Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT02496156
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2015-04-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Shared Medical Decision Making in Pediatric Diabetes
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': 'vfunanag@nemours.org', 'phone': '302-651-6819', 'title': 'Vicky Funanage, PhD, Operational Vice President for Research', 'organization': "Nemours Children's Health System"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A small percentage of all adolescents entering the study actually proceeded to acquire an insulin pump or continuous glucose monitor during the study period, impeding analyses of the effects of the SDM intervention on scores on the CGM Use Profile'}}, 'adverseEventsModule': {'timeFrame': 'Each participant was monitored for study-related and unanticipated adverse events for 1 year during study participation.', 'description': "This trial was educational in nature and the intervention did nothing more than to expose adolescents and parents to the best available information pertinent to deciding whether or not to adopt an insulin pump or continuous glucose monitor as a component of the adolescent's diabetes regimen. The trial was considered by the IRB to pose no greater than minimal risk to participants.", 'eventGroups': [{'id': 'EG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that was received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision is reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.'}, {'id': 'OG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision is reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.'}], 'classes': [{'title': 'Visit 2-Adolescents', 'categories': [{'measurements': [{'value': '32.5', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2-Parents', 'categories': [{'measurements': [{'value': '40.1', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3-Adolescents', 'categories': [{'measurements': [{'value': '33.8', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Visit Visit 3-Parents', 'categories': [{'measurements': [{'value': '30.2', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '35.1', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4-Adolescents', 'categories': [{'measurements': [{'value': '33.7', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4-Parents', 'categories': [{'measurements': [{'value': '34.6', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5-Adolescents', 'categories': [{'measurements': [{'value': '33.3', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5-Parents', 'categories': [{'measurements': [{'value': '34.4', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.39', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is a computed p-value.', 'groupDescription': 'Missing data treatment was done using multiple imputation methods when data were determined to be Missing Completely at Random or Missing at Random. Assumptions underlying each statistical test were evaluated before proceeding with specific analyses.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit."}], 'paramType': 'MEAN', 'timeFrame': 'Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump', 'description': "Adolescent and Parent report regarding degree to which use of the device of interest has become an integral part of the adolescent's daily diabetes self management. Scores may range from 10 to 50, with higher scores reflecting more frequent and meticulous use of the diabetes device of interest.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population of interest consists of adolescents with type 1 diabetes and their parents who are considered to be candidates for adoption of either the insulin pump or continuous glucose monitor as a component of their diabetes management regimens.'}, {'type': 'SECONDARY', 'title': 'Glycated Hemoglobin (Hemoglobin A1C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.'}, {'id': 'OG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision is reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.'}], 'classes': [{'title': 'Visit 1', 'categories': [{'measurements': [{'value': '8.61', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '8.53', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2', 'categories': [{'measurements': [{'value': '8.54', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '8.24', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3', 'categories': [{'measurements': [{'value': '8.80', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '8.55', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '9.24', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '8.59', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '8.69', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '8.83', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Computed p-value exceeded the .05 level of significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit."}], 'paramType': 'MEAN', 'timeFrame': 'Every 3 months for for 1 year', 'description': 'Glycated hemoglobin (Hemoglobin A1C) expressed as the percentage of hemoglobin molecules that are bound to glucose. Normal range is approximately 4.5% to 6.5%, Higher values indicate a higher blood glucose concentration over the preceding 2-3 months.', 'unitOfMeasure': 'percentage (HbA1c)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents with type 1 diabetes and their parents who are considered by their attending diabetes care providers to be candidates for incorporation of the insulin pump or continuous glucose monitoring into their treatment regimens.'}, {'type': 'SECONDARY', 'title': 'Decision Regret Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.'}, {'id': 'OG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision is reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.'}], 'classes': [{'title': 'Visit 3', 'categories': [{'measurements': [{'value': '9.14', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '9.85', 'spread': '4.07', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '8.69', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '8.53', 'spread': '3.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is a computed p-value.', 'groupDescription': 'See description of analysis below.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit."