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The study explores the utilization of artificial intelligence (AI) to predict disease progression trajectories in patients with diabetes. By analyzing historical data from a retrospective cohort, we aim to identify patterns and predictors of disease evolution. The approach seeks to enhance personalized treatment strategies and improve outcomes by foreseeing potential complications and disease milestones. The findings could pave the way for more targeted and effective management of diabetes through AI-driven insights.
The proposed study aims to harness the power of artificial intelligence (AI) and machine learning (ML) to address critical clinical needs in the management of Diabetes Mellitus (DM), a chronic and non-remissive disease that significantly impacts patients' lives. Despite the availability of hypoglycemic therapies, the prevention of both microvascular (retinopathy, nephropathy, neuropathy) and macrovascular (cardiovascular, cerebrovascular disease, and peripheral arterial disease) complications remains a challenge, with diabetic patients at higher risk compared to the general population.
The study focuses on two primary objectives: first, to a priori identify patients with varying probabilities of developing DM complications, allowing for a more resource-intensive approach for those at greater risk; second, to pinpoint the most effective therapeutic choices tailored to individual patient profiles. These objectives stem from distinct clinical characteristics and needs in the management of Type 1 DM (T1DM) and Type 2 DM (T2DM). For T1DM, the phenomenon of partial clinical remission post-diagnosis, marked by reduced insulin need and glycemic variability, suggests a window for improved long-term outcomes. Conversely, T2DM management lacks clear guidance for personalized medication regimens following metformin, highlighting a gap in treatment optimization.
Leveraging AI and ML for the analysis of multidimensional and longitudinal health data presents an innovative approach to predicting disease trajectories and therapeutic outcomes in DM. This observational, retrospective study, initially monocentric with potential for broader data integration, will delve into Electronic Health Records (EHR) using the Smart Digital Clinic Software (Meteda). By screening patients based on specific eligibility criteria, including DM type classification and historical health markers, this research aims to generate two distinct patient cohorts for in-depth analysis.
This study not only addresses a pressing clinical necessity by aiming to enhance personalized DM management and prevent complications but also contributes to the nascent field of AI application in healthcare. Through this exploration, the study seeks to offer new insights, validate AI and ML's utility in medical predictions, and establish a foundation for future research and clinical practices that embrace technological advancements for improved patient care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1DM cohort | A. T1DM label attached in the EHR OR B. patients with at least a record of Glycated Hemoglobin level of >6.5% (48 mmol/mol) AND < 45 years old AND no use of oral antidiabetic drug AND positivity of ≥2 anti-islet antibodies |
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| T2DM cohort: | A. T2DM label attached in the EHR OR B. patients with at least a record of Glycated Hemoglobin level of >6.5% (48 mmol/mol) AND Medication history of antidiabetic drug comprising insulin or not |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Analyis | Other | The study will investigate classification (ie logistic regression, decision tree, random forest, support vector machine, K nearest neighbour, naive bayes) ML models and treatment effect estimation ML models (T-learner, X-learner..). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Development and validation of a model to predict Partial Clinical Remission (PCR) to identify individuals diagnosed with T1D who are most likely to undergo PCR in the early stages of the natural history of the disease. The definition for PCR, namely glycated hemoglobin adjusted for insulin dose (IDAA1c), will be evaluated at 6 and 12 months after the onset of diabetes. Remitters and nonremitters will be dichotomously divided by IDAA1c ≤9 and IDAA1c >9 | 0-36 month |
| Primary Endpoint | Development and validation of a model to predict the development of chronic complications in patients with diabetes | 0-36 month |
| Primary Endpoint | Development and validation of a model to predict the response to different second lines of therapy in addition to metformin in patients with T2D who have failed the first line with metformin alone. | 0-36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Objectives | Gather experience on the AI workflow in the healthcare setting, from data acquisition to model development and testing. | 0-36 month |
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Inclusion Criteria:
Exclusion Criteria:
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The study population comprises individuals diagnosed with Diabetes Mellitus, encompassing both Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM). This population is identified through medical records housed within the Electronic Health Record (EHR) system, specifically utilizing data generated by the Smart Digital Clinic Software (Meteda) since its inception in our hospital environment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Piemonti, MD | Contact | +390226432706 | piemonti.lorenzo@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Piemonti, MD | IRCCS Ospedale San Raffaele srl | Principal Investigator |
| Emanuele Bosi, MD | IRCCS Ospedale San Raffaele srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Research Institute-IRCCS Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |