Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK116901-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
This project will test the efficacy of a multi-component behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-21) with T1D, a group with chronic poor metabolic control. This intervention is grounded in self-determination theory which states that a youth who believes their diabetes management is self-directed, competent, and supported by others is more likely to consistently complete their diabetes self-care. This theory-driven intervention will be scalable to a variety of chronic illness contexts and the knowledge gained from this research will inform self-determination theory and different interventions targeting this population (currently there are no interventions that directly target emerging adults).
This project will use the multiphase optimization strategy (MOST) approach to test the efficacy of an autonomy supportive behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-25) with T1D. Youth this age demonstrate chronic poor metabolic control that persists into adulthood leading to the premature emergence of short- and long-term diabetes complications. Developmentally, adolescence and emerging adulthood is a time when the need for independence and autonomy are particularly salient. This new intervention will leverage youths' desire for autonomy by designing an intervention to support diabetes self-management autonomy. This intervention is guided by self-determination theory (SDT) which suggests that autonomous (i.e., self-initiated, driven by intrinsic versus extrinsic motivation) diabetes management depends upon three conditions: 1) the perception that one's behavior is self-directed, 2) feelings of competence, or self-efficacy, and 3) the existence of caring relationships supportive of the behavior. The investigators have identified three intervention components that target the SDT constructs. A question prompt list (QPL) is a simple, inexpensive tool comprised of a list of questions that patients might consider asking their health care provider during a clinic visit. QPLs empower patients to assume a more active role (asking questions and stating concerns) during clinic visits. The Motivation Enhancing System (MES) is an eHealth intervention to increase intrinsic motivation for health behavior change. MES content is based on the Motivational Interviewing (MI) framework and the Information-Motivation-Behavioral Skills (IMB) model of health behavior change which posits that behavior change results from the joint function of three critical components: accurate information about risk behaviors or their replacement health behaviors, motivation to change behavior, and behavioral skills necessary to perform the behavior (self-efficacy). Text message reminders (TXT) are a strategy to encourage youth to complete their diabetes self-care that also lead to gains in self-efficacy and a stronger relationship with diabetes care providers through greater communication and satisfaction. The investigators will test the efficacy of these intervention components toward improving metabolic control in a component selection experiment (N=320). The experiment will use a full factorial research design with random assignment to determine which intervention components contribute to a clinically significant improvement (≥0.5%) in HbA1c. The result of this research will be an optimized, multi-component intervention with effect size estimates that will be used to inform a large scale, fully powered effectiveness trial. This theory-driven intervention will be scalable to a variety of chronic illness contexts and the knowledge gained from this research will inform self-determination theory and behavioral interventions targeting this population (for which there currently are none).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Question Prompt List (QPL) | Experimental | A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit. |
|
| Motivation Enhancement System (MES) | Experimental | MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management. |
|
| Text Message Reminders (TXT) | Experimental | Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Enhancement System (MES) | Behavioral | MES is a brief eHealth intervention delivered via an internet-based software application. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. The goal of MES is to increase motivation to complete daily diabetes care tasks. MES consists of two 20-minute sessions that integrate psychoeducation with motivation-enhancing therapeutic exercises and behavioral goal setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Hb1Ac will be obtained by using the Accubase A1c test kit. | Baseline/0 month, Treatment End/3 months, and Follow Up/6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Management Scale | The Diabetes Management Scale (DMS) is a self-report measure of diabetes illness management assessing a broad range of diabetes management behaviors, including insulin management, dietary management, blood glucose monitoring, and symptom response with good internal consistency (α=.74 to .84). Ten items ask "What percent of the time do you (diabetes care task)?" with a response scale of 0-100% where higher scores indicate greater (better) diabetes management. A total score, ranging form 0-100%, is obtained by calculating the average response across ten items to reflect overall management behavior. |
Not provided
Inclusion:
Age 16 years, 0 months - 25 years, 11 months
Type 1 diabetes (T1D)
HbA1c ≥7.5% currently and averaged over the previous 6 months
Duration of diabetes ≥6 months
English fluency, both verbal and written
Cell phone access with texting capability
Exclusion:
Psychosis (e.g., schizophrenia or bipolar disorder)
Suicidal
Developmental delay (moderate or severe mental retardation, or autism) or reading level below sixth grade
The presence of another physical health condition that results in atypical diabetes management (e.g., cystic fibrosis)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| April Carcone, PhD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40782842 | Result | Ellis DA, Carcone AI, Buggs-Saxton C, Bhan A, Dekelbab MB. Effects of individual, health system and neighborhood risks on diabetes health outcomes among emerging adults with type 1 diabetes. Diabetes Res Clin Pract. 2025 Sep;227:112415. doi: 10.1016/j.diabres.2025.112415. Epub 2025 Aug 7. | |
| 39110496 | Result | Idalski Carcone A, Holtz BE, Reardon M, Vesey D, Ellis DA, Parks M. Meeting the Needs of Emerging Adults With Type 1 Diabetes Living in a Rural Area With Mobile Health Interventions: Focus Group Study. JMIR Form Res. 2024 Aug 7;8:e55650. doi: 10.2196/55650. |
| Label | URL |
|---|---|
| Principal Investigator-hosted website to share the dissemination products from the research. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The participant enrollment process consisted of informed consent/assent procedures, baseline data collection, and randomization to one of eight study arms. Of the 113 enrolled participants, 109 were randomized and 4 were not: 1 found to be ineligible (age) post-enrollment and 3 were never randomized due to research staff error.