}], 'paramType': 'MEAN', 'timeFrame': 'Obtained at Visits 3 and 5 only', 'description': 'Questionnaire measuring decision making regret. Reflecting on a specific decision (accept or decline opportunity to use CGM or insulin pump), higher score reflect a greater degree of regret regarding the decision that was made. Scores may range from 5 to 20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents with type 1 diabetes and their parents who are considered by their diabetes care providers to be candidates for incorporation of insulin pump or CGM into their treatment regimens.'}, {'type': 'SECONDARY', 'title': 'Knowledge of Insulin Pump or Continuous Glucose Monitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.'}, {'id': 'OG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision is reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.'}], 'classes': [{'title': 'Visit 1', 'categories': [{'measurements': [{'value': '2.86', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2', 'categories': [{'measurements': [{'value': '3.14', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Computed p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in post-test scores with baseline Knowledge test score as the covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months later', 'description': 'Brief test of parent and adolescent knowledge about the pertinent device and its use. Higher scores reflect more precise knowledge about the diabetes device of interest. Scores may range from 1 to 5.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents with T1D and their parents considering adoption of CSII or CGM.'}, {'type': 'SECONDARY', 'title': 'Diabetes Self Management Profile Self Report Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.'}, {'id': 'OG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision is reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.'}], 'classes': [{'title': 'Visit 1', 'categories': [{'measurements': [{'value': '55.03', 'spread': '10.66', 'groupId': 'OG000'}, {'value': '56.19', 'spread': '10.03', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3', 'categories': [{'measurements': [{'value': '55.91', 'spread': '10.83', 'groupId': 'OG000'}, {'value': '56.25', 'spread': '11.17', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '56.08', 'spread': '11.98', 'groupId': 'OG000'}, {'value': '54.14', 'spread': '12.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visits 1, 3 and 5', 'description': 'Composite measure of diabetes treatment adherence consisting of combined scores based on reports of parents and adolescents. Higher scores reflect more meticulous adherence to recommended diabetes self management behaviors. Scores may range from 0 to 86.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents with T1D and parents considering adoption of CSII or CGM.'}, {'type': 'SECONDARY', 'title': 'SURE Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.'}, {'id': 'OG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision is reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.'}], 'classes': [{'title': 'Visit 3', 'categories': [{'measurements': [{'value': '3.43', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '3.74', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '3.70', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '3.73', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Computed p-value', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'See analysis description below.', 'otherAnalysisDescription': "For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit."}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Follow-up Visits 3 and 5 only', 'description': "4-item questionnaire that measures patients' confidence in a health care decision that has been made. Scores may range from 0-4 with higher scores reflecting greater confidence in the decision made regarding insulin pump or CGM.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents with T1D and parents considering adoption of CSII or CGM.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who are not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.'}, {'id': 'FG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump, CGM or both). Adolescents and parents received password-protected, secure access to the decision for their use until a decision was reached. The platform generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '67', 'numSubjects': '67'}, {'groupId': 'FG001', 'numUnits': '66', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '62', 'numSubjects': '62'}, {'groupId': 'FG001', 'numUnits': '53', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '5'}, {'groupId': 'FG001', 'numUnits': '13', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '13SDM dyads did not access Decision Aids', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'typeUnitsAnalyzed': 'Adolescent-Parent dyads', 'recruitmentDetails': "Recruitment occurred from 2015-2017 at all locations of Nemours Children's Health System (Wilmington, DE, Philadelphia, PA and Jacksonville, Orlando and Pensacola, FL. In 2017, the Barbara Davis Center for Childhood Diabetes in Denver was added as a performance site.", 'preAssignmentDetails': 'Of the 153 adolescent-parent dyads who provided consent/assent, 20 dyads did not complete all required baseline measures and were not randomized. 133 dyads were randomized to Usual Clinical Practice or Shared Decision Making.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.\n\nUsual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.'}, {'id': 'BG001', 'title': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision was reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.\n\nShared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '13.5', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '13.7', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hollingshead Four Factor Index of Social Status', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '44.9', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Hollingshead Index of Social Status provides an overall estimate of household socioeconomic status based on parents' categorizations of each parent's educational attainment and occupational category. Scores may range from 16 to 66, with higher scores indicative of higher educational attainment and occupational status.