Type1diabetesNCT04162067
The Current Health Status of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry
An observational study of Type1diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- How many people
- 3,600 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2020to 20 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- clinical diagnosis of type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Type1diabetes
- Keywords
- Diabetes Mellitus, Type 1, hypoglycemia, hemoglobin A1c, time in range, continuous glucose monitor
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (29)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 1 day
Microvascular comorbidity
History of any of the following: retinopathy, neuropathy or nephropathy. The history will be accessed from the patients medical records.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 day
Erectile dysfunction
Proportion of males with erectile dysfunction. The medical history will be accessed from the patients medical records.
Measured: 1 day
Insulin type
Proportion of patients (%) using rapid-acting, intermediate acting and long-acting insulin
Measured: 1 day
Insulin therapy regimen
Proportion of patients (%) using multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII)
Measured: 1 day
Pump model
Proportion of patients (%) using different types of pump models.
Measured: 1 day
Adjunct diabetes therapies
Proportion of patients (%) using non-insulin diabetes therapies, including metformin, SGLT2 inhibitors, DPP4 inhibitors, and GLP-1 receptor agonists
Measured: 1 day
Lipid lowering therapies
Proportion of patients (%) using lipid lowering therapies
Measured: 1 day
Antihypertensive therapies
Proportion of patients (%) using antihypertensive therapies
Measured: 1 day
Mental health therapies
Proportion of patients (%) using therapies for a mental health condition
Measured: 1 day
Glucose meter use
Proportion of patients (%) using a blood glucose monitor
Measured: 1 day
Continuous glucose monitor (CGM) use
Proportion of patients (%) using a CGM device or a flash glucose monitor device
Measured: 1 day
Glucagon availability
Proportion of patients (%) using glucagon
Measured: 1 day
Clinical outcomes stratified by age group
Age groups include 18-25 years, 26-49 years, and greater or equal to 50 years
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start6 Jan 2020
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronnie Aronson, MD, Principal investigator, LMC Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162067
- Sponsor's protocol ID
- T1D Registry
- Status last verified
- Jan 2020
- First submitted
- 10 Nov 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32667835
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04162067
- Acronym / sponsor ID
- T1D Registry
- Conditions
- Type1diabetes
- Keywords
- Diabetes Mellitus, Type 1, hypoglycemia, hemoglobin A1c, time in range, continuous glucose monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- clinical diagnosis of type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
29 secondary outcomes
Fasting plasma glucose
Time frame: 1 day
Proportion of patients with HbA1c ≤7.0%, 7.1 to 8.0%, 8.1 to 9.0% and >9.0%
Time frame: 1 day
Lipid parameters
Time frame: 1 day
Proportion of patients below and above target LDL cholesterol
Time frame: 1 day
Blood pressure
Time frame: 1 day
estimated glomerular filtration rate (eGFR)
Time frame: 1 day
Albuminuria
Time frame: 1 day
Weight
Time frame: 1 day
Body mass index (BMI)
Time frame: 1 day
Waist circumference
Time frame: 1 day
Thyroid stimulating hormone (TSH)
Time frame: 1 day
Alanine aminotransferase (ALT)
Time frame: 1 day
Microvascular comorbidity
Time frame: 1 day
Macrovascular comorbidity
Time frame: 1 day
Weekly incidence of any hypoglycemia
Time frame: 1 day
Yearly incidence of severe hypoglycemia
Time frame: 1 day
Mental health comorbidity
Time frame: 1 day
Erectile dysfunction
Time frame: 1 day
Insulin type
Time frame: 1 day
Insulin therapy regimen
Time frame: 1 day
Pump model
Time frame: 1 day
Adjunct diabetes therapies
Time frame: 1 day
Lipid lowering therapies
Time frame: 1 day
Antihypertensive therapies
Time frame: 1 day
Mental health therapies
Time frame: 1 day
Glucose meter use
Time frame: 1 day
Continuous glucose monitor (CGM) use
Time frame: 1 day
Glucagon availability
Time frame: 1 day
Clinical outcomes stratified by age group
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 32667835Aronson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronnie Aronson, MD principal investigator
LMC Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.