Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT03877068
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2019-03-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexcom G6 Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'geumpie@emory.edu', 'phone': '404-778-1665', 'title': 'Guillermo E. Umpierrez, MD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected from the time consent to participate was given up to 10 days during hospitalization and up to 10 days after discharge (up to 20 days of monitoring).', 'eventGroups': [{'id': 'EG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.", 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 3, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 2, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Minor bleeding with sensor insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Daily Blood Glucose (BG) Concentration While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '186.8', 'spread': '39', 'groupId': 'OG000'}, {'value': '183.2', 'spread': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'PRIMARY', 'title': 'Percent of Time With BG Between 70-180 mg/dL While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.64', 'spread': '24.25', 'groupId': 'OG000'}, {'value': '54.51', 'spread': '27.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.', 'unitOfMeasure': 'percentage of time in range', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'PRIMARY', 'title': 'Number of Clinically Significant Hypoglycemia Events While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The mean number of clinically significant hypoglycemia events, defined as BG \\<54 mg/dl (3.0mmol/L), per participant is presented here.', 'unitOfMeasure': 'events per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycemia Events While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The mean number of hypoglycemia events, defined as BG \\< 70 (\\<3.9 mmol/L), per participant during hospitalization is presented here.', 'unitOfMeasure': 'events per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'SECONDARY', 'title': 'Number of Nocturnal Hypoglycemia Events While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Severe hypoglycemia', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The mean number of events of nocturnal hypoglycemia per participant are presented here. Nocturnal hypoglycemia occurs between the hours of 12:00 midnight and 6:00 ante meridiem (AM). Hypoglycemia is defined as BG \\< 70 mg/dL (\\<3.9 mmol/L) and severe hypoglycemia is defined as BG \\< 54 mg/dL (\\<3.0 mmol/L).', 'unitOfMeasure': 'events per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'SECONDARY', 'title': 'Percent of Time With Hypoglycemia While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'title': 'Hypoglycemia (BG < 70 mg/dL)', 'categories': [{'measurements': [{'value': '2.15', 'spread': '5.91', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': 'Severe hypoglycemia (BG < 54 mg/dL)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The percentage of time spent with BG below the desired range, during the day and night of hospitalization was assessed. Hypoglycemia is defined as BG \\< 70 mg/dL (\\<3.9 mmol/L) and severe hypoglycemia is defined as BG \\< 54 mg/dL (\\<3.0 mmol/L).', 'unitOfMeasure': 'percentage of time below range', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'SECONDARY', 'title': 'Percent of Time With Hyperglycemia While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'title': 'BG > 180mg/dL', 'categories': [{'measurements': [{'value': '49.21', 'spread': '25.50', 'groupId': 'OG000'}, {'value': '44.80', 'spread': '27.89', 'groupId': 'OG001'}]}]}, {'title': 'BG > 250mg/dL', 'categories': [{'measurements': [{'value': '17.08', 'spread': '17.59', 'groupId': 'OG000'}, {'value': '16.24', 'spread': '19.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The percentage of time above the desired BG range, during the day and night while hospitalized was assessed.', 'unitOfMeasure': 'percentage of time above range', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'SECONDARY', 'title': 'Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.02', 'spread': '39.10', 'groupId': 'OG000'}, {'value': '61.24', 'spread': '32.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard deviation of mean glycemia. It is designed to assess major glucose swings and exclude minor ones.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'SECONDARY', 'title': 'Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}, {'units': 'glucose readings', 'counts': [{'value': '1391', 'groupId': 'OG000'}, {'value': '1345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'title': 'MARD CGM arm vs POC reading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}, {'units': 'glucose readings', 'counts': [{'value': '1391', 'groupId': 'OG000'}, {'value': '1345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.717', 'spread': '11.720', 'groupId': 'OG000'}, {'value': '12.771', 'spread': '12.728', 'groupId': 'OG001'}]}]}, {'title': 'MARD CGM abdomen vs POC reading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}, {'units': 'glucose readings', 'counts': [{'value': '1391', 'groupId': 'OG000'}, {'value': '1345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.414', 'spread': '13.778', 'groupId': 'OG000'}, {'value': '15.670', 'spread': '12.816', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The mean absolute relative difference (MARD) reflects accuracy of the CGM glucose reading compared to the reference POC reading. This is the current standard for assessing accuracy of glucometer readings. Lower MARD indicates smaller differences between the CGM and meter value; a higher MARD value indicates larger differences. A three way and direct head-to-head comparison of data from the abdomen, upper arm and POC BG will be compared.