Ignite Creation Date:
2025-12-18 @ 8:44 AM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT06716671
Status:
None
Last Update Posted:
2025-07-02 00:00:00
First Post:
2024-11-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Continuous Glucose Monitoring on Quality of Life in People With Type 2 Diabetes Mellitus
Sponsor:
None
Organization:
Study Overview
Official Title:
Influence of Continuous Glucose Monitoring on Quality of Life in People With Type 2 Diabetes Mellitus
Status:
None
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Glucocavi
Brief Summary:
Study development: The recruitment period runs from September 2024 to February 2025. Participants will be recruited by health professionals (nurse or doctor) CGM referents from each of the 20 primary care centres in the Camp de Tarragona health region. Sampling will be by convenience, all persons who meet the inclusion criteria and none of the exclusion criteria will be offered to participate in the study. Participants must sign an informed consent and their data will be coded.
Participants will be asked to fill in 5 questionnaires at the beginning of the study:
* Sociodemographic questionnaire created ad hoc to know the profile of the patients.
* EsDQOL questionnaire that assesses the quality of life related to diabetes.
* DDS17 questionnaire that assesses diabetes-related distress.
* EsHFS questionnaire that assesses fear of hypoglycaemia.
* Clarke Test that assesses the detection of hypoglycaemia.
The EsDQOL, DDS17, EsHFS and Clarke Test questionnaires must be repeated at 3, 6 and 12 months after the start of the study. Participants will be called to their primary care centre of reference to fill in the questionnaires themselves and these will be kept on paper at the centre until data analysis.
To assess metabolic control, the data provided by the CGM sensor will be used and the results of the AGP (Ambulatory Glucose Profile) report of the first 2 weeks will be compared with the data at 3, 6 and 12 months. No analytical tests or capillary blood glucose measurements will be requested.
Data analysis: A descriptive analysis of the main study variables will be performed using percentages for qualitative variables and mean and standard deviation for quantitative variables. To analyse the differences in the data before and after the intervention, chi-square tests will be used for qualitative variables and the Student's t-test for quantitative variables. Statistical significance will be accepted with a p-value \<0.05. Data will be analysed using SPSS statistical software version 23 or later.
Sample calculation: Accepting an alpha risk of 0.05 and a statistical power greater than 0.8 in a bilateral contrast, 55 subjects are required to detect as statistically significant a difference equal to or greater than 9 units in the EsDQOL questionnaire (main study variable). A common standard deviation of 23.65 is estimated. A loss to follow-up rate of 0% is estimated. \[GRANMO sample size calculator v7.10 available at Calculator (laalamedilla.org)\].
Participants will be asked to fill in 5 questionnaires at the beginning of the study:
* Sociodemographic questionnaire created ad hoc to know the profile of the patients.
* EsDQOL questionnaire that assesses the quality of life related to diabetes.
* DDS17 questionnaire that assesses diabetes-related distress.
* EsHFS questionnaire that assesses fear of hypoglycaemia.
* Clarke Test that assesses the detection of hypoglycaemia.
The EsDQOL, DDS17, EsHFS and Clarke Test questionnaires must be repeated at 3, 6 and 12 months after the start of the study. Participants will be called to their primary care centre of reference to fill in the questionnaires themselves and these will be kept on paper at the centre until data analysis.
To assess metabolic control, the data provided by the CGM sensor will be used and the results of the AGP (Ambulatory Glucose Profile) report of the first 2 weeks will be compared with the data at 3, 6 and 12 months. No analytical tests or capillary blood glucose measurements will be requested.
Data analysis: A descriptive analysis of the main study variables will be performed using percentages for qualitative variables and mean and standard deviation for quantitative variables. To analyse the differences in the data before and after the intervention, chi-square tests will be used for qualitative variables and the Student's t-test for quantitative variables. Statistical significance will be accepted with a p-value \<0.05. Data will be analysed using SPSS statistical software version 23 or later.
Sample calculation: Accepting an alpha risk of 0.05 and a statistical power greater than 0.8 in a bilateral contrast, 55 subjects are required to detect as statistically significant a difference equal to or greater than 9 units in the EsDQOL questionnaire (main study variable). A common standard deviation of 23.65 is estimated. A loss to follow-up rate of 0% is estimated. \[GRANMO sample size calculator v7.10 available at Calculator (laalamedilla.org)\].
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: