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The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time.
The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not.
At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.
The study phases are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-Loop Control System | Experimental | Use of an investigational control-to-range automated insulin management (artificial pancreas) system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. |
|
| Sensor-Augmented Pump (SAP) | Active Comparator | Use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-Loop Control System | Device | This investigational device system included the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent <70 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent <70 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase | 2 weeks |
| Time Spent <70 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, day only (07:00 - 23:00) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sensor Glucose - Extension Phase | Mean CGM sensor glucose during Extension Phase | 3 months |
| Change in HbA1c - Extension Phase | Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase |
Inclusion Criteria:
Exclusion Criteria:
Admission for diabetic ketoacidosis in the 12 months prior to enrollment.
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist.
Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
Cystic fibrosis.
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
7. A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol 8. Current use of the following drugs and supplements:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Beck, MD, PhD | Jaeb Center for Health Research | Principal Investigator |
| Boris Kovatchev, PhD | University of Virginia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27208316 | Result | Anderson SM, Raghinaru D, Pinsker JE, Boscari F, Renard E, Buckingham BA, Nimri R, Doyle FJ 3rd, Brown SA, Keith-Hynes P, Breton MD, Chernavvsky D, Bevier WC, Bradley PK, Bruttomesso D, Del Favero S, Calore R, Cobelli C, Avogaro A, Farret A, Place J, Ly TT, Shanmugham S, Phillip M, Dassau E, Dasanayake IS, Kollman C, Lum JW, Beck RW, Kovatchev B; Control to Range Study Group. Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50. doi: 10.2337/dc15-2468. Epub 2016 Apr 13. |
| Label | URL |
|---|---|
| Multinational Home Use of Closed-Loop Control Is Safe and Effective | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Closed-Loop Control System | A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump |
| |||||||||||||
| 2-Week Overnight-Only Closed-Loop |
| |||||||||||||
| 2-Week 24/7 Closed-Loop |
| |||||||||||||
| 5-Month 24/7 Closed-Loop |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Closed-Loop Control System | A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Time Spent <70 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
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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 | Closed-Loop Control System | A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Lum, Artificial Pancreas Project Director | Jaeb Center for Health Research | 8139758690 | jlum@jaeb.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
|
| Sensor-Augmented Pump (SAP) | Device | This commercial device system included the following components:
|
|
| 2 weeks |
| Time in Range 70-180 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase | 2 weeks |
| Time in Range 70-180 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00) | 2 weeks |
| Time in Range 70-180 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| Mean Sensor Glucose - Main Phase, Day and Night | Mean CGM sensor glucose during study Main Phase | 2 weeks |
| Mean Sensor Glucose - Main Phase, Night Only | Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00) | 2 weeks |
| Mean Sensor Glucose - Main Phase, Day Only | Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| Glucose Coefficient of Variation - Main Phase, Day and Night | CGM Glucose Coefficient of Variation (CV) during study Main Phase | 2 weeks |
| Glucose Coefficient of Variation - Main Phase, Night Only | CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00) | 2 weeks |
| Glucose Coefficient of Variation - Main Phase, Day Only | CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| Glucose Standard Deviation - Main Phase, Day and Night | CGM Glucose Standard Deviation (SD) during study Main Phase | 2 weeks |
| Glucose Standard Deviation - Main Phase, Night Only | CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00) | 2 weeks |
| Glucose Standard Deviation - Main Phase, Day Only | CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| Time Spent >180 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase | 2 weeks |
| Time Spent >180 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, night only (23:00 to 07:00) | 2 weeks |
| Time Spent >180 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| Time Spent <50 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase | 2 weeks |
| Time Spent <50 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, night only (23:00 to 07:00) | 2 weeks |
| Time Spent <50 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| Time Spent <60 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase | 2 weeks |
| Time Spent <60 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, night only (23:00 - 07:00) | 2 weeks |
| Time Spent <60 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| LBGI - Main Phase, Day and Night | Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. | 2 weeks |
| LBGI - Main Phase, Night Only | Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. | 2 weeks |
| LBGI - Main Phase, Day Only | Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. | 2 weeks |
| AOC 70 mg/dL - Main Phase, Day and Night | Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. | 2 weeks |
| AOC 70 mg/dL - Main Phase, Night Only | Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. | 2 weeks |
| AOC 70 mg/dL - Main Phase, Day Only | Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. | 2 weeks |
| HBGI - Main Phase, Day and Night | High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. | 2 weeks |
| HBGI - Main Phase, Night Only | High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. | 2 weeks |
| HBGI - Main Phase, Day Only | High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. | 2 weeks |
| ADRR - Main Phase, Day and Night | Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above. | 2 weeks |
| AUC 180 mg/dL - Main Phase, Day and Night | Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). | 2 weeks |
| AUC 180 mg/dL - Main Phase, Night Only | Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). | 2 weeks |
| AUC 180 mg/dL - Main Phase, Day Only | Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). | 2 weeks |
| Time Spent >250 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase | 2 weeks |
| Time Spent >250 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, night only (23:00 to 07:00) | 2 weeks |
| Time Spent >250 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| Time Spent >300 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase | 2 weeks |
| Time Spent >300 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, night only (23:00 to 07:00) | 2 weeks |
| Time Spent >300 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, day only (07:00 - 23:00) | 2 weeks |
| 5 months |
| Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values <3.9 mmol/L (70 mg/dL) during study Extension Phase | 3 months |
| Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values <3.3 mmol/L (60 mg/dL) during study Extension Phase | 3 months |
| Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values <2.8 mmol/L (50 mg/dL) during study Extension Phase | 3 months |
| Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values in range 3.9-10.0 mmol/L (70-180 mg/dL) | 3 months |
| Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values >10.0 mmol/L (180 mg/dL) during study Extension Phase | 3 months |
| Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values >13.9 mmol/L (250 mg/dL) during study Extension Phase | 3 months |
| Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values >16.7 mmol/L (300 mg/dL) during study Extension Phase | 3 months |
| Episodes of Severe Hypoglycemia Events - Extension Phase | Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. | 5 months |
| Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase | Episodes of DKA events that occurred during the 5-month extension phase | 5 months |
| Reported Serious Adverse Events - Extension Phase | Reported serious adverse events during the 5-month extension phase | 5 months |
| Stanford |
| California |
| 94305 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Montpellier University Hospital | Montpellier | 34295 | France |
| National Center for Childhood Diabetes- Schneider Children's Medical Center | Petah Tikva | 49202 | Israel |
| University of Padova | Padova | 93106 | Italy |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Diabetes duration | Median | Inter-Quartile Range | years |
|
| Body-mass index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
|
| Hemoglobin A1c (HbA1c) | Median | Inter-Quartile Range | percent |
|
| Daily total insulin dose | Median | Inter-Quartile Range | U/kg/day |
|
| Daily basal insulin | Median | Inter-Quartile Range | U/kg/day |
|
| OG002 | 2-Week 24/7 Closed-Loop | 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period |
|
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| Secondary | Time Spent <70 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Time Spent <70 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Time in Range 70-180 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Time in Range 70-180 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Time in Range 70-180 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Mean Sensor Glucose - Main Phase, Day and Night | Mean CGM sensor glucose during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Mean | Standard Deviation | mg/dL | 2 weeks |
|
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| Secondary | Mean Sensor Glucose - Main Phase, Night Only | Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Mean | Standard Deviation | mg/dL | 2 weeks |
|
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| Secondary | Mean Sensor Glucose - Main Phase, Day Only | Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Mean | Standard Deviation | mg/dL | 2 weeks |
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| Secondary | Glucose Coefficient of Variation - Main Phase, Day and Night | CGM Glucose Coefficient of Variation (CV) during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage | 2 weeks |
|
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| Secondary | Glucose Coefficient of Variation - Main Phase, Night Only | CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage | 2 weeks |
|
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| Secondary | Glucose Coefficient of Variation - Main Phase, Day Only | CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage | 2 weeks |
|
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| Secondary | Glucose Standard Deviation - Main Phase, Day and Night | CGM Glucose Standard Deviation (SD) during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
|
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| Secondary | Glucose Standard Deviation - Main Phase, Night Only | CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
|
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| Secondary | Glucose Standard Deviation - Main Phase, Day Only | CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
|
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| Secondary | Time Spent >180 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Time Spent >180 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, night only (23:00 to 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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| Secondary | Time Spent >180 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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| Secondary | Time Spent <50 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Time Spent <50 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, night only (23:00 to 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Time Spent <50 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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| Secondary | Time Spent <60 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
|
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|
|
| Secondary | Time Spent <60 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, night only (23:00 - 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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|
|
| Secondary | Time Spent <60 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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|
|
| Secondary | LBGI - Main Phase, Day and Night | Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | index scores | 2 weeks |
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|
| Secondary | LBGI - Main Phase, Night Only | Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | index scores | 2 weeks |
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|
|
| Secondary | LBGI - Main Phase, Day Only | Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | index scores | 2 weeks |
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|
| Secondary | AOC 70 mg/dL - Main Phase, Day and Night | Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
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|
|
| Secondary | AOC 70 mg/dL - Main Phase, Night Only | Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
|
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|
|
| Secondary | AOC 70 mg/dL - Main Phase, Day Only | Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
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|
| Secondary | HBGI - Main Phase, Day and Night | High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | index scores | 2 weeks |
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|
| Secondary | HBGI - Main Phase, Night Only | High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | index scores | 2 weeks |
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|
| Secondary | HBGI - Main Phase, Day Only | High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | index scores | 2 weeks |
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|
| Secondary | ADRR - Main Phase, Day and Night | Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above. | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | range scores | 2 weeks |
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|
| Secondary | AUC 180 mg/dL - Main Phase, Day and Night | Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
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| Secondary | AUC 180 mg/dL - Main Phase, Night Only | Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
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|
| Secondary | AUC 180 mg/dL - Main Phase, Day Only | Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | mg/dL | 2 weeks |