Recruitment into the clinical trial began on 11/16/2020 and ended 07/31/2024. The primary recruitment locations were local endocrinology clinics and advertising with national (e.g., T1D Exchange) and local (e.g., universities) community-based organizations and social media.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Question Prompt List (QPL) | A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit. |
| FG001 | Motivation Enhancement System (MES) | MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management. |
| FG002 | Text Message Reminders (TXT) | Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders. |
| FG003 | QPL & MES | Participants will receive the QPL and MES interventions as described above. |
| FG004 | QPL & TXT | Participants will receive the QPL and TXT interventions as described above. |
| FG005 | MES & TXT | Participants will receive the MES and TXT interventions as described above. |
| FG006 | MES, QPL & TXT | Participants will receive the MES, QPL, and TXT interventions as described above. |
| FG007 | Standard Medical Care | Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Question Prompt List (QPL) | A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Date of baseline data collection - date of birth |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin A1c | Hb1Ac will be obtained by using the Accubase A1c test kit. | Missing data resulting from participant withdrawal or incomplete HbA1c test kits | Posted | Mean | Standard Deviation | Percentage (%) of glycated hemoglobin | Baseline/0 month, Treatment End/3 months, and Follow Up/6 months |
|
AE data were formally elicited at each post-baseline study visit (3- and 6-months). AEs that were reported to research staff at any time after baseline and before the 6-month data collection (e.g. during a phone call to schedule data collection) were also recorded and reported.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Question Prompt List (QPL) | A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic Ketoacidosis (DKA) | Endocrine disorders | Systematic Assessment | DKA events are diagnosed by a qualified medical professional |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Emergency Diabetes-Related Event | Endocrine disorders | Systematic Assessment |
1) COVID-19 interruptions and other recruitment challenges led to under-enrollment and an an inability to conduct the planned analyses. 2) Changes in clinical practice over the course of the study resulted in many participants experiencing a change in their blood glucose monitoring device which, in turn, made the blood glucose monitoring metric (i.e., tests/day) missing for a significant proportion of the sample with and across participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| April Idalski Carcone, PhD, MSW | Wayne State University | 3135771057 | acarcone@med.wayne.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2026 | Mar 26, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2023 | Mar 26, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
The study will use an 8-arm full factorial design. In arms 1-3 participants will receive 1 of the 3 intervention components, arms 4-6 receive a combination of 2 components, arm 7 receives all 3 components, and arm 8 is the standard care control. The study will use the mixed effects linear model for the ANOVA of a factorial design powered on the main effects to identify the intervention components that significantly contribute to a clinically significant improvement in HbA1c. Each model will include a random intercept and slope and fixed effects for treatment combinations and time, as well as the stratification variable. The component selection experiment will result in empirical evidence supporting the efficacy of an autonomy support intervention composed of one or more components to improve metabolic control.
