Trial Outcomes & Findings for Artificial Pancreas in Pediatric Patients (PEDarPAN) (NCT NCT02620878)

NCT ID: NCT02620878

Last Updated: 2019-07-12

Results Overview

percentage of time spent in hypoglicemia (\< 70 mg/dl or 3.9 mmol/L) both during day and night. All analyses will include a comparison of the results in Artificial Pancreas and SAP period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: 3 days
• Results posted on: 2019-07-12

Participant Flow

Participant milestones

Measure	Open Loop Than Closed Loop Patients used for 3 days subcutaneous delivery of insulin according to usual pump regimen (open loop), than artificial pancreas for 3 days	Closed Loop Than Open Loop Patients used for 3 days artificial pancreas, than subcutaneous delivery of insulin according to usual pump regimen (open loop) for 3 days
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Artificial Pancreas in Pediatric Patients (PEDarPAN)

Baseline characteristics by cohort

Measure	All Study Participants n=32 Participants Experimental arm: A closed-loop control system (artificial pancreas) will be used during night and day for 72 hours (3 days) with the aim of automate insulin infusion by an insulin pump to control glucose level. AP is composed of a CGM device (Dexcom G4), an insulin pump (Accu Chek Spirit combo, Roche), and a model predictive control algorithm that is embedded in a smartphone and wirelessly linked to the CGM device and insulin pump. A remote monitoring will be ensured all the time the AP will be active and study team will be present in the camp. artificial pancreas: Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.
Age, Continuous	7.6 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days

percentage of time spent in hypoglicemia (< 70 mg/dl or 3.9 mmol/L) both during day and night.

All analyses will include a comparison of the results in Artificial Pancreas and SAP period

Outcome measures

Measure	CLOSED LOOP n=30 Participants Experimental arm: A closed-loop control system (artificial pancreas) will be used during night and day for 72 hours (3 days) with the aim of automate insulin infusion by an insulin pump to control glucose level. AP is composed of a CGM device (Dexcom G4), an insulin pump (Accu Chek Spirit combo, Roche), and a model predictive control algorithm that is embedded in a smartphone and wirelessly linked to the CGM device and insulin pump. A remote monitoring will be ensured all the time the AP will be active and study team will be present in the camp. artificial pancreas: Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.	OPEN LOOP n=30 Participants Active Comparator: SAP teraphy (CGM + insulin pump) will be used for 72 hours during day and night (3 days). sensor augmented pump: During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas
Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl)	2 percentage Interval 1.2 to 4.5	6.7 percentage Interval 2.3 to 11.5

PRIMARY outcome

Timeframe: 3 days

percentage of time spent in target range (70-180 mg/dl or 3.9-10.0 mmol/L) both during day and night.

All analyses will include a comparison of the results in Artificial pancraes and SAP period

Outcome measures

Measure	CLOSED LOOP n=30 Participants Experimental arm: A closed-loop control system (artificial pancreas) will be used during night and day for 72 hours (3 days) with the aim of automate insulin infusion by an insulin pump to control glucose level. AP is composed of a CGM device (Dexcom G4), an insulin pump (Accu Chek Spirit combo, Roche), and a model predictive control algorithm that is embedded in a smartphone and wirelessly linked to the CGM device and insulin pump. A remote monitoring will be ensured all the time the AP will be active and study team will be present in the camp. artificial pancreas: Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.	OPEN LOOP n=30 Participants Active Comparator: SAP teraphy (CGM + insulin pump) will be used for 72 hours during day and night (3 days). sensor augmented pump: During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas
Percentage of Time Spent in Target Range (70-180 mg/dl or 3.9-10.0 mmol/L)	56.8 percentage Standard Deviation 13.5	63.1 percentage Standard Deviation 11

SECONDARY outcome

Timeframe: 3 days

percentage of time that the system worked without any technical problem

Outcome measures

Measure	CLOSED LOOP n=30 Participants Experimental arm: A closed-loop control system (artificial pancreas) will be used during night and day for 72 hours (3 days) with the aim of automate insulin infusion by an insulin pump to control glucose level. AP is composed of a CGM device (Dexcom G4), an insulin pump (Accu Chek Spirit combo, Roche), and a model predictive control algorithm that is embedded in a smartphone and wirelessly linked to the CGM device and insulin pump. A remote monitoring will be ensured all the time the AP will be active and study team will be present in the camp. artificial pancreas: Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.	OPEN LOOP Active Comparator: SAP teraphy (CGM + insulin pump) will be used for 72 hours during day and night (3 days). sensor augmented pump: During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas
Percentage of Time Artificial Pancreas is Active	97 percentage of time Interval 93.5 to 98.4	—

Adverse Events

CLOSED LOOP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OPEN LOOP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniela Bruttomesso

Università di Padova-Italy

Phone: 00390498212183

Email: daniela.bruttomesso@unipd.it

Results disclosure agreements

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