A general practice delivered, technology supported, lifestyle program for Type 2 Diabetes (T2D) management – Evaluation Study (GP-T2D)

This is a pragmatic, feasibility trial of . N = 40 participants recruited across 3 GP Clinics in SA and NSW. At the baseline (wk 0) appointment, the treating GP will provide the participant with a product kit, provided free to the participant, consisting of the CSIRO Low Carb Diabetes Diet and Exercise Program (Commercial Book publication) combined with use of a commercially available real-time continuous blood glucose monitoring system (Medtronic, Guardian Connect system including disposable sensors, access to the guardian connect app, and quick start information guide). Education on the product kit and how to use will be delivered by the treating GP and supported by the quick start guides in the product kit in a 45-60 minute face to face session. The product kit consists of the CSIRO Low Carb Diet commercial book (providing, of total energy 10-15% Carb; 40-45 % protein and 40-50% healthy fat(<10% SFA)) with a generalised Exercise Program of entry level strength training with a quick start information guide to inform participants to read specific starter details, i.e. pages 71-77, 82-83 and 276 including starting basic weight based or walking exercises of up to 150 mins a week). Exercises will be Low to Moderate in level, with the information being provided that Participants can be seen by Exercise physiologists as needed for personalisation or support for use of the exercise information. The diet information provided in the product kit will be combined with use of a commercially available real-time continuous blood glucose monitoring system including disposable sensors and user guide (Including associated disposables such as finger sticks, glucometers and glucose testing strips). Note: The quick start guides provide participants with clear and step by step instructions on how to implement the lifestyle pattern and CMG device usage. The quick start guides provide the public health reference, that if additional support is required, to make a booking with the GP to seek a referral to a health care professional for further information, to support individuals needs in obtaining compliance with the CSIRO low carb diet and lifestyle program. The CGM quick start guide provides links to access videos of 5-30 mins in duration that provide education and support to the participant on, sensor insertion techniques, how to and need to change sensor every 10 days, guardian connect app user information for participants. Throughout the intervention participants will have free access to a telephone hotline for personal technical support, without time limits in call access. For intervening lifestyle support visits with health care professionals, access to personal face to face or telehealth medical support is as per usual clinical care and participants can have access to allied health care services, with mandatory trial visits at Baseline education and week 12, each session delivered by the treating GP of 30-45 minutes of face to face time. Intervening weeks are as per clinician and patient agreement based on health care goal setting needs. Intervention adherence will be captured using participant data collected by the GP, by the research office (CSIRO CI Taylor) observing visit attendance seeking 100% attendance (2 visits completed as the mandatory visits week 0 and 12) , compliance with device wear will be defined as at least 80% ( 68 of the total 84 days sensor wear required) and clinical improvements in glycaemic control, observed as a 0.5-1% reduction in A1c. Fidelity will also be assessed by obtaining data to analyse the type, frequency and mode of engagement between baseline and week 12 between the participant and GP and /or Allied Health practitioners. type of information provided will also be captured for a descriptive analysis. End of Trial (Wk 12). Participants attends final visit with the GP, who will provide in addition to routine "usual care" support, personalised feedback on their device use and personal achievements, including but not limited to , weight change, glucose management and medication usage. A post trial focus group, at the final visit, participants and treating GPs and practice managers will be invited by the CSIRO research team (CI Taylor) to participate, with no obligation, in a focus group to understand the efficacy, feasibility and acceptability of the health care model being tested. Two focus groups will be conducted by PI Taylor and the research assistant over a one-hour period. Participants will be asked to respond to questions, only if they feel comfortable to do so. These focus groups will be delivered as: o Group 1: Health care providers delivering the product intervention o Group 2: Participants using the product intervention Focus group questions will consist of semi-structure questions, generally starting with an opening question and several follow up and prompting questions i.e. Topic: Program Delivery o Opening Question: when you first product, can you tell me about how you expected it to be delivered (to or by) you? o Follow-up Question: How did you measure whether the product was being delivered in a successful or effective way for (you or your clinic)? o Probing Question/s: How could this product be delivered better to access more individuals) living with Type 2 Diabetes? Tell us what you found most useful about the product?