Not provided
Not provided
The outcomes assessor/data collector will be kept blind to treatment assignments to the extent possible in a behavioral trial.
| QPL & MES | Experimental | Participants will receive the QPL and MES interventions as described above. |
|
| QPL & TXT | Experimental | Participants will receive the QPL and TXT interventions as described above. |
|
| MES & TXT | Experimental | Participants will receive the MES and TXT interventions as described above. |
|
| MES, QPL & TXT | Experimental | Participants will receive the MES, QPL, and TXT interventions as described above. |
|
| Standard Medical Care | No Intervention | Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner. |
|
| Question Prompt List (QPL) | Behavioral | A QPL is a list of questions related to the physical and psychosocial aspects of diabetes and treatment that youth may want to ask their physicians during a clinic visit. The theoretical foundation for the QPL resides in social-cognitive theory which posits that behavioral performance is a function of self-efficacy and behavioral expectations. Thus, the goal of a QPL is to increase self-efficacy and active participation in clinical care. QPL is completed within 14-days of a diabetes clinic visit and results in a personalized set of questions for youth to bring to their clinic visit. |
|
| Text Message Reminders (TXT) | Behavioral | TXT is a behavioral support strategy composed of one-way text message reminders to promote daily diabetes care task completion. TXT is supported by social cognitive theory which suggests that consistent task completion leads to perceptions of control and supports goal attainment. TXT may also foster a stronger relationship with diabetes care providers through greater communication and satisfaction. Youth will receive daily reminders to complete key diabetes care tasks. |
|
| Baseline/0 month, Treatment End/3 months, and Follow Up/6 months |
| 41313164 | Result | Idalski Carcone A, Baskar D, Mahmood A, MacDonell K, Eggly S, Ghosh S, Buggs-Saxton C, Ondersma SJ, Ellis DA. Developing eHealth Interventions to Improve Diabetes Management in Emerging Adulthood: Qualitative Formative Study. JMIR Form Res. 2025 Nov 27;9:e75623. doi: 10.2196/75623. |
| 33079068 | Result | Idalski Carcone A, Ellis DA, Eggly S, MacDonell KE, Ghosh S, Buggs-Saxton C, Ondersma SJ. Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy. JMIR Res Protoc. 2020 Oct 20;9(10):e20191. doi: 10.2196/20191. |
| Motivation Enhancement System (MES) |
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management. |
| BG002 | Text Message Reminders (TXT) | Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders. |
| BG003 | QPL & MES | Participants will receive the QPL and MES interventions as described above. |
| BG004 | QPL & TXT | Participants will receive the QPL and TXT interventions as described above. |
| BG005 | MES & TXT | Participants will receive the MES and TXT interventions as described above. |
| BG006 | MES, QPL & TXT | Participants will receive the MES, QPL, and TXT interventions as described above. |
| BG007 | Standard Medical Care | Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner. |
| BG008 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Self-described gender identification | Count of Participants | Participants |
|
| Race (NIH/OMB) | Participant-described Race | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Participant-described Ethnicity | Count of Participants | Participants |
|
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
| OG002 | Text Message Reminders (TXT) | Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders. |
| OG003 | QPL & MES | Participants will receive the QPL and MES interventions as described above. |
| OG004 | QPL & TXT | Participants will receive the QPL and TXT interventions as described above. |
| OG005 | MES & TXT | Participants will receive the MES and TXT interventions as described above. |
| OG006 | MES, QPL & TXT | Participants will receive the MES, QPL, and TXT interventions as described above. |
| OG007 | Standard Medical Care | Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner. |
|
|
|
