Impact of Continuous Glucose Monitoring on Quality of Life for Type 2 Diabetes Patients
Influence of Continuous Glucose Monitoring on Quality of Life in People With Type 2 Diabetes Mellitus
This study is testing if using continuous glucose monitors can improve the quality of life for people with type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06716671 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how continuous glucose monitoring (CGM) affects the quality of life in individuals with type 2 diabetes mellitus (T2DM). Participants will be recruited from 20 primary care centers and will complete a series of questionnaires assessing quality of life, diabetes distress, fear of hypoglycemia, and hypoglycemia detection at multiple time points. The study will also analyze metabolic control using data from CGM devices over a 12-month period. The goal is to determine if CGM usage leads to improvements in various aspects of life for T2DM patients.
Who should consider this trial
Good fit: Ideal candidates include adults with type 2 diabetes who are on intensive insulin therapy and willing to use a CGM device.
Not a fit: Patients who have cognitive impairments, are pregnant, or have previously used a CGM device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for patients with type 2 diabetes by demonstrating the benefits of continuous glucose monitoring.
How similar studies have performed: While studies have shown the effectiveness of CGM in glucose control, this specific focus on quality of life in T2DM patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Treatment with intensive insulin therapy (basal bolus regimen with 3 or more daily doses of insulin). * Perform 6 or more daily capillary glycaemia determinations. * Be willing to use a CGM device for at least 70% of the time. * Undergo training on the use of the CGM device by the centre's CGM referent. * Agree to participate in the study. Exclusion Criteria: * Cognitive impairment measured by Pfeiffer test with a score of 3 or more errors. * Previous use of a CGM device. * Pregnancy. * Being institutionalised. * Having participated in another research study related to diabetes mellitus within the last year. * Not having proper handling of the CGM device: inability to download glycaemic control data, inability to keep the sensor attached to the skin, not understanding how it works, etc.
Where this trial is running
Barcelona
- IDIAP Jordi Gol — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Sergi Rodríguez-Soler, Nurse — Institut Català de la Salut
- Study coordinator: Sergi Rodríguez-Soler, Nurse
- Email: ssrodriguez.tgn.ics@gencat.cat
- Phone: 682251783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.