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'glucose readings', 'denomUnitsSelected': 'glucose readings', 'populationDescription': 'This analysis includes participants wearing a CGM device in the indicated bodily location.'}, {'type': 'SECONDARY', 'title': 'Number of Sensor Changes During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'POC Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 CGM System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'Events related to sensor changes (blinded sensor for the POC group or real-time sensor for CGM group), such as removal for procedures or imaging, sensors failures, and sensors dislodgments were recorded.', 'unitOfMeasure': 'count of sensor changes', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.'}, {'type': 'SECONDARY', 'title': 'Mean Daily BG Concentration After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '200.41', 'spread': '55.94', 'groupId': 'OG000'}, {'value': '199.65', 'spread': '45.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the outpatient portion of this study.'}, {'type': 'SECONDARY', 'title': 'Percent of Time With BG Between 70-180 mg/dL After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.42', 'spread': '30.38', 'groupId': 'OG000'}, {'value': '42.66', 'spread': '26.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'Glycemic control after hospital discharge is measured by the percent of time with BG in the range of 70-180 mg/dL.', 'unitOfMeasure': 'percentage of time in range', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the outpatient portion of this study.'}, {'type': 'SECONDARY', 'title': 'Number of Clinically Significant Hypoglycemia Events After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.41', 'spread': '6.28', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'The mean number of clinically significant hypoglycemia events, defined as BG \\<54 mg/dl (3.0mmol/L), during the day and night after hospital discharge, per participant is presented here.', 'unitOfMeasure': 'events per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the outpatient portion of this study.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycemia Events After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.20', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '3.77', 'spread': '3.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'The mean number of hypoglycemia events, defined as BG \\< 70 (\\<3.9 mmol/L), per participant after hospital discharge is presented here.', 'unitOfMeasure': 'events per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the outpatient portion of this study.'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Hypoglycemia After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'title': 'Hypoglycemia (BG < 70 mg/dL)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Severe hypoglycemia (BG < 54 mg/dL)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'Hypoglycemia is defined as BG \\< 70 mg/dL (\\<3.9 mmol/L) and severe hypoglycemia is defined as BG \\< 54 mg/dL (\\<3.0 mmol/L).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the outpatient portion of this study.'}, {'type': 'SECONDARY', 'title': 'Percent of Time With Hyperglycemia After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'title': 'BG > 180mg/dL', 'categories': [{'measurements': [{'value': '52.35', 'spread': '30.57', 'groupId': 'OG000'}, {'value': '54.96', 'spread': '26.52', 'groupId': 'OG001'}]}]}, {'title': 'BG > 250mg/dL', 'categories': [{'measurements': [{'value': '26.29', 'spread': '27.31', 'groupId': 'OG000'}, {'value': '23.03', 'spread': '26.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'The percentage of time above the desired BG range, during the day and night after hospital discharge was assessed.', 'unitOfMeasure': 'percentage of time above range', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the outpatient portion of this study.'}, {'type': 'SECONDARY', 'title': 'Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'OG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.55', 'spread': '23.76', 'groupId': 'OG000'}, {'value': '68.35', 'spread': '46.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard of mean glycemia. It is designed to assess major glucose swings and exclude minor ones', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the outpatient portion of this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'FG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started inpatient portion of the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'Began Optional Outpatient Portion of Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Completed Optional Outpatient Portion of Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'comment': 'Completed inpatient portion of the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Point-of-Care Blood Glucose Monitoring', 'description': "Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team."}, {'id': 'BG001', 'title': 'Dexcom G6 Continuous Glucose Monitoring (CGM) System', 'description': 'Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.32', 'spread': '9.50', 'groupId': 'BG000'}, {'value': '57.24', 'spread': '12.45', 'groupId': 'BG001'}, {'value': '56.29', 'spread': '11.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Black', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Type', 'classes': [{'categories': [{'title': 'Type 1', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Type 2', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline analysis includes participants who completed the inpatient portion of the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-21', 'size': 942482, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-11T16:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-21', 'studyFirstSubmitDate': '2019-03-14', 'resultsFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-21', 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Daily Blood Glucose (BG) Concentration While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.'