Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT04016558
Status:
COMPLETED
Last Update Posted:
2025-10-28
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
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': 'danielle.hessler@ucsf.edu', 'phone': '415-476-6196', 'title': 'Danielle Hessler', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time of consent/baseline to 12 month follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 0, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 0, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diabetes Distress at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.34', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '0.077', 'groupId': 'OG001'}, {'value': '2.06', 'spread': '0.079', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.007', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Self-reported diabetes distress across several domains will be assessed using the Type 1 Diabetes Distress Scale (T1-DDS) a validated measure averaged across items (range 1.0-6.0 with higher scores indicating a higher level of diabetes-related distress).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hemoglobin A1c (HbA1c) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.52', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '7.60', 'spread': '0.098', 'groupId': 'OG001'}, {'value': '7.94', 'spread': '0.101', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.006', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Hemoglobin A1c (HbA1c) assay laboratory result', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypoglycemic Episodes at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '1.66', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '1.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Self-reported number of severe of hypoglycemic episodes in the past 6 months, or since the last assessment. A numeric count is reported, zero indicates no hypoglycemic episodes, and a higher number indicates more hypoglycemic episodes.', 'unitOfMeasure': 'hypoglycemic episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression Symptoms at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.35', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '5.94', 'spread': '4.54', 'groupId': 'OG001'}, {'value': '7.09', 'spread': '5.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Symptoms of depression will be measured using the self-completion Patient Health Questionnaire (PHQ-8). The score ranges from zero to 24 with a higher score indicating more symptoms of depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Missed Insulin Boluses at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.40', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Self-reported number of missed or skipped insulin boluses in the past week', 'unitOfMeasure': 'percentage of insulin boluses skipped', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nonreactivity to Inner Experience at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.68', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '24.34', 'spread': '5.18', 'groupId': 'OG001'}, {'value': '24.22', 'spread': '5.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Nonreactivity to inner experience will be assessed by the nonreactivity sub-scale of the Five Facet Mindfulness Questionnaire. Items are scored from 1-5 with items summed to calculate a total scale score. The total score ranges from 7-35. Higher scores indicate greater nonreactivity to inner emotional experiences.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-judging of Experience at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.29', 'spread': '7.55', 'groupId': 'OG000'}, {'value': '32.13', 'spread': '5.90', 'groupId': 'OG001'}, {'value': '30.48', 'spread': '6.99', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.12', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.65', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Non-judging of experience will be assessed by the nonjudgmental subscale of the Five Facet Mindfulness Questionnaire. Individual items are scored on a 1-5 scale and then summed to calculate a scale score with higher scores indicating greater non-judging of emotional experience. The total score ranges from 8-40.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Personal Control Over Illness at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.77', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '24.68', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '24.99', 'spread': '2.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.39', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': "The personal control subscale from the Revised Illness Perception Questionnaire will assess participants' perceived control over their illness. The items are scored on a 1-5 scale and summed across items for a total score with higher scores indicating greater personal control. The total score ranges from 6-30.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-compassion - Diabetes (SCS-D) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'OG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'OG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.42', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '3.44', 'spread': '0.94', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Diabetes-specific self-compassion will be measured using the validate Self-Compassion Scale - Diabetes (SCS-D) in which the average of items is calculated. Items are scored on a scale from 1 to 5 with higher scores indicative of greater self compassion.