Influence of Continuous Glucose Monitoring on Quality of Life in People With Type 2 Diabetes Mellitus

Background: Diabetes Mellitus (DM) is a chronic disease that affects millions of people worldwide. More than 95% of cases are type 2 diabetes mellitus (T2DM). In recent years, diabetes management has evolved with the introduction of continuous glucose monitoring (CGM) devices. These devices implanted under the skin allow continuous measurement of glucose levels monitoring glucose trends and the rate at which glucose level rise and fall without the need for capillary glycaemias test. While studies demostrate the effectiveness of CGM devices in controlling glucose levels in adults with T2DM, there is no evidence related to quality of life in this patients. Hypothesis: The use of CGM in people with T2DM improves their quality of life, reduces distress about the disease, reduces fear of hypoglycaemia, increases detection of hypoglycaemia, and improves metabolic control. Objectives: To assess quality of life, diabetes distress, fear of hypoglycaemia, detection of hypoglycaemia, and metabolic control in people with T2DM before and after the use of CGM sensors. Methodology: Prospective observational pre-post unblinded study. Adults with type 2 diabetes using a CGM device in the primary care setting will be followed for 12 months. They will be asked to complete 5 questionnaires at baseline, and 4 questionnaires at 3, 6 and 12 months. No other activity that differs from usual clinical practice will be performed. Data analysis: a descriptive analysis of the main study variables will be carried out and the differences in the data before and after the intervention will be analysed using the chi-square test for qualitative variables, and the Student's t-test for quantitative variables. Statistical significance will be accepted at a p-value \< 0.05. Applicability and relevance: The results of the study will provide information on whether CGM devices improve quality of life and glycaemic control in people with type 2 diabetes. With these results it will be possible to assess whether it is beneficial to extend funding for CGM devices to more of the population than is currently the case.

NCT Number	NCT06716671
Lead Sponsor	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Conditions	Continuous Glucose Monitoring, Quality of Life, Type 2 Diabetes Mellitus (T2DM)
Enrollment	55 participants
Start Date	2024-09-04
Primary Completion	2026-05-31 (estimated)
Study Completion	2026-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-02