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rapid Estimate of Adult/Adolescent Literacy in Medicine', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '3.44', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '4.93', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '3.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is a brief practical test of health literacy consisting of comprehension of health-related vocabulary terms. Higher scores indicate more proficient health literacy. Scores may range from 15 to 75.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes Numeracy Test', 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '2.48', 'groupId': 'BG000'}, {'value': '11.0', 'spread': '3.41', 'groupId': 'BG001'}, {'value': '10.7', 'spread': '2.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "This is a brief practical assessment of one's health-related quantitative skills based on reading and comprehension of food labels and medication labels. Higher scores indicate stronger health numeracy skills. Scores may range from 0 to 15.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CGM/Insulin Pump Knowledge Test', 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '5.34', 'groupId': 'BG000'}, {'value': '41.29', 'spread': '5.09', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '5.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'These are brief tests of parent and adolescent knowledge of continuous glucose monitors and insulin pumps, respectively. Scores may range from 15-45 with higher scores reflecting greater knowledge of the diabetes device of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1C', 'classes': [{'categories': [{'measurements': [{'value': '8.61', 'spread': '1.29', 'groupId': 'BG000'}, {'value': '8.53', 'spread': '1.49', 'groupId': 'BG001'}, {'value': '8.58', 'spread': '1.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c expressed as a percentage of hemoglobin molecules that are bound to glucose molecules. Higher values reflect increasingly high average blood glucose levels over the prior 2-3 months. Normal range is 4.5% to 6.5%.', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The population of interest consists of adolescents with type 1 diabetes and their parents who are considered by their attending diabetes care provider to be candidates for incorporation of either the insulin pump or continuous glucose monitoring into their diabetes treatment regimens.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-28', 'size': 16139038, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-22T16:19', 'hasProtocol': True}, {'date': '2016-11-07', 'size': 234190, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-10-29T10:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 group (Usual Clinical Practice or Shared Medical Decision Making X 5 time points (0, 3, 6, 9 and 12 months) repeated measures randomized treatments design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2015-04-23', 'resultsFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2015-07-13', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-25', 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile', 'timeFrame': 'Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump', 'description': "Adolescent and Parent report regarding degree to which use of the device of interest has become an integral part of the adolescent's daily diabetes self management. Scores may range from 10 to 50, with higher scores reflecting more frequent and meticulous use of the diabetes device of interest."}], 'secondaryOutcomes': [{'measure': 'Glycated Hemoglobin (Hemoglobin A1C)', 'timeFrame': 'Every 3 months for for 1 year', 'description': 'Glycated hemoglobin (Hemoglobin A1C) expressed as the percentage of hemoglobin molecules that are bound to glucose. Normal range is approximately 4.5% to 6.5%, Higher values indicate a higher blood glucose concentration over the preceding 2-3 months.'}, {'measure': 'Decision Regret Scale', 'timeFrame': 'Obtained at Visits 3 and 5 only', 'description': 'Questionnaire measuring decision making regret. Reflecting on a specific decision (accept or decline opportunity to use CGM or insulin pump), higher score reflect a greater degree of regret regarding the decision that was made. Scores may range from 5 to 20.'}, {'measure': 'Knowledge of Insulin Pump or Continuous Glucose Monitor', 'timeFrame': 'Baseline and 3 months later', 'description': 'Brief test of parent and adolescent knowledge about the pertinent device and its use. Higher scores reflect more precise knowledge about the diabetes device of interest. Scores may range from 1 to 5.'}, {'measure': 'Diabetes Self Management Profile Self Report Form', 'timeFrame': 'Visits 1, 3 and 5', 'description': 'Composite measure of diabetes treatment adherence consisting of combined scores based on reports of parents and adolescents. Higher scores reflect more meticulous adherence to recommended diabetes self management behaviors. Scores may range from 0 to 86.'}, {'measure': 'SURE Test', 'timeFrame': 'Measured at Follow-up Visits 3 and 5 only', 'description': "4-item questionnaire that measures patients' confidence in a health care decision that has been made. Scores may range from 0-4 with higher scores reflecting greater confidence in the decision made regarding insulin pump or CGM."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 1 diabetes mellitus', 'adolescence', 'adherence', 'insulin pump', 'continuous subcutaneous insulin infusion', 'continuous glucose monitor', 'shared medical decision making'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '27150606', 'type': 'BACKGROUND', 'citation': 'Wysocki T, Hirschfeld F, Miller L, Izenberg N, Dowshen SA, Taylor A, Milkes A, Shinseki MT, Bejarano C, Kozikowski C, Kowal K, Starr-Ashton P, Ross JL, Kummer M, Carakushansky M, Lyness D, Brinkman W, Pierce J, Fiks A, Christofferson J, Rafalko J, Lawson ML. Consideration of Insulin Pumps or Continuous Glucose Monitors by Adolescents With Type 1 Diabetes and Their Parents: Stakeholder Engagement in the Design of Web-Based Decision Aids. Diabetes Educ. 2016 Aug;42(4):395-407. doi: 10.1177/0145721716647492. Epub 2016 May 4.'