Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05733962
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-07
First Post:
2022-05-02
Brief Title:
Evaluation of the Efficacy and Safety of DBL-4pen Mobile Application in Patients With Type 2 Diabetes
Sponsor:
Diabeloop
Organization:
Diabeloop
Study Overview
Official Title:
Multicentric BeforeAfter Study to Assess the Efficacy and Safety of DBL-4pen Mobile Application on Glycemic Control in Patients With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
SERENIT2
Brief Summary:
This study conducted in 40 adults living with type 2 diabetes is an interventional single-arm open-label beforeafter multicentric national study conducted as a clinical investigation according to the law EU 2017745 art 62
After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring CGM and his current therapy multiple daily injection the patient will start a 42-day treatment period during which he will use the DBL-4pen application and two Mallya connected caps in addition to the Dexcom G6 CGM An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of DBL-4pen application
The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes
Data related to efficacy of DBL-4pen global safety of DBL-4pen compliance with recommended insulin injections satisfaction with the system and quality of life will be collected
The study is completed when all patients have their end of study file completed in the electronic Case Report Form eCRF
After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring CGM and his current therapy multiple daily injection the patient will start a 42-day treatment period during which he will use the DBL-4pen application and two Mallya connected caps in addition to the Dexcom G6 CGM An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of DBL-4pen application
The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes
Data related to efficacy of DBL-4pen global safety of DBL-4pen compliance with recommended insulin injections satisfaction with the system and quality of life will be collected
The study is completed when all patients have their end of study file completed in the electronic Case Report Form eCRF
Detailed Description:
This study conducted in 40 adults living with type 2 diabetes is an interventional single-arm open-label beforeafter multicentric national study conducted as a clinical investigation according to the law EU 2017745 art 62
The study periods are as follows
2 weeks of baseline period at home will be performed During this baseline period all patients will use their current therapy MDI In addition to their standard treatment all patients will receive a Dexcom G6 and a smartphone During this study period the smartphone will be used to install the Dexcom G6 application in order to collect the glycemia data The patients will make equivalent therapeutic decisions based on the values of the CGM used in the study Dexcom G6 as if using their usual CGM
Followed by a 6-week treatment period the patients will install the DBL-4pen application on the smartphone provided for the study with help of the research team and they will receive two Mallya caps for their insulin pens
Followed by an optional 6-week extension period with treatment for patients agreeing to pursue the use of the DBL-4pen system
For each patient a comparison will be made first between treatment and baseline periods and second between extension and baseline periods In addition a comparison of treatment vs extension periods will also be performed Each patient will be his her own control
Visit 1 Inclusion and start of baseline phase for a duration of 2 weeks The investigator collects the dated and signed informed consent forms of patients who meet all inclusion and non-inclusion criteria
Blood HbA1c test is performed in routine between one month before the V1 Visit and V1 If there is no routine HbA1c sampling during this period the investigator will prescribe a study specific HbA1c blood test
All patients are equipped with a Dexcom G6 CGM instead of their usual CGM and receive a smartphone on which they will install the Dexcom G6 application in order to collect interstitial glucose data Patients will also be trained in the use of these devices by the medical team Patients keep their current treatment MDI for the first phase of the study which will last two weeks CGM parameters such as alarms and alerts will be matched with their usual treatment and patients will be asked to make equivalent therapeutic decisions based on the values of Dexcom G6 CGM as if using their usual CGM In addition for patients accustomed to using an interstitial glucose data visualization platform the possibility of using Dexcom Clarity will be mentioned
The site team will ensure and confirm the capacity of the patient to daily manage his Dexcom G6
Visit 2 V1 2 weeks 2 days End of baseline and start of the main treatment period The patient will install the investigational application DBL-4pen on the smartphone provided for the study and will be equipped with the Mallya caps and trained
The site team will ensure and confirm the capacity of the patient to daily manage his DBL-4pen System and realize the device setting initialization
The patient is asked to complete Quality of Life questionnaires HFSII and DDS questionnaires and DTSQs for satisfaction with his her current treatment see section 84 Secondary endpoints for more details on the questionnaires
The qualified site staff reviews the patients glucose control via Yourloops a data visualization platform and ensures the system is working as expected
Visit 3 V2 3 days 2 days Phone call The qualified site staff review patients glucose control via Yourloops at least twice a day during the first 3 days after the beginning of treatment
Three days after installation of the DBL-4pen system patients will be contacted by the qualified site staff to discuss its glycemic control and to adjust the systems parameters or patients training if necessary All related events are collected via eCRF
Visit 4 V2 3 weeks 2 days Optional phone call After having reviewed the patients glucose control via Yourloops the medical staff will contact the patient after 3 weeks of using the DBL-4pen system if they consider that some adjustments are needed More specifically the medical staff will analyze the glycemic data with regard to the degree of use of the application by the patient and compliance with the recommendations During this visit adjustments in system settings or in its use by the patient qualitatively andor quantitatively could be performed If the medical staff finds that the glycemic control is stable this visit will not take place
Visit 5 V2 6 weeks 2 days End of the main treatment period - Start of extension optional The patient equipped with the DBL-4pen System can continue with the 6-week extension phase During this visit adjustments in system settings could be performed and recommendations in particular on the use of the application by the patient can be made
The patient is asked to complete Quality of Life questionnaires HFSII and DDS questionnaires and DTSQs for satisfaction with DBL4-pen
