Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Stress
Conditions
Keywords
Stress, Psychological, Mindfulness, Meditation, Mind-Body Therapies, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Brief summary
The purpose of this study is to conduct a randomized controlled trial (RCT) to determine the effects of an online 6-month Mindfulness-based stress reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose control in adults with uncontrolled type 1 or type 2 diabetes. The study will randomize at least 290 adults with uncontrolled diabetes to a 6-month MBSR intervention or SME control. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. Outcomes will be assessed at baseline, a follow-up phone call after Class #4, and study visits at 2-months (2MO) and 6-months (6MO).
Detailed description
Specific Aims are: 1) To conduct a randomized controlled trial to determine the effects of an online 6-month Mindfulness-Based Stress Reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose levels in at least 290 adults with uncontrolled type 1 or type 2 diabetes. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. The primary outcome will be hemoglobin A1c (HbA1c), a measure of the average glucose level over the past 3 months. We hypothesize that between the two groups, there will be a clinically significant 0.5% absolute difference in the mean change in HbA1c from baseline to 6-months. We will also look at the 2-month HbA1c, however it may be too brief a time period to fully capture the impact of MBSR. An absolute reduction in HbA1c of 0.5% would be expected to reduce the risk of any diabetes-related complication by at least 10%. Additionally, we will assess fasting glucose as a secondary outcome as it is linked with adverse health outcomes, and can be lowered with MBSR based on our pilot study; 2) To determine the effects of online MBSR compared to SME control on psychosocial, behavioral and physiological mechanisms potentially mediating the effects of MBSR and/or SME on glucose levels in adults with uncontrolled diabetes. Secondary outcomes include: diabetes-related distress, subjective stress, craving, the impact of Coronavirus Disease 2019 (COVID-19) on subjects' lives, subject expectancy, dietary intake, physical activity, and serum hsCRP as a marker of chronic inflammation. Adverse Childhood Experiences (ACEs) will be assessed at baseline. It is hypothesized that these measures may mediate the effects of MBSR and/or SME on glucose. The proposed study has the potential to transform current standards of care for diabetes by using a novel long-term MBSR intervention as a powerful adjunct intervention for diabetes. MBSR could impact the clinical picture of diabetes by empowering patients with skills for strengthening their own internal resources to promote self regulation and adaptive coping and reduce stress reactivity, which are all essential for implementing healthy behaviors and are expected to lead to improved glucose control and reduced risk of diabetes complications. This proposal is relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct research on diabetes to improve people's health and quality of life.
Interventions
BEHAVIORALMindfulness Based Stress Reduction
Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations.
BEHAVIORALStress Management Education
Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Rowan University
West Chester University of Pennsylvania
Georgetown University
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The PI, study coordinator, and all study personnel collecting outcomes, will be blinded from the treatment assignments. Only the MBSR and SME instructors and the study personnel who schedule the classes, videorecord the classes, and code the videos will have knowledge of the assignments, and these individuals will not be involved in the collection of outcomes. Subjects will be asked to keep their treatment assignment concealed from study personnel collecting outcomes. However, complete blinding may not be possible given the nature of this study.
