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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK116719 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will evaluate (1) the efficacy of REAL-T, a lifestyle-based telehealth intervention, in improving glycemic control (HbA1c) and psychosocial outcomes, (2) which effects are retained over a 6-month follow-up period, and (3) the mediating mechanisms responsible for the intervention's effects. Half of participants will receive REAL-T, while the other half will receive their usual care.
Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will address the unmet self-management and psychosocial needs of young adults (YAs) with type 1 diabetes (T1D).
We will conduct a large-scale randomized controlled trial (n=210) to compare the 6-month REAL-T intervention to usual care in improving glycemic control (A1c and continuous glucose monitor-derived measures), psychosocial well-being, and hypothesized intervention mediators. In addition, we will perform health economic analyses to determine the extent to which REAL-T is cost-effective or produces cost savings.
The study's specific aims are as follows:
Aim 1: Evaluate the efficacy of REAL-T in improving glycemic control and psychosocial well-being.
Aim 2: Assess the post-intervention durability (at 3 and 6 months post-intervention) of REAL-T's effects on glycemic control and psychosocial well-being.
Aim 3: Examine mediating mechanisms of the REAL-T intervention's effects on glycemic control and psychosocial well-being through structural equation modeling (SEM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental | Resilient, Empowered, Active Living-Telehealth (REAL-T) |
|
| Usual Care | No Intervention | Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilient, Empowered, Active Living-Telehealth (REAL-T) | Behavioral | REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C) | HbA1C is a measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C will be measured using a finger-prick test using the DCA Vantage Analyzer point-of-care system OR AccuBase A1c test with DTI Laboratories. Assessed at Baseline and 6 months; change from baseline to 6 months reported. | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 6-months Post-test in Diabetes-related Quality of Life, Using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15) | 15-item questionnaire assessing diabetes-related quality of life (qol). Each item contains two parts. Part A is: "If I did not have diabetes, [the question topic] would be", followed by 5 options ranging from "very much better" (or similar; scored as -3) to "worse" (or similar; scored as 1). The fourth option is always "the same" and scored as 0. Part B is: "[the question topic] is" followed by 4 options ranging from "very important" (scored as 3) to "not at all important" (scored as 0). For each question, scores on parts A and B are multiplied, and the 15 products are summed for a total score. Questions 2, 4, 6, 8, 9, & 11 have preliminary yes/no questions, and when a "no" response is given, parts A and B are skipped and the score for that question is 0. The minimum score on each question is -9 and the maximum is 3, with total scores ranging from -135 to 45. Higher/more positive scores represent a better outcome; Lower/ more negative scores represent a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Pyatak, PhD, OTR/L | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Center for Health Professionals | Los Angeles | California | 90033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Intervention | Resilient, Empowered, Active Living-Telehealth (REAL-T) Resilient, Empowered, Active Living-Telehealth (REAL-T): REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol. |
| FG001 | Usual Care | Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Intervention | Resilient, Empowered, Active Living-Telehealth (REAL-T) Resilient, Empowered, Active Living-Telehealth (REAL-T): REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C) | HbA1C is a measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C will be measured using a finger-prick test using the DCA Vantage Analyzer point-of-care system OR AccuBase A1c test with DTI Laboratories. Assessed at Baseline and 6 months; change from baseline to 6 months reported. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
|
24 months
AE reports reflect a conservative approach to reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle Intervention | Resilient, Empowered, Active Living-Telehealth (REAL-T) Resilient, Empowered, Active Living-Telehealth (REAL-T): REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization: not study related; not hyperglycemia; not hypglycemia | Gastrointestinal disorders | Systematic Assessment | vomiting with blood in it (n=1), or abdominal pain (n=1), or appendicitis (n=1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Physical symptom (not serious, not study-related) | Endocrine disorders | Systematic Assessment | low blood sugar levels |
COVID-19/public health policies may have affected data. COVID-19 led to changes in outcome assessment methods (in-person vs self-administered surveys; Afinion POC vs AccuBase mail-in A1c test) and caused other logistical challenges affecting data collection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Pyatak | University of Southern California | 323-442-2615 | beth.pyatak@chan.usc.edu |
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| 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 | Jun 8, 2022 | Jun 27, 2024 | Prot_SAP_000.pdf |
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| 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 |
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|
| Assessed at Baseline and 6 months; change from baseline to 6 months reported |
| Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the "Diabetes Distress Scale" (DDS) | 17-item questionnaire assessing diabetes-related emotional distress. Total scores (mean score on all 17 items) range from 1 to 6, with higher scores indicating a worse outcome. Sub-scale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress) each range from 1 to 6, with higher scores indicating a worse outcome. A total or sub-scale score 2.0 - 2.9 should be considered 'moderate distress,' and a total or sub-scale score > 3.0 should be considered 'high distress.' | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
| Change in Functional Health and Well-being, Using the "SF-12v2® Health Survey" | Short Form 12-item Health Survey Ver. 2 (SF-12v2) is a 12-item questionnaire assessing functional health & well-being over the last 4 weeks in 8 health domains (physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, mental health), all from the patient's point of view. These 8 domains can be summarized into a physical component summary (PCS) and a mental component summary (MCS). Higher scores indicate a better health state. MCS and PCS scores range from 0-100. Scores are calibrated using general population-derived normative data so that 50 is the avg score or norm. Results can be further summarized into a single preference-based health utility number ranging from 1 (equivalent to perfect health) to 0 (equivalent to being dead), using a complex scoring algorithm (SF-6D) derived from surveying a general U.S. population's preferences for specific health states. | Baseline, 6 months, and 12 months |
| Change in Global Diabetes Self-management, Using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R). | 27-item questionnaire assessing self-care activities associated with glycemic control. Higher values indicate more effective self-management. Transformed scores = Actual sum of items / maximum possible sum of items x 10. Total transformed scores range from 0 to 10. Transformed scores on six sub-scales (Dietary control, Glucose management, Glucose monitoring, Medication adherence, Physical activity, and Physician contact) also range from 0 to 10. | Baseline, 3 months, 6 months, 9 months, and 12 months |
| Change in Medication Adherence, Using the "3-item Adherence Self-report Scale" Questionnaire | 3-item questionnaire (Wilson,Lee, Fowler, & Rogers, 2016) assessing adherence to diabetes medication regimen. Item responses for the three adherence items are linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best. A total summary score is calculated as the mean of the three individual items, with a range of 0 to 100. | Baseline, 3 months, 6 months, 9 months, and 12 months |
| Change in Self-efficacy for Performing Diabetes Self-management, Using the "Diabetes Empowerment Scale - Short Form" (DES-SF) | 8-item questionnaire assessing self-efficacy for performing diabetes self-management, using 5-point likert scales. The scale is scored by averaging the scores of all completed items. Scores range from 8 to 40, with higher scores indicating higher self-efficacy. | Baseline, 3 months, 6 months, 9 months, and 12 months |
| Change in Autonomy of Taking Insulin and/or Checking Blood Sugar, Using the "Treatment Self-Regulation Questionnaire" (TSRQ) | 19-item questionnaire, adapted for type 1 diabetes, assessing the degree to which a person's motivation for a particular behavior or a set of behaviors is relatively autonomous or self-determined. Each item can receive a value ranging from 1 - 7 as selected by the participant. The scale has 2 sub-scales: the autonomous regulatory style and the controlled regulatory style. Calculating the scores for the sub-scales consists of averaging the items on that sub-scale. A Relative Autonomous Motivation Index can be formed by subtracting the average for the controlled reasons from the average for the autonomous reasons. Scores range from 1 to 7, with 7 indicating a strong identification with the given autonomy style. The autonomous regulatory style represents the most self-determined form of motivation. | Baseline, 3 months, 6 months, 9 months, and 12 months |
| Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range | The percentage of time when blood glucose was between 70 and 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days. | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
| Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia | The percentage of time when blood glucose was above 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days. | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
| Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia | The percentage of time when blood glucose was below 70 mg/dl, as measured by a continuous glucose monitor worn for 14 days. | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
| Change in Cost to Patients | 9 diabetes-related expense questions designed by the study (polar questions, multiple choice, and open-ended). Questions assess loss of income or other productivity due to diabetes (3 items), and impact of cost and health insurance on access to and use of insulin and test strips (6 items). | Baseline, 3 months, 6 months, 9 months, and 12 months |
| Change in Cost to Payor | 8-item healthcare utilization questionnaire designed by the study. Polar; Yes/No questions about health service usage in the last month: (e.g., "have you had to be admitted to the hospital?"). Open-ended questions about number of time health services were used, (e.g., "how many times were you admitted to the hospital for reasons related to diabetes?"). | Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months |
| Withdrawal by Subject |
|
| Partially completed testing |
|
