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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK085591 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Juvenile Diabetes Research Foundation | OTHER |
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The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system works by (1) measuring the glucose levels under the skin with the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is likely to occur, and (3) turning off the insulin pump when the computer program predicts that a low blood sugar will occur.
We have tested the system in the home environment in individuals with type 1 diabetes age 15 years and older. We have found an indication that the system can decrease the frequency of hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We are now ready to further test the system in the home environment in a younger age group to learn more about its ability to reduce overnight low blood sugar risk.
This study has several phases and will take about 3 months for a patient to complete.
The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the United States and Canada. First a study of children 8 to less than 15 years old will be done. Then, a study of children 3 to less than 8 years old will be conducted.
Patients who are eligible for the clinical trial initially will use a Veo insulin pump and Enlite sensor at home to verify that the patient is able to use the continuous glucose monitor (CGM) and insert sensors and is eligible to continue in the study. A parent or guardian of the child subject will oversee the actions of the subject and be responsible for the patient's overall participation during the proposed study, including operation of the investigational device system.
The first 10 patients 8 to <15 years of age will participate in an Algorithm Assessment Phase of approximately 10 nights of active system use each (for a nominal total of 100 nights of use) to determine if any adjustments to the algorithm parameters are needed and if it is safe to advance to a randomized clinical trial phase with these subjects. If adjustments are needed, the Algorithm Assessment Phase will be repeated, using the same 10 patients if possible. Once the randomized clinical trial phase begins for patients 8 to <15 years of age, approximately 200 nights of randomized system use will be collected and assessed for safety before any patients 3 to <8 years of age may be enrolled in the study. When enrollment does begin for patients 3 to <8 years of age, a second Algorithm Assessment Phase will be conducted with the first 10 patients in that younger age group using the same approach described above for the older subjects. Once the randomized clinical trial phase begins for patients 3 to <8 years of age, a final Data Safety Monitoring Board safety assessment will be performed after approximately the first 200 nights of randomized system use.
Patients who enroll in the study after the completion of the Algorithm Assessment Phase for their age group will use the closed-loop system at home for at least 5 days to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Patients who successfully demonstrate their ability to use the system at home as described above will be eligible for the randomized trial phase. This phase consists of use of the full system as an outpatient for approximately 42 nights:
Upon completion of the study, patients as well as study clinicians will be asked to complete a human factors usability questionnaire regarding use of the study system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pump suspension algorithm | Active Comparator | The pump suspension algorithm will be running actively on the study laptop during the night and suspend the pump if the algorithm predicts hypoglycemia. |
|
| Standard of Care | No Intervention | The control algorithm will run passively and not suspend the patient's pump. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pump suspension algorithm | Device | The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L) | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use. |
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Inclusion Criteria:
Exclusion Criteria:
Diabetic ketoacidosis in the past 3 months
Hypoglycemic seizure or loss of consciousness in past 6 months
History of seizure disorder (except for hypoglycemic seizures)
Cystic fibrosis
Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
History of ongoing renal disease (other than microalbuminuria), or liver disease (Creatinine is > 1.5 mg/dL (132 µmol/L))
Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
Pregnancy
Liver disease as defined by an Alanine Aminotransferase Test (ALT) greater than 3 times the upper limit of normal
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| Name | Affiliation | Role |
|---|---|---|
| Roy W Beck, MD, PhD | Jaeb Center for Health Research | Principal Investigator |
| Bruce A Buckingham, MD | Stanford University | Study Chair |
| John Lum, MS | Jaeb Center for Health Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Barbara Davis Center for Childhood Diabetes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26049549 | Result | Buckingham BA, Raghinaru D, Cameron F, Bequette BW, Chase HP, Maahs DM, Slover R, Wadwa RP, Wilson DM, Ly T, Aye T, Hramiak I, Clarson C, Stein R, Gallego PH, Lum J, Sibayan J, Kollman C, Beck RW; In Home Closed Loop Study Group. Predictive Low-Glucose Insulin Suspension Reduces Duration of Nocturnal Hypoglycemia in Children Without Increasing Ketosis. Diabetes Care. 2015 Jul;38(7):1197-204. doi: 10.2337/dc14-3053. Epub 2015 Jun 6. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized Nights- Treatment or Control | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
45 Subjects age 11-14 years and 37 subjects age 4-10 years
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Nights- Treatment or Control | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of time | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use. | Number of Nights Analyzed | Participants |
Study duration was about 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Randomized Nights- Treatment or Control | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| methicillin resistant Staphylococcus aureus | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judy Sibayan, MPH, CCRP | Jaeb Center for Health Research | 813-975-8690 | jsibayan@jaeb.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Percentage of Nights With 1 or More Sensor Glucose Values <50 mg/dL (<2.8 mmol/L) | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use |
| Mean Sensor Glucose Overnight | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use |
| 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. | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use |
| Percentage of Overnight Time Spent With CGM Value >250 mg/dL (13.9 mmol/L), Normalized to an 8-hour Period. | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use |
| Mean Morning Blood Glucose | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use |
| Percentage of Mornings With Blood Glucose >250 mg/dL (>13.9 mmol/L) | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use |
| Morning Blood Ketones >=1.0 mmol/L | 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. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use |
| Percent of Mornings With Urine Ketones >/= 15 mg/dl | Urine ketones measured each morning with Ketostix. | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use |
| Aurora |
| Colorado |
| 80045 |
| United States |
| St. Joseph's Health Care | London | Ontario | N6A4V2 | Canada |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Diabetes Duration | Median | Inter-Quartile Range | years |
|
| Body-mass index percentile (BMI) | 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). | Median | Inter-Quartile Range | BMI Percentile |
|
| HbA1c (%) | Median | Inter-Quartile Range | Percent |
|
| HbA1c (mmol/mol) | Median | Inter-Quartile Range | mmol/mol |
|
| Daily insulin dose (U/kg/day) | Median | Inter-Quartile Range | U/kg/day |
|
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| Secondary | Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L) | 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. | 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. | Posted | Number | percentage of nights | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use. | Nights Analyzed | Participants |
|
|
|
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| Secondary | Percentage of Nights With 1 or More Sensor Glucose Values <50 mg/dL (<2.8 mmol/L) | 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. | 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. | Posted | Number | percentage of nights | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use | Nights analyzed | Participants |
|
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| Secondary | Mean Sensor Glucose Overnight | 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use | Nights Analyzed | Participants |
|
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| Secondary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | percentage of time | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use | Nights analyzed | Participants |
|
|
|
|
| Secondary | Percentage of Overnight Time Spent With CGM Value >250 mg/dL (13.9 mmol/L), Normalized to an 8-hour Period. | 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of time | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use | Nights Analyzed | Participants |
|
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| Secondary | Mean Morning Blood Glucose | 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use | Nights analyzed | Participants |
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| Secondary | Percentage of Mornings With Blood Glucose >250 mg/dL (>13.9 mmol/L) | 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. | 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. | Posted | Number | percentage of mornings | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use | Nights analyzed | Participants |
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| Secondary | Morning Blood Ketones >=1.0 mmol/L | 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. | 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. | Posted | Number | percentage of mornings | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use | Nights analyzed | Participants |
|
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| Secondary | Percent of Mornings With Urine Ketones >/= 15 mg/dl | Urine ketones measured each morning with Ketostix. | 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. | Posted | Number | percentage of mornings | Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use | Nights analyzed | Participants |
|
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|
|
| 0 |
| 97 |
| 1 |
| 97 |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Nights Analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |
| Nights analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |
| Nights Analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |
| Nights analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |
| Nights Analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |
| Nights analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |
| Nights analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |
| Nights analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |
| Nights analyzed |
|
| 2-Sided |
| No |
| Superiority or Other |