Intervention model description
This is a randomized, parallel group two-arm trial that will determine the effects of an online 6-month Mindfulness-based stress reduction (MBSR) intervention compared to Stress Management Education (SME) (active control) on glucose control in at least 290 patients with uncontrolled diabetes. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and Women 2. Age 18 years or older 3. Diagnosed with diabetes for at least one year 4. Hemoglobin A1c ≥ 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session) 5. High Subjective stress defined as Perceived Stress Scale-10 score ≥ 12 6. Available for the intervention sessions with reasonable certainty 7. Have a device equipped with internet connection, camera and microphone and willingness to interact with study staff and class instructors virtually/remotely via this platform 8. Must have a Primary Care Provider (PCP) 9. Must have an accessible/active personal e-mail address or be willing to obtain one for study correspondence
Exclusion criteria
1. Current suicidality 2. History of, or meets Mini International Neuropsychiatric Interview (MINI) structured interview criteria for, bipolar disorder, psychosis, or other significant psychopathology; Those with depression or anxiety will be allowed to participate since they are under the care of a PCP. 3. Inpatient admission for psychiatric disorder within the past two years, or ER visit for psychiatric disorder within the past 10 weeks 4. Meets MINI structured interview criteria for Alcohol Use Disorder or Substance Use Disorder (Past 12 months) 5. Inability to read, write or speak English 6. Current enrollment in a stress reduction program, or in any other investigative study 7. Previous participation in a mindfulness-based stress reduction (MBSR) course 8. Pregnant women 9. Have a household member who is currently, or was previously, assigned to study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 6MO data are reported here as the primary comparison. | Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self-Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 2MO data are reported here as the secondary comparison | Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). |
| Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 2MO data are reported here as the comparison for this outcome. | The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 (not a problem) to 6 (a very serious problem), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). |
| Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 6MO data are reported here as the comparison for this outcome. | The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 (not a problem) to 6 (a very serious problem), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). |
| Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 2MO data are presented here as the comparison for this outcome. | PSS-10 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). |
| Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 6MO data are presented here as the comparison for this outcome. | PSS-10 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). |
Countries
United States
Participant flow
Recruitment details
Recruitment from medical clinics, support groups, health fairs, StudyFinder, ResearchMatch, HealthGrades, and social media began 2/26/20 with final participant screened 1/17/24. First consent to study was 7/28/20. Type 2 diabetics were eligible for the study until 7/22/21, then expanding to all diabetics (except gestational diabetes). Eligibility was HbA1c ≥ 8 until 5/9/22, when eligible HbA1c dropped to ≥ 7.5. Final follow-up for primary outcome data collection was on 8/9/24.
Pre-assignment details
497 consents were signed following pre-screening at the start of the initial screening visit, reflecting n=492 unique consented individuals. Study eligibility criteria were assessed further during the screening visit and baseline visit. 183 individuals were consented but never randomized (never enrolled; n=161 ineligible at screening visit, n=1 ineligible at baseline visit, n=14 withdrew from the study, n=1 died, n=6 study team withdraws). 309 (492-183) individuals were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Based Stress Reduction Mindfulness Based Stress Reduction: Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations. | 154 |
| Stress Management Education Stress Management Education: Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc. | 155 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 6 | 2 |
| Overall Study | Participant Non-Compliance: Orientation not completed prior to Class #2 | 2 | 0 |
| Overall Study | Physician Decision | 5 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 24 | 27 |
Baseline characteristics
| Characteristic | Total | Mindfulness Based Stress Reduction | Stress Management Education |
|---|---|---|---|
| A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values | 8.59 percentage of glycated hemoglobin STANDARD_DEVIATION 1.3 | 8.56 percentage of glycated hemoglobin STANDARD_DEVIATION 1.3 | 8.62 percentage of glycated hemoglobin STANDARD_DEVIATION 1.3 |
| Age, Continuous | 54.6 years STANDARD_DEVIATION 11.98 | 55.6 years STANDARD_DEVIATION 12.24 | 53.6 years STANDARD_DEVIATION 11.67 |