}, {'measure': 'Percent of Time With BG Between 70-180 mg/dL While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.'}, {'measure': 'Number of Clinically Significant Hypoglycemia Events While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The mean number of clinically significant hypoglycemia events, defined as BG \\<54 mg/dl (3.0mmol/L), per participant is presented here.'}], 'secondaryOutcomes': [{'measure': 'Number of Hypoglycemia Events While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The mean number of hypoglycemia events, defined as BG \\< 70 (\\<3.9 mmol/L), per participant during hospitalization is presented here.'}, {'measure': 'Number of Nocturnal Hypoglycemia Events While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The mean number of events of nocturnal hypoglycemia per participant are presented here. Nocturnal hypoglycemia occurs between the hours of 12:00 midnight and 6:00 ante meridiem (AM). Hypoglycemia is defined as BG \\< 70 mg/dL (\\<3.9 mmol/L) and severe hypoglycemia is defined as BG \\< 54 mg/dL (\\<3.0 mmol/L).'}, {'measure': 'Percent of Time With Hypoglycemia While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The percentage of time spent with BG below the desired range, during the day and night of hospitalization was assessed. Hypoglycemia is defined as BG \\< 70 mg/dL (\\<3.9 mmol/L) and severe hypoglycemia is defined as BG \\< 54 mg/dL (\\<3.0 mmol/L).'}, {'measure': 'Percent of Time With Hyperglycemia While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The percentage of time above the desired BG range, during the day and night while hospitalized was assessed.'}, {'measure': 'Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard deviation of mean glycemia. It is designed to assess major glucose swings and exclude minor ones.'}, {'measure': 'Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'The mean absolute relative difference (MARD) reflects accuracy of the CGM glucose reading compared to the reference POC reading. This is the current standard for assessing accuracy of glucometer readings. Lower MARD indicates smaller differences between the CGM and meter value; a higher MARD value indicates larger differences. A three way and direct head-to-head comparison of data from the abdomen, upper arm and POC BG will be compared.'}, {'measure': 'Number of Sensor Changes During Hospitalization', 'timeFrame': 'During hospitalization (up to 10 days)', 'description': 'Events related to sensor changes (blinded sensor for the POC group or real-time sensor for CGM group), such as removal for procedures or imaging, sensors failures, and sensors dislodgments were recorded.'}, {'measure': 'Mean Daily BG Concentration After Discharge', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.'}, {'measure': 'Percent of Time With BG Between 70-180 mg/dL After Discharge', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'Glycemic control after hospital discharge is measured by the percent of time with BG in the range of 70-180 mg/dL.'}, {'measure': 'Number of Clinically Significant Hypoglycemia Events After Discharge', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'The mean number of clinically significant hypoglycemia events, defined as BG \\<54 mg/dl (3.0mmol/L), during the day and night after hospital discharge, per participant is presented here.'}, {'measure': 'Number of Hypoglycemia Events After Discharge', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'The mean number of hypoglycemia events, defined as BG \\< 70 (\\<3.9 mmol/L), per participant after hospital discharge is presented here.'}, {'measure': 'Count of Participants With Hypoglycemia After Discharge', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'Hypoglycemia is defined as BG \\< 70 mg/dL (\\<3.9 mmol/L) and severe hypoglycemia is defined as BG \\< 54 mg/dL (\\<3.0 mmol/L).'}, {'measure': 'Percent of Time With Hyperglycemia After Discharge', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'The percentage of time above the desired BG range, during the day and night after hospital discharge was assessed.'}, {'measure': 'Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge', 'timeFrame': 'After hospital discharge (up to 10 days)', 'description': 'Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard of mean glycemia. It is designed to assess major glucose swings and exclude minor ones'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Glycemic control', 'Bedside point-of-care capillary glucose monitoring', 'Dexcom', 'Continuous glucose monitoring', 'Hyperglycemia', 'Inpatient'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '35984478', 'type': 'DERIVED', 'citation': 'Spanakis EK, Urrutia A, Galindo RJ, Vellanki P, Migdal AL, Davis G, Fayfman M, Idrees T, Pasquel FJ, Coronado WZ, Albury B, Moreno E, Singh LG, Marcano I, Lizama S, Gothong C, Munir K, Chesney C, Maguire R, Scott WH, Perez-Guzman MC, Cardona S, Peng L, Umpierrez GE. Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2022 Oct 1;45(10):2369-2375. doi: 10.2337/dc22-0716.'}, {'pmid': '32398351', 'type': 'DERIVED', 'citation': 'Spanakis EK, Singh LG, Siddiqui T, Sorkin JD, Notas G, Magee MF, Fink JC, Zhan M, Umpierrez GE. Association of glucose variability at the last day of hospitalization with 30-day readmission in adults with diabetes. BMJ Open Diabetes Res Care. 2020 May;8(1):e000990. doi: 10.1136/bmjdrc-2019-000990.