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'FG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'FG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'Recruitment occurred virtually (email and phone contact)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'StreamLine', 'description': 'Diabetes education, behavioral management\n\nStreamLine: StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.'}, {'id': 'BG001', 'title': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.\n\nTunedIn: TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'BG002', 'title': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.\n\nFixIt: FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '47.6', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '15.4', 'groupId': 'BG002'}, {'value': '46.3', 'spread': '15.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'categories': [{'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}, {'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}, {'title': 'Female to male (transgender)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male to female (transgender)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'T1-DDS (total diabetes distress) mean score', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '2.8', 'spread': '0.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Diabetes distress is measured on a 1-6 scale and calculated as a mean score. A higher score indicates more distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '8.4', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '8.3', 'spread': '0.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-10', 'size': 158162, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-24T16:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2019-07-08', 'resultsFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-24', 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes Distress at 12 Months', 'timeFrame': '12 months', 'description': 'Self-reported diabetes distress across several domains will be assessed using the Type 1 Diabetes Distress Scale (T1-DDS) a validated measure averaged across items (range 1.0-6.0 with higher scores indicating a higher level of diabetes-related distress).'}, {'measure': 'Hemoglobin A1c (HbA1c) at 12 Months', 'timeFrame': '12 months', 'description': 'Hemoglobin A1c (HbA1c) assay laboratory result'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemic Episodes at 12 Months', 'timeFrame': '12 months', 'description': 'Self-reported number of severe of hypoglycemic episodes in the past 6 months, or since the last assessment. A numeric count is reported, zero indicates no hypoglycemic episodes, and a higher number indicates more hypoglycemic episodes.'}, {'measure': 'Depression Symptoms at 12 Months', 'timeFrame': '12 months', 'description': 'Symptoms of depression will be measured using the self-completion Patient Health Questionnaire (PHQ-8). The score ranges from zero to 24 with a higher score indicating more symptoms of depression.'}, {'measure': 'Missed Insulin Boluses at 12 Months', 'timeFrame': '12 months', 'description': 'Self-reported number of missed or skipped insulin boluses in the past week'}, {'measure': 'Nonreactivity to Inner Experience at 12 Months', 'timeFrame': '12 months', 'description': 'Nonreactivity to inner experience will be assessed by the nonreactivity sub-scale of the Five Facet Mindfulness Questionnaire. Items are scored from 1-5 with items summed to calculate a total scale score. The total score ranges from 7-35. Higher scores indicate greater nonreactivity to inner emotional experiences.'}, {'measure': 'Non-judging of Experience at 12 Months', 'timeFrame': '12 months', 'description': 'Non-judging of experience will be assessed by the nonjudgmental subscale of the Five Facet Mindfulness Questionnaire. Individual items are scored on a 1-5 scale and then summed to calculate a scale score with higher scores indicating greater non-judging of emotional experience. The total score ranges from 8-40.'}, {'measure': 'Personal Control Over Illness at 12 Months', 'timeFrame': '12 months', 'description': "The personal control subscale from the Revised Illness Perception Questionnaire will assess participants' perceived control over their illness. The items are scored on a 1-5 scale and summed across items for a total score with higher scores indicating greater personal control. The total score ranges from 6-30."}, {'measure': 'Self-compassion - Diabetes (SCS-D) at 12 Months', 'timeFrame': '12 months', 'description': 'Diabetes-specific self-compassion will be measured using the validate Self-Compassion Scale - Diabetes (SCS-D) in which the average of items is calculated. Items are scored on a scale from 1 to 5 with higher scores indicative of greater self compassion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Diabetes Distress']}, 'referencesModule': {'references': [{'pmid': '29976567', 'type': 'BACKGROUND', 'citation': 'Fisher L, Hessler D, Polonsky WH, Masharani U, Guzman S, Bowyer V, Strycker L, Ahmann A, Basina M, Blumer I, Chloe C, Kim S, Peters AL, Shumway M, Weihs K, Wu P. T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes. Diabetes Care. 2018 Sep;41(9):1862-1869. doi: 10.2337/dc18-0391. Epub 2018 Jul 5.'