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Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01591681
Recruitment Status : Completed
First Posted : May 4, 2012
Results First Posted : June 5, 2014
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
Enrollment 49
Recruitment Details The study was conducted at Stanford University (Stanford, CA), the Barbara Davis Center (Denver, CO), and St. Joseph's Health Care (London, ON). A total of 49 subjects were enrolled between November 1, 2012 and February 20, 2013. Forty-five participants age 15-45 years old with type 1 diabetes (median HbA1c 6.8%) completed the trial.
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 49
Completed 45
Not Completed 4
Reason Not Completed
Didn't meet min hypoglycemia requirement             3
Failed to use system during run-in             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 45
Hide Baseline Analysis Population Description
There were 45 participants who could use the Continuous Glucose Monitoring device and met a minimum amount of nocturnal hypoglycemia as well as successfully completed the run-in phase of system use at home for 5 nights to verify the ability to use it properly.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 45 participants
30
(22 to 39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
24
  53.3%
Male
21
  46.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
White non-Hispanic 42
Hispanic 2
Black 1
Weight  
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 45 participants
70
(62 to 85)
Height  
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 45 participants
172
(163 to 178)
Body-mass index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 45 participants
24
(22 to 27)
Glycated hemoglobin  
Median (Inter-Quartile Range)
Unit of measure:  Percent
Number Analyzed 45 participants
6.8
(6.4 to 7.6)
Diabetes duration  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 45 participants
15
(12 to 26)
Daily insulin dose  
Median (Inter-Quartile Range)
Unit of measure:  U/day
Number Analyzed 45 participants
45
(32 to 60)
Daily insulin dose  
Median (Inter-Quartile Range)
Unit of measure:  U/kg/day
Number Analyzed 45 participants
0.64
(0.44 to 0.78)
1.Primary Outcome
Title Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl
Hide Description Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤60 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.
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
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Nights Analyzed
942 970
Measure Type: Number
Unit of Measure: percentage of nights
21 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments Sample size was computed to be 45 participants using the system for 42 nights (21 nights with system active and 21 control nights) for a total of 1,890 nights in order to have 90% power with a type 1 error rate of 5% to reject the null hypothesis of no difference in nocturnal hypoglycemia assuming a true population rate of 30% of control nights and 15% of intervention nights with hypoglycemia after adjusting for the correlation from repeated nights and misclassification due to sensor inaccuracy.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance is 0.05.
Method Repeated measures regression model
Comments Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.
2.Secondary Outcome
Title Percentage of Sensor Glucose Values 71 to 180 mg/dL
Hide Description The median percentages of the number of glucose values with values of 71-180 mg/dL overall.
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
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Nights Analyzed
942 970
Median (Inter-Quartile Range)
Unit of Measure: percentage glucose values
82
(54 to 99)
75
(46 to 93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance is 0.05.
Method repeated measures logistic regression
Comments Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.
3.Secondary Outcome
Title Percentage of Nights With a Sensor Glucose Value </= 70 mg/dL
Hide Description [Not Specified]
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
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Nights Analyzed
942 970
Measure Type: Number
Unit of Measure: percentage of nights
32 45
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance is 0.05.
Method Repeated measures regression model
Comments Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.
4.Secondary Outcome
Title Proportion of Nights With a Sensor Glucose Value </= 50 mg/dL
Hide Description [Not Specified]
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
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Nights Analyzed
942 970
Measure Type: Number
Unit of Measure: percentage of nights
10 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance is 0.05.
Method Repeated measures regression model
Comments Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.
5.Secondary Outcome
Title Median Morning Blood Glucose
Hide Description Measured with a study home blood glucose meter.
Time Frame 42 mornings following night of system use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Mornings Analyzed
942 970
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
144
(114 to 186)
129
(96 to 173)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance is 0.05.
Method Repeated measures regression model
Comments Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.
6.Secondary Outcome
Title Percent of Mornings With Glucose >250 mg/dL
Hide Description Measured with a study home blood glucose meter.
Time Frame 42 mornings following night of system use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Mornings Analyzed
942 970
Measure Type: Number
Unit of Measure: percentage of mornings
6 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments The a priori threshold for statistical significance is 0.05.
Method repeated measures logistic regression
Comments Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.
7.Secondary Outcome
Title Percent of Mornings With Blood Ketones >1.0 mmol/L
Hide Description Blood ketones measured with a study blood ketone meter.
Time Frame 42 mornings following night of system use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Mornings Analyzed
942 970
Measure Type: Number
Unit of Measure: percentage of mornings
0.1 0.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments The a priori threshold for statistical significance is 0.05.
Method repeated measures logistic regression
Comments Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.
8.Secondary Outcome
Title Percent of Mornings With Urine Ketones >/= 15 mg/dl
Hide Description Urine ketones measured each morning with Ketostix.
Time Frame 42 mornings following night of system use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Mornings Analyzed
942 970
Measure Type: Number
Unit of Measure: percentage of mornings
3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments The a priori threshold for statistical significance is 0.05.
Method repeated measures logistic regression
Comments Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.
9.Secondary Outcome
Title Overall Mean Sensor Glucose Overnight
Hide Description Calculated as the median of the overall mean.
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
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Nights Analyzed
942 970
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
132
(110 to 163)
125
(98 to 163)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance is 0.05.
Method Repeated measures regression model
Comments Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.
10.Secondary Outcome
Title Overnight Area Under the Curve 250 mg/dl Per 8 Hour
Hide Description The measure is reporting area under the curve for glucose concentrations below 250 mg/dL and above 60 mg/dL. Overall time below and above a threshold and area under a curve was divided by total time and multiplied by 8 hours.
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
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Nights Analyzed
942 970
Median (Inter-Quartile Range)
Unit of Measure: mg*hr/dL
219
(72 to 666)
236
(83 to 772)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments The a priori threshold for statistical significance is 0.05.
Method Repeated measures regression model
Comments Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.
11.Secondary Outcome
Title Percent of Nights With Sensor Glucose >250 mg/dL
Hide Description [Not Specified]
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
[Not Specified]
Arm/Group Title Pump Suspension Algorithm Standard of Care
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.
Overall Number of Participants Analyzed 45 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Nights Analyzed
942 970
Measure Type: Number
Unit of Measure: percentage of nights
20 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pump Suspension Algorithm, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments The a priori threshold for statistical significance is 0.05.
Method Repeated measures regression model
Comments Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pump Suspension Algorithm Standard of Care
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
Pump Suspension Algorithm Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pump Suspension Algorithm Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pump Suspension Algorithm Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
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: Roy W. Beck, M.D., Ph.D.
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01591681     History of Changes
Other Study ID Numbers: PSO3
1R01DK085591-01 ( U.S. NIH Grant/Contract )
First Submitted: April 30, 2012
First Posted: May 4, 2012
Results First Submitted: March 11, 2014
Results First Posted: June 5, 2014
Last Update Posted: August 30, 2016