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Mobile-based Disease Management System for insulin dose adjustment in type 2 diabetes for specialist outreach and diabetes telehealth service (REMODEL-IDA): A pilot randomised controlled trial.

Mobile-based Disease Management System for insulin dose adjustment on glycated haemoglobin in type 2 diabetes for specialist outreach and diabetes telehealth service (REMODEL-IDA): A pilot randomised controlled trial.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000412235
Acronym
REMODEL-IDA: REthinking MOdel of Diabetes care utilising EheaLth – Insulin Dose Adjustment
Enrollment
44
Registered
2018-03-21
Start date
2018-04-02
Completion date
2018-09-30
Last updated
2018-06-11

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

Conditions

None listed

Brief summary

Insulin initiation and/or titration for type 2 diabetes (T2DM) is a resource intensive process requiring a referral to a credentialed diabetes educator (CDE) for insulin dose adjustment (IDA). To address the challenges in IDA, we have developed an innovative mobile health (mhealth) based model of care to support the patients and clinicians in diabetes specialist outreach and telehealth clinics (REMODEL-IDA: REthinking MOdel of Diabetes care utilising EheaLth – Insulin Dose Adjustment). Advances in mhealth have enabled to redesign traditional models of healthcare delivery. This model aims to improve glycaemic management, improve healthcare service delivery efficiency and improve the patients’ experience. A two-arm pilot randomised controlled trial will be conducted for 3 months with 44 participants, randomised at a 1:1 ratio to receive either the mhealth-based model of care (intervention) or routine care (control), in diabetes specialist outreach and telehealth clinics. The intervention arm will exchange glycaemic management information via a Mobile-based Disease Management System (MDMS) developed for T2DM outpatients. They will receive advice for insulin titration from the CDE via the mobile-app and receive automated text-message prompts for better self-management based on their glycaemic management. The routine care arm will be followed up via telephone calls. The primary outcome is change in HbA1c, a marker of glycaemic management, at 3 months. Patient and healthcare provider satisfaction, and time required by health care providers in both arms will be collected. This study will guide the conduct of a large-scale implementation study.

Interventions

In partnership with Australian E-Health Research Centre, CSIRO (Commonwealth Scientific and Industrial Research Organisation), and the Department of Diabetes and Endocrinology at PAH, the Centre for Online Health, University of Queensland, developed a mobile-based disease management system (MDMS) to support the transformation of the provision of specialist diabetes care. This system is modelled on a highly successful CSIRO platform that supports in home cardiac rehabilitation leading to improvem

In partnership with Australian E-Health Research Centre, CSIRO (Commonwealth Scientific and Industrial Research Organisation), and the Department of Diabetes and Endocrinology at PAH, the Centre for Online Health, University of Queensland, developed a mobile-based disease management system (MDMS) to support the transformation of the provision of specialist diabetes care. This system is modelled on a highly successful CSIRO platform that supports in home cardiac rehabilitation leading to improvements in adherence and clinical outcomes . This system has been modified to enable real time monitoring of BGL in patients with diabetes, and to support patient care. The system comprises an app for iOS- (Apple) and Android-based smartphones, and a web-based clinical portal. The mobile app enables patients to use a Bluetooth-enabled glucose meter (Accu-Chek® Aviva Guide, Roche Diagnostics GmbH) to upload their BGL readings to the clinical portal. The mobile app also provides an insulin diary that allows patients to manually enter the dose and time of their insulin injections, along with a free text comment for each dose (e.g. "before dinner"). These data are subsequently transmitted and uploaded to the clinical portal via the internet. The clinical portal presents the uploaded data in graphical and tabular formats for the CDEs and endocrinologists to monitor and manage a patient's condition. Integrated alerts, which can be customised by clinicians, highlight out of range measures. Through the portal, the clinicians can review the patients’ BGL data and insulin dosages, and send messages to the patients’ mobile phones. A summary of their diabetes care is also displayed based on the clinical information entered. Patients receive optional automated individual text-messages based on frequency of BGL testing and BGL values. These messages serve as prompts to test BGL as recommended, consider reasons for out of range BGL measures and to seek medical advice if required. The messages also contain links to national diabetes website for additional information regarding self-management of diabetes. Mobile app screens enable a review of progress. We obtained patient and clinician feedback on the MDMS through a proof of concept trial with diabetes patients who had stable glycaemic management. This enabled enhancements to the MDMS. The management of the intervention group will use the MDMS as described earlier for insulin dose adjustments. For the intervention group, the researcher will (1) install and demonstrate the mobile app on their individual smartphones and (2) provide and demonstrate the use of Accu-Chek® Aviva Guide, Roche Diagnostics GmbH, which pairs via Bluetooth to the mobile app and sends blood glucose recordings automatically to a web-portal daily. The participants will be followed up for the duration of their enrolment into the IDA service which can last up to 4-6 weeks. CDE shall provide advice to the patient on insulin titration through messages sent via the mobile app. The participants who complete the IDA before 3 months will be discharged from the MDMS but followed up at 3 months to obtain an HbA1c. The study will be terminated for participants who continue to be in the IDA at 3 months and an HbA1c obtained. The principal researcher will follow-up the participants in liaison with the CDE. For participants who do not have a compatible smartphone, a smartphone or tablet will be loaned for the duration of the study.

Sponsors

Anish Menon
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Type 2 Diabetes Mellitus ( diagnosed for at least 6 months) attending the telehealth clinic at the Princess Alexandra Hospital (PAH) or specialist outreach clinics run by PAH HbA1c > 8% ( done within 4 weeks of the trial) Age > 16 yrs Using a smartphone/tablet Able to communicate in English

Exclusion criteria

No access to reliable internet connection (3G/4G/Wi-Fi) Pregnant Type 1 DM

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026