Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-10 @ 1:23 AM
Study NCT ID:
NCT04089202
Status:
TERMINATED
Last Update Posted:
2023-02-24
First Post:
2019-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes eConsult Non-Inferiority Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'whyStopped': 'Unable to enroll additional participants and funding ended.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2019-09-11', 'studyFirstSubmitQcDate': '2019-09-11', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c (A1c) at baseline', 'timeFrame': 'baseline', 'description': 'A1c will be obtained as standard of care and values documented in the medical record.'}, {'measure': 'Hemoglobin A1c (A1c) at 3 months', 'timeFrame': '3 months', 'description': 'A1c will be obtained as standard of care and values documented in the medical record.'}, {'measure': 'Hemoglobin A1c (A1c) at 6 months', 'timeFrame': '6 months', 'description': 'A1c will be obtained as standard of care and values documented in the medical record.'}, {'measure': 'Hemoglobin A1c (A1c) at 12 months', 'timeFrame': '12 months', 'description': 'A1c will be obtained as standard of care and values documented in the medical record.'}, {'measure': 'Percentage change in A1c to 6 months', 'timeFrame': 'baseline, 6 months', 'description': 'The percent change in A1c will be calculated from baseline to six months'}, {'measure': 'Percentage change in A1c to 12 months', 'timeFrame': 'baseline, 12 months', 'description': 'The percent change in A1c will be calculated from baseline to 12 months'}, {'measure': 'Proportion of patients with A1c <7%', 'timeFrame': '6 months, 12 months', 'description': 'The proportion of participants with A1c \\<7% (ADA target) will be calculated.'}, {'measure': 'Proportion of patients with A1c <8%', 'timeFrame': '6 months, 12 months', 'description': 'The proportion of participants with A1c \\<8% (ADA target) will be calculated.'}, {'measure': 'Glycemic control based on A1c', 'timeFrame': '12 months', 'description': 'A1c reduction of \\> 1% with 20% non-inferiority margin'}], 'secondaryOutcomes': [{'measure': 'Number of clinical visits for diabetes care', 'timeFrame': '12 months', 'description': 'The number of clinical visits (outpatient, inpatient and emergency department) for diabetes care will be calculated for each participant'}, {'measure': 'Patient assessment of care burden', 'timeFrame': 'within 2 weeks of the physician visit or eConsult', 'description': 'Modified assessment of perceived research burden'}, {'measure': 'Provider assessment of acceptability', 'timeFrame': 'at baseline, 6 months, and completion of study period', 'description': 'Results from a 16 item post intervention questionnaire developed by the investigators will be used to assess provider acceptability. It includes 10 questions with a 5 item Likert scale from 1= Strongly disagree to 5= Strongly agree that asks about the usefulness, feasibility and how much they liked the eConsult and the physician visits. There are also 2 open-ended questions soliciting qualitative information about the intervention.'}, {'measure': 'Patient self efficacy and disease burden based on diabetes self management questionnaire and problem areas in diabetes short five-item short form questionnaire', 'timeFrame': 'at baseline and 6 months', 'description': 'Patient disease burden will be measured by the validated Problem Areas in Diabetes-5 question (PAID-5) survey. The five questions are from the original 20 item PAID survey (specifically questions 3, 6, 12, 16, and 19) and each has a 5-point Likert scale ranging from "not a problem" (score of 0) to "serious problem" (score of 4). The possible total scores of the PAID-5 ranges from 0 to 20, with higher scores implying greater emotional distress.'}, {'measure': 'Efficacy of embedded clinical pharmacists', 'timeFrame': 'baseline, 3, 6, and 12 months', 'description': 'Changes in hemoglobin A1c will be used to assess the efficacy of the embedded clinical pharmacists'}, {'measure': 'Cost effectiveness analysis (CEA)', 'timeFrame': '12 months', 'description': 'A Cost-Effectiveness Analysis will be done to compare the costs and health gains for the eConsult and standard of care interventions.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes specialty care', 'Flash glucose monitoring', 'Clinical pharmacists', 'eConsults', 'Freestyle Libre sensor'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'Flash glucose monitoring is an FDA-approved and widely clinically available, glucose monitoring technology that is worn on the body and measures glucose values every 15 minutes, storing this data for up to 14 days. The Freestyle Libre Pro is already used as a diagnostic technology in clinical care. It provides a full 24-hour glucose profile for each day that the sensor is worn and that can be correlated with daily activities, medication administration, food intake, and other factors that are contextually relevant in meeting glycemic goals for an individual patient.