Trial Outcomes & Findings for USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes (NCT NCT02131766)

Results Overview

Assess the effect size of USS Virginia in increasing time within target (70-180 mg/dL) over a 24-hour period with closed-loop control overnight (23:00 to 07:00) as compared to sensor-augmented pump alone.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

40 hours

Results posted on

2020-04-16

Participant Flow

These results for 40 participants who completed the trial represent the combined results from participants at UVA, Mt. Sinai and Mayo Clinic (NCT02131766) combined with participants at University of Padua in Italy (NCT02008188).

Participant milestones

Participant milestones
Measure	USS Virginia Closed Loop Control and SAP The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM. A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission. DiAs: DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and
Overall Study STARTED	44
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	USS Virginia Closed Loop Control and SAP The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM. A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission. DiAs: DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and
Overall Study Withdrawal by Subject	4

Baseline Characteristics

USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	USS Virginia Closed Loop Control vs SAP n=40 Participants This is a cross-over trial in which each subject participates in two phases: USS Virginia Closed Loop Control (CLC) and Sensor Augmented Pump Therapy (SAP) and is randomized to order. During CLC: The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The DiAs (CLC controller) will be initiated by 11:00 PM and will be discontinued before breakfast. During SAP: The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods). The subject will follow their usual regimen. A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission.
Age, Continuous	45.5 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants
Region of Enrollment Italy	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 40 hours

Population: Cross-over trial with same subjects participating in both arms for a total of 40 subjects.

Assess the effect size of USS Virginia in increasing time within target (70-180 mg/dL) over a 24-hour period with closed-loop control overnight (23:00 to 07:00) as compared to sensor-augmented pump alone.

Outcome measures

Outcome measures
Measure	USS Virginia Closed Loop Control n=40 Participants The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM. A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission. DiAs: DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and	Sensor Augmented Pump Therapy n=40 Participants The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods). The subject will follow their usual regimen. The subject will be asked to use the bolus calculator function on your insulin pump and enter the carbohydrate information that you eat during the week. Sensor Augmented Pump Therapy: Insulin pump plus CGM.
USS Virginia Time Within Target	78.3 percentage of time spent in range Standard Deviation 10.2	71.4 percentage of time spent in range Standard Deviation 11.6

SECONDARY outcome

Timeframe: 40 hours

Population: Cross-over trial for a total of 40 participants

Assess time spent within target range of 80-140 mg/dl overnight with USS Virginia Closed Loop compared to sensor-augmented pump therapy alone

Outcome measures

Outcome measures
Measure	USS Virginia Closed Loop Control n=40 Participants The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM. A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission. DiAs: DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and	Sensor Augmented Pump Therapy n=40 Participants The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods). The subject will follow their usual regimen. The subject will be asked to use the bolus calculator function on your insulin pump and enter the carbohydrate information that you eat during the week. Sensor Augmented Pump Therapy: Insulin pump plus CGM.
Overnight Target Range	61.1 percentage of time overnight Standard Deviation 20.6	39.6 percentage of time overnight Standard Deviation 18.3

SECONDARY outcome

Timeframe: 40 hours

Population: Cross-over trial with a total of 40 participants

Assess the effect of USS Virginia Closed Loop System to decrease hypoglycemia overnight compared to sensor-augmented pump therapy alone

Outcome measures

Outcome measures
Measure	USS Virginia Closed Loop Control n=40 Participants The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM. A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission. DiAs: DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and	Sensor Augmented Pump Therapy n=40 Participants The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods). The subject will follow their usual regimen. The subject will be asked to use the bolus calculator function on your insulin pump and enter the carbohydrate information that you eat during the week. Sensor Augmented Pump Therapy: Insulin pump plus CGM.
Decreased Overnight Hypoglycemia	0.9 percentage of time overnight Standard Deviation 1.5	3.2 percentage of time overnight Standard Deviation 3.4

SECONDARY outcome

Timeframe: 40 hours

Population: Cross-over trial with a total of 40 participants

Assess the distribution of wake-up glucose levels at 07:00 achieved by USS Virginia Closed Loop vs. to sensor-augmented pump therapy alone;

Outcome measures

Outcome measures
Measure	USS Virginia Closed Loop Control n=40 Participants The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM. A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission. DiAs: DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and	Sensor Augmented Pump Therapy n=40 Participants The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods). The subject will follow their usual regimen. The subject will be asked to use the bolus calculator function on your insulin pump and enter the carbohydrate information that you eat during the week. Sensor Augmented Pump Therapy: Insulin pump plus CGM.
Morning Glucose Levels	123.7 mg/dL Standard Deviation 17.8	145.3 mg/dL Standard Deviation 31.0

Adverse Events

USS Virginia Closed Loop Control and SAP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	USS Virginia Closed Loop Control and SAP n=40 participants at risk Combined Group in Cross-Over Trial that had CLC and SAP.
Ear and labyrinth disorders Otitis media	2.5% 1/40 • Number of events 1 • Approximately 2-3 weeks.

Additional Information

Sue Brown, MD

UVA

Phone: 434-982-0602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place