Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624553
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Monitoring With Freestyle Libre 2 Glucose Sensor on Treatment Satisfaction in Patients With Type 2 Diabetes Mellitus Exploratory Study in Patients Starting Monitoring
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Diabetes type2
Brief Summary:
The FreeStyle Libre 2 system is a Flash glucose monitoring system that after a scan provides information on interstitial glucose for the last 8 hours in the form of a reading every 15 min The system is approved for non-adjuvant use for therapeutic decision-making The acceptability and effectiveness of the FSL is well documented in patients with type 1 and 2 diabetes mellitus DM2 Most of the studies in patients with DM2 have been developed in patients with insulin treatment either basal or with multiple doses
For all these reasons we proposed an exploratory study to evaluate satisfaction with treatment main variable in people with DM2 who start glucose monitoring in the Endocrinology Day Hospital context compared to patients who use capillary blood glucose monitoring These are patients treated in a context of debutacute decompensationintercurrent pathology who will not necessarily be using insulin treatment The aim is to know if the use of FSL2 provides benefits of user satisfaction with the treatment assessed with the Diabetes Treatment Satisfaction Questionnaire at the end of follow-up mean score of all items in this context
For all these reasons we proposed an exploratory study to evaluate satisfaction with treatment main variable in people with DM2 who start glucose monitoring in the Endocrinology Day Hospital context compared to patients who use capillary blood glucose monitoring These are patients treated in a context of debutacute decompensationintercurrent pathology who will not necessarily be using insulin treatment The aim is to know if the use of FSL2 provides benefits of user satisfaction with the treatment assessed with the Diabetes Treatment Satisfaction Questionnaire at the end of follow-up mean score of all items in this context
Detailed Description:
When the doctor determines that the patient who has attended the Endocrinology and Nutrition Day Hospital needs to start glucose monitoring and goes to the nursing office if he meets the inclusion criteria he will be asked to participate in the study After signing the informed consent the control group MGC or intervention group FSL2 will be randomised The necessary therapeutic education for glucose monitoring will be carried out in parallel with the other necessary aspects of Diabetes Therapeutic Education
Follow-up visits in both groups will take place 24-48 hours after the first visit a week 2 weeks and 1 2 and 3 months after the first visit During visits frequently according to usual clinical practice by the nurse andor doctor therapeutic decisions will be made based on the monitoring system assigned to the patient
Follow-up visits in both groups will take place 24-48 hours after the first visit a week 2 weeks and 1 2 and 3 months after the first visit During visits frequently according to usual clinical practice by the nurse andor doctor therapeutic decisions will be made based on the monitoring system assigned to the patient
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?:
None