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

Not Applicable

• Conditions: Gestational Diabetes Mellitus (GDM); Reproductive Health and Childbirth - Antenatal care; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12620000127909
• Lead Sponsor: Metro South Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-11
• Last Update Posted: 17 February 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 1000

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite primary endpoints include:<br>i.Uptake and usage of the M?THer App. This is monitored through the clinician portal.<br>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. <br>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. <br>[From time of diagnosis and recruitment to birth.]

Secondary Outcome Measures

Name	Time	Method
umber of BGL clinical reviews by individual clinicians or multidisciplinary team using app data; <br><br>[From diagnosis and recruitment to birth.];Percentage of BGL’s within target 4 weeks after commencement using app data[From diagnosis to birth];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. [From diagnosis to birth]