic visits), impediments to optimal maternal health exist. The project aims to evaluate the real-world implementation of a smartphone- and Internet-based interactive system (called M?THer) to support women with diagnosis of GDM. The project will evaluate the adoption and acceptability of the platform, as well as the impact of using the system on service delivery. The project will implement and evaluate a previously piloted and enhanced M?THer system at Metro South Health Antenatal Services (including Redland, Logan and Beaudesert Hospitals) as well as at the Mater Mother’s Public Hospital.

Interventions

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 hosp

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.

Sponsors

Metro South Hospital and Health Service
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026