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| Secondary | Time Spent >250 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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| Secondary | Time Spent >250 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, night only (23:00 to 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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| Secondary | Time Spent >250 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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| Secondary | Time Spent >300 mg/dL - Main Phase, Day and Night | Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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| Secondary | Time Spent >300 mg/dL - Main Phase, Night Only | Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, night only (23:00 to 07:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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| Secondary | Time Spent >300 mg/dL - Main Phase, Day Only | Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, day only (07:00 - 23:00) | One participant was excluded due to missing baseline CGM data | Posted | Median | Inter-Quartile Range | percentage of CGM values | 2 weeks |
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| Other Pre-specified | Mean Sensor Glucose - Extension Phase | Mean CGM sensor glucose during Extension Phase | One subject had missing CGM data at baseline and was not included in this analysis | Posted | Mean | Standard Deviation | mmol/L | 3 months |
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| Other Pre-specified | Change in HbA1c - Extension Phase | Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase | One participant was excluded due to missing baseline CGM data | Posted | Mean | Standard Deviation | percentage | 5 months |
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| Other Pre-specified | Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values <3.9 mmol/L (70 mg/dL) during study Extension Phase | One subject had missing CGM data at baseline and was not included in this analysis | Posted | Median | Inter-Quartile Range | mmol/L | 3 months |
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| Other Pre-specified | Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values <3.3 mmol/L (60 mg/dL) during study Extension Phase | One subject had missing CGM data at baseline and was not included in this analysis | Posted | Median | Inter-Quartile Range | mmol/L | 3 months |
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| Other Pre-specified | Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values <2.8 mmol/L (50 mg/dL) during study Extension Phase | One subject had missing CGM data at baseline and was not included in this analysis | Posted | Median | Inter-Quartile Range | mmol/L | 3 months |
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| Other Pre-specified | Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values in range 3.9-10.0 mmol/L (70-180 mg/dL) | One subject had missing CGM data at baseline and was not included in this analysis | Posted | Median | Inter-Quartile Range | percentage of CGM values in range | 3 months |
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| Other Pre-specified | Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values >10.0 mmol/L (180 mg/dL) during study Extension Phase | One subject had missing CGM data at baseline and was not included in this analysis | Posted | Median | Inter-Quartile Range | percentage of CGM values >10.0 mmol/L | 3 months |
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| Other Pre-specified | Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values >13.9 mmol/L (250 mg/dL) during study Extension Phase | One subject had missing CGM data at baseline and was not included in this analysis | Posted | Median | Inter-Quartile Range | percentage of CGM values in range | 3 months |
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| Other Pre-specified | Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase | Percentage of CGM Measured Glucose Values >16.7 mmol/L (300 mg/dL) during study Extension Phase | One subject had missing CGM data at baseline and was not included in this analysis | Posted | Median | Inter-Quartile Range | percentage of CGM values in range | 3 months |
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| Other Pre-specified | Episodes of Severe Hypoglycemia Events - Extension Phase | Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. | Posted | Number | events | 5 months |
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| Other Pre-specified | Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase | Episodes of DKA events that occurred during the 5-month extension phase | Posted | Number | events | 5 months |
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| Other Pre-specified | Reported Serious Adverse Events - Extension Phase | Reported serious adverse events during the 5-month extension phase | Posted | Number | events | 5 months |
|
|
|
| 0 |
| 30 |
| 9 |
| 30 |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Sinus Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Cold | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Ketosis | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Tooth Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
| Hyperglycemia | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Was assessed by site principal investigator and study medical monitor as unrelated to study device and/or procedure. |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.91 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.20 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.49 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.06 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.18 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.07 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.02 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.52 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.41 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.12 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.06 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.26 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.11 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.61 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.29 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | >0.99 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.09 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.26 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.53 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.22 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | <0.001 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.26 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.05 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.52 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.71 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.39 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.06 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.86 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.74 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.09 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.68 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.62 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.23 | No adjustments were made for multiple comparisons. | Superiority |
No adjustments were made for multiple comparisons. |
| Superiority |
| t-test, 2 sided | 0.22 | No adjustments were made for multiple comparisons. | Superiority |