Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 2:26 AM
Study NCT ID:
NCT04439903
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2020-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pc2jx@virginia.edu', 'phone': '434-924-5592', 'title': 'Patricio Colmegna, PhD', 'organization': 'University of Virginia Center for Diabetes Technology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The Tandem t:connect web application was down for one month due to maintenance work, affecting considerably 4 participants who did not have the opportunity to interact with up-to-date data during a significant part of Phase 2 (system-use phase).\n\nNo data was excluded in computing the outcomes, despite this issue (and the COVID positive case).'}}, 'adverseEventsModule': {'timeFrame': '5 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations.", 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations."}], 'classes': [{'title': 'Burdens_Baseline', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '38.1'}]}]}, {'title': 'Burdens_Post-intervention', 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '51.3'}]}]}, {'title': 'Benefits_Baseline', 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '52.7', 'upperLimit': '68.8'}]}]}, {'title': 'Benefits_Post-intervention', 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '66.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': 'Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are made of 27 items. Responses to the TE questionnaire were collected at week 0 (baseline), and responses to the TA questionnaire at week 5 (post-intervention). Each questionnaire has 5 categories: burdens (14 items), benefits (10 items), ease of use, usefulness, and trustworthiness (last 3, 1 item each). Items are scored on a 5-point Likert scale ranging from 1 to 5 (from strongly disagree to strongly agree for burdens and benefits, and from very poor to excellent for ease of use, usefulness, and trustworthiness). Here we report the results for burdens and benefits. The original 1-to-5 scale is converted to a 0-to-4 scale, the mean scores for burdens and benefits are averaged and then converted into a percentage ranging from 0% to 100%. Higher percentages mean a better outcome for benefits and a worse outcome for burdens.', 'unitOfMeasure': 'percentage of mean item score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations."}], 'classes': [{'title': 'ease-of-use_Baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': 'ease-of-use_Post-intervention', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': 'usefulness_Baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}]}]}, {'title': 'usefulness_Post-intervention', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': 'trustworthiness_Baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}]}]}, {'title': 'trustworthiness_Post-intervention', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': 'Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are made of 27 items. Responses to the TE questionnaire were collected at week 0 (baseline), and responses to the TA questionnaire at week 5 (post-intervention). Each questionnaire has 5 categories: burdens (14 items), benefits (10 items), ease of use, usefulness, and trustworthiness (last 3, 1 item each). Items are scored on a 5-point Likert scale ranging from 1 to 5 (from strongly disagree to strongly agree for burdens and benefits, and from very poor to excellent for ease of use, usefulness, and trustworthiness). Here we report the results for ease of use, usefulness, and trustworthiness of the system. Higher scores mean a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations."}], 'classes': [{'title': 'Total-Diabetes-Distress_Baseline', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.0'}]}]}, {'title': 'Total-Diabetes-Distress_Post-intervention', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '2.4'}]}]}, {'title': 'Emotional-Burden_Baseline', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '3.4'}]}]}, {'title': 'Emotional-Burden_Post-intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.4'}]}]}, {'title': 'Regimen-Distress_Baseline', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.5'}]}]}, {'title': 'Regimen-Distress_Post-intervention', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.3'}]}]}, {'title': 'Interpersonal-Distress_Baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.6'}]}]}, {'title': 'Interpersonal-Distress_Post-intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '2.6'}]}]}, {'title': 'Physician-Distress_Baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1.2'}]}]}, {'title': 'Physician-Distress_Post-intervention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': "The Diabetes Distress Scale (DDS) is a 17-item scale that yields a total diabetes distress score plus 4 subscale scores: Emotional burden (5 items), regimen distress (5 items), interpersonal distress (3 items) and physician distress (4 items). Scores range from 1 to 6 (from Not a problem to A very serious problem). To compute the total diabetes distress score and the 4 subscale scores, participants' responses in each scale are summed and divided by the corresponding number of items. A mean item score lower than 2.0 is considered little or no distress, between 2.0 and 2.9 is considered moderate distress, and higher than 3.0 is considered high distress. Thus, higher scores mean a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Potential Correlation Between System Use and Changes in the Percentage of Time Spent in 70-180 mg/dL Between First Week (Observation) and Following 4 Weeks (Intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '5.