Trial Outcomes & Findings for Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control (NCT NCT04016558)
NCT ID: NCT04016558
Last Updated: 2025-10-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
296 participants
Primary outcome timeframe
12 months
Results posted on
2025-10-28
Participant Flow
Recruitment occurred virtually (email and phone contact)
Participant milestones
| Measure |
StreamLine
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
FixIt
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
|---|---|---|---|
|
Overall Study
COMPLETED
|
89
|
77
|
78
|
|
Overall Study
NOT COMPLETED
|
12
|
20
|
20
|
|
Overall Study
STARTED
|
101
|
97
|
98
|
|
Overall Study
Received Intervention
|
97
|
91
|
88
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
Baseline characteristics by cohort
| Measure |
StreamLine
n=101 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=97 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
FixIt
n=98 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
97 participants
n=7 Participants
|
98 participants
n=5 Participants
|
296 participants
n=4 Participants
|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 15.2 • n=4 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Female to male (transgender)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Male to female (transgender)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
257 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
T1-DDS (total diabetes distress) mean score
|
2.8 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants
|
|
HbA1c
|
8.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
8.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.4 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
|
8.3 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsSelf-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).
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
|---|---|---|---|
|
Diabetes Distress at 12 Months
|
2.06 score on a scale
Standard Error 0.079
|
2.34 score on a scale
Standard Error 0.074
|
2.03 score on a scale
Standard Error 0.077
|
PRIMARY outcome
Timeframe: 12 monthsHemoglobin A1c (HbA1c) assay laboratory result
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
|---|---|---|---|
|
Hemoglobin A1c (HbA1c) at 12 Months
|
7.94 percentage of glycosylated hemoglobin
Standard Error 0.101
|
7.52 percentage of glycosylated hemoglobin
Standard Error 0.092
|
7.60 percentage of glycosylated hemoglobin
Standard Error 0.098
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
|---|---|---|---|
|
Hypoglycemic Episodes at 12 Months
|
1.23 hypoglycemic episodes
Standard Deviation 1.46
|
1.17 hypoglycemic episodes
Standard Deviation 1.15
|
1.32 hypoglycemic episodes
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: 12 monthsSymptoms 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.
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
|---|---|---|---|
|
Depression Symptoms at 12 Months
|
7.09 score on a scale
Standard Deviation 5.73
|
6.35 score on a scale
Standard Deviation 5.72
|
5.94 score on a scale
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: 12 monthsSelf-reported number of missed or skipped insulin boluses in the past week
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
|---|---|---|---|
|
Missed Insulin Boluses at 12 Months
|
0.19 percentage of insulin boluses skipped
Standard Deviation 0.17
|
0.15 percentage of insulin boluses skipped
Standard Deviation 0.15
|
0.17 percentage of insulin boluses skipped
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 12 monthsNonreactivity 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.
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
|---|---|---|---|
|
Nonreactivity to Inner Experience at 12 Months
|
24.22 score on a scale
Standard Deviation 5.00
|
23.68 score on a scale
Standard Deviation 5.29
|
24.34 score on a scale
Standard Deviation 5.18
|
SECONDARY outcome
Timeframe: 12 monthsNon-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.
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
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|---|---|---|---|
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Non-judging of Experience at 12 Months
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30.48 score on a scale
Standard Deviation 6.99
|
31.29 score on a scale
Standard Deviation 7.55
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32.13 score on a scale
Standard Deviation 5.90
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SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
|---|---|---|---|
|
Personal Control Over Illness at 12 Months
|
24.99 score on a scale
Standard Deviation 2.97
|
24.77 score on a scale
Standard Deviation 3.23
|
24.68 score on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 12 monthsDiabetes-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.
Outcome measures
| Measure |
FixIt
n=88 Participants
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
FixIt: 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.
Between 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.
|
StreamLine
n=97 Participants
Diabetes education, behavioral management
StreamLine: 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.
Participants 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.
|
TunedIn
n=91 Participants
Diabetes distress reduction, emotion regulation techniques.
TunedIn: 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).
Between 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.
|
|---|---|---|---|
|
Self-compassion - Diabetes (SCS-D) at 12 Months
|
3.44 score on a scale
Standard Deviation 0.94
|
3.42 score on a scale
Standard Deviation 0.85
|
3.60 score on a scale
Standard Deviation 0.81
|
Adverse Events
TunedIn
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FixIt
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
StreamLine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Danielle Hessler
University of California, San Francisco
Phone: 415-476-6196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place