Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): Study protocol for a randomized controlled trial
Open accessAbstract
BACKGROUND: An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for < 10% of the variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Use of telemonitoring systems offer new opportunities to support patients with T2DM while waiting to be seen by their health care providers at actual office visits. A variety of interventions testing the efficacy of telemedicine interventions have been conducted, but the outcomes have yielded equivocal results, emphasizing the shortage of controlled, randomized trials in this area. This study provides a unique opportunity to address this gap in the literature by optimizing two strategies that have been shown to improve glycemic control, while simultaneously implementing clinical outcomes measures, using a sufficient sample size, and offering health care delivery to rural, underserved and low income communities with T2DM who are seen at Federally Qualified Health Centers (FQHCs) in coastal South Carolina. METHODS: We describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200) male and female participants, 18 years of age or older and with an HbA1c ≥ 8%, will be randomized into one of two groups: (1) an intervention arm employing the innovative FORA system coupled with nurse case management or (2) a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care. DISCUSSION: Results from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM) for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's. TRIAL REGISTRATION: National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489.
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[23] employed a combination of surveys and clinical assessments to investigate racial disparities in sleep and diabetes risk.
“For instance, [23] employed a combination of surveys and clinical assessments to investigate racial disparities in sleep and diabetes risk, while [37] integrated behavioral surveys with risk perception analysis to assess the gap between perceived and actual preventive behaviors.”
From Methodological Approaches in Studying Type-2 Diabetes-Related Health Behaviors—A Systematic Review (2025) · cites this paper as [23]
The Methods (Study Instruments and Data Collection Schedule; Data Analysis; pages unavailable) propose questionnaires and clinical measurements, with race/ethnicity considered in exploratory analyses. But this is a trial protocol for adults with type 2 diabetes, not a completed investigation of racial disparities in sleep or diabetes risk; the searched passages do not identify a sleep measure. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAmong the nine technology-assisted studies, physical activity was the most commonly targeted behavior (67%, 6/9 studies), followed by medication adherence (44%, 4/9), dietary behaviors (33%, 3/9), and self-monitoring of blood glucose (22%, 2/9).
“Among the nine technology-assisted studies, physical activity was the most commonly targeted behavior (67%, 6/9 studies), followed by medication adherence (44%, 4/9), dietary behaviors (33%, 3/9), and self-monitoring of blood glucose (SMBG) (22%, 2/9) [10,20,23], [25,26,30,31,34,37].”
From Methodological Approaches in Studying Type-2 Diabetes-Related Health Behaviors—A Systematic Review (2025) · cites this paper as [23]
Mixed-methods designs were particularly useful in understanding motivations behind complex behaviors such as diet and exercise.
“They achieved 78% accuracy, 80% sensitivity, and 74% specificity, and were particularly useful in understanding the motivations behind complex behaviors such as diet and exercise [23,37].”
From Methodological Approaches in Studying Type-2 Diabetes-Related Health Behaviors—A Systematic Review (2025) · cites this paper as [23]
The Methods sections describe a randomized trial that will measure motivation and diabetes self-care activities and analyze them with statistical models. They do not address whether mixed-methods designs are particularly useful for understanding motivations behind diet or exercise; searches for mixed-methods and those behaviors found no supporting passage. No page numbers were available in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredMixed-methods designs achieved 78% accuracy, 80% sensitivity, and 74% specificity.
“They achieved 78% accuracy, 80% sensitivity, and 74% specificity, and were particularly useful in understanding the motivations behind complex behaviors such as diet and exercise [23,37].”
From Methodological Approaches in Studying Type-2 Diabetes-Related Health Behaviors—A Systematic Review (2025) · cites this paper as [23]
The Methods > Data Analysis section describes planned statistical analyses, not results from mixed-methods designs. Searches for the stated accuracy, sensitivity, and specificity figures and for mixed-methods work on diet and exercise found no passage addressing the claim in our copy (page numbers unavailable). (LLM, conf=0.76)
Experimental — accuracy not yet measuredCombining statistical data with participant narratives provided a more comprehensive understanding of behavior change, especially in diet and exercise interventions.
“For example, [37] and [23] demonstrated how combining statistical data with participant narratives provided a more comprehensive understanding of behavior change, especially in diet and exercise interventions.”
From Methodological Approaches in Studying Type-2 Diabetes-Related Health Behaviors—A Systematic Review (2025) · cites this paper as [23]
The Methods > Data Analysis section (page unavailable) describes planned statistical analyses, not an analysis combining statistical data with participant narratives. A search for qualitative interviews and diet-and-exercise narratives found no passage showing that the protocol demonstrated the claimed benefit for understanding behavior change. (LLM, conf=0.76)
Experimental — accuracy not yet measured
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- Authors
- Egede, L. E., Strom, J. L., Fernandes, J., Knapp, R. G., & Rojugbokan, A.
- Affiliations
- Ralph H. Johnson VA Medical Center (US)
- Medical University of South Carolina (US)
- Corresponding author
- Egede, Leonard E
- Venue
- Trials
- Published
- 2011-10-20
- Volume
- 12
- Issue
- 1
- Pages
- 231-231
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC3219699
- OpenAlex
- W2172196372
- Cited by
- 24
- References
- 40
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 2 · 2021: 4 · 2020: 2 · 2017: 4 · 2016: 2 · 2015: 3 · 2014: 2 · 2012: 2
- FWCI
- 1.05
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- U.S. Department of Defense (W81XWH, W81XWH1020057)
- Medical University of South Carolina
- University of South Carolina
- National Institute of Diabetes and Digestive and Kidney Diseases (K24DK093699)
- Medical Research and Materiel Command
- Telemedicine and Advanced Technology Research Center
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- type 2 diabetes, remote patient monitoring, glycemic control, HbA1c, nurse case management, low-income adults, rural health, federally qualified health centers, underserved populations, telemedicine, South Carolina, South Carolina coast, diabetes care delivery, health care delivery systems, health care costs, health care utilization, quality of care
- MeSH terms
- Adult, Blood Glucose, Blood Pressure, Clinical Protocols, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Male, Prospective Studies, Case Management
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