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.61532', 'groupIds': ['OG000'], 'paramType': 'Intercept', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.9726', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.8238', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5128', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.68016', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0084', 'estimateComment': 'Predictor variable 1: Number of simulations per participant per week.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.68197', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.15238', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3629', 'estimateComment': 'Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'First Week (Observation) and Following 4 Weeks (Intervention)', 'description': "The percentage of time spent in 70-180 mg/dL (time in range, TIR) is computed per participant on a weekly basis (1 week of observation, 4 weeks of intervention) using glucose sensor data. The higher the TIR the better the glucose control. Percentages during the intervention period are averaged per participant, thus obtaining 2 TIRs for each participant (one Observation TIR and one Intervention TIR). A linear regression analysis is performed to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in TIR between Observation and Intervention periods (response variable).\n\nPredictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.\n\nResponse variable: Intervention TIR - Observation TIR. The higher the response variable the better the outcome.", 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Potential Correlation Between System Use and Changes in Perceived Regimen Distress at Baseline and Week 5 (Post-intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.28789', 'groupIds': ['OG000'], 'paramType': 'Intercept', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.49527', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44535', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.17848', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.16785', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11745', 'estimateComment': 'Predictor variable 1: Number of simulations per participant per week.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.17514', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.06091', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.042266', 'estimateComment': 'Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': "Perceived regimen distress is estimated at Baseline and Week 5 (Post-intervention) using the Diabetes Distress Scale (DDS). Scores range from 1 to 6 (from Not a problem to A very serious problem). Participants' responses to the DSS's regimen distress items are summed and divided by the number of items in that scale. Higher scores mean a worse outcome. Scores at week 5 are compared with scores at baseline and used in a linear regression analysis to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in treatment satisfaction (response variable).\n\nPredictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.\n\nResponse variable: Regimen distress score at week 5 - Regimen distress score at baseline. The higher the response variable the worse.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Potential Correlation Between System Use and Changes in Perceived Emotional Burden at Baseline and Week 5 (Post-intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.934', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.63929', 'groupIds': ['OG000'], 'paramType': 'Intercept', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.28825', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59949', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.37964', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.14422', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1581', 'estimateComment': 'Predictor variable 1: Number of simulations per participant per week.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.26057', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.06718', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.056895', 'estimateComment': 'Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': "Perceived emotional burden is estimated at Baseline and Week 5 (Post-intervention) using the Diabetes Distress Scale (DDS). Scores range from 1 to 6 (from Not a problem to a very serious problem). Participants' responses to the DSS's emotional burden items are summed and divided by the number of items in that scale. Higher scores mean a worse outcome. Scores at week 5 are compared with scores at baseline and used in a linear regression analysis to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in treatment satisfaction (response variable).\n\nPredictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.\n\nResponse variable: Emotional burden score at week 5 - Emotional burden score at baseline.\n\nThe higher the response variable the worse.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Web-based Simulation Tool (WST)', 'description': "Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '35', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1c', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant did not meet inclusion criteria, and 2 participants withdrew for scheduling purposes prior to Hemoglobin A1c measurement.