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NCT06716671: Glucocavi

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

Active, enrolled Last updated 2 July 2025
What this trial tests

trial in Continuous Glucose Monitoring in 55 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
4 September 2024
Primary endpoint
31 May 2026
31 May 2026

Quick facts

Lead sponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment55
Start date4 September 2024
Primary completion31 May 2026
Estimated completion31 May 2026
Sites1 location across Spain

Conditions studied

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina — full company profile →

Who can join

18 and older, any sex, with Continuous Glucose Monitoring or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06716671.

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