Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT06074458
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2023-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GO TEAM: Glucose Optimization Through Technology Assisted Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-11-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months'}, {'measure': 'Change in percentage of participants who remain on AID as measured by medical record review', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)', 'timeFrame': '3 months and 12 months', 'description': '4 item measure of acceptability using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree'}, {'measure': 'Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)', 'timeFrame': '3 months and 12 months', 'description': '4 item measure of feasibility using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree'}, {'measure': 'Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)', 'timeFrame': '3 months and 12 months', 'description': '4 item measure of appropriateness using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree'}, {'measure': 'Number of times patient reached out to team as measured by medical record review', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of automatically generated alerts as measured by dashboard/app review', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of alerts as measured by dashboard review', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of phone calls initiated by patients as measured by dashboard review', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of downloads of the app', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of days of patient/family use interaction with the app as measured by dashboard review', 'timeFrame': 'Up to 12 months'}, {'measure': 'Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months'}, {'measure': 'Change in percentage of CGM wear time as measured by CGM data', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months'}, {'measure': 'Change in percentage of participants using an insulin pump as measured by chart review', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months'}, {'measure': 'Change in capillary HbA1c', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months'}, {'measure': 'Change in time in range as measured by continuous glucose monitoring', 'timeFrame': '4 weeks, 6 months, 12 months', 'description': 'Time in range is time glucose is between 70-180 mg/dL'}, {'measure': 'Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring', 'timeFrame': '4 weeks, 6 months, 12 months'}, {'measure': 'Change in time glucose >250 mg/dL as measured by continuous glucose monitoring', 'timeFrame': '4 weeks, 6 months, 12 months'}, {'measure': 'Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents', 'timeFrame': 'Baseline', 'description': '25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly true'}, {'measure': 'Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale', 'timeFrame': '4 weeks, 12 months', 'description': '19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always'}, {'measure': 'Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy', 'timeFrame': '4 weeks, 12 months', 'description': '28-item questionnaire using 5-point Likert scale, where 0 is almost never a problem and 4 is almost always a problem'}, {'measure': 'Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version', 'timeFrame': '4 weeks, 12 months', 'description': '18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree'}, {'measure': 'Change in medical distrust, as measured by the Group Based Medical Distrust Scale', 'timeFrame': 'Baseline, 12 months', 'description': '12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree'}, {'measure': 'Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index', 'timeFrame': 'Baseline, 12 months', 'description': '7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime'}, {'measure': 'Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index', 'timeFrame': 'Baseline, 12 months', 'description': '4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree'}, {'measure': 'Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale', 'timeFrame': 'Baseline, 12 months', 'description': '5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree'}, {'measure': 'Change in barriers to technology as measured by Barriers to Technology Checklist', 'timeFrame': 'Baseline, 12 months', 'description': '19-item yes/no questionnaire'}, {'measure': 'CGM satisfaction as measured by the CGM satisfaction scale', 'timeFrame': '12 months', 'description': '37-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree'}, {'measure': 'Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version', 'timeFrame': '4 weeks, 12 months', 'description': '10-item questionnaire using 6-point Likert scale, where 1 is "very sure I can\'t" and 6 is "very sure I can"'}, {'measure': 'Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale', 'timeFrame': '12 months', 'description': '16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree'}, {'measure': 'Episodes of Diabetic Ketoacidosis as measured by chart review', 'timeFrame': 'up to 12 months', 'description': 'DKA defined as presence of all of the following: 1) blood glucose greater than 250 mg/dL, 2) pH less than 7.3 OR bicarbonate less 15 mEq/L, 3)Moderate or large ketones in urine OR blood ketone \\>3 mmol/L, 4) Requiring treatment within a health care facility.'}, {'measure': 'Episodes of severe hypoglycemia as measured by chart review', 'timeFrame': 'up to 12 months', 'description': 'Unconscious or having a seizure due to hypoglycemia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric', 'Diabetes Technology', 'Disparities'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Black/African American children and young adults with type 1 diabetes are less likely to use diabetes technologies, such as continuous glucose monitors, insulin pumps, and automated insulin delivery systems, compared to White children and young adults. The investigators are working to find ways to make sure that all patients with type 1 diabetes are equally able to use these technologies. The purpose of this study is to find out if a new computer program for the diabetes team, along with a smartphone app (called Glucosano) for patients/parents, as well as a community health worker, are accepted and used by Black/African American patients and parents living with type 1 diabetes, and if this can help decrease racial disparities in the use of diabetes technologies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported as Non-Hispanic Black\n* Clinical diagnosis of T1D requiring treatment with insulin at the time of consent\n* Not currently (within the past 3 months) using an automated insulin delivery system \\\\\n* Willingness to wear a continuous glucose monitor for 10 days at 3 different time points, and willingness to consider use of a personal continuous glucose monitor\n\nExclusion Criteria:\n\n* Clinical diagnosis of Type 2 or monogenic diabetes\n* Completed high school\n* Non-English speaking guardians\n* Automated insulin delivery system use within the past 3 months\n* Custody of children and family services'}, 'identificationModule': {'nctId': 'NCT06074458', 'briefTitle': 'GO TEAM: Glucose Optimization Through Technology Assisted Management', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'GO TEAM INTERVENTION PROTOCOL: GLUCOSE OPTIMIZATION THROUGH TECHNOLOGY ASSISTED MANAGEMENT: Use of a Diabetes Dashboard and Community Health Worker to Decrease Disparities in Technology Use in Pediatric T1D', 'orgStudyIdInfo': {'id': 'Study20230860'}, 'secondaryIdInfos': [{'id': '1R01DK134953', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK134953', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participants in this arm follow standard of care procedures.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetes Dashboard and Community Health Worker', 'description': 'Participants diabetes technology devices will be linked to a remote patient monitoring dashboard and will have access to a Smartphone application, as well as scheduled and as needed visits with a community health worker.', 'interventionNames': ['Other: Glucosano', 'Behavioral: Community Health Worker diabetes technology coach']}], 'interventions': [{'name': 'Glucosano', 'type': 'OTHER', 'description': 'Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application', 'armGroupLabels': ['Diabetes Dashboard and Community Health Worker']}, {'name': 'Community Health Worker diabetes technology coach', 'type': 'BEHAVIORAL', 'description': 'Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits', 'armGroupLabels': ['Diabetes Dashboard and Community Health Worker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie Hutter, RN', 'role': 'CONTACT', 'email': 'julie.hutter@uhhospitals.org', 'phone': '216-844-3661'}, {'name': 'Terri Casey, RN, CDCES', 'role': 'CONTACT', 'email': 'terri.casey@uhhospitals.org', 'phone': '216-844-3627'}, {'name': 'Sarah A MacLeish, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jamie R Wood, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katherine Kutney, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah Ronis, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rebecca Hazen, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Sarah MacLeish, DO', 'role': 'CONTACT', 'email': 'sarah.macleish2@uhhospitals.org', 'phone': '216-844-3661'}, {'name': 'Julie Hutter, RN', 'role': 'CONTACT', 'email': 'julie.hutter@uhhospitals.org', 'phone': '216-844-3661'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarah MacLeish', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'KeborMed', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Sarah MacLeish', 'investigatorAffiliation': 'Case Western Reserve University'}}}}