MedTrace Logo

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

NCT04013919 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2019-12-26

No results posted yet for this study

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

Interventions

DRUG

Multiple Daily Injections of Insulin

Basal/ Bolus insulin injections

DRUG

Single insulin injections

Basal insulin injections only

Sponsors & Collaborators

  • DreaMed Diabetes

    lead INDUSTRY

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04013919 on ClinicalTrials.gov