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

Launched by SMARTEST TECHNOLOGIES · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the Smartest-AE, which helps people monitor their blood sugar levels without needing to prick their fingers. It aims to see how well this device works compared to traditional finger-pricking methods, especially in terms of accuracy, safety, and the level of pain experienced by users. The trial will include adults between the ages of 18 and 80 who have been diagnosed with diabetes or are at high risk of developing it.

To participate, individuals must be able to use a glucose monitoring device and provide consent to join the study. Those who have conditions that affect their ability to feel pain, such as neuropathy, or have certain mental health issues, will not be eligible. Participants can expect to test the Smartest-AE device and share their experiences regarding its ease of use and any discomfort they may feel. This study is an important step in finding better ways for people with diabetes to manage their health with less pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Man or Woman, 18 through 80 years of age
• 2. 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
• • 3. Able to self-test using a glucose level device
• • 4. Subject is willing and able to comply with protocol requirements and has provided a signed informed consent form (ICF)
• Exclusion Criteria:
• • 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.