Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-03 @ 6:32 AM
Study NCT ID:
NCT03705260
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2018-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012306', 'term': 'Risk'}], 'ancestors': [{'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1C', 'timeFrame': '1 year', 'description': 'Hemoglobin A1C'}], 'secondaryOutcomes': [{'measure': 'Weight Change', 'timeFrame': 'baseline to 1 year', 'description': "Difference in patient's weight measured in pounds."}, {'measure': 'Change in diabetes medication requirements', 'timeFrame': 'baseline to 1 year', 'description': 'Change in average daily doses of diabetes medications'}, {'measure': 'Change in percentage of time glucose is out of range', 'timeFrame': 'baseline to 1 year', 'description': 'Change in percentage of time glucose is out of range (70 mg/dl-140 mg/dl) on CGM.'}, {'measure': 'Blood Pressure', 'timeFrame': '1 year', 'description': 'Blood Pressure'}, {'measure': 'Change in rate of Micro-vascular complications', 'timeFrame': 'Baseline to 1 Year', 'description': 'Change in rate of micro-vascular complications. (The micro-vascular complications assessed will be retinopathy, neuropathy, nephropathy)'}, {'measure': 'Change in rate of symptomatic hypoglycemia requiring medical intervention', 'timeFrame': 'Baseline to 1 year', 'description': 'Change in rate of symptomatic hypoglycemia requiring medical intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Michigan Medicine patient treated by a physician in the Family Medicine Department at the Chelsea Health Center\n* Diagnosis of T2D as recorded in the patient's problem list or as documented by medication list and lab results\n* HbA1C \\>8 for the high-risk sub-cohort\n\nExclusion Criteria:\n\n* Individuals for whom tight control (ie A1C \\< 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition\n* Individuals with cognitive or psychological diagnoses that might make CGM or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia\n* Women who are pregnant or breast feeding\n* Individuals who had previous bariatric surgery"}, 'identificationModule': {'nctId': 'NCT03705260', 'briefTitle': 'Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication', 'orgStudyIdInfo': {'id': 'HUM00147295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator- High Risk', 'description': 'A high risk sub group of those assigned to the comparator arm will be identified by their most recent A1C \\> 8. Patients in this group will receive usual care from their Primary Care Physician and dietitian.', 'interventionNames': ['Other: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator- Well Controlled', 'description': 'The low risk sub group from the comparator arm (A1C \\< 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their Primary Care Physician and their dietitian.', 'interventionNames': ['Other: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Care- High Risk', 'description': 'A high risk sub group of those assigned to the enhanced care arm will be identified by their most recent A1C \\> 8. Patients in this group will receive the intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.', 'interventionNames': ['Behavioral: Intensive Behavioral Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Care- Well Controlled.', 'description': 'The low risk sub group from the enhanced care arm (A1C \\< 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their PCP and their dietitian. If they are found to be poorly controlled through monthly screening for risk, they may have the opportunity to move into the Enhanced Care High Risk group.', 'interventionNames': ['Other: Usual Care', 'Other: Monthly Screening for Risk']}], 'interventions': [{'name': 'Usual Care', 'type': 'OTHER', 'description': 'Usual care from Primary Care Physician and dietitian.', 'armGroupLabels': ['Comparator- High Risk', 'Comparator- Well Controlled', 'Enhanced Care- Well Controlled.']}, {'name': 'Intensive Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.', 'armGroupLabels': ['Enhanced Care- High Risk']}, {'name': 'Monthly Screening for Risk', 'type': 'OTHER', 'description': 'Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.', 'armGroupLabels': ['Enhanced Care- Well Controlled.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48118', 'city': 'Chelsea', 'state': 'Michigan', 'country': 'United States', 'facility': 'Chelsea Health Center', 'geoPoint': {'lat': 42.31807, 'lon': -84.02181}}], 'overallOfficials': [{'name': 'Caroline Richardson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Twine Clinical Consulting', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Caroline Richardson', 'investigatorAffiliation': 'University of Michigan'}}}}