The role of continuous glucose monitoring (CGM) systems as a self-monitoring tool to optimise blood glucose control in individuals with type 2 diabetes (T2D) - Pilot

INTERVENTION: A pilot feasibility study, to determine the effectiveness of real‐time continuous glucose monitoring (RT‐CGMS) compared with standard care self‐management blood glucose (SMBG) approach for improving glycaemic control, reducing cardiovascular disease risk markers and enhancing quality of life in response to the prescription of a lifestyle modification program in overweight and obese individuals with type 2 diabetes (T2D). Both groups will also perform usual self‐monitoring blood glucose readings before each meal and at bedtime as per standard practice with morning fasting recordings to be provided to the study dietitian and Endocrinologist for review and support. At study commencement (Week 0), participants will be counselled by a research dietitian for 1 hrs and receive a prescriptive low carbohydrate (50g or 14% of total energy) higher protein (28% of total energy) higher fat (58% of total energy) dietary plan and supporting materials (Meal plans, recipes, food lists), individualised for energy level using the Schofields’ energy equation. To facilitate dietary adherence, the dietary prescription will be structured to include a specific daily eating plan with foods listed in a quantitative food record that participants will be required to complete as a measure of overall dietary adherence, whilst dietitian for the trial will be entering the food data into a food database to ensure macronutrient adherence. At week 3, participants will be provided face to face education on how to adapt the diet and add food exchanges into their day whilst remaining compliant to the intervention. Participants will be counselled by an accredited practising dietitian for up to 45 minutes and will be provided comprehensive materials including dietary plans, recipes, shopping lists to assist them to make appropriate energy and food exchanges to maintain the prescribed energy level and macronutrient profile. Participants will also receive a home‐based exercise plan incorporating moderate intensity aerobic (walking)/resistance exercises (Theraband), consistent with diabetes Australia exercise recommendations. Materials provided will be visual guides and instructions on specific exercises and how to complete the activity journal. Intensity recommended will be 60‐70% of max heart rate. Exercise session will be of at 30 mins a session every day (210mins minimum target a week) as per the diabetes Australia recommendations. The activity journal will be provided to participants who will be asked to document their exercise type and time, this will be provided to the identify adherence to physical activity. Apart from the introductory counselling session, participants will receive no further formal counselling regarding the components of the diet or exercise, but will have a contact number for the clinical trial manager for any queries. Queries of a lifestyle or medical nature will be directed to the respective researchers for follow‐up. Participants will attend 3 weekly follow‐up clinic visits to return and collect glucose sensors, to document any adverse events and to have any questions regarding sensor management answered. At these visits, participants will be required to return activity journals and food records for compliance assessment. For the intervention group, the Real Time CGM sensor will be inserted by a nurse into the lower abdominal, subcutaneous tissue, instructions on insertion will be provided. Duration: 12‐week randomized controlled study Participant: 20 overweight/obese individuals (BMI:26‐45 kg/m2, age:20‐75 yrs) with T2D will be randomly allocated to undertake 1 of 2 interventions: Group 2 (N=10) ‐ Prescription of a LC diet combined with the use of a non‐display, ‘masked’ continuous glucose monitor (worn continuously for 12 weeks). These visits will be face to face with the trial manager for 30 minutes and a trial manager or PhD student will also measure weight, body composition and blood pressure and review blood glucose data for assessment of medication change requirements. It is likely that participants may be taking hypoglycaemic, antihypertensive and lipid‐lowering medications and changes to oral hypoglycaemic medication will be required. The participant’s health will be monitored and periodically assessed by project clinician (Prof. Thompson) who will conduct a medication review when necessary . ** CGM sensor wear will be monitored by the clinical research nurse and returning of used sensors will be taken as a measure of compliance. The real time CGM instructions for participants is an attachment to this ANZCTR Trial record. Group 1 (N=10) – Prescription of a low carbohydrate, high protein and unsaturated fat diet (LC diet) combined with the use of a real‐time continuous glucose monitor (worn continuously for 12 weeks). CONDITION: Glycaemic Control Overweight/Obesity Type 2 Diabetes PRIMARY OUTCOME: 24hr Blood Glucose Profile measured by continuous blood glucose monitoring device ‐ Medtronic Guardian Connect (Commercially Available in Australia) Diabetes‐related medication changes assessed by the validated an anti‐glycemic medication effect score (MES) based on Medication changes documented by medication type and dosage changes. Glycated Haemaglobin (A1C%) SECONDARY OUTCOME: Mental wellbeing using a series of validated assessment questionnaires, including ‐ Diabetes Distress ‐ Problem Areas in Diabetes Questionnaire (PAID); Diabetes Quality of life questionnaire: Diabetes 39 – Quality of Life Questionnaire, Acceptance and Tolerance of CGM Wear and Lifestyle plan ( 5 Subjective likert questions) Blood Pressure using an automated sphygmomanometer (SureSigns Vs3, Phillips Medical Systems, MA, USA). Body Composition using InBody 270 bioimpendance scales Food Craving Eating Style using the food Craving Inventory (FCI); Food intake using a 3 day weighed food records and diet histories Physical activity measured using 7‐day accelerometery and the international physical activity questionnaire (Ipaq) Sleep quality using the Pittsburgh Sleep Quality Index (PSQI); Stress Survey using Perceived Stress Scale (PSS); INCLUSION CRITERIA: Inclusion Criteria *Adults aged 20‐75yrs (Male and Female) *BMI 26‐45kg/m2 * Diagnosed with Type 2 Diabetes *With a HbA1c between 5.9‐6.9% and ARE taking oral medications or insulin * With a HbA1c between 7‐12% with or without medications * Must be willing to comply with the study procedures *Have signed informed consent *Able to attend appointments and live within the Adelaide Metropolitan area *If female, not pregnant or breast feeding *No history of heart disease or other heart abnormalities *Do not strictly control or restrict the food and drinks that you have daily (i.e. *restrained eater questionnaire score greater than 10) *Being weight stable (+/‐ 3kg) in the past 3 months