Diabetes Distress, Type 1 Diabetes
Conditions
Brief summary
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.
Detailed description
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. The 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.
Interventions
BEHAVIORALStreamLine
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.
BEHAVIORALTunedIn
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.
BEHAVIORALFixIt
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with type 1 diabetes (confirmed by clinical history and/or anti-glutamic acid decarboxylase\] antibody testing) on intensive insulin treatment; * Diagnosis of type 1 diabetes for at least 12 months that occurred at or below age 40; * Have a recent HbA1c of 7.5% or higher; * 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; * Internet access through a computer or smart phone; * Ability to speak/read English.
Exclusion criteria
* No documented psychosis, blindness, dementia, active dialysis, substance abuse, amputations, or severe functional deficits, or recent major surgery or hospitalization in the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress at 12 Months | 12 months | 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). |
| Hemoglobin A1c (HbA1c) at 12 Months | 12 months | Hemoglobin A1c (HbA1c) assay laboratory result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Missed Insulin Boluses at 12 Months | 12 months | Self-reported number of missed or skipped insulin boluses in the past week |
| Nonreactivity to Inner Experience at 12 Months | 12 months | 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. |
| Hypoglycemic Episodes at 12 Months | 12 months | 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. |
| Personal Control Over Illness at 12 Months | 12 months | 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. |
| Self-compassion - Diabetes (SCS-D) at 12 Months | 12 months | 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. |
| Non-judging of Experience at 12 Months | 12 months | 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. |
| Depression Symptoms at 12 Months | 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred virtually (email and phone contact)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| 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. | 97 |
| 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. | 98 |
| Total | 296 |
Baseline characteristics
| Characteristic | StreamLine | TunedIn | FixIt | Total |
|---|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 15.2 | 47.6 years STANDARD_DEVIATION 15.3 | 42.5 years STANDARD_DEVIATION 15.4 | 46.3 years STANDARD_DEVIATION 15.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 12 Participants | 9 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 82 Participants | 88 Participants | 257 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| HbA1c | 8.2 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.8 | 8.2 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.9 | 8.4 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.1 | 8.3 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 89 Participants | 89 Participants | 86 Participants | 264 Participants |
| Region of Enrollment United States | 101 participants | 97 participants | 98 participants | 296 participants |
| Sex/Gender, Customized Gender Female | 77 Participants | 76 Participants | 80 Participants | 233 Participants |
| Sex/Gender, Customized Gender Female to male (transgender) | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Sex/Gender, Customized Gender Male | 23 Participants | 18 Participants | 17 Participants | 58 Participants |
| Sex/Gender, Customized Gender Male to female (transgender) | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Gender Unknown | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| T1-DDS (total diabetes distress) mean score | 2.8 units on a scale STANDARD_DEVIATION 0.8 | 2.8 units on a scale STANDARD_DEVIATION 0.8 | 3.0 units on a scale STANDARD_DEVIATION 0.7 | 2.8 units on a scale STANDARD_DEVIATION 0.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 91 | 0 / 88 |
| other Total, other adverse events | 0 / 97 | 0 / 91 | 0 / 88 |
| serious Total, serious adverse events | 0 / 97 | 0 / 91 | 0 / 88 |
Outcome results
Primary
Diabetes Distress at 12 Months
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).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Diabetes Distress at 12 Months | 2.34 score on a scale | Standard Error 0.074 |
| TunedIn | Diabetes Distress at 12 Months | 2.03 score on a scale | Standard Error 0.077 |
| FixIt | Diabetes Distress at 12 Months | 2.06 score on a scale | Standard Error 0.079 |
p-value: 0.007ANCOVA
Primary
Hemoglobin A1c (HbA1c) at 12 Months
Hemoglobin A1c (HbA1c) assay laboratory result
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Hemoglobin A1c (HbA1c) at 12 Months | 7.52 percentage of glycosylated hemoglobin | Standard Error 0.092 |
| TunedIn | Hemoglobin A1c (HbA1c) at 12 Months | 7.60 percentage of glycosylated hemoglobin | Standard Error 0.098 |
| FixIt | Hemoglobin A1c (HbA1c) at 12 Months | 7.94 percentage of glycosylated hemoglobin | Standard Error 0.101 |
p-value: 0.006ANCOVA
Secondary
Depression Symptoms at 12 Months
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Depression Symptoms at 12 Months | 6.35 score on a scale | Standard Deviation 5.72 |
| TunedIn | Depression Symptoms at 12 Months | 5.94 score on a scale | Standard Deviation 4.54 |
| FixIt | Depression Symptoms at 12 Months | 7.09 score on a scale | Standard Deviation 5.73 |
p-value: 0.01ANCOVA
Secondary
Hypoglycemic Episodes at 12 Months
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Hypoglycemic Episodes at 12 Months | 1.17 hypoglycemic episodes | Standard Deviation 1.15 |
| TunedIn | Hypoglycemic Episodes at 12 Months | 1.32 hypoglycemic episodes | Standard Deviation 1.66 |
| FixIt | Hypoglycemic Episodes at 12 Months | 1.23 hypoglycemic episodes | Standard Deviation 1.46 |
p-value: 0.82ANCOVA
Secondary
Missed Insulin Boluses at 12 Months
Self-reported number of missed or skipped insulin boluses in the past week
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Missed Insulin Boluses at 12 Months | 0.15 percentage of insulin boluses skipped | Standard Deviation 0.15 |
| TunedIn | Missed Insulin Boluses at 12 Months | 0.17 percentage of insulin boluses skipped | Standard Deviation 0.16 |
| FixIt | Missed Insulin Boluses at 12 Months | 0.19 percentage of insulin boluses skipped | Standard Deviation 0.17 |
p-value: 0.4ANCOVA
Secondary
Non-judging of Experience at 12 Months
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Non-judging of Experience at 12 Months | 31.29 score on a scale | Standard Deviation 7.55 |
| TunedIn | Non-judging of Experience at 12 Months | 32.13 score on a scale | Standard Deviation 5.9 |
| FixIt | Non-judging of Experience at 12 Months | 30.48 score on a scale | Standard Deviation 6.99 |
p-value: 0.12ANCOVA
Secondary
Nonreactivity to Inner Experience at 12 Months
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Nonreactivity to Inner Experience at 12 Months | 23.68 score on a scale | Standard Deviation 5.29 |
| TunedIn | Nonreactivity to Inner Experience at 12 Months | 24.34 score on a scale | Standard Deviation 5.18 |
| FixIt | Nonreactivity to Inner Experience at 12 Months | 24.22 score on a scale | Standard Deviation 5 |
Secondary
Personal Control Over Illness at 12 Months
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Personal Control Over Illness at 12 Months | 24.77 score on a scale | Standard Deviation 3.23 |
| TunedIn | Personal Control Over Illness at 12 Months | 24.68 score on a scale | Standard Deviation 2.7 |
| FixIt | Personal Control Over Illness at 12 Months | 24.99 score on a scale | Standard Deviation 2.97 |
p-value: 0.39ANCOVA
Secondary
Self-compassion - Diabetes (SCS-D) at 12 Months
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StreamLine | Self-compassion - Diabetes (SCS-D) at 12 Months | 3.42 score on a scale | Standard Deviation 0.85 |
| TunedIn | Self-compassion - Diabetes (SCS-D) at 12 Months | 3.60 score on a scale | Standard Deviation 0.81 |
| FixIt | Self-compassion - Diabetes (SCS-D) at 12 Months | 3.44 score on a scale | Standard Deviation 0.94 |
p-value: <0.01ANCOVA