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-22', 'size': 694752, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-17T15:49', 'hasProtocol': True}, {'date': '2020-09-26', 'size': 351587, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-02-10T18:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm, single center, non-randomized, uncontrolled pilot clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2020-06-14', 'resultsFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-28', 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Potential Correlation Between System Use and Changes in the Percentage of Time Spent in 70-180 mg/dL Between First Week (Observation) and Following 4 Weeks (Intervention)', 'timeFrame': 'First Week (Observation) and Following 4 Weeks (Intervention)', 'description': "The percentage of time spent in 70-180 mg/dL (time in range, TIR) is computed per participant on a weekly basis (1 week of observation, 4 weeks of intervention) using glucose sensor data. The higher the TIR the better the glucose control. Percentages during the intervention period are averaged per participant, thus obtaining 2 TIRs for each participant (one Observation TIR and one Intervention TIR). A linear regression analysis is performed to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in TIR between Observation and Intervention periods (response variable).\n\nPredictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.\n\nResponse variable: Intervention TIR - Observation TIR. The higher the response variable the better the outcome."}, {'measure': 'Potential Correlation Between System Use and Changes in Perceived Regimen Distress at Baseline and Week 5 (Post-intervention)', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': "Perceived regimen distress is estimated at Baseline and Week 5 (Post-intervention) using the Diabetes Distress Scale (DDS). Scores range from 1 to 6 (from Not a problem to A very serious problem). Participants' responses to the DSS's regimen distress items are summed and divided by the number of items in that scale. Higher scores mean a worse outcome. Scores at week 5 are compared with scores at baseline and used in a linear regression analysis to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in treatment satisfaction (response variable).\n\nPredictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.\n\nResponse variable: Regimen distress score at week 5 - Regimen distress score at baseline. The higher the response variable the worse."}, {'measure': 'Potential Correlation Between System Use and Changes in Perceived Emotional Burden at Baseline and Week 5 (Post-intervention)', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': "Perceived emotional burden is estimated at Baseline and Week 5 (Post-intervention) using the Diabetes Distress Scale (DDS). Scores range from 1 to 6 (from Not a problem to a very serious problem). Participants' responses to the DSS's emotional burden items are summed and divided by the number of items in that scale. Higher scores mean a worse outcome. Scores at week 5 are compared with scores at baseline and used in a linear regression analysis to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in treatment satisfaction (response variable).\n\nPredictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.\n\nResponse variable: Emotional burden score at week 5 - Emotional burden score at baseline.\n\nThe higher the response variable the worse."}], 'primaryOutcomes': [{'measure': 'Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': 'Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are made of 27 items. Responses to the TE questionnaire were collected at week 0 (baseline), and responses to the TA questionnaire at week 5 (post-intervention). Each questionnaire has 5 categories: burdens (14 items), benefits (10 items), ease of use, usefulness, and trustworthiness (last 3, 1 item each). Items are scored on a 5-point Likert scale ranging from 1 to 5 (from strongly disagree to strongly agree for burdens and benefits, and from very poor to excellent for ease of use, usefulness, and trustworthiness). Here we report the results for burdens and benefits. The original 1-to-5 scale is converted to a 0-to-4 scale, the mean scores for burdens and benefits are averaged and then converted into a percentage ranging from 0% to 100%. Higher percentages mean a better outcome for benefits and a worse outcome for burdens.'}, {'measure': 'Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': 'Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are made of 27 items. Responses to the TE questionnaire were collected at week 0 (baseline), and responses to the TA questionnaire at week 5 (post-intervention). Each questionnaire has 5 categories: burdens (14 items), benefits (10 items), ease of use, usefulness, and trustworthiness (last 3, 1 item each). Items are scored on a 5-point Likert scale ranging from 1 to 5 (from strongly disagree to strongly agree for burdens and benefits, and from very poor to excellent for ease of use, usefulness, and trustworthiness). Here we report the results for ease of use, usefulness, and trustworthiness of the system. Higher scores mean a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)', 'timeFrame': 'Baseline and Week 5 (Post-intervention)', 'description': "The Diabetes Distress Scale (DDS) is a 17-item scale that yields a total diabetes distress score plus 4 subscale scores: Emotional burden (5 items), regimen distress (5 items), interpersonal distress (3 items) and physician distress (4 items). Scores range from 1 to 6 (from Not a problem to A very serious problem). To compute the total diabetes distress score and the 4 subscale scores, participants' responses in each scale are summed and divided by the corresponding number of items. A mean item score lower than 2.0 is considered little or no distress, between 2.0 and 2.9 is considered moderate distress, and higher than 3.0 is considered high distress. Thus, higher scores mean a worse outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Web-based Simulation Tool (WST)', 'Continuous Glucose Monitoring (CGM)', 'Glucose Metabolism Model', 'Insulin Pump'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '36149995', 'type': 'BACKGROUND', 'citation': 'Colmegna P, Bisio A, McFadden R, Wakeman C, Oliveri MC, Nass R, Breton M. Evaluation of a Web-Based Simulation Tool for Self-Management Support in Type 1 Diabetes: A Pilot Study. IEEE J Biomed Health Inform. 