Clinical trial NCT04162067: The Current Health Status of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1diabetes
Keywords: Diabetes Mellitus, Type 1
hypoglycemia
hemoglobin A1c
time in range
continuous glucose monitor
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: 1 day
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 1 day
measure: Proportion of patients with HbA1c ≤7.0%, 7.1 to 8.0%, 8.1 to 9.0% and >9.0%
timeFrame: 1 day
measure: Lipid parameters
timeFrame: 1 day
measure: Proportion of patients below and above target LDL cholesterol
timeFrame: 1 day
measure: Blood pressure
timeFrame: 1 day
measure: estimated glomerular filtration rate (eGFR)
timeFrame: 1 day
measure: Albuminuria
timeFrame: 1 day
measure: Weight
timeFrame: 1 day
measure: Body mass index (BMI)
timeFrame: 1 day
measure: Waist circumference
timeFrame: 1 day
measure: Thyroid stimulating hormone (TSH)
timeFrame: 1 day
measure: Alanine aminotransferase (ALT)
timeFrame: 1 day
measure: Microvascular comorbidity
timeFrame: 1 day
measure: Macrovascular comorbidity
timeFrame: 1 day
measure: Weekly incidence of any hypoglycemia
timeFrame: 1 day
measure: Yearly incidence of severe hypoglycemia
timeFrame: 1 day
measure: Mental health comorbidity
timeFrame: 1 day
measure: Erectile dysfunction
timeFrame: 1 day
measure: Insulin type
timeFrame: 1 day
measure: Insulin therapy regimen
timeFrame: 1 day
measure: Pump model
timeFrame: 1 day
measure: Adjunct diabetes therapies
timeFrame: 1 day
measure: Lipid lowering therapies
timeFrame: 1 day
measure: Antihypertensive therapies
timeFrame: 1 day
measure: Mental health therapies
timeFrame: 1 day
measure: Glucose meter use
timeFrame: 1 day
measure: Continuous glucose monitor (CGM) use
timeFrame: 1 day
measure: Glucagon availability
timeFrame: 1 day
measure: Clinical outcomes stratified by age group
timeFrame: 1 day
Other outcomes:
measure: Mean CGM glucose
timeFrame: 5 to 90 days
measure: Time in range
timeFrame: 5 to 90 days
measure: Time in hypoglycemia
timeFrame: 5 to 90 days
measure: Time in hyperglycemia
timeFrame: 5 to 90 days
measure: Standard deviation (SD) of CGM glucose
timeFrame: 5 to 90 days
measure: Co-efficient of variation (CV) of CGM glucose
timeFrame: 5 to 90 days
measure: HbA1c at referral
timeFrame: 1 day
measure: HbA1c in sub-group of patients using CSII therapy
timeFrame: 1 day
measure: Brand of insulin pump
timeFrame: 1 day
measure: Brand of bolus insulin
timeFrame: 1 day
measure: Sociodemographics in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: Weekly incidence of any self-reported hypoglcyemia in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: Yearly incidence of severe hypoglycemia in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: Weight in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: BMI in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: eGFR in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: LDL-cholesterol in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: Blood pressure in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: Comorbidities in the subgroup of patients using CSII therapy
timeFrame: 1 day
measure: HbA1c in the subgroup of patients using CSII therapy and using a do-it-yourself (DIY) closed loop system
timeFrame: 1 day
measure: HbA1c in the subgroup of patients using CSII therapy and using a hybrid closed loop system
timeFrame: 1 day
measure: HbA1c in the subgroup of patients using CSII therapy, stratified by age group
timeFrame: 1 day
measure: CGM metrics in the subgroup of patients using CSII therapy and a CGM device
timeFrame: 5 to 90 days
measure: HbA1c in the subgroup of patients using a CGM device
timeFrame: 1 day
measure: HbA1c in the subgroup of patients using CSII therapy, stratified by mean self-measured blood glucose testing frequency.
timeFrame: one week
measure: HbA1c in the subgroup of patients using CSII therapy, stratified by patients considered "atypical" for pumping by Canadian regulatory authorities
timeFrame: one week
Locations:
city: Toronto
country: Canada
facility: LMC Healthcare
Study officials:
affiliation: LMC Healthcare
name: Ronnie Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.