NCT05058690

Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Caristo Diagnostics Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus

Detailed description

This multicentre prospective study will evaluate the ability of the FatHealth technology to correctly identify individuals with pre-diabetes and diabetes, validating the technology against the current gold-standard diagnostic method, oral glucose tolerance testing. Participants will be individuals who have undergone a CT scan of the chest (coronary CT angiogram \[CCTA\] or CT chest) as part of observational cohort studies. Participants will be invited for an oral glucose tolerance test (OGTT), which is the current gold-standard method for detecting pre-diabetes and diabetes mellitus. All patients must have an evaluable OGTT. The study population will include: 1. Approximately 90 individuals who had a CCTA as part of their clinical care (45 identified as having an abnormal FatHealth algorithm calculation and 45 with a normal FatHealth algorithm calculation) will undergo OGTT which is evaluable; and 2. Approximately 90 individuals who had a chest CT as part of their clinical care (45 identified as having an abnormal FatHealth algorithm calculation and 45 with a normal FatHealth algorithm calculation) will undergo OGTT which is evaluable.

Conditions

• Pre-diabetes
• Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oral Glucose Tolerance Test	* Obtain blood sample for glucose assessment (time "0" sample). This may be obtained via venepuncture or after cannula insertion. * Test a small sample using a near patient glucose testing meter. If the result on the glucose meter is greater than or equal to 11mmol/L, send the blood sample urgently to lab. If it is confirmed by biochemistry to be above 11mmol/L, there is no need to continue test. * If the result is less than 11mmol/L on meter, give the patient the glucose solution to drink. * Collect a further blood sample at 120 minutes. * Send samples all together to laboratory for glucose measurement.

Timeline

• Start date: 2025-02-15
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2021-09-28
• Last updated: 2025-02-13