Trial Outcomes & Findings for Helius in Hypertension-I: The UK Hypertension Registry (NCT NCT02553512)

NCT ID: NCT02553512

Last Updated: 2017-06-16

Results Overview

Percent timing adherence is determined by the number of ingestion sensors detected by the wearable monitor, divided by the total number of ingestion sensors prescribed, for the 2 week-time frame.

• Recruitment status: COMPLETED
• Target enrollment: 151 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2017-06-16

Participant Flow

Participant milestones

Measure	Helius Ingestible Sensor and Wearable Sensor
Overall Study STARTED	167
Overall Study COMPLETED	144
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Helius in Hypertension-I: The UK Hypertension Registry

Baseline characteristics by cohort

Measure	Helius n=151 Participants Ingestible Sensor and Wearable Sensor
Age, Continuous	68 Years STANDARD_DEVIATION 9 • n=93 Participants
Sex: Female, Male Female	63 Participants n=93 Participants
Sex: Female, Male Male	88 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	151 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	151 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United Kingdom	151 Participants n=93 Participants
Blood Pressure Systolic	154 mm Hg n=93 Participants
Blood Pressure Diastolic	88 mm Hg n=93 Participants
Diabetes	45 Participants n=93 Participants
Anti-Hypertensives (Type) Generic	136 Participants n=93 Participants
Anti-Hypertensives (Type) Generic and Branded	15 Participants n=93 Participants
Anti-Hypertensives (Type) Branded	0 Participants n=93 Participants
Anti-Hypertensives (Number) 1	0 Participants n=93 Participants
Anti-Hypertensives (Number) 2	93 Participants n=93 Participants
Anti-Hypertensives (Number) 3-5	58 Participants n=93 Participants
Anti-Hypertensives (Class) ACE inhibitor	82 Participants n=93 Participants
Anti-Hypertensives (Class) Angiotensin receptor blocker	57 Participants n=93 Participants
Anti-Hypertensives (Class) Beta-blocker	43 Participants n=93 Participants
Anti-Hypertensives (Class) Calcium channnel antagonist	93 Participants n=93 Participants
Anti-Hypertensives (Class) Diuiretic	72 Participants n=93 Participants
Anti-Hypertensives (Class) Fixed-dose combination	3 Participants n=93 Participants
Anti-Hypertensives (Class) Other	29 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 weeks

Percent timing adherence is determined by the number of ingestion sensors detected by the wearable monitor, divided by the total number of ingestion sensors prescribed, for the 2 week-time frame.

Outcome measures

Measure	Helius n=151 Participants Ingestible Sensor and Wearable Sensor
Frequency of Medication-taking (% Taking Adherence)	75 percentage of taking adherence Interval 53.0 to 100.0

PRIMARY outcome

Timeframe: 2 weeks

Percent scheduling adherence is determined by the number of ingestion sensors detected within a ± 2-hour time window around the prescribed dosing period, divided by the number of ingestion sensors detected by the wearable sensor during that dosing period, over the 2-week time frame.

Outcome measures

Measure	Helius n=151 Participants Ingestible Sensor and Wearable Sensor
Pattern of Medication-taking (% Scheduling Adherence)	65 percentage of scheduling adherence Interval 21.0 to 100.0

SECONDARY outcome

Timeframe: 2 weeks

Percentage of participants

Outcome measures

Measure	Helius n=151 Participants Ingestible Sensor and Wearable Sensor
Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment	32 percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Decrease in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline

Outcome measures

Measure	Helius n=151 Participants Ingestible Sensor and Wearable Sensor
Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering Systolic	9.7 mm Hg Interval 7.0 to 12.5
Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering Diastolic	5.0 mm Hg Interval 3.5 to 6.5

SECONDARY outcome

Timeframe: 4 weeks

Summary of provider actions following review of final report with patient (dose or medication change, adherence counseling, referral to a hypertension specialist)

Outcome measures

Measure	Helius n=151 Participants Ingestible Sensor and Wearable Sensor
Blood Pressure Management After Use of Digital Health Offering Meds review/Adherence counseling/no med changes	122 Participants
Blood Pressure Management After Use of Digital Health Offering Antihypertensive medication change	19 Participants
Blood Pressure Management After Use of Digital Health Offering No further action taken	10 Participants

Adverse Events

Helius

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Helius n=151 participants at risk Ingestible Sensor and Wearable Sensor
Skin and subcutaneous tissue disorders Rash	7.9% 12/151 • 8 weeks
Gastrointestinal disorders Gastrointestinal complaint	4.0% 6/151 • 8 weeks

Additional Information

Lorenzo DiCarlo MD, Vice-President of Clinical and Medical Affairs

Proteus Digital Health

Phone: +1 650 637 6199

Email: ldicarlo@proteus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place