The Current Health Status of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry
- Conditions
- Type1diabetes
- Registration Number
- NCT04162067
- Lead Sponsor
- LMC Diabetes & Endocrinology Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3600
- 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
- clinical diagnosis of type 2 diabetes
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c 1 day 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
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose 1 day 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
Weekly incidence of any hypoglycemia 1 day 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
Yearly incidence of severe hypoglycemia 1 day 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
Insulin therapy regimen 1 day Proportion of patients (%) using multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII)
Adjunct diabetes therapies 1 day Proportion of patients (%) using non-insulin diabetes therapies, including metformin, SGLT2 inhibitors, DPP4 inhibitors, and GLP-1 receptor agonists
Lipid lowering therapies 1 day Proportion of patients (%) using lipid lowering therapies
Glucose meter use 1 day Proportion of patients (%) using a blood glucose monitor
Glucagon availability 1 day Proportion of patients (%) using glucagon
Clinical outcomes stratified by age group 1 day Age groups include 18-25 years, 26-49 years, and greater or equal to 50 years
Proportion of patients with HbA1c ≤7.0%, 7.1 to 8.0%, 8.1 to 9.0% and >9.0% 1 day 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
Proportion of patients below and above target LDL cholesterol 1 day 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
Blood pressure 1 day 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
Thyroid stimulating hormone (TSH) 1 day 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
Microvascular comorbidity 1 day History of any of the following: retinopathy, neuropathy or nephropathy. The history will be accessed from the patients medical records.
Albuminuria 1 day 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
Macrovascular comorbidity 1 day 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.
Insulin type 1 day Proportion of patients (%) using rapid-acting, intermediate acting and long-acting insulin
Lipid parameters 1 day 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
estimated glomerular filtration rate (eGFR) 1 day 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
Weight 1 day 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
Body mass index (BMI) 1 day 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.
Alanine aminotransferase (ALT) 1 day 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
Pump model 1 day Proportion of patients (%) using different types of pump models.
Antihypertensive therapies 1 day Proportion of patients (%) using antihypertensive therapies
Mental health therapies 1 day Proportion of patients (%) using therapies for a mental health condition
Continuous glucose monitor (CGM) use 1 day Proportion of patients (%) using a CGM device or a flash glucose monitor device
Waist circumference 1 day 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
Mental health comorbidity 1 day 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.
Erectile dysfunction 1 day Proportion of males with erectile dysfunction. The medical history will be accessed from the patients medical records.
Trial Locations
- Locations (1)
LMC Healthcare
🇨🇦Toronto, Canada