Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT07154251
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003150', 'term': 'Community Health Workers'}], 'ancestors': [{'id': 'D000488', 'term': 'Allied Health Personnel'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm pilot intervention study with use of historic controls'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of meetings with community health worker', 'timeFrame': 'Up to 6 months'}, {'measure': 'Duration in hours/minutes of meetings with community health worker', 'timeFrame': 'Up to 6 months'}], 'primaryOutcomes': [{'measure': 'Change in capillary HbA1c', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months'}, {'measure': 'Change in number of participants who use an automated insulin delivery system with at least 80% time in automated mode over the past 30 days, as measured by download of data from the automated insulin delivery system', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Time in range (70-180 mg/dL) will be assessed over the 30 day increment prior to each study visit'}, {'measure': 'Change in time under 70 mg/dL as measured by continuous glucose monitoring', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Time under 70 mg/dL will be assessed over the 30 day time increment prior to each study visit'}, {'measure': 'Change in time over 250 mg/dL as measured by continuous glucose monitoring', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Time above 250 mg/dL will be assessed over the 30 day increment prior to each study visit'}, {'measure': 'Change in continuous glucose monitor wear time as measured by continuous glucose monitoring', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Wear time will be assessed over the 30 day increment prior to each study visit'}, {'measure': 'Change in time in automated mode as measured by automated insulin delivery system', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Time in automated mode will be assessed over the 30 day increment prior to each study visit.'}, {'measure': 'Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians', 'timeFrame': 'Baseline, 6 months', 'description': 'Description: 25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly'}, {'measure': 'Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale', 'timeFrame': 'Baseline, 6 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': 'Baseline, 6 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': 'Baseline, 6 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, 6 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, 6 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, 6 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, 6 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, 6 months', 'description': '19-item yes/no questionnaire'}, {'measure': 'Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version', 'timeFrame': 'Baseline, 6 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': 'Change in Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale', 'timeFrame': 'Baseline, 6 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': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Automated insulin delivery', 'Community Health Worker', 'Disparities', 'Type 1 Diabetes'], 'conditions': ['Type 1 Diabetes (T1D)']}, 'descriptionModule': {'briefSummary': 'This study uses community health workers (CHW) as diabetes technology coaches for African American children using automated insulin delivery systems but have an HbA1c of 8% or higher. Families will meet with the CHW monthly x 6 months with additional visits as needed. All participants and parents/guardians will fill out questionnaires at the beginning and end of the 6 month intervention in addition to an interview at 6 months. This will be followed by 6 months with no extra help from the CHW, but we will continue to follow CGM and pump download data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported as non-Hispanic Black\n* Clinical diagnosis of type 1 diabetes, requiring treatment with insulin at the time of consent\n* Currently using, or have used within the past 3 months, an automated insulin delivery system (consisting of a continuous glucose monitor and an insulin pump as well as an automated insulin delivery algorithm)\n* Clinical care provided at UH Cleveland Medical Center\n* Has not previously worked with a community health worker for help with diabetes technology\n\nExclusion Criteria:\n\n* Clinical diagnosis of Type 2 or monogenic diabetes\n* Completed high school\n* At least 1 parent/guardian or family support person not willing to participate\n* Non-English speaking guardians\n* Has not used automated insulin delivery within the past 3 months\n* Has previously worked with a CHW for help with diabetes technology\n* Custody of children and family services'}, 'identificationModule': {'nctId': 'NCT07154251', 'acronym': 'CHWs AID Youth', 'briefTitle': 'Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Utilizing a Community Health Worker in the Role of a Diabetes Technology Coach for Black Children Using Automated Insulin Delivery and Not Meeting Glycemic Targets (CHWs AID Youth)', 'orgStudyIdInfo': {'id': 'STUDY20250042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community Health Worker', 'description': 'Community Health Workers will meet with families monthly in the role of a diabetes technology coach, with additional visits as needed.', 'interventionNames': ['Other: Community Health Worker']}], 'interventions': [{'name': 'Community Health Worker', 'type': 'OTHER', 'description': 'Community Health Worker will meet with families monthly (and more often as needed) in the role of a diabetes technology coach', 'armGroupLabels': ['Community Health Worker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wendy Campbell, RN, CDCES', 'role': 'CONTACT', 'email': 'wendy.campbell@uhhospitals.org', 'phone': '216-844-3661'}, {'name': 'Julie Hutter, RN', 'role': 'CONTACT', 'email': 'julie.hutter@uhhospitals.org', 'phone': '216-844-3661'}, {'name': 'Sarah A MacLeish, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Wendy Campbell, RN, CDCES', 'role': 'CONTACT', 'email': 'wendy.campbell@uhhospitals.org', 'phone': '216-844-3661'}, {'name': 'Julie Hutter, RN', 'role': 'CONTACT', 'email': 'julie.hutter@uhhospitals.org', 'phone': '216-844-3661'}], 'overallOfficials': [{'name': 'Sarah A MacLeish, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a pilot study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Sarah A. MacLeish', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}