Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT02827669
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2016-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 297}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-10', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a 12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2 diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch in combination with the One Drop app and Experts program, and assess whether this group is more engaged or experiences a different impact as compared to participants who utilized the One Drop app and Experts program only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported Type 2 diabetes diagnosis\n* Has not changed treatment regimen in the last 3 months\n* HbA1c levels ≥ 7.5% by self-report and verified by lab test\n* Motivated to use a daily diabetes self-management coaching program to improve diabetes control\n* Owns and uses an iPhone with a compatible iOS operating system and has successfully downloaded and used a smartphone application previously\n\nExclusion Criteria:\n\n* Current use of a smartphone application to manage their diabetes\n* Currently participating in a diabetes self-management education or coaching program\n* Currently pregnant\n* Does not understand English\n* History of serious mental illness or dementia\n* Has severe diabetic complications such as severe diabetic retinopathy, chronic kidney disease (stages 4-5), severe diabetic neuropathy, diabetic foot ulcer or infection'}, 'identificationModule': {'nctId': 'NCT02827669', 'briefTitle': 'One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evidation Health'}, 'officialTitle': 'One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c', 'orgStudyIdInfo': {'id': 'EH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One Drop Experts Program', 'description': 'Participants will be able to use the One Drop mobile app and One Drop Experts program on their smartphones. The One Drop mobile app is a diabetes management platform that allows users to track and log their blood glucose levels, medications, food, and activities. One Drop Experts is a diabetes education and coaching program delivered entirely through the One Drop mobile application.', 'interventionNames': ['Behavioral: One Drop Experts Program']}, {'type': 'EXPERIMENTAL', 'label': 'One Drop Experts Program + Apple Watch', 'description': 'An Apple Watch will be provided to study participants in this arm. In addition to using the One Drop mobile app and One Drop Experts program on their smartphones, participants will also be able to engage with the app and program on their Apple Watch.', 'interventionNames': ['Behavioral: One Drop Experts Program + Apple Watch']}], 'interventions': [{'name': 'One Drop Experts Program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['One Drop Experts Program']}, {'name': 'One Drop Experts Program + Apple Watch', 'type': 'BEHAVIORAL', 'armGroupLabels': ['One Drop Experts Program + Apple Watch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94401', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Evidation Health', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evidation Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'One Drop', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sr. Director, Health Outcomes Research', 'investigatorFullName': 'Jessie Juusola', 'investigatorAffiliation': 'Evidation Health'}}}}