Abstract
INTRODUCTION: Optimising patient adherence to prescribed lifestyle interventions to achieve improved blood glucose control remains a challenge. Combined use of real-time continuous glucose monitoring systems (RT-CGM) may promote improved glycaemic control. This pilot study examines the effects of a prescriptive lifestyle modification programme when combined with RT-CGM on blood glucose control and cardiovascular disease risk markers. METHODS: Twenty adults (10 men, 10 women) with obesity and type-2 diabetes (T2D) (age 60.55 ± 8.38 years, BMI 34.22 ± 4.67 kg/m(2)) were randomised to a prescriptive low-carbohydrate diet and lifestyle plan whilst continuously wearing either an RT-CGM or an 'offline-blinded' monitor (control) for 12 weeks. Outcomes were glycaemic control (HbA1c, fasting glucose, glycaemic variability [GV]), diabetes medication (MeS), weight, blood pressure and lipids assessed pre- and post-intervention. RESULTS: Both groups experienced reductions in body weight (RT-CGM - 7.4 ± 4.5 kg vs. control - 5.5 ± 4.0 kg), HbA1c (- 0.67 ± 0.82% vs. - 0.68 ± 0.74%), fasting blood glucose (- 1.2 ± 1.9 mmol/L vs. - 1.0 ± 2.2 mmol/L), LDL-C (- 0.07 ± 0.34 mmol/L vs. - 0.26 ± 0.42 mmol/L) and triglycerides (- 0.32 ± 0.46 mmol/L vs. - 0.36 ± 0.53 mmol/L); with no differential effect between groups (P ≥ 0.10). At week 12, GV indices were consistently lower by at least sixfold in RT-CGM compared to control (CONGA-1 - 0.27 ± 0.36 mmol/L vs. 0.06 ± 0.19 mmol/L; CONGA-2 - 0.36 ± 0.54 mmol/L vs. 0.05 ± 2.88 mmol/L; CONGA-4 - 0.44 ± 0.67 mmol/L vs. - 0.02 ± 0.42 mmol/L; CONGA-8 - 0.36 ± 0.61 vs. 0.02 ± 0.52 mmol/L; MAGE - 0.69 ± 1.14 vs. - 0.09 ± 0.08 mmol/L, although there was insufficient power to achieve statistical significance (P ≥ 0.11). Overall, there was an approximately 40% greater reduction in blood glucose-lowering medication (MeS) in RT-CGM (- 0.30 ± 0.59) compared to control (0.02 ± 0.23). CONCLUSION: This study provides preliminary evidence that RT-CGM may be an effective strategy to optimise glucose control whilst following a low-carbohydrate lifestyle programme that targets improved glycaemic control, with minimal professional support. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry identifier, ANZTR: 372898. FUNDING: Grant funding was received for the delivery of the clinical trial only, by the Diabetes Australia Research Trust (DART).