| Secondary | Diabetes Management Scale | The Diabetes Management Scale (DMS) is a self-report measure of diabetes illness management assessing a broad range of diabetes management behaviors, including insulin management, dietary management, blood glucose monitoring, and symptom response with good internal consistency (α=.74 to .84). Ten items ask "What percent of the time do you (diabetes care task)?" with a response scale of 0-100% where higher scores indicate greater (better) diabetes management. A total score, ranging form 0-100%, is obtained by calculating the average response across ten items to reflect overall management behavior. | Posted | Mean | Standard Deviation | Percentage score (%) | Baseline/0 month, Treatment End/3 months, and Follow Up/6 months |
|
|
|
|
| 0 |
| 15 |
| 3 |
| 15 |
| 3 |
| 15 |
| EG001 | Motivation Enhancement System (MES) | MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management. | 0 | 10 | 5 | 10 | 3 | 10 |
| EG002 | Text Message Reminders (TXT) | Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders. | 0 | 16 | 5 | 16 | 7 | 16 |
| EG003 | QPL & MES | Participants will receive the QPL and MES interventions as described above. | 0 | 12 | 3 | 12 | 2 | 12 |
| EG004 | QPL & TXT | Participants will receive the QPL and TXT interventions as described above. | 0 | 14 | 2 | 14 | 3 | 14 |
| EG005 | MES & TXT | Participants will receive the MES and TXT interventions as described above. | 0 | 17 | 6 | 17 | 7 | 17 |
| EG006 | MES, QPL & TXT | Participants will receive the MES, QPL, and TXT interventions as described above. | 0 | 11 | 4 | 11 | 6 | 11 |
| EG007 | Standard Medical Care | Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner. | 0 | 14 | 4 | 14 | 5 | 14 |
|
| Diabetes-related unscheduled visit | Endocrine disorders | Systematic Assessment |
|
| Psychiatric emergency | Psychiatric disorders | Systematic Assessment |
|
| Non-diabetes health problem | General disorders | Systematic Assessment |
|
| Non-Emergency Mental Health Condition | Psychiatric disorders | Systematic Assessment |
|
| Non-Diabetes Related Event | General disorders | Systematic Assessment |
|
| Behavioral / Social Events | General disorders | Systematic Assessment | Family or school conflict |
|
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Post-Treatment / 3 Months |
|
| Follow Up / 6 Months |
|
| .27 |
| Mean Difference (Final Values) |
| 2.25 |
| Standard Deviation |
| 13.92 |
| Superiority |
| Within group change in DMS from Baseline to 3-months | t-test, 1 sided | .086 | Mean Difference (Final Values) | 5.93 | Standard Deviation | 12.64 | Superiority |
| Within group change in DMS from Baseline to 6-months | t-test, 1 sided | .053 | Mean Difference (Final Values) | 7.29 | Standard Deviation | 12.86 | Superiority |
| Within group change in DMS from Baseline to 3-months | t-test, 1 sided | .068 | Mean Difference (Final Values) | 3.09 | Standard Deviation | 7.83 | Superiority |
| Within group change in DMS from Baseline to 6-months | t-test, 1 sided | .304 | Mean Difference (Final Values) | 1.23 | Standard Deviation | 9.41 | Superiority |
| Within group change in DMS from Baseline to 3-months | t-test, 1 sided | .003 | Mean Difference (Final Values) | 10.34 | Standard Deviation | 10.81 | Superiority |
| Within group change in DMS from Baseline to 6-months | t-test, 1 sided | .002 | Mean Difference (Final Values) | 10.61 | Standard Deviation | 10.36 | Superiority |
| Within group change in DMS from Baseline to 3-months | t-test, 1 sided | .096 | Mean Difference (Final Values) | 2.74 | Standard Deviation | 7.15 | Superiority |
| Within group change in DMS from Baseline to 6-months | t-test, 1 sided | .017 | Mean Difference (Final Values) | 7.25 | Standard Deviation | 10.94 | Superiority |
| Within group change in DMS from Baseline to 3-months | t-test, 1 sided | .319 | Mean Difference (Final Values) | 1.63 | Standard Deviation | 13.64 | Superiority |
| Within group change in DMS from Baseline to 6-months | t-test, 1 sided | .128 | Mean Difference (Final Values) | 3.20 | Standard Deviation | 10.84 | Superiority |
| Within group change in DMS from Baseline to 3-months | t-test, 1 sided | .024 | Mean Difference (Final Values) | 9.76 | Standard Deviation | 14.44 | Superiority |
| Within group change in DMS from Baseline to 6-months | t-test, 1 sided | .033 | Mean Difference (Final Values) | 11.28 | Standard Deviation | 18.09 | Superiority |
| Within group change in DMS from Baseline to 3-months | t-test, 1 sided | .102 | Mean Difference (Final Values) | 5.51 | Standard Deviation | 15.42 | Superiority |
| Within group change in DMS from Baseline to 6-months | t-test, 1 sided | .054 | Mean Difference (Final Values) | 7.66 | Standard Deviation | 16.63 | Superiority |