None listed
Conditions
Brief summary
Current service model for specialist diabetes care is based in a tertiary setting and involves care by a multidisciplinary team led by the endocrinologist. Continuation of conventional approaches with unchanged outcomes will require dramatic and potentially unaffordable expansion of current services to meet the increasing demand. The primary aim of this proposal is to determine the clinical efficacy of a new model of care employing mHealth (mobile Health) intervention in diabetes patients with suboptimal glycaemic control attending an outpatient specialist clinic as compared to usual care. This study follows on from a proof of concept and feasibility of mobile-based remote monitoring for stabilisation of insulin therapy in type 2 diabetes. Mobilehealth (Use of mobile technology like smartphone in health care management) create an opportunity to redesign outpatient services and meet unmet demands of existing healthcare. Collaboration between Diabetes and Endocrinology Department at Princess Alexandra Hospital (PAH), the UQ Centre for Online Health and the CSIRO has led to the development of a mobile-based remote monitoring system to support the management of complex outpatient diabetes patients. This system utilises a Bluetooth-enabled glucose meter to automatically transfer blood glucose levels to a clinician dashboard via an application installed on the patient’s smartphone. This will enable the endocrinologist/diabetes nurse to remotely monitor blood glucose levels and communicate with the patient in real time. The clinical data shall only be reviewed at set times decided by the clinician or on patient request and will not be continuously monitored. Patients receive individual alerts based on the frequency of BGL testing and BGL values. Individual patient screens enable a review of progress in advance of conventional outpatient encounters or during telephone consultations. Type 2 diabetes patients attending the outpatient diabetes clinic at the PAH shall be invited to attend. They shall be randomised to the intervention or control group with both groups followed up for a year. Control group shall receive routine care. The intervention group shall use the mobile-based remote monitoring system. Based on the data received in the intervention group, the endocrinologist in liaison with the patient shall decide to substitute scheduled face to face clinic consultation with virtual clinics ( via videoconference or telephone at home) if required. They will be required to get recommended pathology tests before their consultation as per routine practice. The patients have the option to enter via an online survey, relevant details before their intended clinic appointment. The participants will be followed for 12 months. We expect the new model of care will improve diabetes-related clinical outcomes, with improvement in patient and health care provider satisfaction at similar or lower costs.
Interventions
In partnership with CSIRO, a mobile-based disease monitoring system (MDMS) has been developed for people with diabetes (MDMS- Diabetes). This system was modelled on a highly successful CSIRO platform that supports in-home cardiac rehabilitation which resulted in improvements in adherence and clinical outcomes . This platform has been modified to enable real time monitoring of blood glucose levels in patients with diabetes, and support patient care. The system comprises an app for iOS (Apple) a
In partnership with CSIRO, a mobile-based disease monitoring system (MDMS) has been developed for people with diabetes (MDMS- Diabetes). This system was modelled on a highly successful CSIRO platform that supports in-home cardiac rehabilitation which resulted in improvements in adherence and clinical outcomes . This platform has been modified to enable real time monitoring of blood glucose levels in patients with diabetes, and 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 participants to use a Bluetooth-enabled glucose meter (AVIVA Connect, Roche) to automatically upload their BGL readings to the clinical portal. The mobile app also provides an insulin diary that allows participants to manually enter their insulin injections’ dose and time, along with free text comment for each dose (e.g. "before dinner"). These data are subsequently transmitted and uploaded to the clinical portal via a mobile internet connection such as Wi-Fi, 3G or 4G. The clinical portal presents the uploaded data in graphical and tabular formats, for the DNEs and endocrinologists to monitor and manage a patient's condition. Integrated alerts, which can be customised by clinicians, highlight out of range measures. Patients receive individual, computer generated alerts based on the frequency of BGL testing and BGL values. Individual patient screens enable a review of progress in advance of conventional outpatient encounters or in the course of telephone consultations. Through the portal, the clinicians can review the participants’ BGL data, insulin dosages, and send messages to the participants’ mobile phones. A summary of their diabetes care is also displayed based on the clinical information entered. Using the MRMS platform, an alternative model of outpatient service delivery has been designed at Princess Alexandra Hospital , which incorporates the following elements: 1. Short or long-term monitoring of BGL, insulin dosage using the MRMS. 2. Targeting of intensive MRMS use to patients with suboptimal control. 3. Computer generated alerts sent to patient via text message. 4. Patient input before each clinic visit via online survey 5. Substitution of conventional in-person follow-up consultations with telephone or video-consultations The participants will be followed up for 12 months.
Sponsors
Anish Menon
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
Type 2 Diabetes Mellitus ( diagnosed for at least 6 months) attending the outpatient clinic at the Princess Alexandra Hospital HbA1c > 8% ( done within 4 weeks of the trial) Age > 18 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 Complex unstable medical conditions (participants likely to require frequent hospital admissions unrelated to diabetes glycaemic control; those on weaning doses of medications which can impact on glycaemic control and those with bariatric surgery in the last one year) Enrolled in another interventional study
Outcome results
None listed