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

Type1diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162067
• Other study ID #: T1D Registry
• Status: Completed
• Start date: January 6, 2020
• Est. completion date: January 20, 2020

Study information

• Verified date: January 2020
• Source: LMC Diabetes & Endocrinology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3600
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Locations

Country	Name	City	State
Canada	LMC Healthcare	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
LMC Diabetes & Endocrinology Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Sociodemographics in the subgroup of patients using CSII therapy	Sociodemographics include age, gender, ethnicity, education, household income and health coverage.	1 day
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Comorbidities in the subgroup of patients using CSII therapy	Comorbidities include microvascular complications and macrovascular complications.	1 day
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Microvascular comorbidity	History of any of the following: retinopathy, neuropathy or nephropathy. The history will be accessed from the patients medical records.	1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Erectile dysfunction	Proportion of males with erectile dysfunction. The medical history will be accessed from the patients medical records.	1 day
Secondary	Insulin type	Proportion of patients (%) using rapid-acting, intermediate acting and long-acting insulin	1 day
Secondary	Insulin therapy regimen	Proportion of patients (%) using multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII)	1 day
Secondary	Pump model	Proportion of patients (%) using different types of pump models.	1 day
Secondary	Adjunct diabetes therapies	Proportion of patients (%) using non-insulin diabetes therapies, including metformin, SGLT2 inhibitors, DPP4 inhibitors, and GLP-1 receptor agonists	1 day
Secondary	Lipid lowering therapies	Proportion of patients (%) using lipid lowering therapies	1 day
Secondary	Antihypertensive therapies	Proportion of patients (%) using antihypertensive therapies	1 day
Secondary	Mental health therapies	Proportion of patients (%) using therapies for a mental health condition	1 day
Secondary	Glucose meter use	Proportion of patients (%) using a blood glucose monitor	1 day
Secondary	Continuous glucose monitor (CGM) use	Proportion of patients (%) using a CGM device or a flash glucose monitor device	1 day
Secondary	Glucagon availability	Proportion of patients (%) using glucagon	1 day
Secondary	Clinical outcomes stratified by age group	Age groups include 18-25 years, 26-49 years, and greater or equal to 50 years	1 day