Trial Outcomes & Findings for Outpatient Control-to-Range: System and Monitoring Testing (NCT NCT01578980)

Last Updated: 2014-09-16

Results Overview

The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation for the entire arm.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

42 hours

Results posted on

2014-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Outpatient Control-to-Range Outpatient Control-to-Range: Testing system connectivity Outpatient Control-to-Range: Subjects will spend two nights (\~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outpatient Control-to-Range: System and Monitoring Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Outpatient Control-to-Range n=20 Participants Outpatient Control-to-Range: Testing system connectivity Outpatient Control-to-Range: Subjects will spend two nights (\~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants
Region of Enrollment France	5 participants n=93 Participants
Region of Enrollment Italy	5 participants n=93 Participants
HbA1c 6-9%	20 participants n=93 Participants

PRIMARY outcome

Timeframe: 42 hours

Population: The three pilot subjects (one for each country) were not included in the analysis.

Outcome measures

Outcome measures
Measure	Outpatient Control-to-Range n=17 Participants Outpatient Control-to-Range: Testing system connectivity Outpatient Control-to-Range: Subjects will spend two nights (\~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. 42 hours total: 14 hours in open-loop 28 hours in closed-loop
Percent Time of Active CTR	98 percentage of time of active CTR

SECONDARY outcome

Timeframe: 42 hours

Population: The three pilot subjects (one for each country) were not included in the analysis.

Frequency of unplanned system resets or restarts Secondary endpoints include the estimation of the failure rates of system components, frequency analysis of lost or inaccurate CGM records, and percent time of active CTR. The failure/missing data records will be compared to failure/missing data records from our past in-clinic studies.

Outcome measures

Outcome measures
Measure	Outpatient Control-to-Range n=17 Participants Outpatient Control-to-Range: Testing system connectivity Outpatient Control-to-Range: Subjects will spend two nights (\~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. 42 hours total: 14 hours in open-loop 28 hours in closed-loop
Frequency of Unplanned System Resets or Restarts Viliv S5 tablet (n=7)	2.89 events per 24 hours
Frequency of Unplanned System Resets or Restarts Galaxy Nexus phone (n=10)	0.58 events per 24 hours

Adverse Events

Outpatient Control-to-Range

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Outpatient Control-to-Range n=20 participants at risk Outpatient Control-to-Range: Testing system connectivity Outpatient Control-to-Range: Subjects will spend two nights (\~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.
Endocrine disorders Hypoglycemia	30.0% 6/20 • Number of events 6 • 42 hours
Endocrine disorders Staff Initiated System Shut-dowm	15.0% 3/20 • Number of events 3 • 42 hours

Other adverse events

Adverse event data not reported

Additional Information

Boris Kovatchev, PhD

University of Virginia

Phone: 434-924-5592

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place