Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT00451334
Brief Summary:
This study is a prospective, open label, controlled, single center study. 40 patients will be recruited for the study, according to patients' inflow and meeting eligibility criteria.
Primary Goal
\* To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level measurement technology.
Secondary Goal
\* To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level measurement technology.
Detailed Description:
Primary Endpoint Parameter
• Primary study endpoint will be to establish the safety of using the GlucoSat technology as a non-invasive glucose level measurement technology. Safety will be established by paucity of adverse events. Adverse Events occurrence will be documented throughout the study.
Secondary Endpoint Parameters
Efficacy of the GlucoSat technology will be assessed by:
* Proving the accuracy and precision of the GlucoSat technology by comparing the glucose level measured by the GlucoSat device to the glucose level observed by any certified for clinics invasive device. Inter device variability should be within 15%.
* Patient satisfaction questionnaire.
* Physician satisfaction will be assessed by questionnaire.
Study:
NCT00451334
Study Brief:
Protocol Section:
NCT00451334