Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
Study NCT ID:
NCT04210128
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2019-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2019-12-20', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severe hyperglycemia', 'timeFrame': '1 year', 'description': 'glucose \\> 400 mg/dL for over 3 contiguous hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucose Monitoring', '19-315'], 'conditions': ['Breast Cancer', 'Pancreatic Cancer', 'Diabetes', 'Pre Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if continuous glucose monitoring can identify how often people who have pre-diabetes or medical obesity or well-controlled diabetes experience very high glucose values while receiving chemotherapy for breast cancer or pancreatic.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited through the breast and gastrointestinal (GI) medicine oncology clinics at MSKCC.', 'genderDescription': 'Breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient aged 18 or older undergoing neoadjuvant chemotherapy regimens including taxane and/or anthracycline for breast cancer.\n* Patient aged 18 or older undergoing any chemotherapy regimen for pancreatic cancer\n* Have 'high metabolic risk(either pre-diabetes, obesity, or well-controlled diabetes) defined as either:\n\n * Pre-diabetes and/or obesity group: one or more of known HbA1c 5.7-6.5%, fasting glucose \\> 100 mg/dL, or BMI \\> 30\n * Well-controlled diabetes: Known HbA1c \\< 7.5 on lifestyle alone or up to one oral antidiabetic agent\n * Any patient undergoing treatment for pancreatic adenocarcinoma on either no antidiabetic agent or up to one oral antidiabetic agent\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes, a history of hospitalization for either hyperglycemia or ketoacidosis, a history of hypoglycemia requiring hospitalization, rashes or other skin reactions that would preclude placement of the CGM\n* Use of anticoagulants or antiplatelet agents other than aspirin\n* Platelet count \\< 50 K/μL within 60 days prior to enrollment."}, 'identificationModule': {'nctId': 'NCT04210128', 'briefTitle': 'Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Continuous Glucose Monitoring For Prediction and Treatment of Steroid-Induced Hyperglycemia', 'orgStudyIdInfo': {'id': '19-315'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients', 'description': 'A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of breast neoadjuvant chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.'}, {'label': 'Pancreatic cancer patients', 'description': 'A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of pancreatic chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'James Flory, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}