Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Smartest Technologies
Collaborating Sponsors:
Israel Innovation Authority
Conditions:
Diabetes Mellitus
Gestational Diabetes Mellitus (GDM)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The study is conducted in Israel so plain language for the study is exist in Hebrew only
Detailed Description
Protocol Title: 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 Bloo...
Eligibility Criteria
Inclusion
- Man or Woman, 18 through 80 years of age
- Diagnosed with either:
- Group 1: Type I/II Diabetes Melitus/ GDM who regularly prick his/her fingers to monitor blood glucose levels or,
- Group 2: High risk individuals who do not typically engage in finger pricking but are at high risk of developing prediabetes or diabetes due to one of the following various risk factors:
- BMI \> 25
- Age 45 or older
- Have a parent or sibling with type 2 diabetes
- Have ever had gestational diabetes
- Hypercholesterolemia - according to blood level and\\or using medication for lowering cholesterol
- Dyslipidemia- according to blood level and\\or using medication for lowering lipids
- Or any other risk factor according to the staff's discretion
- Able to self-test using a glucose level device
- Subject is willing and able to comply with protocol requirements and has provided a signed informed consent form (ICF)
Exclusion
- 1\. Subject suffers from neuropathy, chronic pains, pain diseases, impaired sensation in the fingers\' area 2. Subject diagnosed with dementia 3. Subject diagnosed with major psychiatric disorders 4. Subject use Narcotics or Analgesics, chronically or at the time of enrollment to the study and up to 4 hours prior to first test of the study 5. Any other medical condition that is considered not eligible by the medical team members 6. Subject Is not capable to report pain levels, objectively 7. Participation in an interventional study at the time of enrollment to this study.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06587087
Start Date
September 20 2024
End Date
February 15 2025
Last Update
September 19 2024
Active Locations (1)
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1
The BARUCH PADEH Medical Center, Poriya
Poria – Neve Oved, The Lower Galilee, Israel, 15208