| Class Cohort Number Cohort 10: Orientation Date = 01/24/2023 | 40 Participants | 19 Participants | 21 Participants |
| Class Cohort Number Cohort 11: Orientation Date = 04/18/2023 | 44 Participants | 24 Participants | 20 Participants |
| Class Cohort Number Cohort 12: Orientation Date = 07/11/2023 | 33 Participants | 16 Participants | 17 Participants |
| Class Cohort Number Cohort 13: Orientation Date = 09/26/2023 | 35 Participants | 18 Participants | 17 Participants |
| Class Cohort Number Cohort 14: Orientation Date = 01/23/2024 | 33 Participants | 16 Participants | 17 Participants |
| Class Cohort Number Cohort 1: Orientation Date = 09/22/2020 | 8 Participants | 4 Participants | 4 Participants |
| Class Cohort Number Cohort 2: Orientation Date = 01/26/2021 | 6 Participants | 4 Participants | 2 Participants |
| Class Cohort Number Cohort 3: Orientation Date = 05/06/2021 | 6 Participants | 2 Participants | 4 Participants |
| Class Cohort Number Cohort 4: Orientation Date = 07/20/2021 | 11 Participants | 6 Participants | 5 Participants |
| Class Cohort Number Cohort 5: Orientation Date = 09/28/2021 | 14 Participants | 7 Participants | 7 Participants |
| Class Cohort Number Cohort 6: Orientation Date = 01/25/2022 | 18 Participants | 8 Participants | 10 Participants |
| Class Cohort Number Cohort 7: Orientation Date = 04/19/2022 | 22 Participants | 10 Participants | 12 Participants |
| Class Cohort Number Cohort 8: Orientation Date = 07/26/2022 | 19 Participants | 11 Participants | 8 Participants |
| Class Cohort Number Cohort 9: Orientation Date = 10/04/2022 | 20 Participants | 9 Participants | 11 Participants |
| Diabetes Distress Scale (DDS) Mean Item Score | 2.42 scores on a scale STANDARD_DEVIATION 0.94 | 2.50 scores on a scale STANDARD_DEVIATION 0.98 | 2.33 scores on a scale STANDARD_DEVIATION 0.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 6 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 285 Participants | 147 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Perceived Stress Scale-10 (PSS-10) Score | 19.13 scores on a scale STANDARD_DEVIATION 6.71 | 19.88 scores on a scale STANDARD_DEVIATION 6.66 | 18.39 scores on a scale STANDARD_DEVIATION 6.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 21 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 251 Participants | 125 Participants | 126 Participants |
| Randomization Stratification Factor; Taking Insulin at Baseline No | 127 Participants | 63 Participants | 64 Participants |
| Randomization Stratification Factor; Taking Insulin at Baseline Yes | 182 Participants | 91 Participants | 91 Participants |
| Region of Enrollment United States | 309 Participants | 154 Participants | 155 Participants |
| Sex: Female, Male Female | 206 Participants | 104 Participants | 102 Participants |
| Sex: Female, Male Male | 103 Participants | 50 Participants | 53 Participants |
| Type of Diabetes Diabetes due to pancreatitis or pancreatectomy (surgical removal of all or part of the pancreas) | 3 Participants | 2 Participants | 1 Participants |
| Type of Diabetes Drug- or chemical-induced diabetes (such as with steroid use or after organ transplantation) | 1 Participants | 1 Participants | 0 Participants |
| Type of Diabetes Latent Autoimmune Diabetes in Adults (LADA) | 3 Participants | 0 Participants | 3 Participants |
| Type of Diabetes Type 1 | 47 Participants | 24 Participants | 23 Participants |
| Type of Diabetes Type 2 | 255 Participants | 127 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 154 | 0 / 155 | 1 / 183 |
| other Total, other adverse events | 43 / 154 | 46 / 155 | 0 / 183 |
| serious Total, serious adverse events | 15 / 154 | 18 / 155 | 1 / 183 |
Outcome results
Primary
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO)
Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self-Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect).
Time frame: Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 6MO data are reported here as the primary comparison.
Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=306 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=151; SME=155) and n=237 contributing values to the 6MO timepoint Least Squares Mean (MBSR=114; SME=123).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | Baseline | 8.50 percentage of glycated hemoglobin |
| Mindfulness Based Stress Reduction | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | 6MO | 8.15 percentage of glycated hemoglobin |
| Mindfulness Based Stress Reduction | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | Change from Baseline to 6MO | -0.35 percentage of glycated hemoglobin |
| Stress Management Education | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | Baseline | 8.60 percentage of glycated hemoglobin |
| Stress Management Education | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | 6MO | 8.24 percentage of glycated hemoglobin |
| Stress Management Education | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | Change from Baseline to 6MO | -0.36 percentage of glycated hemoglobin |
p-value: 0.9695% CI: [-0.36, 0.34]Mixed Models Analysis
Secondary
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO)
Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect).
