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
Summary
The study is conducted in Israel so plain language for the study is exist in Hebrew only
Conditions
- Diabetes Mellitus
- Gestational Diabetes Mellitus (GDM)
- Pre Diabetes
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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