LMC Healthcare
Toronto, Canada
NCT Number: NCT04162067
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.
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Notify Me18 year and older
All sexes
Observational
Toronto, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 day
History of any of the following: retinopathy, neuropathy or nephropathy. The history will be accessed from the patients medical records.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 1 day
Proportion of males with erectile dysfunction. The medical history will be accessed from the patients medical records.
Time frame: 1 day
Proportion of patients (%) using rapid-acting, intermediate acting and long-acting insulin
Time frame: 1 day
Proportion of patients (%) using multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII)
Time frame: 1 day
Proportion of patients (%) using different types of pump models.
Time frame: 1 day
Proportion of patients (%) using non-insulin diabetes therapies, including metformin, SGLT2 inhibitors, DPP4 inhibitors, and GLP-1 receptor agonists
Time frame: 1 day
Proportion of patients (%) using lipid lowering therapies
Time frame: 1 day
Proportion of patients (%) using antihypertensive therapies
Time frame: 1 day
Proportion of patients (%) using therapies for a mental health condition
Time frame: 1 day
Proportion of patients (%) using a blood glucose monitor
Time frame: 1 day
Proportion of patients (%) using a CGM device or a flash glucose monitor device
Time frame: 1 day
Proportion of patients (%) using glucagon
Time frame: 1 day
Age groups include 18-25 years, 26-49 years, and greater or equal to 50 years
Time frame: 5 to 90 days
Mean CGM glucose in sub-group of patients with available CGM data. The last 5 to 90 days of the patients CGM data will be accessed from the patients medical records.
Time frame: 5 to 90 days
Percentage of time with CGM glucose concentration between 4-10 mmol/L in sub-group of patients with available CGM data. The last 5 to 90 days of the patients CGM data will be accessed from the patients medical records.
Time frame: 5 to 90 days
Percentage of time with CGM glucose concentration < 4 mmol/L in sub-group of patients with available CGM data. The last 5 to 90 days of the patients CGM data will be accessed from the patients medical records.
Time frame: 5 to 90 days
Percentage of time with CGM glucose concentration > 10 mmol/L in sub-group of patients with available CGM data. The last 5 to 90 days of the patients CGM data will be accessed from the patients medical records.
Time frame: 5 to 90 days
SD (mmol/L) of CGM glucose in sub-group of patients with available CGM data. The last 5 to 90 days of the patients CGM data will be accessed from the patients medical records.
Time frame: 5 to 90 days
Proportion of patients with CV ≤ 36% and CV >36% in sub-group of patients with available CGM data. The last 5 to 90 days of the patients CGM data will be accessed from the patients medical records.
Time frame: 1 day
Mean HbA1c (%) in the six months prior to referral. The last measured value will be used and will be accessed through the patients medical records.
Time frame: 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.
Time frame: 1 day
The proportion of patients using each type of insulin pump model will be reported in the sub-group of patients using CSII therapy
Time frame: 1 day
The proportion of patients using each type of bolus insulin brand will be reported in the sub-group of patients using CSII therapy
Time frame: 1 day
Sociodemographics include age, gender, ethnicity, education, household income and health coverage.
Time frame: 1 day
Weekly incidence of any self-reported 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.
Time frame: 1 day
Yearly incidence of severe 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.
Time frame: 1 day
Weight 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.
Time frame: 1 day
BMI 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.
Time frame: 1 day
eGFR will be expressed as the proportion of patients with eGFR <30, 30 to 60 and >60 mL/min/1.73 m2. eGFR 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.
Time frame: 1 day
LDL cholesterol will be expressed as a mean and the proportion of patients with LDL-cholesterol ≤ 2 mmol/L and >2 mmol/L. LDL cholesterol 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.
Time frame: 1 day
Blood pressure 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.
Time frame: 1 day
Comorbidities include microvascular complications and macrovascular complications.
Time frame: 1 day
The last available HbA1c measurement will be used that was collected between January 2015 and June 2019
Time frame: 1 day
The last available HbA1c measurement will be used that was collected between January 2015 and June 2019
Time frame: 1 day
The last available HbA1c measurement will be used that was collected between January 2015 and June 2019. Age categories will include 18-25 years, 26-49 years, and greater than or equal to 50 years.
Time frame: 5 to 90 days
CGM metrics include: mean CGM glucose, SD of CGM glucose, time in range, time in hyperglycemia, time in hypoglycemia, and co-efficient of variation of CGM glucose. The last 5 to 90 days of patients data will be used.
Time frame: 1 day
The last available HbA1c measurement will be used that was collected between January 2015 and June 2019. This outcome will be further stratified by CSII vs MDI therapy.
Time frame: one week
HbA1c will be evaluated in patients who have a mean daily testing frequency < two times/day and ≥ two times/day. The last week of recorded self-measured blood glucose testing frequency data will be used (between January 2015 and June 2019).
Time frame: one week
HbA1c will be evaluated in patients who use carbohydrate counting to calculate insulin dose <50% of the time and <20% of the time
LMC Diabetes & Endocrinology Ltd.
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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