Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-31 @ 5:39 AM
Study NCT ID:
NCT04874532
Status:
SUSPENDED
Last Update Posted:
2025-04-04
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-18', 'size': 330122, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-16T13:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'whyStopped': 'Unable to deliver the intervention due to program staffing.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes Self-Management', 'timeFrame': 'Baseline, 1 month, 4 months', 'description': 'Change in Diabetes Self-Management Questionnaire (DSMQ) score'}], 'secondaryOutcomes': [{'measure': 'Self-reported hypoglycemia', 'timeFrame': 'Baseline, 1 month, 4 months', 'description': 'Self-reported level 1 and level 2 hypoglycemia'}, {'measure': 'Health-related Quality of life (EQ-5D)', 'timeFrame': 'Baseline, 1 month, 4 months', 'description': 'Change in EQ-5D score'}, {'measure': 'Diabetes distress', 'timeFrame': 'Baseline, 1 month, 4 months', 'description': 'Change in the Diabetes Distress Scale'}, {'measure': 'Glycemic control', 'timeFrame': 'Baseline, 4 months', 'description': 'Hemoglobin A1c level'}, {'measure': 'Qualitative experience with hypoglycemia and its prevention', 'timeFrame': 'Baseline (one-time interview only)', 'description': 'Eligible individuals who decline participation in the D-REM trial will be offered participation in a one-time interview conducted via audio technology to understand their experiences with hypoglycemia and its prevention. These interviews will be qualitatively analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Hypoglycemia', 'Diabetes Type 1', 'Diabetes Type 2']}, 'referencesModule': {'references': [{'pmid': '40489473', 'type': 'DERIVED', 'citation': 'Bhagra S, Ducharme-Smith AL, Juntunen MB, Liedl CP, Golembiewski EH, Sundt WJ, Krpata TS, Lampman MA, Espinoza AL, McCoy RR. Diabetes rescue, engagement, and management (D-REM) for hypoglycemia: Clinical trial protocol of a community paramedic program to improve diabetes management among adults with severe hypoglycemia. PLoS One. 2025 Jun 9;20(6):e0322177. doi: 10.1371/journal.pone.0322177. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will assess the feasibility, preliminary efficacy, and acceptability of the Diabetes-REM (Rescue, Engagement, and Management), a comprehensive patient-centered intervention delivered by community paramedics in the community setting to improve diabetes self-management, prevent recurrent hypoglycemia, reduce diabetes distress, and improve quality of life among adults in southeast Minnesota who have experienced severe hypoglycemia.', 'detailedDescription': "Severe hypoglycemia in the management of diabetes is associated with high morbidity, mortality, psychological distress, and impaired quality of life. Recognizing, actively engaging, and providing comprehensive care to at-risk patients to address hypoglycemia risk factors and enhance diabetes self-management skills may help reduce the frequency/severity of hypoglycemic events, alleviate diabetes distress, and improve quality of life.\n\nThis study will assess the feasibility, preliminary efficacy, and acceptability of Diabetes-REM (Rescue, Engagement, and Management) to improve diabetes self-management among adults in southeast Minnesota who have experienced severe hypoglycemia. The D-REM program is a one month long intervention delivered by community paramedics at the patient's home. Community paramedics are trained in disease prevention, management, and wellness in addition to emergency response.\n\nUsing a two-group parallel design, 150 adults will be randomly assigned to 1 month of Diabetes-REM or usual care. Both groups will receive education materials on hypoglycemia/diabetes and clinical/community resources. One group, comprised of 75 patients, will also be cared for by community paramedics at no cost to them. Study measures will include surveys (completed by participants in both arms) and an interview (completed by a subset of participants in the arm receiving community paramedic support).\n\nEligible individuals who decline participation in the D-REM trial will then be offered participation in a one-time interview conducted via audio technology to understand their experiences with hypoglycemia and its prevention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years of age or older.\n* Experience of level 3 hypoglycemia\n* Type 1 or type 2 diabetes.\n* Paneled to a Mayo Clinic or Mayo Clinic Health System practice.\n* Able to provide informed consent.\n* Community-dwelling in either Freeborn, Mower, Olmsted, Steele, or Wabasha county.\n\nIdentifying patients who experienced level 3 hypoglycemia:\n\n1. Treated by Mayo Clinic Ambulance for hypoglycemia\n2. Treated in Mayo Clinic ED or hospital for hypoglycemia.\n3. Patients who have a diagnosis of hypoglycemia on their electronic health record problem list.\n4. Patients who experienced level 3 hypoglycemia and are referred to the community paramedic service by their healthcare provider.\n\nExclusion Criteria:\n\n* Under 18 years of age.\n* Cognitive impairment precluding informed consent.\n* Lack of conversational English skills.\n* Residency in a long-term care facility.\n* Enrolled in hospice.\n* Enrolled in a care coordination or disease management program.\n* Advanced or terminal illness.'}, 'identificationModule': {'nctId': 'NCT04874532', 'briefTitle': 'A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Community Paramedicine Program to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia', 'orgStudyIdInfo': {'id': '20-006799'}, 'secondaryIdInfos': [{'id': 'R03DK127010', 'link': 'https://reporter.nih.gov/quickSearch/R03DK127010', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community Paramedic (CP) program and Education Materials', 'description': 'Subjects will receive CP home visits and telephone calls for 1 month, along with printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.', 'interventionNames': ['Other: Community Paramedic Program', 'Other: Education Material']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care and Education Materials', 'description': 'Subjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.', 'interventionNames': ['Other: Education Material']}], 'interventions': [{'name': 'Community Paramedic Program', 'type': 'OTHER', 'description': 'Patients will be seen for a 1-hr in person evaluation and follow-up will be determined on an individual basis based on patient need. During each visit, CPs will perform health status and social determinants of health assessments, physical exam, medication review/counseling, and goal setting/review.', 'armGroupLabels': ['Community Paramedic (CP) program and Education Materials']}, {'name': 'Education Material', 'type': 'OTHER', 'description': 'Participants will be provided with a diabetes resource card, which will provide a list of clinic and community-based diabetes resources, along with a diabetes education packet, which will include information on diabetes self-management, healthy diet, physical activity, glucose self-monitoring, and hypoglycemia.', 'armGroupLabels': ['Community Paramedic (CP) program and Education Materials', 'Usual Care and Education Materials']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Rozalina G McCoy, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rozalina G. McCoy', 'investigatorAffiliation': 'Mayo Clinic'}}}}