Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749693
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2021-02-02
Brief Title:
Observational Study of the Use of DBLG1 System in Real Life
Sponsor:
Diabeloop
Organization:
Diabeloop
Study Overview
Official Title:
Observational Study of the Use of DBLG1 System in Real Life
Status:
RECRUITING
Status Verified Date:
2024-05
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:
SP12
Brief Summary:
This study will be conducted on human subjects and is observational prospective and uncontrolled defined as a category 3 according to the Jardé Law RIPH3 It is a national and multicentric study Enrolled patients are Type 1 Diabetes T1D patients who receive the DBLG1 System CE marked medical device to be treated Patients have their regular visits with their own clinician No change from their usual care must and will be done including trainings and treatment At the end of the study patients will keep their system for their usual care and will continue having usual follow-up visits with their clinician
Data related to their glycemia complications and quality of life will be collected for 1 year from the beginning of their treatment A comparison with data collected during the 2 weeks of run-in period prior to the activation of loop mode is planned In case the run-in phase lasts longer than 2 weeks data collected from the two last weeks only will be kept for analysis and comparison
The study is completed when all patients have their end of study file completed in the electronic Case Report Form eCRF
Data related to their glycemia complications and quality of life will be collected for 1 year from the beginning of their treatment A comparison with data collected during the 2 weeks of run-in period prior to the activation of loop mode is planned In case the run-in phase lasts longer than 2 weeks data collected from the two last weeks only will be kept for analysis and comparison
The study is completed when all patients have their end of study file completed in the electronic Case Report Form eCRF
Detailed Description:
The study is designed to address the specific requirements from National Commission for the Evaluation of Medical Devices and Health Technologies CNEDiMTS and to complete data obtained up to now with a larger cohort and in real life settings
In order to increase variability in the profiles of patients included and to be as representative as possible of all eligible patients 20 centers will participate in the study both private and public with a mix of university and regional centers and 348 patients will be included consecutively
The inclusion period lasts 6 months and each patient will be included in the study for a period of 2 weeks of run-in and 1 year of treatment An inclusion period of 6 months is enough according to investigation site data and estimation of inclusion over 6 months detailed in part Healthcare professional and investigation centers recruitment
This study is observational Patients included follow their usual medical care and will only be asked for the specific need of the study to answer two questionnaires at the beginning and at the end of the study and give their HbA1c results performed in their current medical follow-up As it is a post-registration study medical devices are provided to patients on medical prescription by healthcare providers which have signed a distribution agreement with and have been trained by Diabeloop Patients have their system for 4 a maximum of 4 years life duration of the medical device DBLG1 System
Patients follow-up visits are not mandatory and no frequency is imposed Investigators according to their habits have follow-up visits corresponding to what they usually propose to patients having a new treatment
During the whole study and apart from scheduled visits inclusion beginning of run-in beginning of treatment enf of study each patient may contact hisher clinician investigator in case of issue heshe judges as serious for questions etc In that case the clinician may program a visit with the patient and deal with adverse events Phone calls are recorded in Case Report Form CRF as well as on-site visits
Note with Yourloops investigators may follow the state of their patients regarding the time in range mean glycemia value etc Based on this they may require a visit at their convenience with the patient in order to change parameters of the system discuss adverse events etc
Objectives are the following To evaluate improvement in blood glucose control with use of DBLG1 System after one year in real life
To evaluate details of glycemic control improvement safety and adverse events due to the DBLG1 System evolution of quality of life after one year in real life and healthcare professional support
Study endpoints Improvement of the time in glycemic range 70 - 180 mgdL in percentage on 24hours and nighttime
HbA1c Mean CGM glucose - on 24hours and nighttime Time in 70 - 140 mgdL range on 24hours and nighttime only Time in hypoglycemia under 70 mgdL 60 mgdL and 50 mgdL - on 24hours and nighttime Time in hyperglycemia above 180 mgdL 250 mgdL and 300 mgdL - on 24hours and nighttime Percentage of time using activated loop mode vs deactivated loop mode Standard Deviation SD and Coefficient of variation CV of Continuous Glucose Monitoring CGM values on 24hours and nighttime Number and type of adverse events Overall and diabetic-specific quality of life Quantification of the healthcare professional support required
An descriptive interim analysis will be made on the first 100 enrolled patients after 6 months of use of the DBLG1
In order to increase variability in the profiles of patients included and to be as representative as possible of all eligible patients 20 centers will participate in the study both private and public with a mix of university and regional centers and 348 patients will be included consecutively
The inclusion period lasts 6 months and each patient will be included in the study for a period of 2 weeks of run-in and 1 year of treatment An inclusion period of 6 months is enough according to investigation site data and estimation of inclusion over 6 months detailed in part Healthcare professional and investigation centers recruitment
This study is observational Patients included follow their usual medical care and will only be asked for the specific need of the study to answer two questionnaires at the beginning and at the end of the study and give their HbA1c results performed in their current medical follow-up As it is a post-registration study medical devices are provided to patients on medical prescription by healthcare providers which have signed a distribution agreement with and have been trained by Diabeloop Patients have their system for 4 a maximum of 4 years life duration of the medical device DBLG1 System
Patients follow-up visits are not mandatory and no frequency is imposed Investigators according to their habits have follow-up visits corresponding to what they usually propose to patients having a new treatment
During the whole study and apart from scheduled visits inclusion beginning of run-in beginning of treatment enf of study each patient may contact hisher clinician investigator in case of issue heshe judges as serious for questions etc In that case the clinician may program a visit with the patient and deal with adverse events Phone calls are recorded in Case Report Form CRF as well as on-site visits
Note with Yourloops investigators may follow the state of their patients regarding the time in range mean glycemia value etc Based on this they may require a visit at their convenience with the patient in order to change parameters of the system discuss adverse events etc
Objectives are the following To evaluate improvement in blood glucose control with use of DBLG1 System after one year in real life
To evaluate details of glycemic control improvement safety and adverse events due to the DBLG1 System evolution of quality of life after one year in real life and healthcare professional support
Study endpoints Improvement of the time in glycemic range 70 - 180 mgdL in percentage on 24hours and nighttime
HbA1c Mean CGM glucose - on 24hours and nighttime Time in 70 - 140 mgdL range on 24hours and nighttime only Time in hypoglycemia under 70 mgdL 60 mgdL and 50 mgdL - on 24hours and nighttime Time in hyperglycemia above 180 mgdL 250 mgdL and 300 mgdL - on 24hours and nighttime Percentage of time using activated loop mode vs deactivated loop mode Standard Deviation SD and Coefficient of variation CV of Continuous Glucose Monitoring CGM values on 24hours and nighttime Number and type of adverse events Overall and diabetic-specific quality of life Quantification of the healthcare professional support required
An descriptive interim analysis will be made on the first 100 enrolled patients after 6 months of use of the DBLG1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None