An interventional study of Living Healthier with Diabetes in Diabetes Mellitus, Type 2, sponsored by Texas A&M University. Completed at 1 site in United States. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Texas A&M University · Not applicable, Interventional, and Supportive care
Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.
Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.
These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions.
A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 191 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Virtual asynchronous training and periodic one-on-one counseling with a clinical diabetes educator, either a Registered Nurse (RN) or Registered Dietitian Nutritionist (RDN). The program was recognized by the American Diabetes Association during this study. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, and 3 and 6-month follow-ups.
Behavioral: Living Healthier with Diabetes
Smartphone application for more continuous but less structured chat support. This app was recognized by the American Diabetes Association. The intervention included access to online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.
Behavioral: Living Healthier with Diabetes
A combined approach for maximal support and reinforcement. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, access to the app with online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.
Behavioral: Living Healthier with Diabetes
Interventions are different aspects of digital health utilizing American Diabetes Association recognized diabetes programs/applications or a combined approach. All participants were randomly assigned to their education arm and received an A1c kit, glucometer, testing strips, and surveys.
A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.
A1C values will be treated continuously in analyses, with possible values ranging from 4 to 14 due to instrument precision at the higher values.
Time frame: 12 months
Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version).
Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version). 10 True False questions will be included with answers of True, False, and I don't know. Correct responses receive 1 point indicating a range of 0-10 points for this outcome measure.
Time frame: 12 months
Diabetes Self Care
Diabetes self-management behavior will be measured by the adapted Summary of Diabetes Self-Care Activities Measure (SDSCA). The SDSCA is a brief self-report questionnaire that includes items assessing the following aspects of the diabetes regimen: general diet, specific exercise, blood-glucose testing, foot care, alcohol, and smoking. The scale has been adapted to examine self-care activities before and since COVID-19. Furthermore, a question about alcohol drinking has been added. Diabetes Self-care is the number of days a participant performed certain activities pertaining to diabetes care in a typical week. The diabetes self care scale is 8 questions asking how many days per week a participant engaged in a behavior on a scale of 0-7 days. Therefore, the scale ranged from 0-56 points, with higher points indicating greater occurrence of diabetes self care.
Time frame: 12 months
Diabetes Care Confidence
Confidence in doing specific activities related to diabetes will be measured by the Self-Efficacy for Diabetes Scale. The scale is a self-report instrument that asks how confident individuals feel doing specific activities related to diabetes (e.g., diet, exercise, blood sugar monitoring).Diabetes confidence is how confident a participant is in their own ability to perform certain activities. To analyze this, a sum of 8 questions was taken. Diabetes confidence scale is 8 questions on scale of 1-10 ranging from ("not at all confident" to "totally confident"). The higher the sum is, the higher the confidence. Therefore, final outcome scores will range from 8-80, with higher scores indicating greater confidence in diabetes management.
Time frame: 12 months
Diabetes care distress
Distress related to living with diabetes will be measured by the 2-item Diabetes Distress Screening Scale (DDS2). The DDS2 asks participants to rate the degree to which of perceived magnitudes of problems concerning diabetes that may have distressed or bothered participants. Diabetes distress is how distress a participant is in performing activities pertaining to diabetes care. Diabetes distress scale is 6 questions on a scale of 1-6 ranging from ("not a problem" to "a very serious problem"). To analyze this, a sum of 6 questions was taken. The higher the sum is, the more distressed the participant is. Therefore, the scale ranged from 6-36 points, with higher points more diabetes distress.
Time frame: 12 months
A1C
-Number of participants with A1c reduction that is at least .5 (clinically significant). In addition to the continuous A1C measurements, an indicator variable will be created to indicate a clinically meaningful change (e.g., whether A1C dropped more than 0.5 at the 6-month). Possible A1c values ranging from 4 to 14 due to instrument precision at the higher values.
Time frame: 12 months
Plan to share: No
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Texas A&M University