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Trial registered on ANZCTR


Registration number
ACTRN12618000412235
Ethics application status
Approved
Date submitted
2/03/2018
Date registered
21/03/2018
Date last updated
21/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 294219 0
None
Universal Trial Number (UTN)
Trial acronym
REMODEL-IDA: REthinking MOdel of Diabetes care utilising EheaLth – Insulin Dose Adjustment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 306883 0
Condition category
Condition code
Metabolic and Endocrine 305979 305979 0 0
Diabetes
Public Health 305980 305980 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300512 0
Treatment: Other
Comparator / control treatment
The control group will receive routine care provided by the clinical staff based on existing national evidence based guideline for the management of type 2 diabetes . The control group will be provided with standard glucose meters if their current glucose meter is more than 2 years old and followed up as per current model of care.
Control group
Active

Outcomes
Primary outcome [1] 305016 0
Change in HbA1c. HbA1c is measured in serum using high performance liquid chromatography method.
Timepoint [1] 305016 0
0, and 3 months
Secondary outcome [1] 343872 0
Serum Fructosamine.
Timepoint [1] 343872 0
0 and 4 weeks
Secondary outcome [2] 343873 0
Participant acceptability of MDMS. This will be assessed by administering questionnaire (modified SUTAQ -Service User Technology Acceptability Questionnaire)
Timepoint [2] 343873 0
4 weeks
Secondary outcome [3] 343875 0
Patient Satisfaction will be assessed by a questionnaire designed specifically for this study.
Timepoint [3] 343875 0
At baseline and 4 weeks
Secondary outcome [4] 343876 0
Self-reported hypoglycaemic events assessed by questionnaire designed specifically for this study..
Timepoint [4] 343876 0
Baseline, 4 weeks and 3 months
Secondary outcome [5] 343877 0
Health care provider satisfaction assessed by questionnaire designed specifically for this study.
Timepoint [5] 343877 0
End of participant follow-up when all recruited participants have finished their 3-month follow-up.
Secondary outcome [6] 343878 0
Completion rate of IDA from medical records.
Timepoint [6] 343878 0
At 3 months
Secondary outcome [7] 343879 0
Clinician time as self-reported
Timepoint [7] 343879 0
End of participant follow-up when all recruited participants have finished their 3-month follow-up.
Secondary outcome [8] 343880 0
Diabetes related visits to GP/diabetes educator/Hospital as self-reported
Timepoint [8] 343880 0
3 months

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No access to reliable internet connection (3G/4G/Wi-Fi)
Pregnant
Type 1 DM

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be based on ‘intention to treat’ and per protocol. The primary analysis will be intention to treat. A secondary analysis will be based on per protocol. Differences between groups at baseline and the relevant endpoints will be compared using either the Student’s t-test or Mann-Whitney U-test as appropriate. A p value of less than 0.05 will be considered statistically significant. A subgroup analysis of the participants based on their location – regional versus urban will be conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2018
Actual
Date of last participant enrolment
Anticipated
30/09/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10250 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 10251 0
Roma Hospital - Roma
Recruitment postcode(s) [1] 21916 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 21917 0
4455 - Roma

Funding & Sponsors
Funding source category [1] 298857 0
Government body
Name [1] 298857 0
Telehealth Seed funding, Department of Health. Queensland Health
Country [1] 298857 0
Australia
Primary sponsor type
Individual
Name
Anish Menon
Address
Centre for Online Health, University of Queensland
Ground Floor, Building 33
PA Hospital
Woolloongabba
QLD -4102
Country
Australia
Secondary sponsor category [1] 298062 0
Individual
Name [1] 298062 0
Prof Len Gray
Address [1] 298062 0
Centre for Health Services Research, University of Queensland
Ground Floor, Building 33
PA Hospital
Woolloongabba
QLD -4102
Country [1] 298062 0
Australia
Secondary sponsor category [2] 298063 0
Individual
Name [2] 298063 0
A/Prof Anthony Russell
Address [2] 298063 0
Dept of Diabetes & Endocrinology
Main Building, Princess Alexandra Hospital
Woolloongabba
QLD -4102
Country [2] 298063 0
Australia
Secondary sponsor category [3] 298064 0
Individual
Name [3] 298064 0
Dr Farhad Fatehi
Address [3] 298064 0
Centre for Online Health, University of Queensland
Ground Floor, Building 33
PA Hospital
Woolloongabba
QLD -4102
Country [3] 298064 0
Australia
Secondary sponsor category [4] 298065 0
Individual
Name [4] 298065 0
Dr Darsy Darshan
Address [4] 298065 0
Centre for Health Services Research | Faculty of Medicine | The University of Queensland
Level 5, R-Wing, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba QLD 4102
Country [4] 298065 0
Australia
Secondary sponsor category [5] 298066 0
Individual
Name [5] 298066 0
Dr Dominique Bird
Address [5] 298066 0
Centre for Online Health, University of Queensland
Ground Floor, Building 33
PA Hospital
Woolloongabba
QLD -4102
Country [5] 298066 0
Australia
Secondary sponsor category [6] 298067 0
Individual
Name [6] 298067 0
Dr Mohan Karunanithi
Address [6] 298067 0
The Australian E-Health Research Centre
CSIRO Health and Biosecurity. Level 5 - UQ Health Sciences Building 901/16,
Royal Brisbane and Women's Hospital, Herston, 4029, Brisbane, Queensland,
Country [6] 298067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299802 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 299802 0
Centres for Health Research
Princess Alexandra Hospital
Woolloongabba
QLD -4102
Ethics committee country [1] 299802 0
Australia
Date submitted for ethics approval [1] 299802 0
18/01/2018
Approval date [1] 299802 0
13/02/2018
Ethics approval number [1] 299802 0
HREC/18/QPAH/42

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81606 0
Dr Anish Menon
Address 81606 0
Centre for Online Health, University of Queensland
Ground Floor, Building 33
PA Hospital
Woolloongabba
QLD -4102
Country 81606 0
Australia
Phone 81606 0
+61 7 3176 8187
Fax 81606 0
Email 81606 0
[email protected]
Contact person for public queries
Name 81607 0
Anish Menon
Address 81607 0
Centre for Online Health, University of Queensland
Ground Floor, Building 33
PA Hospital
Woolloongabba
QLD -4102
Country 81607 0
Australia
Phone 81607 0
+61 7 3176 8187
Fax 81607 0
Email 81607 0
[email protected]
Contact person for scientific queries
Name 81608 0
Anish Menon
Address 81608 0
Centre for Online Health, University of Queensland
Ground Floor, Building 33
PA Hospital
Woolloongabba
QLD -4102
Country 81608 0
Australia
Phone 81608 0
+61 7 3176 8187
Fax 81608 0
Email 81608 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseMobile-based insulin dose adjustment for type 2 diabetes in community and rural populations: study protocol for a pilot randomized controlled trial.2019https://dx.doi.org/10.1177/2042018819836647
N.B. These documents automatically identified may not have been verified by the study sponsor.