Diabetes Mellitus Clinical Trial
Official title:
Observational, Data Collection Study for Subjects With Diabetes Using Daily Insulin Injections and Monitoring Glucose by Continuous Glucose Monitoring or Self-Monitoring Blood Glucose
This is an observational, multicenter prospective study including up to 260 subjects with
type 1 or type 2 diabetes who use insulin injections (either basal insulin only or multiple
daily injections (MDI)) and CGM or SMBG to manage their diabetes. The study aims to generate
the database needed for future development and verification of insulin-glucose modules of
subjects with diabetes using insulin injections.
During the study, subjects will continue their regular diabetes management using their
regular glucose monitoring method (either CGM or SMBG), insulin injections and oral
medication (as applicable). Subjects will be requested to document glucose levels and insulin
delivery during basal only or basal/bolus insulin treatment. In addition, subjects will have
their daily activities recorded (meals, physical activity etc) using electronic log
(implemented on the CGM/FGM receiver, Dedicated App, Neura App and/or other logbooks). Data
will be captured during regular daily life using Insulin Connected pens and daily diary
application software, for a period of 1 month.
n/a
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