Evaluation of a Novel Continuous Glucose Monitoring System in Children and Adults with Type 1 and Type 2 Diabetes

This is a prospective, single arm, open label study to evaluate efficacy and safety of a novel continuous glucose monitoring (CGM) device by evaluating the glucose measured in comparison with an already commercially available CGM system (referred to as cCGM) and the reference standard which is capillary blood glucose in children and adult patients with type 1 and type 2 diabetes. The study will enrol 50 children and adolescents (7-17 years of age) and 50 adults (18 years and over). Parents/guardians of minors (under 16 years of age) will be involved in this study to support their children during the study visits, including device training, and with BG monitoring and record-keeping at home. The novel CGM system consists of an interstitial glucose sensor worn in the upper arm continuously for up to 21 days, and which continuously transmits glucose data to a hand-held receiver to display sensor glucose readings, including current glucose value and a predicted glucose trend. Participants will not use the investigational novel CGM device (from here onwards referred to as nCGM) to make clinical or treatment decisions. Both cCGM and nCGM consist of (1) a sensor worn on the upper arm that measures the glucose concentration in the interstitial fluid, (2) an integrated transmitter that send the results wirelessly and (3) a handheld receiver (e.g. mobile phone), that receives and displays the glucose data. While cCGM can be worn for up to 10 days, nCGM can be worn for up to 21 days. Both systems are calibration-free, and blood glucose calibrations can be performed at will by participants. Participants are involved in the study for up to 51 days from screening to the final follow-up. Wear time of CGM devices is 23 days for participants. Participants will wear nCGM for 21 days to monitor the glucose values while maintaining their usual treatment method. All procedures at the clinic will be performed by trained members of the study team. On day 1 of the study, participants will receive training on the use of the cCGM device and have a cCGM inserted in the back of one upper arm, then return home. This visit will take approximately 1 hour. On study day 2, participants will receive training on the use of the nCGM system and have 3 nCGM devices inserted in the back of the upper arms (in total 2 CGM devices worn on each upper arm). Participants will also receive training on the self-monitoring of blood glucose device CareSens Dual (hereinafter referred to as SMBG) for measuring of capillary blood glucose, and will be instructed to keep a daily blood glucose log. Following start-up of the nCGM devices, which takes approximately 30 minutes, capillary blood glucose testing will be performed every 10 minutes over a period of 2 hours. This visit will take approximately 3 hours. On days 8 and 17, participants return to the site for replacement of the cCGM devices. During the study, participants will be instructed to test their blood glucose a minimum of 8 times daily (more if required) and record all values. The study ends after completing the final study visit on day 23, including return of all study devices and completion of a questionnaire on the functionality of the nCGM system. 14 days after the final study visit, participants will receive a follow-up phone call by the study team to capture any health concerns potentially related to the study.

This is a prospective, single arm, open label study to evaluate efficacy and safety of a novel continuous glucose monitoring (CGM) device by evaluating the glucose measured in comparison with an already commercially available CGM system (referred to as cCGM) and the reference standard which is capillary blood glucose in children and adult patients with type 1 and type 2 diabetes. Phase 1: The study will enrol 50 children and adolescents (7-17 years of age) and 50 adults (18 years and over). Parents/guardians of minors (under 16 years of age) will be involved in this study to support their children during the study visits, including device training, and with BG monitoring and record-keeping at home. The novel CGM system consists of an interstitial glucose sensor worn in the upper arm continuously for up to 21 days, and which continuously transmits glucose data to a hand-held receiver to display sensor glucose readings, including current glucose value and a predicted glucose trend. Participants will not use the investigational novel CGM device (from here onwards referred to as nCGM) to make clinical or treatment decisions. Both cCGM and nCGM consist of (1) a sensor worn on the upper arm that measures the glucose concentration in the interstitial fluid, (2) an integrated transmitter that send the results wirelessly and (3) a handheld receiver (e.g. mobile phone), that receives and displays the glucose data. While cCGM can be worn for up to 10 days, nCGM can be worn for up to 21 days. Both systems are calibration-free, and blood glucose calibrations can be performed at will by participants. Participants are involved in the study for up to 51 days from screening to the final follow-up. Wear time of CGM devices is 23 days for participants. Participants will wear nCGM for 21 days to monitor the glucose values while maintaining their usual treatment method. All procedures at the clinic will be performed by trained members of the study team. On day 1 of the study, participants will receive training on the use of the cCGM device and have a cCGM inserted in the back of one upper arm, then return home. This visit will take approximately 1 hour. On study day 2, participants will receive training on the use of the nCGM system and have 3 nCGM devices inserted in the back of the upper arms (in total 2 CGM devices worn on each upper arm). Participants will also receive training on the self-monitoring of blood glucose device CareSens Dual (hereinafter referred to as SMBG) for measuring of capillary blood glucose, and will be instructed to keep a daily blood glucose log. Following start-up of the nCGM devices, which takes approximately 30 minutes, capillary blood glucose testing will be performed every 10 minutes over a period of 2 hours. This visit will take approximately 3 hours. On days 8 and 17, participants return to the site for replacement of the cCGM devices. During the study, participants will be instructed to test their blood glucose a minimum of 8 times daily (more if required) and record all values. The study ends after completing the final study visit on day 23, including return of all study devices and completion of a questionnaire on the functionality of the nCGM system. 14 days after the final study visit, participants will receive a follow-up phone call by the study team to capture any health concerns potentially related to the study. Phase 2: Following the first phase, a second phase will be commenced, where a subset of participants from Phase 1 (10 children and adolescents aged 7-17 years and 30 adults aged 18 years and older with T1D or T2D) will be recruited on a first-come first-serve basis. Phase 2 will test a new form factor of the sensor insertion device including a stamp-type mechanism instead of the release-button-type used in Phase 1, and will otherwise follow the same study schedule as described above for Phase 1.