Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

Diabetes Mellitus Clinical Trial

— ACRE-CT  

Official title:

Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05058690
• Other study ID #: ACRE-CT
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Caristo Diagnostics Limited
• Contact: Lisa Dicken, PhD
• Phone: +44 (0) 1865 950720
• Email: lisa.dicken[@]caristo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 to 80 years.

• Body mass index (BMI) = 25kg/m2

• FatHealth status assessed as the following:

• Elevated FatHealth status (50% of participants)

• Non-elevated FatHealth status (50% of participants)

Exclusion Criteria:

• Participant is unable or unwilling to give informed consent

• Participant is unable to understand English language

• Confirmed diagnosis of diabetes mellitus treated with oral medication or Insulin

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre-diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Caristo Diagnostics Limited	Milton Keynes University Hospital NHS Foundation Trust, University of Leeds, University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants identified with pre-diabetes/type 2 diabetes mellitus when fasting blood sample test results are compared against FatHealth algorithm results	The investigators will measure if the fasting blood sample results indicate that the individual has pre-diabetes/type 2 diabetes mellitus and compare if our FatHealth algorithm indicates the same results for the individual	Baseline
Secondary	Number of participants identified with pre-diabetes/type 2 diabetes mellitus when oral glucose tolerance test results are compared against FatHealth algorithm results	The investigators will measure if the oral glucose tolerance test results indicate that the individual has pre-diabetes/type 2 diabetes mellitus and compare if our FatHealth algorithm indicates the same results for the individual	120 minutes after baseline