}, {'pmid': '28739179', 'type': 'BACKGROUND', 'citation': 'Fisher L, Hessler D, Polonsky W, Strycker L, Guzman S, Bowyer V, Blumer I, Masharani U. Emotion regulation contributes to the development of diabetes distress among adults with type 1 diabetes. Patient Educ Couns. 2018 Jan;101(1):124-131. doi: 10.1016/j.pec.2017.06.036. Epub 2017 Jul 8.'}, {'pmid': '28498610', 'type': 'BACKGROUND', 'citation': 'Hessler DM, Fisher L, Polonsky WH, Masharani U, Strycker LA, Peters AL, Blumer I, Bowyer V. Diabetes distress is linked with worsening diabetes management over time in adults with Type 1 diabetes. Diabet Med. 2017 Sep;34(9):1228-1234. doi: 10.1111/dme.13381. Epub 2017 Jun 18.'}, {'pmid': '27118163', 'type': 'BACKGROUND', 'citation': 'Fisher L, Hessler D, Polonsky W, Strycker L, Masharani U, Peters A. Diabetes distress in adults with type 1 diabetes: Prevalence, incidence and change over time. J Diabetes Complications. 2016 Aug;30(6):1123-8. doi: 10.1016/j.jdiacomp.2016.03.032. Epub 2016 Apr 4.'}, {'pmid': '25765489', 'type': 'BACKGROUND', 'citation': 'Fisher L, Polonsky WH, Hessler DM, Masharani U, Blumer I, Peters AL, Strycker LA, Bowyer V. Understanding the sources of diabetes distress in adults with type 1 diabetes. J Diabetes Complications. 2015 May-Jun;29(4):572-7. doi: 10.1016/j.jdiacomp.2015.01.012. Epub 2015 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'This study is comparing three programs to reduce Diabetes Distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. About a third of participants will take part in the TunedIn program, about a third will take part in the FixIt program, and about a third in the StreamLine program.', 'detailedDescription': "Diabetes Distress (DD) is the personal, often hidden side of diabetes: it reflects the unique emotional burdens and strains that individuals with diabetes may experience as they struggle to keep blood glucose levels within range. When high, DD can have a major, negative impact on disease management and glycemic control. High DD is characterized by frustration, feeling overwhelmed, and feeling hopeless and discouraged by the unceasing demands of diabetes. DD is also linked to an individual's beliefs, expectations, current life situation, and personal and social resources.\n\nThe proposed study is a three-arm, 12-month randomized comparison trial to test the added value of a DD-targeted (TunedIn) intervention vs. a unified DD and management intervention (FixIt), relative to a traditional, educational/behavioral-management intervention (StreamLine). Each of the three programs (arms) will follow a separate, standardized protocol. All participants will receive three months of intervention with nine months of follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with type 1 diabetes (confirmed by clinical history and/or anti-glutamic acid decarboxylase\\] antibody testing) on intensive insulin treatment;\n* Diagnosis of type 1 diabetes for at least 12 months that occurred at or below age 40;\n* Have a recent HbA1c of 7.5% or higher;\n* Not have started to use any new (to the participant) diabetes device (such as an insulin pump or continuous glucose monitor) in the past 6 months;\n* Internet access through a computer or smart phone;\n* Ability to speak/read English.\n\nExclusion Criteria:\n\n* No documented psychosis, blindness, dementia, active dialysis, substance abuse, amputations, or severe functional deficits, or recent major surgery or hospitalization in the past year.'}, 'identificationModule': {'nctId': 'NCT04016558', 'acronym': 'EMBARK', 'briefTitle': 'Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control', 'orgStudyIdInfo': {'id': '133107A'}, 'secondaryIdInfos': [{'id': 'R01DK121241-02', 'link': 'https://reporter.nih.gov/quickSearch/R01DK121241-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'StreamLine', 'description': 'Diabetes education, behavioral management', 'interventionNames': ['Behavioral: StreamLine']}, {'type': 'EXPERIMENTAL', 'label': 'TunedIn', 'description': 'Diabetes distress reduction, emotion regulation techniques.', 'interventionNames': ['Behavioral: TunedIn']}, {'type': 'EXPERIMENTAL', 'label': 'FixIt', 'description': 'Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.', 'interventionNames': ['Behavioral: FixIt']}], 'interventions': [{'name': 'StreamLine', 'type': 'BEHAVIORAL', 'description': 'StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.\n\nParticipants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.', 'armGroupLabels': ['StreamLine']}, {'name': 'TunedIn', 'type': 'BEHAVIORAL', 'description': 'TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).\n\nBetween the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.', 'armGroupLabels': ['TunedIn']}, {'name': 'FixIt', 'type': 'BEHAVIORAL', 'description': 'FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.\n\nBetween the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.', 'armGroupLabels': ['FixIt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Danielle Hessler, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}