Trial Outcomes & Findings for Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller (NCT NCT02280863)
NCT ID: NCT02280863
Last Updated: 2018-07-03
Results Overview
Our definition of a subject successfully participating in a cohort is: 1. No more than one meter glucose value \<50 mg/dL and no values \<40 mg/dL 2. No more than two episodes with meter glucose values remaining \>300 mg/dL for more than 1 hour that are unrelated to an infusion set failure 3. No ketonemia \>1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure 4. No seizures or loss of consciousness while system is on and functional
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Up to 10 days
Results posted on
2018-07-03
Participant Flow
Adults were recruited in the first 2 cohorts. Following analysis of the adult cohorts, adolescents were recruited in the third cohort.
Participant milestones
| Measure |
Adult Cohort
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|
|
Android Platform
STARTED
|
8
|
0
|
|
Android Platform
COMPLETED
|
8
|
0
|
|
Android Platform
NOT COMPLETED
|
0
|
0
|
|
Integrated Platform
STARTED
|
9
|
15
|
|
Integrated Platform
COMPLETED
|
9
|
14
|
|
Integrated Platform
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Adult Cohort
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|
|
Integrated Platform
Met stopping criteria
|
0
|
1
|
Baseline Characteristics
Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Baseline characteristics by cohort
| Measure |
Adult Cohort
n=9 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
n=15 Participants
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
0-12 year
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
13-17 years
|
0 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Customized
18-64 years
|
9 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Customized
65 year and older
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 10 daysOur definition of a subject successfully participating in a cohort is: 1. No more than one meter glucose value \<50 mg/dL and no values \<40 mg/dL 2. No more than two episodes with meter glucose values remaining \>300 mg/dL for more than 1 hour that are unrelated to an infusion set failure 3. No ketonemia \>1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure 4. No seizures or loss of consciousness while system is on and functional
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=8 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
n=9 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
n=15 Participants
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Participants who completed the protocol were included in the analysis.
Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values).
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=8 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
n=9 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
n=14 Participants
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Mean Glucose Values
Night (open loop)
|
156 mg/dL
Standard Deviation 26
|
142 mg/dL
Standard Deviation 18
|
168 mg/dL
Standard Deviation 39
|
|
Mean Glucose Values
Day (open loop)
|
151 mg/dL
Standard Deviation 14
|
144 mg/dL
Standard Deviation 15
|
171 mg/dL
Standard Deviation 30
|
|
Mean Glucose Values
Day (closed loop)
|
156 mg/dL
Standard Deviation 14
|
152 mg/dL
Standard Deviation 14
|
153 mg/dL
Standard Deviation 17
|
|
Mean Glucose Values
Night (closed loop)
|
155 mg/dL
Standard Deviation 22
|
148 mg/dL
Standard Deviation 20
|
144 mg/dL
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Data are presented for adult cohorts only.
Mean glucose values are reported as assessed by fingerstick glucose meter value.
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=8 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
n=9 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
Open loop
|
148 mg/dL
Standard Deviation 31
|
164 mg/dL
Standard Deviation 41
|
—
|
|
Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
Closed loop
|
127 mg/dL
Standard Deviation 14
|
151 mg/dL
Standard Deviation 36
|
—
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis.
Median an glucose values are reported as assessed by fingerstick glucose meter value.
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=14 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort
Open loop
|
181 mg/dL
Interval 121.0 to 191.0
|
—
|
—
|
|
Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort
Closed loop
|
132 mg/dL
Interval 121.0 to 138.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Participants who completed the protocol were included in the analysis.
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=8 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
n=9 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
n=14 Participants
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Percentage of Time Within Glucose Range of 70-180 mg/dL
Open loop
|
71.9 percentage of time in range
Standard Deviation 10.6
|
67.7 percentage of time in range
Standard Deviation 8.1
|
55.2 percentage of time in range
Standard Deviation 14.2
|
|
Percentage of Time Within Glucose Range of 70-180 mg/dL
Closed loop
|
71.0 percentage of time in range
Standard Deviation 12.4
|
71.8 percentage of time in range
Standard Deviation 12.5
|
69.8 percentage of time in range
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Participants who completed the protocol were included in the analysis.
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=8 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
n=9 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
n=14 Participants
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
Open loop
|
4.7 percentage of tests
Standard Deviation 5.1
|
13.0 percentage of tests
Standard Deviation 9.7
|
11.7 percentage of tests
Standard Deviation 9.9
|
|
Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
Closed loop
|
1.4 percentage of tests
Standard Deviation 1.7
|
7.6 percentage of tests
Standard Deviation 2.9
|
13.5 percentage of tests
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Data are presented for adult cohorts only.
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=8 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
n=9 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
Day (closed loop)
|
1.4 percentage of time
Standard Deviation 1.8
|
2.0 percentage of time
Standard Deviation 1.4
|
—
|
|
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
Day (open loop)
|
2.7 percentage of time
Standard Deviation 1.3
|
7.6 percentage of time
Standard Deviation 5.4
|
—
|
|
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
Night (open loop)
|
3.5 percentage of time
Standard Deviation 4.3
|
8.2 percentage of time
Standard Deviation 8.7
|
—
|
|
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
Night (closed loop)
|
1.9 percentage of time
Standard Deviation 3.4
|
1.2 percentage of time
Standard Deviation 1.7
|
—
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis.
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=14 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Day (open loop)
|
2.7 percentage of time
Interval 0.8 to 9.2
|
—
|
—
|
|
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Day (closed loop)
|
2.5 percentage of time
Interval 1.7 to 3.5
|
—
|
—
|
|
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Night (open loop)
|
2.5 percentage of time
Interval 0.5 to 4.7
|
—
|
—
|
|
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Night (closed loop)
|
0.7 percentage of time
Interval 0.0 to 4.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Data are presented for the Adult Cohort - Medtronic Android Interface only
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=8 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
Open loop
|
0.0 percentage of readings
Interval 0.0 to 3.3
|
—
|
—
|
|
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
Closed loop
|
0.7 percentage of readings
Interval 0.0 to 3.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: Data are presented for the Adult Cohort - Integrated System Interface and the Adolescent Cohort only. Participants who completed the protocol were included in the analysis.
Outcome measures
| Measure |
Adult Cohort - Medtronic Android Interface
n=9 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adult Cohort - Integrated System Interface
n=14 Participants
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|---|
|
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
Open loop
|
3.0 percentage of readings
Standard Deviation 4.3
|
8.9 percentage of readings
Standard Deviation 9.8
|
—
|
|
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
Closed loop
|
3.1 percentage of readings
Standard Deviation 2.5
|
6.7 percentage of readings
Standard Deviation 9.2
|
—
|
Adverse Events
Adult Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adolescent Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adult Cohort
n=9 participants at risk
In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
Adolescent Cohort
n=15 participants at risk
Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump.
Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm.
|
|---|---|---|
|
Endocrine disorders
Hypoglycaemia
|
0.00%
0/9 • Up to 10 days
|
6.7%
1/15 • Number of events 2 • Up to 10 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER