Dhirrabuu Maaruma-li: Identify the most promising approach of improving diabetes risk factors for Indigenous Australians with type 2 diabetes using Flash Libre continuous glucose monitoring and a 10-week intensive lifestyle program

The aim of this project is to identify the most promising approach of improving diabetes risk factors for Indigenous Australians with type 2 diabetes using LibrePro continuous glucose monitoring and a 10-week intensive lifestyle program. Up to 90 participants who identify as Aboriginal and/or Torres Strait Islander, have been diagnosed with type 2 diabetes and have recently recorded a HbA1c >7.5% will be recruited from multiple locations. This study follows a basket trial methodology with 2 groups assessed at each stage: participants taking insulin &/- sulfonylureas and other diabetes medications; and participants on other diabetes medication (NOT taking insulin &/or sulfonylureas). Fifteen participants will be recruited for each group at each stage. All participants will use both the Freestyle Libre Pro iQ blinded sensor, and the Libre 2 unblinded sensor. Both sensors uses a wired enzyme technology, coated with glucose oxidase, to measure interstitial blood glucose levels, and are worn on the upper arm for 14 days. All participants will have diabetes education sessions on the use of the device by the Diabetes Educator or Chronic Care Nurse. The Freestyle Libre Pro iQ will be worn for a period of two (2) weeks prior to commencing the lifestyle program, and again for the last 2 weeks of the lifestyle program. Participants will be provided with a Freestyle Libre 2 unblinded sensor every 2 weeks, commencing from Week 0 (the beginning of the lifestyle program). Participants will be informed to scan with purpose, at least 10 times per day. Participants will be provided the option of using the Abbott reader or the Freestyle Mobile App (FreeStyle LibreLink) on their smartphone (Android or iOS operating system compatible). Participants will be asked to bring the device (mobile phone and/or reader) to study visits which occur each week. They will be shown how to replace their sensor every 2 weeks. The 10-week intervention will be delivered within the AMS by a nurse or allied health professional depending on the availability of staff. Each staff member will undergo training in a 4-hour face to face seminar. It will be completed within the Aboriginal health service as outcomes are improved when programs are provided in a culturally safe environment. Initial screening, weekly weigh-in, weekly phone call, and referral for medication reviews will form the main role for medical centre staff. Initial screening will consist of height, weight, blood pressure, HbA1c, fasting glucose, fasting lipid profile, Full Blood Count (FBE), Urea Electrolytes and Creatinine (UEC), Liver Function Test (LFT) and urine albumin:creatinine ratio. Weekly weigh in sessions will occur during the 10 weeks of the porgram and be approximately 15 20 minutes in duration. Participants are required to attend the weekly weigh ins but if they cannot attend they can have a phone consultation. They are not required to participate in any other support activities unless they would like to.In these weekly visits, the nurse will measure weight, glucose levels and blood pressure. There will also be a discussion on upholding to the meal plan and exercise program and any assistance or support the patient might require. If the patient has experienced consistent fasting blood glucose levels less than 6.0mmol/L in the morning (2-3 consecutive days), then an appointment will be made with the GP for a medication review. The GP providing guidance and support at each medical centre is an investigator on the study and the participant’s usual GP. They will continue to provide support to the participant through to the completion of the study. The meal plan is provided via a website or in print form. The meal plan has been designed with input from dietitians, and consists of fresh, unprocessed foods that are accessible within the local supermarket. A range of recipes are provided to the participant for them to choose the ones most suited to them. The participants are provided with options for 3 main meals and 2 snacks per day. Depending on the recipes chosen, their kilojoule intake may range from 5000kj-6300kj per day. The meal plan is administered via the program app, however if a dietitian is available at the study site they will provde additional feedback and support. The meal plan is designed so that each participant can easily individualise it to suit their own requirements. Adherence to the diet will be measured through food recall questionnaires. Education on lifestyle strategies will be provided to the participants through short daily videos via email, and video messages to their mobile phone as well as feedback during their weekly consultation. The topics cover strategies for many of the common misconceptions and obstacles surrounding weight loss. Support is an important component of any successful lifestyle intervention and in this program, it is provided via the weekly weigh ins, a closed Facebook group, and text messages. Participants will be encouraged to walk for 20-30 minutes each day and complete a short body weight resistance program 2-3 times per week. The body weight resistance circuit is designed to start at a low skill level and consists of exercises such as wall push-ups, squats, and crunches. If the participant has greater capacity, there are options to make the circuit more challenging. It is not a requirement of the study that participants complete the walking program or the body weight circuit, however they will be encouraged by the health care professional employed by the Aboriginal health service to complete some form of physical activity each day. If they have been exercising prior to commencing the study they will be encouraged to continue with that activity. As participants establish a foundation of physical fitness and mobility they will be encouraged to participate in activities they have an interest in, at an intensity they can tolerate. This format removes many barriers to regular physical activity and will improve the sustainability of following their choice of physical activity. Where an exercise professional is available, instruction on body weight circuits or additional exercise formats will be provided by an exercise physiologist, physiotherapist, or fitness intructor. Adherence will be measured by a 60% participation rate as reported by the participant at each weekly weigh in.