Trial Outcomes & Findings for Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms (NCT NCT02438189)
NCT ID: NCT02438189
Last Updated: 2026-08-11
Results Overview
Mean percent of time participant spent with glucose values 70-180 mg/dl, measured by continuous glucose monitor of each night
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Up to 42 nights
Results posted on
2026-08-11
Participant Flow
The study was conducted at Stanford University (Stanford, CA), the Barbara Davis Center (Denver, CO), and Children's Hospital, London Health Sciences Centre (London, ON). A total of 33 subjects were enrolled, with 30 entering the randomized trial and and completing the study.
A run-in phase preceded the randomized trial. During the initial part of the run-in phase, the sensor was initiated and used for 14-21 days to verify that the participant could successfully use the pump and sensor. Successful participants then used the PHHM system at home for 5 nights to verify the ability to use it successfully.
Participant milestones
| Measure |
Randomized Nights - PHHM or PLGS
Each night, following initiation procedures, the system randomly activated either PHHM or PLGS according to a predefined schedule with the aim of completing 21 nights with PHHM and 21 nights with PLGS. Participants were blinded to the assignment.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Randomized Nights - PHHM or PLGS
Each night, following initiation procedures, the system randomly activated either PHHM or PLGS according to a predefined schedule with the aim of completing 21 nights with PHHM and 21 nights with PLGS. Participants were blinded to the assignment.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms
Baseline characteristics by cohort
| Measure |
Randomized Nights - PHHM or PLGS
n=30 Participants
Each night, following initiation procedures, the system randomly activated either PHHM or PLGS according to a predefined schedule with the aim of completing 21 nights with PHHM and 21 nights with PLGS. Participants were blinded to the assignment.
|
|---|---|
|
Age, Continuous
|
31 years
n=54 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=54 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=54 Participants
|
|
Diabetes duration
|
17 years
n=54 Participants
|
|
Body-mass index
|
26.4 kg/m^2
n=54 Participants
|
|
Daily insulin dose
|
0.58 U/kg/day
n=54 Participants
|
|
Enrollment HbA1c
|
7.5 percentage of hemoglobin A1c
n=54 Participants
|
PRIMARY outcome
Timeframe: Up to 42 nightsMean percent of time participant spent with glucose values 70-180 mg/dl, measured by continuous glucose monitor of each night
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent 70-180 mg/dL
|
71 percent
Standard Deviation 10
|
78 percent
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Up to 42 nightsMean CGM sensor glucose
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Mean Sensor Glucose
|
152 mg/dL
Standard Deviation 16
|
143 mg/dL
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Up to 42 nightsMedian percent of time participant spent with glucose values \<50 mg/dl, measured by continuous glucose monitor of each night.
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent <50 mg/dL (2.8 mmol/L)
|
0.0 percent
Interval 0.0 to 0.2
|
0.1 percent
Interval 0.0 to 0.2
|
SECONDARY outcome
Timeframe: Up to 42 nightsMedian percent of time participant spent with glucose values \<60 mg/dl, measured by continuous glucose monitor of each night
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent of Time Spent <60 mg/dL (3.3 mmol/L)
|
0.3 percent
Interval 0.0 to 1.0
|
0.4 percent
Interval 0.1 to 0.8
|
SECONDARY outcome
Timeframe: Up to 42 nightsMedian percent of time participant spent with glucose values \<70 mg/dl, measured by continuous glucose monitor of each night
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent <70 mg/dL (3.9 mmol/L)
|
1.0 percent
Interval 0.6 to 2.5
|
1.1 percent
Interval 0.7 to 2.3
|
SECONDARY outcome
Timeframe: Up to 42 nightsMedian percent of time participant spent with glucose values \>180 mg/dl, measured by continuous glucose monitor of each night
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent >180 mg/dL (10.0 mmol/L)
|
26 percent of time
Interval 21.0 to 35.0
|
20 percent of time
Interval 14.0 to 26.0
|
SECONDARY outcome
Timeframe: 42 nightsMedian percent of time participant spent with glucose values \>250 mg/dl, measured by continuous glucose monitor of each night
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent >250 mg/dL (13.9 mmol/L)
|
5 percent
Interval 2.0 to 9.0
|
2 percent
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Up to 42 nightsMedian percent of time participant spent with glucose values \>300 mg/dl (16.7 mmol/L), measured by continuous glucose monitor of each night
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent >300 mg/dL (16.7 mmol/L)
|
0.2 Percent of time
Interval 0.0 to 1.3
|
0.1 Percent of time
Interval 0.0 to 0.2
|
SECONDARY outcome
Timeframe: Up to 42 nightsPercent of time participant spent \>30 minutes and \>60 minutes consecutively with glucose values \<50 mg/dl (2.8 mmol/L) of all nights
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent >30 Min and >60 Min Consecutive <50 mg/dL (2.8 mmol/L)
|
2 Percent
|
3 Percent
|
SECONDARY outcome
Timeframe: Up to 42 nightsPercent of time participant spent \>30 minutes and \>60 minutes consecutively with glucose values \<60 mg/dl (3.3 mmol/mol) of all nights
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent >30 Min and >60 Min Consecutively <60 mg/dL (3.3 mmol/L)
|
8 percent
|
8 percent
|
SECONDARY outcome
Timeframe: Up to 42 nightsPercent of time participant spent with \>30 min and \>60 min consecutively \<70 mg/dL (3.9 mmol/L) of all nights
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent With >30 Min and >60 Min Consecutively <70 mg/dL (3.9 mmol/L)
|
20 Percent
|
19 Percent
|
SECONDARY outcome
Timeframe: Up to 42 nightsOutcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Glucose Coefficient of Variation (CV)
|
34 Percent
Interval 30.0 to 37.0
|
31 Percent
Interval 27.0 to 34.0
|
SECONDARY outcome
Timeframe: Up to 42 nightsOutcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Amount of Total Insulin Boluses
|
7.5 insulin units
Interval 5.2 to 10.8
|
8.4 insulin units
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: Up to 42 nightsOutcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Mean Home Glucose Meter Morning Glucose
|
163 mg/dL
Standard Deviation 23
|
142 mg/dL
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Up to 42 nightsPercent of mornings participant spent with glucose \>250 mg/dL (13.9 mmol/L), measured by home glucose monitor of all mornings
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent of Mornings With Glucose >250 mg/dL (13.9 mmol/L)
|
8 percent
|
2 percent
|
SECONDARY outcome
Timeframe: Up to 42 nightsPercent of time participant spent with glucose values 70 to 180 mg/dl (2.8 mmol/L), measured by continuous glucose monitor, during each night
Outcome measures
| Measure |
Predictive Low Glucose Suspend (PLGS)
n=30 Participants
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
Predictive Hyper/Hypo Minimizer (PHHM)
n=30 Participants
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Predictive Hyperglycemia Minimization Algorithm: A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL
Predictive Hypoglycemia Minimization Algorithm: A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or \<230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes
|
|---|---|---|
|
Percent Time Spent 70 to 180 mg/dL (3.9 to 10.0 mmol/L) Overnight
|
71 percent
Standard Deviation 10
|
78 percent
Standard Deviation 10
|
Adverse Events
Predictive Low Glucose Suspend (PLGS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Predictive Hyper/Hypo Minimizer (PHHM)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place