NCT04013919

Observational, Data Collection Study for Subjects With Diabetes Using Insulin Injections

Observational, Data Collection Study for Subjects With Diabetes Using Daily Insulin Injections and Monitoring Glucose by Continuous Glucose Monitoring or Self-Monitoring Blood Glucose

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 260 (estimated)
• Sponsor: DreaMed Diabetes · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Multiple Daily Injections of Insulin	Basal/ Bolus insulin injections
DRUG	Single insulin injections	Basal insulin injections only

Timeline

• Start date: 2019-09-20
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2019-07-10
• Last updated: 2019-12-26

Locations

1 site across 1 country: Israel