None listed
Conditions
Brief summary
For better educating patients and sustaining their self-management, we have developed, based on digital health principles, an innovative Mobile-based Diabetes Management System (MDMS). The MDMS consists of a clinician portal, as well as a consumer-facing smartphone application. The proof-of-concept, feasibility and pilot trials of the Mobile Diabetes Management System (MDMS) that we have completed have demonstrated a significant improvement in blood glucose levels, a high degree of consumer satisfaction and a good proportion of conventional in-person visits being substituted in a tertiary diabetes service at the Princess Alexandra Hospital, Brisbane. In this project we have added an insulin titration feature to the MDMS, which will be trialled with people living in regional, rural and remote Queensland. Participants will be recruited from the PA’s telehealth service. The aim of the project is to trial the updated MDMS for efficacy and safety. We anticipate that this project will lead to improved glycaemic outcomes.
Interventions
In order to avoid bias, all participants will receive a Bluetooth-enabled glucose meter and a box of 100 test strips, and they will be encouraged to test their blood glucose levels daily, however, there are no specified testing requirements for this trial.
The participants in the intervention group will be connected to a Mobile Diabetes Management System (MDMS), which consists of a smartphone application where participants can track their glucose readings and access their insulin prescriptions,
In order to avoid bias, all participants will receive a Bluetooth-enabled glucose meter and a box of 100 test strips, and they will be encouraged to test their blood glucose levels daily, however, there are no specified testing requirements for this trial. The participants in the intervention group will be connected to a Mobile Diabetes Management System (MDMS), which consists of a smartphone application where participants can track their glucose readings and access their insulin prescriptions, and a browser-based clinician portal for patient monitoring and communication. Participants using the MDMS will also receive text messages with self-management advice, which will be based on their most recent readings and their frequency of testing. There will also be general lifestyle advice. Examples of text messages: •“Blood glucose checks were less than once daily. More regular checks can help your diabetes management. Any problem? Talk to your diabetes team” •“Foods that affect blood sugar are carbohydrates - breads, cereals, starchy vegetables (potato & corn), snack foods (biscuits & cake) and some fruits.” Every Monday, participants will receive insulin dose adjustment (IDA) advice based on the previous week’s glucose readings. The advice will be generated by Insulin Insights, an FDA-cleared insulin titration algorithm from Mellitus Health. For safety, an endocrinologist will review the IDA advice before the patient is notified of the new advice via text message. The insulin dose adjustment service will be available for the first 8 weeks of the 6-month trial. After that, participants will have access to the app and receive text message advice until the end of the study at the 6-month mark. Adherence and fidelity to the system can be estimated by observing the participants’ testing frequency in the clinician portal, as well as the number of insulin dose adjustment advice generated and accepted by the participants.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
People living with type 2 diabetes, attending the PA diabetes telehealth service: • with a glycated haemoglobin (HbA1c) >8%, • with an age >=18 years, • with pre-existing type 2 diabetes for at least 6 months, and • on insulin.
Exclusion criteria
The exclusion criteria will be participants • those referred to conventional IDA • those using the insulin pump, flash glucose monitoring or continuous glucose monitoring devices, • with a recent bariatric surgery of less than 12 months, • unable to communicate in English, • who are pregnant or those planning pregnancy in the next 12 months, • on insulin Ryzodeg • those who do not have a reliable internet connection (either through Wi-fi at home or 3G/4G).
Outcome results
None listed