Evaluation of the Efficacy and Safety of DBL-4pen Mobile Application in Patients With Type 2 Diabetes — SERENIT2  

Diabetes Mellitus, Type 2 Clinical Trial

Official title: Multicentric Before/After 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

Clinical Trial Summary

This study conducted in 40 adults living with type 2 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 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).

Clinical Trial Description

This study conducted in 40 adults living with type 2 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 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 8.4 Secondary endpoints for more details on the questionnaires). The qualified site staff reviews the patient's 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 patient's 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 system's parameters or patient's training if necessary. All related events are collected via eCRF. Visit 4 : V2 + 3 weeks (± 2 days): Optional phone call After having reviewed the patient's 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 and/or 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 ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

• NCT number: NCT05733962
• Study type: Interventional
• Source: Diabeloop
• Contact: Benjamin CHATEL
• Phone: +33781862065
• Email: benjamin.chatel@diabeloop.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Completion date: January 2025