| BG001 | Usual Care | Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Recruitment Source | Count of Participants | Participants |
|
| Household composition (non-exclusive) | Household Composition (non-exclusive). Participants can be counted more than once in the appropriate category. | Count of Participants | Participants |
|
| Household size | Mean | Standard Deviation | Persons |
|
| Educational Attainment | Count of Participants | Participants |
|
| Employment Status (non-exclusive) | Employment Status (non-exclusive). Participants can be counted more than once in the appropriate category. | Count of Participants | Participants |
|
| Health Insurance (non-exclusive) | Count of Participants | Participants |
|
| Social Deprivation Index (SDI) | Social Deprivation Index (SDI) is a composite measure of area level deprivation based on seven demographic characteristics collected in the American Community Survey and used to quantify the socio-economic variation in health outcomes. Total range: 0-100 (Higher values indicate greater social deprivation, representing a worse outcome.) | Mean | Standard Deviation | units on a scale |
|
| Social Vulnerability Index (SVI) | Social Vulnerability Index (SVI) is a place-based index, database, and mapping application designed to identify and quantify communities experiencing social vulnerability, which refers to the demographic and socioeconomic factors that adversely affect communities that encounter hazards and other community-level stressors. Total range: 0-100 (Higher values indicate greater social vulnerability, representing a worse outcome.) | Mean | Standard Deviation | units on a scale |
|
| Social Needs | Social Needs is a study-designed questionnaire adapted from the Health Leads Social Needs Screening Tool for assessing various social needs. These needs span categories such as housing, food, transportation, utilities, child care, employment, education, and finances. Total range: 0-10 (higher scores indicate greater social needs). citation: Health Leads. (2023). The Health Leads Screening Toolkit. Available at: https://healthleadsusa.org/communications-center/resources/the-health-leads-screening-toolkit/ | Mean | Standard Deviation | units on a scale |
|
| T1D diagnosis age | Mean | Standard Deviation | years |
|
| Baseline A1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Diabetes device use | Count of Participants | Participants |
|
| OG001 | Usual Care | Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention. |
|
|
| Secondary | Change From Baseline to 6-months Post-test in Diabetes-related Quality of Life, Using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15) | 15-item questionnaire assessing diabetes-related quality of life (qol). Each item contains two parts. Part A is: "If I did not have diabetes, [the question topic] would be", followed by 5 options ranging from "very much better" (or similar; scored as -3) to "worse" (or similar; scored as 1). The fourth option is always "the same" and scored as 0. Part B is: "[the question topic] is" followed by 4 options ranging from "very important" (scored as 3) to "not at all important" (scored as 0). For each question, scores on parts A and B are multiplied, and the 15 products are summed for a total score. Questions 2, 4, 6, 8, 9, & 11 have preliminary yes/no questions, and when a "no" response is given, parts A and B are skipped and the score for that question is 0. The minimum score on each question is -9 and the maximum is 3, with total scores ranging from -135 to 45. Higher/more positive scores represent a better outcome; Lower/ more negative scores represent a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
|
|
|
| Secondary | Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the "Diabetes Distress Scale" (DDS) | 17-item questionnaire assessing diabetes-related emotional distress. Total scores (mean score on all 17 items) range from 1 to 6, with higher scores indicating a worse outcome. Sub-scale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress) each range from 1 to 6, with higher scores indicating a worse outcome. A total or sub-scale score 2.0 - 2.9 should be considered 'moderate distress,' and a total or sub-scale score > 3.0 should be considered 'high distress.' | Posted | Mean | Standard Deviation | score on a scale | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
|
|
|
| Secondary | Change in Functional Health and Well-being, Using the "SF-12v2® Health Survey" | Short Form 12-item Health Survey Ver. 2 (SF-12v2) is a 12-item questionnaire assessing functional health & well-being over the last 4 weeks in 8 health domains (physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, mental health), all from the patient's point of view. These 8 domains can be summarized into a physical component summary (PCS) and a mental component summary (MCS). Higher scores indicate a better health state. MCS and PCS scores range from 0-100. Scores are calibrated using general population-derived normative data so that 50 is the avg score or norm. Results can be further summarized into a single preference-based health utility number ranging from 1 (equivalent to perfect health) to 0 (equivalent to being dead), using a complex scoring algorithm (SF-6D) derived from surveying a general U.S. population's preferences for specific health states. | Not Posted | Baseline, 6 months, and 12 months | Participants |
| Secondary | Change in Global Diabetes Self-management, Using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R). | 27-item questionnaire assessing self-care activities associated with glycemic control. Higher values indicate more effective self-management. Transformed scores = Actual sum of items / maximum possible sum of items x 10. Total transformed scores range from 0 to 10. Transformed scores on six sub-scales (Dietary control, Glucose management, Glucose monitoring, Medication adherence, Physical activity, and Physician contact) also range from 0 to 10. | Not Posted | Baseline, 3 months, 6 months, 9 months, and 12 months | Participants |
