Improving Emotional Well-Being and Cardio-Metabolic Health with Continuous Glucose Monitoring.

Continuous glucose monitoring (CGM) is extensively used in diabetic populations but understudied in non-diabetic patients. Glycemic variability is a risk factor for cardiovascular disease, and emerging evidence suggests close monitoring of glycemic control may have a positive impact on chronic disease. CGM increases awareness of glycemic dysregulation and empowers patients to create sustainable changes in eating behaviors. The purpose of this study (ClinicalTrials.gov Identifier: NCT04920058) was to determine if access to continuous blood glucose data using a CGM-Levels software system improves cardiometabolic health, sleep quality, and emotional well-being in nondiabetic patients undergoing a comprehensive wellness program. In this 12-week randomized clinical trial, patients enrolled in a low carbohydrate-based wellness program were randomly assigned to monitor glucose using a CGM with Levels software (CGM, N=14) or classic glucometer (Ctrl, N=11). Weight, BMI, waist circumference, liver fat (via abdominal ultrasound), and a cardiometabolic blood panel were measured pre-and post-program. Ketones were tested weekly, and glucose tested daily using a glucometer in both groups (CGM and Ctrl). Psychological measures of emotional well-being, depression, anxiety and sleep quality were performed with a subjective well-being survey, Patient Health Questionnaire-9 (PHQ9), generalized anxiety disorder-7 (GAD-7) and Pittsburgh Sleep Quality Index (PSQI), respectively, pre-program, week 6, and post-program. Differences were observed between the groups for liver fat which decreased over time in the CGM but not Ctrl group (p<0.05). Other cardio-metabolic biomarkers improved in both groups over the course of the study, including weight loss, BMI, waist circumference, triglycerides, VLDL, and fasting insulin, but no differences between groups were observed. Total cholesterol, Non-HDL, LDL, and HDL ratio increased in both groups over time, but did not differ between groups. Assessments of emotional well-being, depression, anxiety, and sleep quality also improved in both groups over time, again with no intergroup differences. In a non-diabetic population, a 12-week comprehensive wellness program inclusive of glycemic monitoring using CGM was effective at improving liver fat while several biomarkers of cardio-metabolic health, sleep quality, and emotional well-being improved regardless of the type of glycemic monitor used. CGM was endorsed by patients to be more comfortable and easier to use than finger stick glucometers, and its use did not impair trial results compared to Ctrl. Thus, CGM with Levels software appears to be a viable and effective method for monitoring glycemic variability in a non-diabetic population seeking to improve cardio-metabolic health.