\n\nIn this study, patients referred to Endocrinology for specialty diabetes care will be randomized to an in-person visit as is typically done or to wear the Freestyle Libre Pro placed by staff at their primary care clinic. Patients who wear the Freestyle Libre Pro will have a professional interpretation of their glucose data completed by an endocrinologist as well as a remote eConsult completed using this glucose data and information from their medical record. The recommendations from the eConsult regarding medication and lifestyle adjustment as well as potential referral on to see Endocrinology will be implemented by the primary care physician at their clinical discretion.\n\nThe investigators will utilize glycemic measures including hemoglobin A1c, number of clinical visits (outpatient, inpatient and emergency department) for diabetes care, patient reported outcomes including self-efficacy, and patient and provider assessments of burden to determine if eConsults utilizing flash glucose monitoring technology are non-inferior to in-person visits with a diabetes specialist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects age 18-80, inclusive\n* Diagnosed with type 2 diabetes at least 6 months prior to screening\n* Not previously seen within the prior three years in the endocrinology clinic for diabetes management\n* Referred to endocrinology for diabetes care directly from primary care\n* Willing to wear an Abbott® FreeStyle Libre Pro for 7-14 days\n* English speaking\n* Able and willing to complete questionnaires\n\nExclusion Criteria:\n\n* Planned travel or surgery during the time of libre wear\n* Patients without a diagnosis of type 2 diabetes, including individuals with type 1 diabetes and gestational diabetes\n* Women referred for diabetes care during pregnancy, or while breastfeeding or who intend to become pregnant during involvement in this trial\n* Currently using real time CGM or FGM system\n* Concurrent involvement in another clinical trial using diabetes pharmacotherapy\n* Individuals with active malignancy undergoing treatment with chemotherapy and/or high dose glucocorticoids\n* Individuals with rheumatic disease undergoing treatment with high dose glucocorticoids\n* Planned magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the time of Libre wear\n* Any cognitive or other disorders, in the investigator's opinion, that may interfere with participation or ability to follow the study protocol"}, 'identificationModule': {'nctId': 'NCT04089202', 'briefTitle': 'Diabetes eConsult Non-Inferiority Study', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Comparing Electronic Versus In-Person Access to Specialty Diabetes Expertise', 'orgStudyIdInfo': {'id': 'H-38363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'In-person visit arm', 'description': 'In this arm, patients meeting eligibility criteria and consented into the study are randomized to an in-person visit with an Endocrinologist. This is currently the standard of care for patients referred for diabetes specialty care.\n\nCare by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.\n\nSurveys will be administered to measure patient burden and self efficacy.', 'interventionNames': ['Other: Standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'Freestyle Libre sensor arm', 'description': "In this arm, patients meeting eligibility criteria and consented into the study are randomized to have the Freestyle Libre Pro continuous glucose monitor (CGM) placed at their primary care clinic. The data collected from the diagnostic CGM will be utilized in conjunction with diet, exercise and medication logs provided by the patient and information from the patient's electronic medical record to complete an eConsult with treatment recommendations. Implementation of these recommendations will be per the primary care provider's discretion in conjunction with conversation with the patient in follow up visits.\n\nSurveys will be administered to measure patient burden and self efficacy.", 'interventionNames': ['Other: eConsult']}], 'interventions': [{'name': 'eConsult', 'type': 'OTHER', 'description': 'Completion of electronic consult utilizing data collected from flash glucose monitoring', 'armGroupLabels': ['Freestyle Libre sensor arm']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.', 'armGroupLabels': ['In-person visit arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Devin Steenkamp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center, Endocrinology, Diabetes & Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}