If they refuse to participate in the extension the patients leave the study and the material is returned to the investigation site
Visit 6 V5 6 weeks 2 days End of study visit The patient is asked to complete Quality of Life questionnaires HFSII and DDS questionnaires and DTSQs for satisfaction with the system
Blood HbA1c test is performed The material is returned to the investigation site
Contact by phone calls or additional visits are allowed during the study They might be useful to discuss treatments system parameters and adverse events These additional visits can be initiated by the medical staff or by the patient In addition if the medical staff deems it necessary the visits initially planned by telephone can be organized on site
The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes Analysis will be made between the 6-week treatment period versus the 2-week baseline period
The secondary objectives of this study are to
assess the efficacy of DBL-4pen
assess the global safety of DBL-4pen
assess the compliance with recommended insulin injections
assess the quality of life and satisfaction and adherence of subjects to the system
The study periods are as follows
2 weeks of baseline period at home will be performed During this baseline period all patients will use their current therapy MDI In addition to their standard treatment all patients will receive a Dexcom G6 and a smartphone During this study period the smartphone will be used to install the Dexcom G6 application in order to collect the glycemia data The patients will make equivalent therapeutic decisions based on the values of the CGM used in the study Dexcom G6 as if using their usual CGM
Followed by a 6-week treatment period the patients will install the DBL-4pen application on the smartphone provided for the study with help of the research team and they will receive two Mallya caps for their insulin pens
Followed by an optional 6-week extension period with treatment for patients agreeing to pursue the use of the DBL-4pen system
For each patient a comparison will be made first between treatment and baseline periods and second between extension and baseline periods In addition a comparison of treatment vs extension periods will also be performed Each patient will be his her own control
Visit 1 Inclusion and start of baseline phase for a duration of 2 weeks The investigator collects the dated and signed informed consent forms of patients who meet all inclusion and non-inclusion criteria
Blood HbA1c test is performed in routine between one month before the V1 Visit and V1 If there is no routine HbA1c sampling during this period the investigator will prescribe a study specific HbA1c blood test
All patients are equipped with a Dexcom G6 CGM instead of their usual CGM and receive a smartphone on which they will install the Dexcom G6 application in order to collect interstitial glucose data Patients will also be trained in the use of these devices by the medical team Patients keep their current treatment MDI for the first phase of the study which will last two weeks CGM parameters such as alarms and alerts will be matched with their usual treatment and patients will be asked to make equivalent therapeutic decisions based on the values of Dexcom G6 CGM as if using their usual CGM In addition for patients accustomed to using an interstitial glucose data visualization platform the possibility of using Dexcom Clarity will be mentioned
The site team will ensure and confirm the capacity of the patient to daily manage his Dexcom G6
Visit 2 V1 2 weeks 2 days End of baseline and start of the main treatment period The patient will install the investigational application DBL-4pen on the smartphone provided for the study and will be equipped with the Mallya caps and trained
The site team will ensure and confirm the capacity of the patient to daily manage his DBL-4pen System and realize the device setting initialization
The patient is asked to complete Quality of Life questionnaires HFSII and DDS questionnaires and DTSQs for satisfaction with his her current treatment see section 84 Secondary endpoints for more details on the questionnaires
The qualified site staff reviews the patients glucose control via Yourloops a data visualization platform and ensures the system is working as expected
Visit 3 V2 3 days 2 days Phone call The qualified site staff review patients glucose control via Yourloops at least twice a day during the first 3 days after the beginning of treatment
Three days after installation of the DBL-4pen system patients will be contacted by the qualified site staff to discuss its glycemic control and to adjust the systems parameters or patients training if necessary All related events are collected via eCRF
Visit 4 V2 3 weeks 2 days Optional phone call After having reviewed the patients glucose control via Yourloops the medical staff will contact the patient after 3 weeks of using the DBL-4pen system if they consider that some adjustments are needed More specifically the medical staff will analyze the glycemic data with regard to the degree of use of the application by the patient and compliance with the recommendations During this visit adjustments in system settings or in its use by the patient qualitatively andor quantitatively could be performed If the medical staff finds that the glycemic control is stable this visit will not take place
Visit 5 V2 6 weeks 2 days End of the main treatment period - Start of extension optional The patient equipped with the DBL-4pen System can continue with the 6-week extension phase During this visit adjustments in system settings could be performed and recommendations in particular on the use of the application by the patient can be made
The patient is asked to complete Quality of Life questionnaires HFSII and DDS questionnaires and DTSQs for satisfaction with DBL4-pen
If they refuse to participate in the extension the patients leave the study and the material is returned to the investigation site
Visit 6 V5 6 weeks 2 days End of study visit The patient is asked to complete Quality of Life questionnaires HFSII and DDS questionnaires and DTSQs for satisfaction with the system
Blood HbA1c test is performed The material is returned to the investigation site
Contact by phone calls or additional visits are allowed during the study They might be useful to discuss treatments system parameters and adverse events These additional visits can be initiated by the medical staff or by the patient In addition if the medical staff deems it necessary the visits initially planned by telephone can be organized on site
The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes Analysis will be made between the 6-week treatment period versus the 2-week baseline period
The secondary objectives of this study are to
assess the efficacy of DBL-4pen
assess the global safety of DBL-4pen
assess the compliance with recommended insulin injections
assess the quality of life and satisfaction and adherence of subjects to the system
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