NCT04162067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

14 days

First QC Date

November 10, 2019

Last Update Submit

January 27, 2020

Conditions

Keywords

Diabetes Mellitus, Type 1hypoglycemiahemoglobin A1ctime in rangecontinuous glucose monitor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (29)

  • Fasting plasma glucose

    1 day

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

    1 day

  • Lipid parameters

    1 day

  • Proportion of patients below and above target LDL cholesterol

    1 day

  • Blood pressure

    1 day

  • +24 more secondary outcomes

Other Outcomes (26)

  • Mean CGM glucose

    5 to 90 days

  • Time in range

    5 to 90 days

  • Time in hypoglycemia

    5 to 90 days

  • +23 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • clinical diagnosis of type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LMC Healthcare

Toronto, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ronnie Aronson, MD

    LMC Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 14, 2019

Study Start

January 6, 2020

Primary Completion

January 20, 2020

Study Completion

January 20, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations