Trial Outcomes & Findings for Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T) (NCT NCT04023487)

Last Updated: 2024-08-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

209 participants

Primary outcome timeframe

Assessed at Baseline and 6 months; change from baseline to 6 months reported

Results posted on

2024-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	104	105
Overall Study COMPLETED	86	90
Overall Study NOT COMPLETED	18	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	5	4
Overall Study Pregnancy	1	2
Overall Study Withdrawal by Subject	4	5
Overall Study Partially completed testing	8	4

Baseline Characteristics

Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Intervention n=104 Participants 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.	Usual Care n=105 Participants Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.	Total n=209 Participants Total of all reporting groups
Age, Continuous	23.88 years STANDARD_DEVIATION 3.78 • n=5 Participants	24.77 years STANDARD_DEVIATION 3.62 • n=7 Participants	24.33 years STANDARD_DEVIATION 3.72 • n=5 Participants
Sex/Gender, Customized Male	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Sex/Gender, Customized Female	62 Participants n=5 Participants	63 Participants n=7 Participants	125 Participants n=5 Participants
Sex/Gender, Customized Other	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex/Gender, Customized Decline to Answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latinx	49 Participants n=5 Participants	42 Participants n=7 Participants	91 Participants n=5 Participants
Race/Ethnicity, Customized White	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized >1 Race/ethnicity	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Decline to Answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	104 participants n=5 Participants	105 participants n=7 Participants	209 participants n=5 Participants
Recruitment Source Clinic	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Recruitment Source Social Media (California)	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Recruitment Source Social Media (Texas)	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Recruitment Source Social Media (Oregon, Washington, Colorado)	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Household composition (non-exclusive) Alone	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Household composition (non-exclusive) With parents	50 Participants n=5 Participants	44 Participants n=7 Participants	94 Participants n=5 Participants
Household composition (non-exclusive) With roommates	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Household composition (non-exclusive) With partner	39 Participants n=5 Participants	34 Participants n=7 Participants	73 Participants n=5 Participants
Household composition (non-exclusive) Missing/Declined to State	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Household size	3.62 Persons STANDARD_DEVIATION 1.81 • n=5 Participants	3.65 Persons STANDARD_DEVIATION 2.00 • n=7 Participants	3.63 Persons STANDARD_DEVIATION 1.91 • n=5 Participants
Educational Attainment Some High School	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Educational Attainment High School Graduate	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants
Educational Attainment Some college/AA degree	51 Participants n=5 Participants	38 Participants n=7 Participants	89 Participants n=5 Participants
Educational Attainment Bachelor's Degree	17 Participants n=5 Participants	31 Participants n=7 Participants	48 Participants n=5 Participants
Educational Attainment Graduate Degree	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Educational Attainment Decline to Answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Employment Status (non-exclusive) Student	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Employment Status (non-exclusive) Full-time work	42 Participants n=5 Participants	48 Participants n=7 Participants	90 Participants n=5 Participants
Employment Status (non-exclusive) Part-time work	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Employment Status (non-exclusive) Full-time homemaker	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Employment Status (non-exclusive) Unemployed	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Employment Status (non-exclusive) On leave	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Employment Status (non-exclusive) Disabled	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Employment Status (non-exclusive) Other/decline to answer	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Health Insurance (non-exclusive) Private	53 Participants n=5 Participants	57 Participants n=7 Participants	110 Participants n=5 Participants
Health Insurance (non-exclusive) MediCal/Medicaid	38 Participants n=5 Participants	43 Participants n=7 Participants	81 Participants n=5 Participants
Health Insurance (non-exclusive) Other public insurance	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Health Insurance (non-exclusive) No Insurance	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Health Insurance (non-exclusive) Don't know	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Health Insurance (non-exclusive) Decline to answer	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Social Deprivation Index (SDI)	63.11 units on a scale STANDARD_DEVIATION 27.99 • n=5 Participants	63.92 units on a scale STANDARD_DEVIATION 27.04 • n=7 Participants	63.52 units on a scale STANDARD_DEVIATION 27.46 • n=5 Participants
Social Vulnerability Index (SVI)	0.57 units on a scale STANDARD_DEVIATION 0.28 • n=5 Participants	0.55 units on a scale STANDARD_DEVIATION 0.29 • n=7 Participants	0.56 units on a scale STANDARD_DEVIATION 0.29 • n=5 Participants
Social Needs	2.13 units on a scale STANDARD_DEVIATION 1.87 • n=5 Participants	2.07 units on a scale STANDARD_DEVIATION 1.80 • n=7 Participants	2.10 units on a scale STANDARD_DEVIATION 1.83 • n=5 Participants
T1D diagnosis age	10.77 years STANDARD_DEVIATION 6.01 • n=5 Participants	12.22 years STANDARD_DEVIATION 5.94 • n=7 Participants	11.50 years STANDARD_DEVIATION 6.00 • n=5 Participants
Baseline A1c	9.12 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.44 • n=5 Participants	9.26 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.66 • n=7 Participants	9.19 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.55 • n=5 Participants
Diabetes device use Injections only	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Diabetes device use Insulin pump only	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Diabetes device use Injections + CGM	27 Participants n=5 Participants	20 Participants n=7 Participants	47 Participants n=5 Participants
Diabetes device use Pump + CGM	33 Participants n=5 Participants	38 Participants n=7 Participants	71 Participants n=5 Participants
Diabetes device use Other combination	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at Baseline and 6 months; change from baseline to 6 months reported

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=104 Participants 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.	Usual Care n=105 Participants Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C)	-0.44 percentage of glycosylated hemoglobin Standard Deviation 1.22	-0.31 percentage of glycosylated hemoglobin Standard Deviation 1.35

SECONDARY outcome

Timeframe: Assessed at Baseline and 6 months; change from baseline to 6 months reported

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=104 Participants 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.	Usual Care n=105 Participants Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
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)	0.39 score on a scale Standard Deviation 1.37	-0.15 score on a scale Standard Deviation 1.59

SECONDARY outcome

Timeframe: Assessed at Baseline and 6 months; change from baseline to 6 months reported

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.'

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=104 Participants 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.	Usual Care n=105 Participants Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the "Diabetes Distress Scale" (DDS)	-0.48 score on a scale Standard Deviation 1.01	-0.25 score on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: Baseline, 6 months, and 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at Baseline and 6 months; change from baseline to 6 months reported

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=104 Participants 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.	Usual Care n=105 Participants Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range	4.44 percentage of time Standard Deviation 22.18	1.02 percentage of time Standard Deviation 24.02

SECONDARY outcome

Timeframe: Assessed at Baseline and 6 months; change from baseline to 6 months reported

The percentage of time when blood glucose was above 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=104 Participants 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.	Usual Care n=105 Participants Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia	-4.48 percentage of time Standard Deviation 24.68	-1.61 percentage of time Standard Deviation 26.5

SECONDARY outcome

Timeframe: Assessed at Baseline and 6 months; change from baseline to 6 months reported

The percentage of time when blood glucose was below 70 mg/dl, as measured by a continuous glucose monitor worn for 14 days.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=104 Participants 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.	Usual Care n=105 Participants Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia	0.04 percentage of time Standard Deviation 4.99	0.59 percentage of time Standard Deviation 5.09

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

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?").

Outcome measures

Outcome data not reported

Adverse Events

Lifestyle Intervention

Serious events: 34 serious events

Other events: 8 other events

Deaths: 0 deaths

Usual Care

Serious events: 28 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Lifestyle Intervention n=104 participants at risk 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.	Usual Care n=105 participants at risk Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
Endocrine disorders Physical symptom (not serious, not study-related)	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
General disorders Physical symptom (not serious, not study-related)	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Infections and infestations Physical symptom (not serious, not study-related)	1.9% 2/104 • Number of events 2 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Injury, poisoning and procedural complications Physical symptom (not serious, not study-related)	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Musculoskeletal and connective tissue disorders Physical symptom (not serious, not study-related)	2.9% 3/104 • Number of events 3 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Product Issues Physical symptom (not serious, Study-related)	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	1.9% 2/105 • Number of events 2 • 24 months AE reports reflect a conservative approach to reporting.
Psychiatric disorders Psychological symptom (not serious, not study-related)	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Psychiatric disorders Psychological symptom (not serious, Study-related)	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.

Additional Information

Beth Pyatak

University of Southern California

Phone: 323-442-2615

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lifestyle Intervention n=104 participants at risk 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.	Usual Care n=105 participants at risk Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
Gastrointestinal disorders Inpatient Hospitalization: not study related; not hyperglycemia; not hypglycemia	1.9% 2/104 • Number of events 2 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
General disorders Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Infections and infestations Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	2.9% 3/105 • Number of events 3 • 24 months AE reports reflect a conservative approach to reporting.
Musculoskeletal and connective tissue disorders Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Psychiatric disorders Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Reproductive system and breast disorders Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Vascular disorders Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Gastrointestinal disorders Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Nervous system disorders Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	1.9% 2/104 • Number of events 2 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Cardiac disorders Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Endocrine disorders Severe hypoglycemia (not study-related) -> seizure, loss of consciousness, or emergency transport	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Endocrine disorders Severe hyperglycemia or diabetic ketoacidosis (not study-related)	3.8% 4/104 • Number of events 4 • 24 months AE reports reflect a conservative approach to reporting.	2.9% 3/105 • Number of events 3 • 24 months AE reports reflect a conservative approach to reporting.
General disorders Severe hyperglycemia or diabetic ketoacidosis (not study-related)	1.9% 2/104 • Number of events 2 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Endocrine disorders Important medical event based upon appropriate medical judgment (not study-related)	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	1.9% 2/105 • Number of events 2 • 24 months AE reports reflect a conservative approach to reporting.
Gastrointestinal disorders Important medical event based upon appropriate medical judgment (not study-related)	1.9% 2/104 • Number of events 2 • 24 months AE reports reflect a conservative approach to reporting.	2.9% 3/105 • Number of events 3 • 24 months AE reports reflect a conservative approach to reporting.
General disorders Important medical event based upon appropriate medical judgment (not study-related)	2.9% 3/104 • Number of events 3 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Immune system disorders Important medical event based upon appropriate medical judgment (not study-related)	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	1.9% 2/105 • Number of events 2 • 24 months AE reports reflect a conservative approach to reporting.
Infections and infestations Important medical event based upon appropriate medical judgment (not study-related)	2.9% 3/104 • Number of events 3 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Injury, poisoning and procedural complications Important medical event based upon appropriate medical judgment (not study-related)	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Musculoskeletal and connective tissue disorders Important medical event based upon appropriate medical judgment (not study-related)	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.
Nervous system disorders Important medical event based upon appropriate medical judgment (not study-related)	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Surgical and medical procedures Important medical event based upon appropriate medical judgment (not study-related)	0.00% 0/104 • 24 months AE reports reflect a conservative approach to reporting.	0.95% 1/105 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.
Product Issues Important medical event based upon appropriate medical judgment (not study-related)	0.96% 1/104 • Number of events 1 • 24 months AE reports reflect a conservative approach to reporting.	0.00% 0/105 • 24 months AE reports reflect a conservative approach to reporting.