Table 1.
Overview of the features of the studies
| Paper IDa | Country | Study design | Study population | Aim(s) of the study | REC/IRBb Approval |
|---|---|---|---|---|---|
| Au-yeung 2011 [32] | USA | 3 prospective observational studies | 30 patients with Tuberculosis, 8 with Heart Failure, 43 with Hypertensionc | Evaluate the system and characterize technical performance. | Yes |
| Belknap 2013 [33] | USA | Feasibility study: prospective and observational. | 30 patients with active tuberculosis (TB) | Evaluate accuracy, safety and acceptability of the system. | Yes |
| Browne 2015 [34] | USA | Prospective observational cohort-study | 5 patients with type II diabetes | Characterize the at-home adherence patterns of patients through modern methods of visual analytics. | Yes |
| Browne 2018 [35] | USA | Randomized cross-over study | 12 patients with active tuberculosis | Address Good Manufacturing Practice methods to combine the ingestion sensor with oral medications. | Yes |
| Chai 2017a [36]d | USA | Prospective descriptive study | 16 patient with acute fracturese | Report data on opioid ingestion patterns detected by DP | Yes |
| Chai 2017b [37]d | USA | Pilot study: Prospective, non-randomized and observational. | 10 patients with acute fractures | Determine the feasibility the digital pill system to measure opioid ingestion patterns | Yes |
| Dicarlo 2016 [38] | USA | Feasibility study: prospective, non-randomized, observational. | 37 patients with hypertension | Record patterns of medication-taking, step count, daily blood pressure and weight. Study safety and acceptability of digital pills | Yes |
| Eisenberg 2013 [39] | Switzerland | Exploratory study: open-label, non-randomised and prospective. | 20 patients after kidney transplant under Enteric-coated mycophenolate sodium (ECMPS) | Evaluate the detection accuracy, usability, and safety of DP combined with ECMPS in kidney transplants. | Yes |
| Frias 2017 [40] | USA | Pilot study: prospective, open-label, cluster-randomized (three arms). | 109 adults with uncontrolled Hypertension and type II diabetes | Study the effect of digital pills on blood pressure, glycemic and lipid control, engagement, and provider decision making. | Yes |
| Kane 2013 [41] | USA | Pilot study: observational, non randomised. | 28 subjects with schizophrenia (16) or bipolar disorder (12) | Compare the detection accuracy to that of a directly observed method. Characterise safety and user satisfaction. | Yes |
| Kopelowicz 2017 [42] | USA | Pilot study: observational, open-label and non-randomised. | 49 subjects with bipolar disorder, major depressive disorder, or schizophrenia | Evaluate the functionality of an integrated call center in optimizing the use of the digital pills and assess its use. | Yes |
| Moorhead 2017 [43] | USA | Post hoc studies based on a study following a cluster randomised design. | 113 patients with uncontrolled hypertension. | Study the incremental impact of seeing versus not seeing DP medication dose reminders on medication-taking and assess the safety of the digital pills with respect to possible risk of overdosing. | Yes |
| Naik 2017 [44] | UK | Prospective registry-based observational study. | 151 patients with uncontrolled hypertensionf | Characterize patterns of medication use. Assess usability and acceptability of digital pills. | Yes |
| Noble 2016 [45] | UK | Prospective observational study. | 39 patients with uncontrolled hypertension | Report and summarise the first use of digital pills by pharmacists to establish blood pressure management recommendations. | Not required |
| Peters-strickland 2016 [46] | USA | Phase II open-label observational study. | 67 patients with schizophrenia | Assess the usability of the system, satisfaction, safety and tolerability. | Yes |
| Peters-strickland 2018 [47] | USA | Six formative human factors studies | 129 patients with confirmed diagnosis of schizophrenia, bipolar I disorder, or major depressive disorder (MDD) | Assess the safe and effective use of a system. Assess whether the three intended groups of users (patients, healthcare providers, and caregivers) can appropriately use the technology. | Yes |
| Rohatagi 2016 [48] | USA | Phase 4 exploratory observational study: open-label and single-arm. | 58 stable patients with a diagnosis of bipolar I disorder (n = 35) or MDD (n = 23) | Obtain descriptive feedback from patients, assess safety and summarize patient adherence | Yes |
| Thompson 2017 [49] | UK | Prospective observational study | 21 patients with either established cardiovascular disease or high multifactorial risk | Test the system in a group of patients at elevated cardiovascular risk attending a cardiac prevention and rehabilitation program | N/A |
a First author and publication year
b Research Ethics Committee (REC) or Institutional Review Board (IRB)
cOnly 40 completed the study
d this study used a version of the ingestible sensor and wearable patch produced by a different company
e Only 15 patients completed the study
f 167 patients were enrolled in the registry, but 16 were excluded from the study