The Current Health Status of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry

Study Overview
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Brief Summary
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This retrospective study uses the Canadian LMC Diabetes Registry to describe the current health status of Canadians with type 1 diabetes. The study provides a detailed report of the demographic composition, treatment regimens, self-care approaches, health status, metabolic outcomes, and glycemic control of a large Canadian community-based, specialist-led cohort of patients with type 1 diabetes. Specific study outcomes will also be evaluated in a subgroup of patients using continuous subcutaneous insulin infusion (CSII) therapy.

Official Title
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Type 1 Diabetes in Canada: The Demographic, Care Profiles and Glycemic Control of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry

Conditions
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Type1diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of type 1 diabetes for ≥ 6 months Assessed by an LMC endocrinologist between July 1, 2015 and June 30, 2018 Followed by an LMC endocrinologist for > 6 months Informed consent provided and signed for medical record data to be used for research purposes Exclusion Criteria: clinical diagnosis of type 2 diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose | Fasting plasma glucose will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Proportion of patients with HbA1c ≤7.0%, 7.1 to 8.0%, 8.1 to 9.0% and >9.0% | HbA1c will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Lipid parameters | Mean LDL cholesterol (mmol/L), mean HDL cholesterol (mmol/L), mean non-HDL cholesterol (mmol/L) and mean triglycerides (mmol/L) will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Proportion of patients below and above target LDL cholesterol | LDL cholesterol (mmol/L) will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Blood pressure | Mean systolic blood pressure (mmHg) and mean diastolic blood pressure (mmHg) will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| estimated glomerular filtration rate (eGFR) | Proportion of patients (%) with eGFR <30 mL/min/1.73 m2, between 30-60 mL/min/1.73 m2, and >60 mL/min/1.73 m2 will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Albuminuria | Proportion of patients (%) with urine albumin to creatinine ratio (uACR) <2.0 mg/mmol and ≥ 2.0 mg/mmol will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Weight | Mean body weight (kg) will be measured by accessing patients medical records and it will be evaluated at one time point only.The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Body mass index (BMI) | Mean BMI (kg/m2) and proportion of patients (%) with BMI <18.5, 18.5 to <25, 25 to <30 and ≥ 30 kg/m2, will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019. | 1 day | 
| Waist circumference | Mean waist circumference (cm) will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Thyroid stimulating hormone (TSH) | Mean thyroid stimulating hormone (µIU/mL) will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Alanine aminotransferase (ALT) | Mean ALT (U) will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Microvascular comorbidity | History of any of the following: retinopathy, neuropathy or nephropathy. The history will be accessed from the patients medical records. | 1 day | 
| Macrovascular comorbidity | History of any of the following: coronary artery disease, angina, cardiovascular disease, congestive heart failure, coronary vascular disease, myocardial infarction, coronary artery bypass grafting, angioplasty, cerebral vascular disease, stroke, cerebrovascular accident, peripheral vascular disease, atherosclerotic disease, intermittent claudication, aorto-femoral bypass or femoral popliteal bypass. The history will be accessed from the patients medical records. | 1 day | 
| Weekly incidence of any hypoglycemia | Self-reported weekly incidence of any hypoglycemia will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Yearly incidence of severe hypoglycemia | Self-reported yearly incidence of hypoglycemia will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019 | 1 day | 
| Mental health comorbidity | History of any of the following: anxiety, depression, bipolar affective disorder, eating disorder, schizophrenia, sleep disorder. The history will be accessed from the patients medical records. | 1 day | 
| Erectile dysfunction | Proportion of males with erectile dysfunction. The medical history will be accessed from the patients medical records. | 1 day | 
| Insulin type | Proportion of patients (%) using rapid-acting, intermediate acting and long-acting insulin | 1 day | 
| Insulin therapy regimen | Proportion of patients (%) using multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII) | 1 day | 
| Pump model | Proportion of patients (%) using different types of pump models. | 1 day | 
| Adjunct diabetes therapies | Proportion of patients (%) using non-insulin diabetes therapies, including metformin, SGLT2 inhibitors, DPP4 inhibitors, and GLP-1 receptor agonists | 1 day | 
| Lipid lowering therapies | Proportion of patients (%) using lipid lowering therapies | 1 day | 
| Antihypertensive therapies | Proportion of patients (%) using antihypertensive therapies | 1 day | 
| Mental health therapies | Proportion of patients (%) using therapies for a mental health condition | 1 day | 
| Glucose meter use | Proportion of patients (%) using a blood glucose monitor | 1 day | 
| Continuous glucose monitor (CGM) use | Proportion of patients (%) using a CGM device or a flash glucose monitor device | 1 day | 
| Glucagon availability | Proportion of patients (%) using glucagon | 1 day | 
| Clinical outcomes stratified by age group | Age groups include 18-25 years, 26-49 years, and greater or equal to 50 years | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, hypoglycemia, hemoglobin A1c, time in range, continuous glucose monitor