First Use of an Ingestible Sensor to Manage Uncontrolled Blood Pressure in Primary Practice: The UK Hypertension Registry
Open accessAbstract
Background: Primary care physicians used a CE-marked ingestible sensor in a real world setting to assess patients with persistent hypertension. The objectives were to (1) characterize the pattern of their medication use, (2) differentiate medication use from pharmacologic unresponsiveness as a potential underlying cause for uncontrolled hypertension; (3) categorize and summarize subsequent management decisions; and (4) assess the usability and acceptability of passive electronic monitoring for managing hypertension. Methods: There were 167 patients with uncontrolled hypertension whilst chronically prescribed 2 to 5 antihypertensives; 40% were chronically prescribed ≥ 3 antihypertensives. Patients were instructed to ingest a pharmacologically inert tablet containing the ingestible sensor whenever they took their prescribed medications. A wearable sensor on the patient's torso passively recorded the dates/times of tablet ingestion. Taking adherence (i.e., the total number passively detected divided by the total number prescribed) and timing adherence were determined for a period of two weeks with no change in therapy. Findings: Taking adherence ranged from 53-100%; timing adherence ranged from 21-100%. Systolic blood pressure decreased from 154 ± 13 to 145 ± 18 mmHg (mean -9.7 mmHg; 95% CI: -12.5, -7.0 mmHg, p<0.001). Diastolic blood pressure decreased from 85 ± 11 to 80 ± 12 mmHg (mean -5.0 mmHg; 95% CI: -6.5, -3.5 mmHg, p<0.001). Thirty-two percent (32%) of participants achieved their treatment goals using their existing therapy. Subsequent management included: medication reviews and/or adherence counseling with no anti-hypertensive changes in 81%, anti-hypertensive changes in 13%, referrals to specialists in 1%, and no additional actions were taken in 6%. Practitioners found the offering easy to utilise, and the majority of patients expressed a positive experience in using it. Conclusion: In patients with uncontrolled blood pressure, the inclusion of an ingestible sensor in everyday practice helped practitioners to identify potential factors contributing to persistent hypertension and to determine subsequent patient-specific interventions.
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The uncontrolled prior studies did not focus on disease control.
“However, these uncontrolled studies did not focus on disease control.”
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 [20]
The cited registry was uncontrolled, but its Introduction says it assessed patients with persistent hypertension, and its Discussion reports whether patients achieved blood-pressure control. The paper does not characterize prior uncontrolled studies as lacking a focus on disease control; its own study makes the contrary point. (LLM, conf=0.82)
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Experimental — accuracy not yet measuredIn the prior hypertension registry study, 37% of participants achieved blood pressure control after 2 weeks with no adjustments to their antihypertensive medications.
“Additionally, 37% of participants achieved BP control after 2 weeks with no adjustments to their antihypertensive medications [20].”
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 [20]
The Abstract reports that 32% of registry participants achieved their treatment goals using existing therapy, and the methods state that antihypertensive treatment was unchanged during the two weeks of sensor use. The Discussion mentions approximately 30% reaching their goals after two weeks without prescribing changes, but attributes that finding to a separate community-pharmacy study. Our copy does not support the claimed 37% for this registry. (LLM, conf=0.88)
Experimental — accuracy not yet measuredA prior hypertension registry study conducted in several primary care centers in the United Kingdom demonstrated that a prior version of the DMO with no patient feedback (digital medicines plus patch) uncovered a root cause for uncontrolled hypertension in all participants after 2 weeks of use.
“A prior hypertension registry study conducted in several primary care centers in the United Kingdom demonstrated the ability of a prior version of the DMO with no patient feedback (ie, digital medicines plus patch) to uncover a root cause for uncontrolled HTN in all participants after 2 weeks of use.”
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 [20]
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Experimental — accuracy not yet measuredPrior clinical studies demonstrated the accuracy, safety, and feasibility of using the DMO in patients across a range of medical conditions, including hypertension and type 2 diabetes mellitus.
“Prior clinical studies demonstrated the accuracy, safety, and feasibility of using the DMO in patients across a range of medical conditions, including HTN and type 2 diabetes mellitus (T2DM)”
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 [20]
The Introduction (page not available) reports prior ingestible-sensor studies involving people with hypertension and diabetes, and describes a low rate of side effects and no device-related serious adverse events. It does not report that those studies demonstrated accuracy, nor does it specify type 2 diabetes; the Results support usability in this hypertension registry, not feasibility across all the listed conditions. (LLM, conf=0.86)
Experimental — accuracy not yet measuredPrior clinical studies suggested this DMO can identify reasons for uncontrolled hypertension and help patients achieve blood pressure control.
“and suggested this DMO can identify reasons for uncontrolled HTN and help patients achieve BP control [16-21].”
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- Authors
- R, N., N, M., RJ, W., P, G., SC, T., R, F., W, X., Y, K., I, S., S, L., & L, D.
- Venue
- Journal of Community Medicine & Health Education
- Publisher
- OMICS Publishing Group
- Published
- 2017
- Volume
- 07
- Issue
- 01
- ISSN
- 2161-0711 (ISSN-L)
- OpenAlex
- W2598668318
- Cited by
- 18
- References
- 10
- Citations by year
- 2024: 2 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 5 · 2018: 1 · 2017: 2
- FWCI
- 2.35
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Journal of Community Medicine & Health Education (publishedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- ingestible sensors, uncontrolled hypertension, medication adherence, antihypertensive drugs, timing of drug administration, primary care, blood pressure control, medication review, patient acceptability
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