| Secondary | Change in Medication Adherence, Using the "3-item Adherence Self-report Scale" Questionnaire | 3-item questionnaire (Wilson,Lee, Fowler, & Rogers, 2016) assessing adherence to diabetes medication regimen. Item responses for the three adherence items are linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best. A total summary score is calculated as the mean of the three individual items, with a range of 0 to 100. | Not Posted | Baseline, 3 months, 6 months, 9 months, and 12 months | Participants |
| Secondary | Change in Self-efficacy for Performing Diabetes Self-management, Using the "Diabetes Empowerment Scale - Short Form" (DES-SF) | 8-item questionnaire assessing self-efficacy for performing diabetes self-management, using 5-point likert scales. The scale is scored by averaging the scores of all completed items. Scores range from 8 to 40, with higher scores indicating higher self-efficacy. | Not Posted | Baseline, 3 months, 6 months, 9 months, and 12 months | Participants |
| Secondary | Change in Autonomy of Taking Insulin and/or Checking Blood Sugar, Using the "Treatment Self-Regulation Questionnaire" (TSRQ) | 19-item questionnaire, adapted for type 1 diabetes, assessing the degree to which a person's motivation for a particular behavior or a set of behaviors is relatively autonomous or self-determined. Each item can receive a value ranging from 1 - 7 as selected by the participant. The scale has 2 sub-scales: the autonomous regulatory style and the controlled regulatory style. Calculating the scores for the sub-scales consists of averaging the items on that sub-scale. A Relative Autonomous Motivation Index can be formed by subtracting the average for the controlled reasons from the average for the autonomous reasons. Scores range from 1 to 7, with 7 indicating a strong identification with the given autonomy style. The autonomous regulatory style represents the most self-determined form of motivation. | Not Posted | Baseline, 3 months, 6 months, 9 months, and 12 months | Participants |
| Secondary | Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range | The percentage of time when blood glucose was between 70 and 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days. | Posted | Mean | Standard Deviation | percentage of time | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
|
|
|
| Secondary | Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia | The percentage of time when blood glucose was above 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days. | Posted | Mean | Standard Deviation | percentage of time | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
|
|
|
| Secondary | Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia | The percentage of time when blood glucose was below 70 mg/dl, as measured by a continuous glucose monitor worn for 14 days. | Posted | Mean | Standard Deviation | percentage of time | Assessed at Baseline and 6 months; change from baseline to 6 months reported |
|
|
|
| Secondary | Change in Cost to Patients | 9 diabetes-related expense questions designed by the study (polar questions, multiple choice, and open-ended). Questions assess loss of income or other productivity due to diabetes (3 items), and impact of cost and health insurance on access to and use of insulin and test strips (6 items). | Not Posted | Baseline, 3 months, 6 months, 9 months, and 12 months | Participants |
| Secondary | Change in Cost to Payor | 8-item healthcare utilization questionnaire designed by the study. Polar; Yes/No questions about health service usage in the last month: (e.g., "have you had to be admitted to the hospital?"). Open-ended questions about number of time health services were used, (e.g., "how many times were you admitted to the hospital for reasons related to diabetes?"). | Not Posted | Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months | Participants |
| 0 |
| 104 |
| 34 |
| 104 |
| 8 |
| 104 |
| EG001 | Usual Care | Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention. | 0 | 105 | 28 | 105 | 7 | 105 |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | General disorders | Systematic Assessment | orthostatic hypotension (n=1), or diabetic foot ulcer (n=1), or urinary tract infection + blood clot (n=1), or unknown reason (n=2), |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | Infections and infestations | Systematic Assessment | "stomach infection" unrelated to diabetes (n=1), or COVID-19 (n=1), or unknown infection (n=1) |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | Musculoskeletal and connective tissue disorders | Systematic Assessment | ankle fracture |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | Psychiatric disorders | Systematic Assessment | mental health issues (further details not known) (n=2) |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | Reproductive system and breast disorders | Systematic Assessment | gynecological surgery |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | Vascular disorders | Systematic Assessment | stroke |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | Gastrointestinal disorders | Non-systematic Assessment | appendectomy |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | Nervous system disorders | Non-systematic Assessment | seizures (n=1), or MRI for unknown reason (n=1) |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | Cardiac disorders | Non-systematic Assessment | heart surgery (unrelated to diabetes) |
|
| Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia | General disorders | Non-systematic Assessment | "stress-related diabetes issue" |
