Algorithm

AIM-T2DM classifies individual patients as eligible for medical management with a sodium-glucose cotransporter 2 (“SGLT2”) inhibitor or glucagon-like peptide-1 receptor agonist (“GLP-1 RA”) according to Chapter 13 of the 2020 Diabetes Canada guidelines ↗︎. Its input parameters are extracted from electronic health records by the Operations team of Ensho Health using the Apollo aEDC system and include:

• Any prior diagnosis of diabetes mellitus not classified gestational or type 1

• The most recent hemoglobin A1c measured within 12 months of the last encounter

• The presence of cardiovascular disease defined as any documented history of unstable angina, coronary artery disease (>=50% stenosis in at least one coronary artery), myocardial infarction, acute coronary syndrome, coronary revascularization procedure, stroke or transient ischemic attack or peripheral arterial disease

• Active or prior medical management with metformin, an SGLT inhibitor, a GLP-1 RA, a dipeptidyl peptidase-4 (“DPP-4”) inhibitor, sulfonylurea, insulin, thiazolidinediones, statins, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, acetylsalicylic acid and non-vitamin K antagonist oral anticoagulants

• Contraindications or other considerations relevant to SGLT2 inhibition or management with a GLP-1 RA including prior amputation, hypoglycemic episodes, acute kidney injury, urinary tract infection, hypotension, cirrhosis, chronic kidney disease, diabetic ketoacidosis, estimated glomerular filtration rate of < 15 mL/min/1.73m2, a diagnosis of type 1 diabetes mellitus and treatment with mixed insulin

Ordering

AIM-T2DM is available as a monitoring service for whole electronic medical record databases ("Whole Database"). Whole Database analyses include all patients for which an office encounter was billed in the previous 90 days and recur every 90 days until terminated through Compass.

Requests for analyses can be made to eligible Data Labs by general practitioners:

• Through Compass ↗︎

• From within an EMR system that supports direct ordering

• By email or efax (using a PDF requisition ↓)

All requests placed between the hours of 8:00am and 8:00pm Monday through Friday are reviewed by a member of the Clinical Operations team within 48 hours. Requests for Single Record analyses are fulfilled within 72 hours. Requests for Whole Database screens are fulfilled within 10 business days.

Reports

Comprehensive reports ↗︎ are prepared and distributed for each patient eligible for SGLT2 inhibition or medical management with a GLP-1 RA. Each report includes:

• A summary of the results

• The specific guideline recommendations relating to the patient

• The evidence upon which the results are based

Reports are made available online in HTML and PDF formats through Compass. Requesting physicians and office staff are notified of new results by email.

Pricing

Intended Use

AIM-T2DM is intended for use as a decision support tool to aid qualified healthcare professionals in identifying individuals in which Chapter 13 of the 2020 Diabetes Canada guidelines recommend medical management with an SGLT2 inhibitor or GLP-1 RA. It is not diagnostic and does not replace the independent judgment of the treating physician. Any medical diagnosis and all decisions related to patient care and treatment choices should be based on the independent judgment of the treating physician and should take into account all information related to the patient, including without limitation, the patient and family history, direct physical examination and diagnostic tests.

Regulatory

AIM-T2DM is a process for converting input parameters to a likelihood estimate. It is deployed at the Toronto, Canada Data Lab of Ensho Health through the AIM-T2DM Module ("CDL Module"). The CDL Module is comprised of the AIM-T2DM Algorithm ("Algorithm") which encodes it in software and a graphical user interface called the AIM-T2DM Controller ("Controller"). The CDL Module is deployed exclusively at the Toronto Data Lab of Ensho Health where it is applied to the data of requesting physicians as a service. The CDL Module was developed to the ISO 13485:2016 standard for medical devices in compliance with Ensho’s Quality Management System.

United States

The AIM-T2DM CDL Module is classified as Clinical Decision Support Software according to Food and Drug Administration guidance FDA-2017-D-6569 ↗︎ on the interpretation of Section 3060(a) of the 21st Century Cures Act (Cures Act) since its input parameters are clinical characteristics recorded in patient charts at a single point in time (criterion 1-2) and it provides established guideline recommendations to health care professionals whose basis are clearly communicated (criterion 3-4).

Canada

The AIM-T2DM CDL Module is Clinical Decision Support Software in Canada.

Rest of World

The AIM-T2DM CDL Module is not yet available in Australia, European Union member states or Israel.