}]}, 'descriptionModule': {'briefSummary': "This work is testing a shared medical decision making intervention for adolescents with type 1 diabetes and their parents who are candidates for adding either an insulin pump or continuous glucose monitor to their treatment plan. The first half of the work consisted of the stakeholder driven design, construction and refinement of web-delivered multimedia decision aids for each of these decisions. The randomized controlled trial of that intervention began enroling participants in February 2015. A sample of 166 eligible adolescents who receive care at an operating entity of the Nemours Children's Health System will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the Shared Medical Decision Making intervention. Primary outcomes include measures of engagement with the pertinent technology if it is chosen and measures of decision quality; Secondary outcomes include indices of metabolic control, quality of life and parent-adolescent relationships around diabetes management.", 'detailedDescription': 'Abstract (modified after achievement of Aims 1 and 2):\n\nTreatment adherence in type 1 diabetes (T1D) tends to decline among adolescents, increasing risks of acute and chronic complications, excess health care use, poorer quality of life, and T1D-related family conflict. Poor adherence is associated with psychiatric and family dysfunction and often persists into early adulthood. Therapeutic advances such as continuous subcutaneous insulin infusion (CSII or "insulin pump") and continuous glucose monitoring (CGM) could improve metabolic control and quality of life.\n\nBut, teens often do not benefit fully from such advances. Many studies of adults show that patient-centered communication styles predict more favorable clinical outcomes. Shared medical decision making (SMDM) interventions have improved outcomes among adults with diabetes and other conditions. Research in pediatrics has also shown that patient-centered and family-centered communication styles predict favorable outcomes, but most of this research is in primary care and has not studied youth with chronic conditions. Since there have been no controlled trials of SMDM with chronically ill youths, we propose a randomized controlled trial of an SMDM intervention compared with Usual Clinical Practice (UCP). Qualitative interviews of youths and parents who have previously faced these decisions and reliance on expert consultants, pediatric endocrinologists and diabetes educators have preceded this trial and provided valued input for refining the planned intervention and adapting the structured SMDM format for pediatrics. Now, we will recruit and randomize 166 11-\\<17 year old youth with T1D who are candidates for CSII or CGM (and a parent/caregiver) at all Nemours sites. The SMDM intervention will be delivered via a web-based platform, facilitated by Diabetes Educators (DEs) at each site in a standardized, yet individually tailored format. SMDM will employ multimedia "decision aids" prepared with the award-winning Nemours Center for Children\'s Health Media and the "e-city interactive" web design firm in Philadelphia in accord with pertinent international standards. SMDM will also include individualized assistance from the DE in assuring that each youth\'s and parent\'s preferences, values and cultural beliefs are carefully addressed and communicated to the attending endocrinologist. After a baseline evaluation and randomization to SMDM or UCP, effects on the primary outcome (treatment adherence; device utilization) and secondary outcomes (glycemic control, treatment alliance, decision conflict and regret, treatment satisfaction, diabetes-related distress and self-efficacy) will be measured over 1 year. Mixed effects modeling will be the primary analytic technique for evaluating effects on primary/secondary outcomes, examining selected variables as moderators and mediators of treatment effects, and assessing whether such effects are comparable for the two medical decisions of interest. The results will verify whether SMDM in this context enhances treatment adherence, device use and parent/patient-reported outcomes in youth with T1D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 1 diabetes for 1 year or more\n* At least 2 diabetes clinic visits at the enrolling site in the prior year\n* Considered by treating endocrinologist to be a candidate for insulin pump or continuous glucose monitor\n* Intent to continue care at Nemours for 1 year\n* Internet access at home, school, work or relative's home\n\nExclusion Criteria:\n\n* Open case with child protection agency\n* Unable to read and speak English"}, 'identificationModule': {'nctId': 'NCT02496156', 'briefTitle': 'Shared Medical Decision Making in Pediatric Diabetes', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Shared Medical Decision Making in Pediatric Diabetes', 'orgStudyIdInfo': {'id': 'PCORI 805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Clinical Practice (UCP)', 'description': 'UCP participants will receive the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who are not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.', 'interventionNames': ['Behavioral: Usual Clinical Practice']}, {'type': 'EXPERIMENTAL', 'label': 'Shared Medical Decision Making (SMDM)', 'description': 'Participants randomized to SMDM receive all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents will receive password-protected, secure access to the decision for their use until a decision is reached. The platform will then generate a summary report that the adolescent and parent will discuss with a diabetes nurse and then a visit with the treating endocrinologist will be scheduled to conclude the SMDM intervention for that adolescent and parent.', 'interventionNames': ['Behavioral: Shared Medical Decision Making']}], 'interventions': [{'name': 'Usual Clinical Practice', 'type': 'BEHAVIORAL', 'description': 'Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.', 'armGroupLabels': ['Usual Clinical Practice (UCP)']}, {'name': 'Shared Medical Decision Making', 'type': 'BEHAVIORAL', 'description': 'Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.', 'armGroupLabels': ['Shared Medical Decision Making (SMDM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Tim Wysocki, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nemours Biomedical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}