A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors
Open accessPublished version of a preprint
Abstract
Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s) (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG) and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large short-term increases or decreases in health care costs or utilization associated with monitoring chronic health conditions using mobile health or digital medicine technologies. Among secondary outcomes there was some evidence of improvement in health self-management which was characterized by a decrease in the propensity to view health status as due to chance factors in the intervention group.
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The inclusion criteria in the Bloss et al study were based on cost versus level of disease control and may have enrolled participants not needing additional interventions.
“Finally, the inclusion criteria were based on cost versus level of disease control and may have enrolled participants not needing additional interventions.”
From Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial (2017) · cites this paper as [34]
The Methods (Study design and Study recruitment; pages not provided) say eligibility was based on a condition-related insurance claim, while recruitment was prioritized by the dollar amount of claims—not by measured disease control. This makes it plausible that some participants did not need additional intervention, but the paper does not establish that they were enrolled. The claim also conflates recruitment priority with inclusion criteria. (LLM, conf=0.85)
Experimental — accuracy not yet measuredMany participants with diabetes in the control arm of the Bloss et al study used insulin and likely made insulin-titration decisions based on blood glucose results.
“For example, many participants with diabetes in the control arm used insulin and likely made insulin-titration decisions based on blood glucose results.”
From Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial (2017) · cites this paper as [34]
Table 1 in Results > Participant demographics and information (page not available) lists 10 control-arm participants with insulin-dependent diabetes, supporting the claim that some participants with diabetes in that arm used insulin. The paper does not report whether they used blood glucose results to make insulin-titration decisions; that remains an inference. (LLM, conf=0.85)
Experimental — accuracy not yet measuredBloss et al failed to demonstrate benefits of digital health interventions (telemonitoring devices for BP, blood glucose, or electrocardiogram rhythm) compared to usual care in a large controlled study.
“Bloss et al [34] failed to demonstrate benefits of digital health interventions (telemonitoring devices for BP, blood glucose, or electrocardiogram rhythm) compared to usual care in a large controlled study.”
From Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial (2017) · cites this paper as [34]
The Abstract reports little evidence of differences in health care costs or utilization, and the Results report no between-group difference in blood pressure or HbA1c. But the Abstract also reports some improvement in health self-management, so the blanket statement that the intervention showed no benefits overstates the findings. The Introduction describes a randomized trial of 160 people, which also limits the characterization of it as a large study. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIn the Bloss et al study, no instructions were given to providers on use of the device data; this has been shown to make blood glucose monitoring less effective in non-insulin-using diabetes patients.
“In that study, no instructions were given to providers on use of the device data; this has been shown to make blood glucose monitoring less effective in non-insulin-using diabetes patients [30,34].”
From Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial (2017) · cites this paper as [34]
The Study enrollment section says HealthComp nurses could view device readings and describes instructions given to participants, but does not say whether providers received instructions on using the data. The Health self-management results report no difference in HbA1c, but do not test whether a lack of provider instructions made glucose monitoring less effective for non-insulin-using patients. Searches for provider instructions and that proposed effect found no decisive passage in our copy; page numbers were not available. (LLM, conf=0.74)
Experimental — accuracy not yet measured
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- Authors
- Bloss, C. S., Wineinger, N. E., Peters, M., Boeldt, D. L., Ariniello, L., Kim, J. Y., Sheard, J., Komatireddy, R., Barrett, P., & Topol, E. J.
- Affiliations
- Scripps Health (US)
- Scripps Research Institute (US)
- Corresponding author
- Topol, Eric J.
- ORCID
- Venue
- PeerJ
- Publisher
- PeerJ
- Published
- 2016-01-14
- Volume
- 4
- Pages
- e1554
- ISSN
- 2167-8359 (ISSN-L)
- PMC
- PMC4715435
- OpenAlex
- W2949426068
- Cited by
- 107
- References
- 29
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 10 · 2023: 3 · 2022: 6 · 2021: 7 · 2020: 21 · 2019: 10 · 2018: 15 · 2017: 14 · 2016: 17
- FWCI
- 34.45
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PeerJ (publishedVersion, cc-by)
- bioRxiv (Cold Spring Harbor Laboratory) (acceptedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- NIH/NCATS flagship Clinical and Translational Science Award Grant (1UL1 TR001114)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Epidemiology › Chronic Disease Management Strategies
- Health Sciences › Health Professions › Health Information Management › Health, Technology, Consumer Behavior
- Keywords
- mobile health, digital medicine, health care utilization, health care costs, hypertension, diabetes mellitus, cardiac arrhythmias, remote patient monitoring, self-management, health insurance claims, chronic disease management
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