2023 Jan;27(1):515-525. doi: 10.1109/JBHI.2022.3209090. Epub 2023 Jan 4.'}, {'pmid': '38662425', 'type': 'RESULT', 'citation': 'Colmegna P, McFadden R, Fabris C, Lobo B, Nass R, Oliveri MC, Brown SA, Kovatchev B. Adaptive Biobehavioral Control: A Pilot Analysis of Human-Machine Coadaptation in Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):644-651. doi: 10.1089/dia.2023.0399. Epub 2024 Apr 30.'}]}, 'descriptionModule': {'briefSummary': "This project focuses on embedding the participants' own diabetes data into state-of-the-art technology platforms to constitute a novel educational simulation interface for decision-support in Type 1 Diabetes (T1D) - the Web-based Simulation Tool (WST).", 'detailedDescription': "The Web-based Simulation Tool (WST) allows patients with Type 1 Diabetes (T1D) to not only visualize their data, but also to explore changes to their meals and insulin parameters, and easily estimate their potential clinical impact. WST is an educational tool, and as such, it does not have prescriptive power. This platform collects glucose, insulin and meal data from the participants' insulin pump, and generates personalized models of their glucose metabolism. Both data collection and model personalization are backend processes, that is, without user intervention.\n\nParticipants can interact with WST through a user interface (UI) that is equipped with a dashboard page, where they can:\n\n(i) select a particular date range using a calendar to visualize their historical glucose control, such as glucose traces, and time in range;\n\n(ii) control the amount of information on the screen - users can show/hide more details, such as glucose variability;\n\n(iii) select different insulin therapy parameters: basal rate, insulin sensitivity factor, and carbohydrate ratio;\n\n(iv) change their values by moving a slider;\n\n(v) select informed meals within the selected date range, and modify their time and size by moving a slider;\n\n(vi) run a simulation with the modified insulin therapy parameters and meals by tapping a button;\n\n(vii) save the insulin and meal settings of the simulations to compare multiple configurations; and\n\n(viii) generate a report from the selected simulation, comparing both original and simulated or replay data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥21 and ≤65 years old at time of consent.\n* Clinical diagnosis, based on investigator assessment, of T1D for at least one year.\n* Using insulin for at least 1 year prior to study enrollment.\n* Using an insulin pump for at least 6 months prior to study enrollment.\n* Currently using a CGM for at least 6 months.\n* Willingness to use a Dexcom G6 CGM during the study; a study Dexcom CGM will be provided if needed.\n* Current user of the Tandem t:slim X2 insulin pump.\n* Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.\n* Total daily insulin (TDI) dose at least 10 U/day.\n* HbA1c ≤9.0% at screening; if HbA1c \\<6.0%, then TDI must be ≥ 0.5 U/kg.\n* Having access to internet (Wi-Fi or 3G, 4G, 5G, or similar).\n* Willingness to interact with a computer program.\n* An understanding of and willingness to follow the protocol and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Participants who are not able to read and complete questionnaires on the computer or interact with a program for which they will be trained because of language, reading, or cognitive issues.\n* Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.\n* History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist and not currently on a seizure medication.\n* Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures.\n* If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.\n* A known medical condition that in the judgment of the investigator might interfere with the completion of the study.\\*\n* Abuse of alcohol or recreational drugs.\n* Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, etc).\n* Uncontrolled arterial hypertension (resting diastolic blood pressure \\>90 mmHg and/or systolic blood pressure \\>160 mmHg).\n* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.\n* Current use of the following drugs and supplements:\n\n * Any drug other than insulin to treat diabetes.\n * Any other medication that according to the investigator's criteria is a contraindication for the subject's participation.\n\n * Note: The software implementation, in the current development status, is designed to interact with subjects with T1D that only use insulin for diabetes treatment and do not present any comorbidity related to diabetes."}, 'identificationModule': {'nctId': 'NCT04439903', 'acronym': 'WST', 'briefTitle': 'Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '200157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Web-based Simulation Tool (WST)', 'interventionNames': ['Other: Web-based Simulation Tool']}], 'interventions': [{'name': 'Web-based Simulation Tool', 'type': 'OTHER', 'description': "Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations.", 'armGroupLabels': ['Web-based Simulation Tool (WST)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia - Center for Diabetes Technology', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Patricio Colmegna, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia, Center for Diabetes Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}, {'name': 'Tandem Diabetes Care, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Boris Kovatchev, PhD', 'investigatorAffiliation': 'University of Virginia'}}}}