Evidence map›Paper›PMID 28597911›Full record

Trial reportClinical pharmacology and therapeutics2018

Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation.

S H Browne, C Peloquin, F Santillo, R Haubrich, L Muttera, K Moser, G M Savage, C A Benson, T F Blaschke

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
6.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Innovative Approaches to Enhance and Measure Medication Adherence in Chronic Disease Management: A Review.Medical science monitor : international medical journal of experimental and clinical research · 2024
    Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2021
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

S H BrowneUniversity of California, San Diego School of Medicine, Division of Infectious Diseases, San Diego, California, USA.
C PeloquinUniversity of Florida, College of Pharmacy and Emerging Pathogens Institute, Gainesville, Florida, USA.
F SantilloResearch and Analytic Services, Sharp Clinical Services, Pennsylvania, USA.
R HaubrichUniversity of California, San Diego School of Medicine, Division of Infectious Diseases, San Diego, California, USA.
L MutteraUniversity of California, San Diego Department of Medicine, Research Pharmacy, San Diego, California, USA.
K MoserSan Diego County Health and Human Services Agency, San Diego, California, USA.
G M SavageProteus Digital Health, Inc., Redwood City, California, USA.
C A BensonUniversity of California, San Diego School of Medicine, Division of Infectious Diseases, San Diego, California, USA.
T F BlaschkeStanford University, Stanford, California, USA.
University of California, San Diego · USAnalytical Services · USHealth and Human Services Agency · USProteus Digital Health · USStanford University · USUniversity of Florida · US

Funding

UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
A Novel Wireless Ingestible Sensor System for Measurement of Medication Adherence in HIV Treatment and PreventionR01MH110057 · NIMH · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN, BROWNE, SARA H. · 2015 to 2019
$5.9M
Wirelessly Observed Therapy to Monitor Treatment of Mycobacterium TuberculosisR43AI100479 · NIAID · PROTEUS DIGITAL HEALTH, INC. · PI DICARLO, LORENZO · 2013 to 2013
$300k
NIAID NIH HHS R43 AI100479NIAID NIH HHS UM1 AI069432NIMH NIH HHS R01 MH110057
6 · The paper itself

Abstract

High-resolution measurement of medication adherence is essential to personalized drug therapy. A US Food and Drug Administration (FDA)-cleared device, using an edible ingestion sensor (IS), external wearable patch, and paired mobile device can detect and record ingestion events. Oral medications must be combined with an IS to generate precise "digitized-medication" ingestion records. We developed a Good Manufacturing Practice protocol to repackage oral medications with the IS within certified Capsugel capsules, termed co-encapsulation (CoE). A randomized bioequivalence study of CoE-IS-Rifamate (Isoniazid/Rifampin 150/300 mg) vs. native-Rifamate was conducted in 12 patients with active Mycobacterium tuberculosis and demonstrated bioequivalence using the population method ratio test (95% confidence interval). Subsequently, CoE-IS-medications across all biopharmaceutical classes underwent in vitro dissolution testing utilizing USP and FDA guidelines. CoE-IS medications tested met USP dissolution specifications and were equivalent to their native formulations. CoE combines oral medications with the IS without altering the quality of the native formulation, generating "digitized" medications for remote capture of dosing histories.

Indexed as

CapsulesDrug CombinationsDrug MonitoringAntihypertensive AgentsAntitubercular AgentsCross-Over StudiesDrug TherapyElectronicsGlipizideHumansHypoglycemic AgentsHypolipidemic AgentsMobile ApplicationsPrecision MedicineSolubilityTelemedicineAntihypertensive AgentsAntitubercular AgentsCapsulesDrug CombinationsGlipizideHypoglycemic AgentsHypolipidemic Agents

Identifiers

PMID28597911
PMCPMC5836848
OpenAlexW2621695780

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.