Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 7:42 AM
Study NCT ID:
NCT04162067
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2019-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Current Health Status of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-10', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean CGM glucose', 'timeFrame': '5 to 90 days', 'description': '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.'}, {'measure': 'Time in range', 'timeFrame': '5 to 90 days', 'description': '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.'}, {'measure': 'Time in hypoglycemia', 'timeFrame': '5 to 90 days', 'description': '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.'}, {'measure': 'Time in hyperglycemia', 'timeFrame': '5 to 90 days', 'description': '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.'}, {'measure': 'Standard deviation (SD) of CGM glucose', 'timeFrame': '5 to 90 days', 'description': '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.'}, {'measure': 'Co-efficient of variation (CV) of CGM glucose', 'timeFrame': '5 to 90 days', 'description': '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.'}, {'measure': 'HbA1c at referral', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'HbA1c in sub-group of patients using CSII therapy', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Brand of insulin pump', 'timeFrame': '1 day', 'description': 'The proportion of patients using each type of insulin pump model will be reported in the sub-group of patients using CSII therapy'}, {'measure': 'Brand of bolus insulin', 'timeFrame': '1 day', 'description': 'The proportion of patients using each type of bolus insulin brand will be reported in the sub-group of patients using CSII therapy'}, {'measure': 'Sociodemographics in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': 'Sociodemographics include age, gender, ethnicity, education, household income and health coverage.'}, {'measure': 'Weekly incidence of any self-reported hypoglcyemia in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Yearly incidence of severe hypoglycemia in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Weight in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'BMI in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'eGFR in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'LDL-cholesterol in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Blood pressure in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Comorbidities in the subgroup of patients using CSII therapy', 'timeFrame': '1 day', 'description': 'Comorbidities include microvascular complications and macrovascular complications.'}, {'measure': 'HbA1c in the subgroup of patients using CSII therapy and using a do-it-yourself (DIY) closed loop system', 'timeFrame': '1 day', 'description': 'The last available HbA1c measurement will be used that was collected between January 2015 and June 2019'}, {'measure': 'HbA1c in the subgroup of patients using CSII therapy and using a hybrid closed loop system', 'timeFrame': '1 day', 'description': 'The last available HbA1c measurement will be used that was collected between January 2015 and June 2019'}, {'measure': 'HbA1c in the subgroup of patients using CSII therapy, stratified by age group', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'CGM metrics in the subgroup of patients using CSII therapy and a CGM device', 'timeFrame': '5 to 90 days', 'description': '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.'}, {'measure': 'HbA1c in the subgroup of patients using a CGM device', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'HbA1c in the subgroup of patients using CSII therapy, stratified by mean self-measured blood glucose testing frequency.', 'timeFrame': 'one week', 'description': '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).'}, {'measure': 'HbA1c in the subgroup of patients using CSII therapy, stratified by patients considered "atypical" for pumping by Canadian regulatory authorities', 'timeFrame': 'one week', 'description': 'HbA1c will be evaluated in patients who use carbohydrate counting to calculate insulin dose \\<50% of the time and \\<20% of the time'}], 'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '1 day', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Fasting plasma glucose', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Proportion of patients with HbA1c ≤7.0%, 7.1 to 8.0%, 8.1 to 9.0% and >9.0%', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Lipid parameters', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Proportion of patients below and above target LDL cholesterol', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Blood pressure', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'estimated glomerular filtration rate (eGFR)', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Albuminuria', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Weight', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Body mass index (BMI)', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Waist circumference', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Thyroid stimulating hormone (TSH)', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Alanine aminotransferase (ALT)', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Microvascular comorbidity', 'timeFrame': '1 day', 'description': 'History of any of the following: retinopathy, neuropathy or nephropathy. The history will be accessed from the patients medical records.'}, {'measure': 'Macrovascular comorbidity', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Weekly incidence of any hypoglycemia', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Yearly incidence of severe hypoglycemia', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Mental health comorbidity', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Erectile dysfunction', 'timeFrame': '1 day', 'description': 'Proportion of males with erectile dysfunction. The medical history will be accessed from the patients medical records.'}, {'measure': 'Insulin type', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using rapid-acting, intermediate acting and long-acting insulin'}, {'measure': 'Insulin therapy regimen', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII)'}, {'measure': 'Pump model', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using different types of pump models.'}, {'measure': 'Adjunct diabetes therapies', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using non-insulin diabetes therapies, including metformin, SGLT2 inhibitors, DPP4 inhibitors, and GLP-1 receptor agonists'}, {'measure': 'Lipid lowering therapies', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using lipid lowering therapies'}, {'measure': 'Antihypertensive therapies', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using antihypertensive therapies'}, {'measure': 'Mental health therapies', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using therapies for a mental health condition'}, {'measure': 'Glucose meter use', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using a blood glucose monitor'}, {'measure': 'Continuous glucose monitor (CGM) use', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using a CGM device or a flash glucose monitor device'}, {'measure': 'Glucagon availability', 'timeFrame': '1 day', 'description': 'Proportion of patients (%) using glucagon'}, {'measure': 'Clinical outcomes stratified by age group', 'timeFrame': '1 day', 'description': 'Age groups include 18-25 years, 26-49 years, and greater or equal to 50 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 1', 'hypoglycemia', 'hemoglobin A1c', 'time in range', 'continuous glucose monitor'], 'conditions': ['Type1diabetes']}, 'referencesModule': {'references': [{'pmid': '32667835', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of type 1 diabetes for ≥ 6 months\n* Assessed by an LMC endocrinologist between July 1, 2015 and June 30, 2018\n* Followed by an LMC endocrinologist for \\> 6 months\n* Informed consent provided and signed for medical record data to be used for research purposes\n\nExclusion Criteria:\n\n* clinical diagnosis of type 2 diabetes'}, 'identificationModule': {'nctId': 'NCT04162067', 'briefTitle': 'The Current Health Status of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry', 'organization': {'class': 'OTHER', 'fullName': 'LMC Diabetes & Endocrinology Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'T1D Registry'}}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'country': 'Canada', 'facility': 'LMC Healthcare', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ronnie Aronson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LMC Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMC Diabetes & Endocrinology Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}