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 | Not Yet Recruiting

• 1 other identifier: SMT000018
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes; Gestational Diabetes Mellitus (GDM); Pre-Diabetes

Outcome Measures

Primary Outcomes (2)

• Algorithm verification

  Stage I- Smartest-AE system algorithm verification (R2\>0.9)

  1 months

• Stage II- Accuracy

  Stage II- Assess the accuracy of the Smartest-AE glucose measurements' results in comparison to the results received from a commercial approved glucometer.

  3 months

Secondary Outcomes (2)

• Pain Level

  4 months

• accuracy vs. lab results

  4 months

Other Outcomes (1)

• Safety

  4 months

Study Arms (2)

Investigational Glucose level device- Smartest-AE

EXPERIMENTAL

The Smartest's System is intended to measure blood glucose levels in home environment. The Smartest's System consists of a disposable single-use device and a mobile app.

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

Commercial Glucometer

ACTIVE COMPARATOR

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

Interventions

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

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

Commercial Glucometer; Investigational Glucose level device- Smartest-AE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Smartest Technologies: lead
• Israel Innovation Authority: collaborator

Study Sites (1)

The BARUCH PADEH Medical Center, Poriya

Poria – Neve Oved, The Lower Galilee, 15208, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes, Gestational; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hyperglycemia

Study Officials

• Enav Yefet, MD

  Baruch Padeh Medical center Poriya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel Horwitz, CEO

CONTACT

972-54-8884330; ariel@smarttest.io

Eliezer Anavi, CTO

CONTACT

972-54-3970629; eliezer@smarttest.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IL (1)