|
| Severe hypoglycemia (not study-related) -> seizure, loss of consciousness, or emergency transport | Endocrine disorders | Systematic Assessment |
|
| Severe hypoglycemia (not study-related) -> seizure, loss of consciousness, or emergency transport | Endocrine disorders | Non-systematic Assessment |
|
| Severe hyperglycemia or diabetic ketoacidosis (not study-related) | Endocrine disorders | Systematic Assessment |
|
| Severe hyperglycemia or diabetic ketoacidosis (not study-related) | Endocrine disorders | Non-systematic Assessment |
|
| Severe hyperglycemia or diabetic ketoacidosis (not study-related) | General disorders | Systematic Assessment |
|
| Severe hyperglycemia or diabetic ketoacidosis (not study-related) | General disorders | Non-systematic Assessment |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Endocrine disorders | Systematic Assessment | unknown diabetes-related issue (n=1), or loss of consciousness (diabetes-related) (n=1) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Gastrointestinal disorders | Systematic Assessment | vomiting due to medication (unrelated to diabetes) (n=1), or "stomach issues" (unrelated to diabetes) (n=1), or appendix or gallbladder issue (unrelated to diabetes) (n=1), or food poisoning/dehydration (n=1), or "gastro" (n=1) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | General disorders | Systematic Assessment | swollen foot, retinopathy, chest pain, cocaine overdose/heart problems, diabetic neuropathy, Crohn's disease, car or motorcycle accident, abdominal pain, hand foot and mouth disease, fainting after COVID-19 vaccine, or unknown reason |
|
| Important medical event based upon appropriate medical judgment (not study-related) | General disorders | Non-systematic Assessment | diabetes-related gastroparesis (n=1), or blood clot + urinary tract infection + pancreatitis + gallstones (n=1), or respiratory issues requiring nebulizer (n=1) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Immune system disorders | Systematic Assessment | anaphylactic reaction (n=1), or allergic reaction (n=1) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Infections and infestations | Systematic Assessment | eye infection (n=1), or kidney infection (unrelated to diabetes) (n=1), or kidney infection (related to diabetes (n=1), or mastitis (n=1), or COVID-19 (n=3), or respiratory syncytial virus (n=1) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Infections and infestations | Non-systematic Assessment | abscess (n=2), or COVID-19 (n=1) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Injury, poisoning and procedural complications | Systematic Assessment | unknown infection (unrelated to diabetes) (n=1), or food poisoning (n=2) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Injury, poisoning and procedural complications | Non-systematic Assessment | food poisoning |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Musculoskeletal and connective tissue disorders | Systematic Assessment | broken patella (n=1), or broken arm (n=1), or broken wrist from horseback riding accident (n=1) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | broken arm |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Nervous system disorders | Systematic Assessment | concussion (unrelated to diabetes) (n=1) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Surgical and medical procedures | Systematic Assessment | issues with picc line (unrelated to diabetes) |
|
| Important medical event based upon appropriate medical judgment (not study-related) | Product Issues | Systematic Assessment | "sensor copper wire lost in stomach" (not from any study-related CGM) |
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| Physical symptom (not serious, not study-related) | General disorders | Systematic Assessment | acid reflux, related to diabetes |
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| Physical symptom (not serious, not study-related) | Infections and infestations | Systematic Assessment | stomach flu (n=1), or flu/cold symptoms (n=1) |
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| Physical symptom (not serious, not study-related) | Injury, poisoning and procedural complications | Systematic Assessment | food poisoning/dehydration |
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| Physical symptom (not serious, not study-related) | Endocrine disorders | Non-systematic Assessment | hypoglycemia (though no loss of consciousness or seizure) |
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| Physical symptom (not serious, not study-related) | Infections and infestations | Non-systematic Assessment | cyst/mass (n=1), or walking pneumonia (n=1) |
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| Physical symptom (not serious, not study-related) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | finger injury for shopping cart (n=1), or ankle injury from skateboarding (n=1), or elbow injury/inflammation (n=1) |
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| Physical symptom (not serious, Study-related) | Product Issues | Non-systematic Assessment | Skin reaction/irritation from study CGM or adhesive tape used to apply study CGM |
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| Psychological symptom (not serious, not study-related) | Psychiatric disorders | Systematic Assessment | stress |
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| Psychological symptom (not serious, Study-related) | Psychiatric disorders | Non-systematic Assessment | Participant reported that they disliked/disagreed with several questions on study questionnaires, especially questions about food because they have an eating disorder. |
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Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |