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Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children (PSO4)

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ClinicalTrials.gov Identifier: NCT01823341
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : August 24, 2015
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Type 1 Diabetes
Intervention Device: Pump suspension algorithm
Enrollment 97
Recruitment Details 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 53 subjects 11-14 years old and 44 subjects 4-10 years old were enrolled. Forty-five of the 11-14 year old subjects and 37 of the 4-10 year old subjects completed.
Pre-assignment Details After the run-in phase, a 42-night randomized trial was conducted in which each night was randomly assigned to have either predictive low glucose suspend system active (intervention) or inactive (control) with half of the nights being intervention and half control nights.
Arm/Group Title Randomized Nights- Treatment or Control
Hide Arm/Group Description Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
Period Title: Overall Study
Started 97
Completed 82
Not Completed 15
Reason Not Completed
Failed run-in             7
Withdrawal by Subject             7
Adverse Event             1
Arm/Group Title Randomized Nights- Treatment or Control
Hide Arm/Group Description Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
Overall Number of Baseline Participants 82
Hide Baseline Analysis Population Description
45 Subjects age 11-14 years and 37 subjects age 4-10 years
Age, Customized  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 82 participants
11-14 Year olds
13
(11 to 13)
4-10 Year olds
8
(6 to 9)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants
Male Participants 11-14 year old age group 25
Female Participants 11-14 year old age group 20
Male Participants 4-10 year old age group 17
Female Participants 4-10 year old age group 20
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants
White non-Hispanic Participants 11-14 years old 43
Hispanic Participants 11-14 years old 1
Asian Participants 11-14 years old 1
White non-Hispanic Participants 4-10 years old 35
Hispanic Participants 4-10 years old 2
Asian Participants 4-10 years old 0
Diabetes Duration  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 82 participants
Participants 11-14 years old
6
(3 to 9)
Participants 4-10 years old
3
(2 to 5)
Body-mass index percentile (BMI)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  BMI Percentile
Number Analyzed 82 participants
Participants 11-14 years old
69
(44 to 82)
Participants 4-10 years old
69
(51 to 82)
[1]
Measure Description: Body-mass index percentiles adjusted for age and gender were computed using the 2000 CDC population growth chart data (Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, et al. CDC growth charts: United States. Adv Data 2000:1-27).
HbA1c (%)  
Median (Inter-Quartile Range)
Unit of measure:  Percent
Number Analyzed 82 participants
Participants 11-14 years old
7.7
(7.3 to 8.2)
Participants 4-10 years old
7.8
(7.5 to 8.0)
HbA1c (mmol/mol)  
Median (Inter-Quartile Range)
Unit of measure:  Mmol/mol
Number Analyzed 82 participants
Participants 11-14 years old
61
(56 to 66)
Participants 3-10 years old
62
(58 to 64)
Daily insulin dose (U/kg/day)  
Median (Inter-Quartile Range)
Unit of measure:  U/kg/day
Number Analyzed 82 participants
Participants 11-14 years old
0.83
(0.72 to 0.96)
Participants 4-10 years old
0.76
(0.69 to 0.86)
1.Primary Outcome
Title Comparison of the Time Spent in Hypoglycemia (<70 mg/dl, 3.9 mmol/L) Overnight on Intervention Nights Versus Control Nights, Normalized to an 8-hour Period.
Hide Description Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤70 mg/dL (3.9 mmol/L). The time period for outcome assessment each night will be from the time the system is activated in the evening until the time it is deactivated in the morning. The percentage of hypoglycemic nights (CGM glucose value ≤70 mg/dL (3.9 mmol/L)) will be tabulated separately with versus without the closed-loop control system in use. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Nights Analyzed
955 941 769 755
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
4.6
(2.9 to 7.3)
10.1
(5.9 to 13.8)
3.1
(1.6 to 5.0)
6.2
(3.0 to 7.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years), Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L)
Hide Description Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights Analyzed
955 941 769 755
Measure Type: Number
Unit of Measure: percentage of nights
34 39 28 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Nights With 1 or More Sensor Glucose Values <50 mg/dL (<2.8 mmol/L)
Hide Description Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights analyzed
955 941 769 755
Measure Type: Number
Unit of Measure: percentage of nights
12 17 10 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Mean Sensor Glucose Overnight
Hide Description Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights Analyzed
955 941 769 755
Mean (Standard Deviation)
Unit of Measure: mg/dL
152  (19) 144  (18) 160  (16) 153  (14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Time Overnight Sensor Glucose Values 71 to 180 mg/dL (3.9 to 10.0 mmol/L), Normalized to an 8-hour Period.
Hide Description Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights analyzed
955 941 769 755
Mean (Standard Deviation)
Unit of Measure: percentage of time
66  (10) 64  (10) 63  (11) 63  (10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Overnight Time Spent With CGM Value >250 mg/dL (13.9 mmol/L), Normalized to an 8-hour Period.
Hide Description Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights Analyzed
955 941 769 755
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
6
(4 to 9)
4
(3 to 8)
6
(5 to 12)
7
(4 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Mean Morning Blood Glucose
Hide Description Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights analyzed
955 941 769 755
Mean (Standard Deviation)
Unit of Measure: mg/dL
176  (28) 159  (29) 158  (22) 154  (25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Mornings With Blood Glucose >250 mg/dL (>13.9 mmol/L)
Hide Description Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights analyzed
955 941 769 755
Measure Type: Number
Unit of Measure: percentage of mornings
11 10 7 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Morning Blood Ketones >=1.0 mmol/L
Hide Description Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights analyzed
955 941 769 755
Measure Type: Number
Unit of Measure: percentage of mornings
1.0 0.4 2.3 2.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Percent of Mornings With Urine Ketones >/= 15 mg/dl
Hide Description Urine ketones measured each morning with Ketostix.
Time Frame Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.
Arm/Group Title Pump Suspension Algorithm (Participants 11-14 Years) Standard of Care (Participants 11-14 Years) Pump Suspension Algorithm (Participants 4-10 Years) Standard of Care (Participants 4-10 Years)
Hide Arm/Group Description:

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

The control algorithm will run passively and not recommend control the patient's pump.
Overall Number of Participants Analyzed 45 45 36 36
Overall Number of Units Analyzed
Type of Units Analyzed: Nights analyzed
955 941 769 755
Measure Type: Number
Unit of Measure: percentage of mornings
1.7 1.4 3.5 2.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 11-14 Years), Standard of Care (Participants 11-14 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm (Participants 4-10 Years), Standard of Care (Participants 4-10 Years)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Study duration was about 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Randomized Nights- Treatment or Control
Hide Arm/Group Description Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
All-Cause Mortality
Randomized Nights- Treatment or Control
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Randomized Nights- Treatment or Control
Affected / at Risk (%) # Events
Total   0/97 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Randomized Nights- Treatment or Control
Affected / at Risk (%) # Events
Total   1/97 (1.03%)    
Infections and infestations   
methicillin resistant Staphylococcus aureus * 1 [1]  1/97 (1.03%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Infection at pump infusion set site.
Only selected participants prone to nocturnal hypoglycemia and only tested one continuous glucose sensor. Participants didn't know if system was active before activation so could not observe what would happen if the participants knew it was.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Judy Sibayan, MPH, CCRP
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01823341     History of Changes
Other Study ID Numbers: PSO4
5R01DK085591 ( U.S. NIH Grant/Contract )
First Submitted: March 29, 2013
First Posted: April 4, 2013
Results First Submitted: June 25, 2015
Results First Posted: August 24, 2015
Last Update Posted: August 30, 2016