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Completed

NCT Number: NCT04162067

The Current Health Status 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMC Healthcare

Toronto, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. HbA1c

    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

Secondary outcomes

  1. Fasting plasma glucose

    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

  2. Proportion of patients with HbA1c ≤7.0%, 7.1 to 8.0%, 8.1 to 9.0% and >9.0%

    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

  3. Lipid parameters

    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

  4. Proportion of patients below and above target LDL cholesterol

    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

  5. Blood pressure

    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

  6. estimated glomerular filtration rate (eGFR)

    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

  7. Albuminuria

    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

  8. Weight

    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

  9. Body mass index (BMI)

    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.

  10. Waist circumference

    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

  11. Thyroid stimulating hormone (TSH)

    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

  12. Alanine aminotransferase (ALT)

    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

  13. Microvascular comorbidity

    Time frame: 1 day

    History of any of the following: retinopathy, neuropathy or nephropathy. The history will be accessed from the patients medical records.

  14. Macrovascular comorbidity

    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.

  15. Weekly incidence of any hypoglycemia

    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

  16. Yearly incidence of severe hypoglycemia

    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

  17. Mental health comorbidity

    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.

  18. Erectile dysfunction

    Time frame: 1 day

    Proportion of males with erectile dysfunction. The medical history will be accessed from the patients medical records.

  19. Insulin type

    Time frame: 1 day

    Proportion of patients (%) using rapid-acting, intermediate acting and long-acting insulin

  20. Insulin therapy regimen

    Time frame: 1 day

    Proportion of patients (%) using multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII)

  21. Pump model

    Time frame: 1 day

    Proportion of patients (%) using different types of pump models.

  22. Adjunct diabetes therapies

    Time frame: 1 day

    Proportion of patients (%) using non-insulin diabetes therapies, including metformin, SGLT2 inhibitors, DPP4 inhibitors, and GLP-1 receptor agonists

  23. Lipid lowering therapies

    Time frame: 1 day

    Proportion of patients (%) using lipid lowering therapies

  24. Antihypertensive therapies

    Time frame: 1 day

    Proportion of patients (%) using antihypertensive therapies

  25. Mental health therapies

    Time frame: 1 day

    Proportion of patients (%) using therapies for a mental health condition

  26. Glucose meter use

    Time frame: 1 day

    Proportion of patients (%) using a blood glucose monitor

  27. Continuous glucose monitor (CGM) use

    Time frame: 1 day

    Proportion of patients (%) using a CGM device or a flash glucose monitor device

  28. Glucagon availability

    Time frame: 1 day

    Proportion of patients (%) using glucagon

  29. Clinical outcomes stratified by age group

    Time frame: 1 day

    Age groups include 18-25 years, 26-49 years, and greater or equal to 50 years

Other outcomes

  1. Mean CGM glucose

    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.

  2. Time in range

    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.

  3. Time in hypoglycemia

    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.

  4. Time in hyperglycemia

    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.

  5. Standard deviation (SD) of CGM glucose

    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.

  6. Co-efficient of variation (CV) of CGM glucose

    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.

  7. HbA1c at referral

    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.

  8. HbA1c in sub-group of patients using CSII therapy

    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.

  9. Brand of insulin pump

    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

  10. Brand of bolus insulin

    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

  11. Sociodemographics in the subgroup of patients using CSII therapy

    Time frame: 1 day

    Sociodemographics include age, gender, ethnicity, education, household income and health coverage.

  12. Weekly incidence of any self-reported hypoglcyemia in the subgroup of patients using CSII therapy

    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.

  13. Yearly incidence of severe hypoglycemia in the subgroup of patients using CSII therapy

    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.

  14. Weight in the subgroup of patients using CSII therapy

    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.

  15. BMI in the subgroup of patients using CSII therapy

    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.

  16. eGFR in the subgroup of patients using CSII therapy

    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.

  17. LDL-cholesterol in the subgroup of patients using CSII therapy

    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.

  18. Blood pressure in the subgroup of patients using CSII therapy

    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.

  19. Comorbidities in the subgroup of patients using CSII therapy

    Time frame: 1 day

    Comorbidities include microvascular complications and macrovascular complications.

  20. HbA1c in the subgroup of patients using CSII therapy and using a do-it-yourself (DIY) closed loop system

    Time frame: 1 day

    The last available HbA1c measurement will be used that was collected between January 2015 and June 2019

  21. HbA1c in the subgroup of patients using CSII therapy and using a hybrid closed loop system

    Time frame: 1 day

    The last available HbA1c measurement will be used that was collected between January 2015 and June 2019

  22. HbA1c in the subgroup of patients using CSII therapy, stratified by age group

    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.

  23. CGM metrics in the subgroup of patients using CSII therapy and a CGM device

    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.

  24. HbA1c in the subgroup of patients using a CGM device

    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.

  25. HbA1c in the subgroup of patients using CSII therapy, stratified by mean self-measured blood glucose testing frequency.

    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).

  26. HbA1c in the subgroup of patients using CSII therapy, stratified by patients considered "atypical" for pumping by Canadian regulatory authorities

    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

Sponsors and collaborators

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2019
Registry last updated
Jan 28, 2020

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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