The current study provides simple feedback and motivation to the enrolled diabetic patients, with fitness tracking, dietary advice and meal tracking, and lifestyle advice delivered through their smartphones and email. This information is a summary of the Study design and criteria
Inclusion and exclusion criteria
We need 30 diabetic patients for this project conforming to the following inclusion and exclusion criteria. Both subjects and medical practices will be paid for their time and contribution to the study, and subjects will keep their fitness trackers at the end of the study.
Requirements for inclusion in the Study
- Non-insulin-dependent type T2DM of more than 1 year’s duration
- Participants between 45 years and 75 years old (at entry)
- HbA1c between 7.5% - 9.0% (58 - 75 mmol/mol) measured in the 12 months prior to commencement of study
- Ownership and ability to operate a smart phone and personal computer
- Willingness to wear a fitness tracker wristband day and night (24 hours) throughout the 6 months of the study
- No chronic disease apart from (minor) complications of T2DM
- Cognitive ability to give informed consent to participate
Exclusion Criteria
- History of alcohol or substance abuse including use of illicit drugs
- Female participants who are lactating or pregnant
- Presence of significant diagnosed disease unrelated to T2DM
- Presence of diagnosed psychiatric disease which would impair participation or where participation could adversely the subject
- Any other clinically relevant condition or abnormality which, in the judgment of the treating doctor or the principal investigator, would make the subject unsuitable for the trial (e.g., dietary allergies, psychiatric symptoms, visual impairment etc. )
The study process
- The study has ethics committee approval and is registered with the Australian and New Zealand Clinical Trials Register
- Information about the Study will be provided for display in your waiting room
- Doctors identify patients who fulfil the inclusion / exclusion criteria and offer their patient an ethics approved information pack for entry into the Study
- Each patient who chooses to participate in the Study is provided a fitness tracker linked to their smartphone (android or iPhone) for automated daily step / distance tracking
- Each patient is given a recipe book and access to online dietary resources
- Each patient is measured for HbA1c, BP, weight, height and waist circumference at the start and end of the Study in your Practice by your staff
- Each participant completes three psychological questionnaires to access cognitive function (mood and emotional state)
- Each patient receives regular and personalised email and text communications from Personalised e-Health Clinic to encourage increased exercise and improvement in dietary habits and nutrition.
Payment
For each qualifying patient who agrees to participate, your Practice will receive $300 compensation to cover your your costs of subject identification, the measurement and recording of BP, weight, height and waist circumference at start and end of the 6 month study period, and a de-identified copy of the HbA1c measurement you perform at the start and end of the Study.
Your practice will also receive an additional $300 to be passed on to your patient (the Study subject) - $100 paid at entry and $200 paid on completion and recording of the measurements after six months (including repeat HbA1c). This is done to preserve patient anonymity and privacy.
Contact
Dr Mark Donohoe: 0422 997-408
Principal Investigator
Or use this page to register your interest in your Practice being involved