Time frame: Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 2MO data are reported here as the secondary comparison
Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=306 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=151; SME=155) and n=244 contributing values to the 2MO timepoint Least Squares Mean (MBSR=122; SME=122).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | Baseline | 8.50 percentage of glycated hemoglobin |
| Mindfulness Based Stress Reduction | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | 2MO | 8.27 percentage of glycated hemoglobin |
| Mindfulness Based Stress Reduction | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | Change from Baseline to 2MO | -0.23 percentage of glycated hemoglobin |
| Stress Management Education | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | Baseline | 8.60 percentage of glycated hemoglobin |
| Stress Management Education | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | 2MO | 8.30 percentage of glycated hemoglobin |
| Stress Management Education | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | Change from Baseline to 2MO | -0.30 percentage of glycated hemoglobin |
p-value: 0.6895% CI: [-0.38, 0.25]Mixed Models Analysis
Secondary
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO)
The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 (not a problem) to 6 (a very serious problem), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect).
Time frame: The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 2MO data are reported here as the comparison for this outcome.
Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=247 contributing values to the 2MO timepoint Least Squares Mean (MBSR=123; SME=124).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | Baseline | 2.48 scores on a scale |
| Mindfulness Based Stress Reduction | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | 2MO | 2.15 scores on a scale |
| Mindfulness Based Stress Reduction | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | Change from Baseline to 2MO | -0.33 scores on a scale |
| Stress Management Education | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | Baseline | 2.31 scores on a scale |
| Stress Management Education | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | 2MO | 2.05 scores on a scale |
| Stress Management Education | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | Change from Baseline to 2MO | -0.26 scores on a scale |
p-value: 0.4195% CI: [-0.09, 0.21]Mixed Models Analysis
Secondary
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO)
The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 (not a problem) to 6 (a very serious problem), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect).
Time frame: The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 6MO data are reported here as the comparison for this outcome.
Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=236 contributing values to the 6MO timepoint Least Squares Mean (MBSR=115; SME=121).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | Baseline | 2.48 scores on a scale |
| Mindfulness Based Stress Reduction | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | 6MO | 2.13 scores on a scale |
| Mindfulness Based Stress Reduction | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | Change from Baseline to 6MO | -0.34 scores on a scale |
| Stress Management Education | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | 6MO | 1.92 scores on a scale |
| Stress Management Education | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | Baseline | 2.31 scores on a scale |
| Stress Management Education | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | Change from Baseline to 6MO | -0.39 scores on a scale |
p-value: 0.5995% CI: [-0.22, 0.12]Mixed Models Analysis
Secondary
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO)
PSS-10 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect).
Time frame: PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 2MO data are presented here as the comparison for this outcome.
Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=246 contributing values to the 2MO timepoint Least Squares Mean (MBSR=123; SME=123).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | Baseline | 19.85 scores on a scale |
| Mindfulness Based Stress Reduction | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | 2MO | 16.65 scores on a scale |
| Mindfulness Based Stress Reduction | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | Change from Baseline to 2MO | -3.20 scores on a scale |
| Stress Management Education | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | Baseline | 18.18 scores on a scale |
| Stress Management Education | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | 2MO | 16.55 scores on a scale |
| Stress Management Education | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | Change from Baseline to 2MO | -1.63 scores on a scale |
p-value: 0.0495% CI: [0.07, 3.06]Mixed Models Analysis
Secondary
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO)
PSS-10 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect).
Time frame: PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 6MO data are presented here as the comparison for this outcome.
Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=238 contributing values to the 6MO timepoint Least Squares Mean (MBSR=115; SME=123).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | Baseline | 19.85 scores on a scale |
| Mindfulness Based Stress Reduction | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | 6MO | 17.04 scores on a scale |
| Mindfulness Based Stress Reduction | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | Change from Baseline to 6MO | -2.81 scores on a scale |
| Stress Management Education | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | Baseline | 18.18 scores on a scale |
| Stress Management Education | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | 6MO | 16.21 scores on a scale |
| Stress Management Education | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | Change from Baseline to 6MO | -1.98 scores on a scale |
p-value: 0.395% CI: [-0.74, 2.4]Mixed Models Analysis