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

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

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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes

• Study Type: Observational
• Enrollment (Actual): 3600

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
    • LMC Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 diabetes under the care of an endocrinologist at an LMC Healthcare centre, in the provinces of Ontario, Quebec, or Alberta, Canada.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean CGM glucose	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.	5 to 90 days
Time in range	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.	5 to 90 days
Time in hypoglycemia	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.	5 to 90 days
Time in hyperglycemia	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.	5 to 90 days
Standard deviation (SD) of CGM glucose	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.	5 to 90 days
Co-efficient of variation (CV) of CGM glucose	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.	5 to 90 days
HbA1c at referral	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.	1 day
HbA1c in sub-group of patients using CSII therapy	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
Brand of insulin pump	The proportion of patients using each type of insulin pump model will be reported in the sub-group of patients using CSII therapy	1 day
Brand of bolus insulin	The proportion of patients using each type of bolus insulin brand will be reported in the sub-group of patients using CSII therapy	1 day
Sociodemographics in the subgroup of patients using CSII therapy	Sociodemographics include age, gender, ethnicity, education, household income and health coverage.	1 day
Weekly incidence of any self-reported hypoglcyemia in the subgroup of patients using CSII therapy	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.	1 day
Yearly incidence of severe hypoglycemia in the subgroup of patients using CSII therapy	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.	1 day
Weight in the subgroup of patients using CSII therapy	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.	1 day
BMI in the subgroup of patients using CSII therapy	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.	1 day
eGFR in the subgroup of patients using CSII therapy	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.	1 day
LDL-cholesterol in the subgroup of patients using CSII therapy	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.	1 day
Blood pressure in the subgroup of patients using CSII therapy	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.	1 day
Comorbidities in the subgroup of patients using CSII therapy	Comorbidities include microvascular complications and macrovascular complications.	1 day
HbA1c in the subgroup of patients using CSII therapy and using a do-it-yourself (DIY) closed loop system	The last available HbA1c measurement will be used that was collected between January 2015 and June 2019	1 day
HbA1c in the subgroup of patients using CSII therapy and using a hybrid closed loop system	The last available HbA1c measurement will be used that was collected between January 2015 and June 2019	1 day
HbA1c in the subgroup of patients using CSII therapy, stratified by age group	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.	1 day
CGM metrics in the subgroup of patients using CSII therapy and a CGM device	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.	5 to 90 days
HbA1c in the subgroup of patients using a CGM device	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.	1 day
HbA1c in the subgroup of patients using CSII therapy, stratified by mean self-measured blood glucose testing frequency.	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).	one week
HbA1c in the subgroup of patients using CSII therapy, stratified by patients considered "atypical" for pumping by Canadian regulatory authorities	HbA1c will be evaluated in patients who use carbohydrate counting to calculate insulin dose <50% of the time and <20% of the time	one week

Collaborators and Investigators

• Sponsor: LMC Diabetes & Endocrinology Ltd.

Publications and helpful links

General Publications

• Aronson R, Brown RE, Abitbol A, Goldenberg R, Yared Z, Ajala B, Yale JF. The Canadian LMC Diabetes Registry: A Profile of the Demographics, Management, and Outcomes of Individuals with Type 1 Diabetes. Diabetes Technol Ther. 2021 Jan;23(1):31-40. doi: 10.1089/dia.2020.0204. Epub 2020 Jul 31.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: November 10, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: hypoglycemia; continuous glucose monitor; hemoglobin A1c; time in range; Diabetes Mellitus, Type 1
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: T1D Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No