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).', 'detailedDescription': 'Diabetes is reported in 20-34% of hospitalized adult patients in general medicine and surgery units and there is a large body of literature showing a strong association between diabetes and increased hospital mortality and morbidity. Clinical guidelines have recommended the use of basal bolus insulin regimens as the preferred management approach of non-intensive care unit (ICU) patients with diabetes, as it has been shown to be effective in improving glycemic control and reducing hospital complications. However, hypoglycemia is a common adverse event of insulin therapy, with incidence rates ranging between 12% and 35% in randomized studies in non-ICU settings. The development of hypoglycemia, like hyperglycemia, has been associated with higher rates of hospital complications, higher health care resource utilization, and hospital mortality.\n\nBedside point-of-care (POC) capillary glucose monitoring is the standard of care to assess glycemic control in the hospital. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. In contrast to POC testing, continuous glucose monitoring (CGM) measures interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile during 24-hours compared to standard POC glucose testing. The study will assess if CGM represents a better tool to guide healthcare providers in adjusting insulin therapy by providing a more complete 24-hour assessment of glucose values compared to POC testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D.\n\nParticipants will be randomized to have the standard of care POC testing plus wear a sham CGM or to wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days during hospitalization. At the point of hospital discharge, participants with poorly controlled diabetes will be invited to participate in an open label outpatient study where they will wear a Dexcom G6 CGM or sham device for 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females ≥ 18 years admitted to a general medicine or surgical services.\n2. History of T1D or T2D receiving insulin therapy during hospital admission.\n3. Subjects must have a randomization BG \\<400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \\< 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) \\< 7.30, or positive serum or urinary ketones).\n4. Patients with expected hospital length-of-stay of 2 or more day\n\nExclusion Criteria:\n\n1. Patients with acute illness admitted to the ICU or expected to require admission to the ICU.\n2. Patients expected to require MRI procedures during hospitalization.\n3. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).\n4. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.\n5. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.\n6. Coronavirus Disease 2019 (COVID-19) infection'}, 'identificationModule': {'nctId': 'NCT03877068', 'briefTitle': 'Dexcom G6 Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Management of Inpatient Hyperglycemia by Continuous Glucose Monitoring in Insulin-treated Patients With Diabetes: Dexcom G6 Intervention Study', 'orgStudyIdInfo': {'id': 'IRB00107703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexcom G6 CGM - Continues Glucose Monitoring sensor system', 'description': 'Patients will wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days. In addition, patients will undergo POC testing before meals and bedtime per hospital protocol. Insulin therapy will be titrated based on daily CGM printouts, which will include BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Patients will wear a CGM in the current approved insertion site, the abdomen, and in the upper arm.', 'interventionNames': ['Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system', 'Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'POC BG - Point-of-Care Blood Glucose monitoring', 'description': "Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded in the electronic medical record (EMR) system. The research team together with the PCP team will adjust daily insulin orders based on POC readings (standard of care). In addition, patients will wear a 'blinded' CGM where no results will be visualized by patients, nursing staff, primary care physician (PCP) or research teams.", 'interventionNames': ['Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring']}], 'interventions': [{'name': 'Dexcom G6 CGM - Continues Glucose Monitoring sensor system', 'type': 'DEVICE', 'description': 'A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay up to 10 days using the Dexcom Studio software to download the Dexcom receiver data.', 'armGroupLabels': ['Dexcom G6 CGM - Continues Glucose Monitoring sensor system']}, {'name': 'POC BG - Point-of-Care Blood Glucose monitoring', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Standard of Care capillary glucose test'], 'description': 'Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay up to 10 days.', 'armGroupLabels': ['Dexcom G6 CGM - Continues Glucose Monitoring sensor system', 'POC BG - Point-of-Care Blood Glucose monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Health System', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Univeristy of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Guillermo Umpierrez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available for sharing beginning 6 months after publication and ending 5 years after publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in publications for this study (including text, tables, figures, and appendices) will be available for sharing after de-identification.', 'accessCriteria': 'Individual participant data will be made available for sharing with researchers who provide a methodologically sound proposals should email proposals to geumpie@emory.edu. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guillermo Umpierrez', 'investigatorAffiliation': 'Emory University'}}}}