A Proof of Concept (PoC), Randomized, Controlled Study to Validate the Algorithm and Evaluate the Accuracy, Safety and Pain Level of the Smartest-AE in Comparison to Self-measure Blood Glucose Levels

NCT06587087 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-09-19

No results posted yet for this study

Summary

The study is conducted in Israel so plain language for the study is exist in Hebrew only

Conditions

Interventions

DEVICE

Smartest-AE: The lancet that will be used will be the Vitrex Soft Lite lll 28G.

The lancet that will be used for all subjects will be the Vitrex Soft Lite lll 28G.

Sponsors & Collaborators

  • Israel Innovation Authority

    collaborator UNKNOWN
  • Smartest Technologies

    lead INDUSTRY

Principal Investigators

  • Enav Yefet, MD · Baruch Padeh Medical center Poriya

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2025-01-31
Completion
2025-02-15

Countries

  • Israel

Study Locations

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Entities

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 NCT06587087 on ClinicalTrials.gov