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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK080831 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in adolescence could improve treatment outcomes. But, behavioral barriers may prevent adolescents from enjoying optimal benefits from this new technology. This study will randomize adolescents (11 to not yet 17 years old) with type 1 diabetes for at least 2 years who are not achieving targeted HbA1c levels (> 7.5%) to continue in standard care (SC), to add continuous glucose monitoring (CGM) to their care with appropriate education and medical management (CGS) or to add CGM to their care as above but to also receive support and assistance from a behavior therapist who will assist the patient and family in optimizing the adolescents' therapeutic benefit from CGS (CGS+BT). A variety of outcomes will be measured, including blood glucose control, quality of life, and CGS satisfaction and impact. An enrollment criterion for this study is that the adolescent must have established consistent care for type 1 diabetes at a Nemours Children's Clinic location either in Wilmington, DE, Philadelphia, PA, Orlando, FL or Pensacola, FL for at least 12 months prior to enrollment in the study. Adolescents treated elsewhere are not eligible to enroll in the study.
Management of type 1 diabetes mellitus (T1DM) in adolescents is very difficult and innovative approaches are needed to help them achieve better glycemic control and behavioral outcomes. Continuous glucose sensors (CGS) have been refined progressively and provide acceptably accurate, nearly continuous estimates of glucose levels and trends. This increased quality and quantity of glucose data could be an excellent adjunct to conventional self-monitoring of blood glucose, permitting more informed diabetes decision-making. CGS could yield medical, educational and psychological benefits for adolescents with T1DM, but those with extremely variable self-management habits and suboptimal glycemic control may not realize these benefits readily. We hypothesize that a targeted, family-focused behavioral intervention could optimize benefit from adding CGS to T1DM therapy for youths with glycosylated hemoglobin (HbA1c) > 7.5%. A multi-site sample of 150 adolescents with T1DM and HbA1C of 7.5% to 10.0% will be randomized to either Standard Care for T1DM (SC), or to augmentation of SC with 9 months' use of a CGS device (CGS) or use of a CGS device supplemented with a targeted behavior therapy intervention (CGS+BT). Multiple measures of glycemic control, glycemic variability and health care use will be obtained during the study and there will be periodic assessments of demographic factors, diabetes self-management, family relations and psychological adjustment. Three specific aims will be addressed: 1. Evaluate whether CGS+BT yields more improvement in glycemic outcomes than CGS or SC; 2. Evaluate whether CGS+BT yields more improvement in behavioral outcomes than CGS or SC; and 3. Identify behavioral variables that mediate and moderate glycemic benefit from use of the CGS device. The study will also compare the cost effectiveness of CGS and CGS+BT relative to SC and evaluate the predictive utility of various indices of glycemic variability in youths. We hypothesize that, compared with SC and CGS, CGS+BT will yield significantly better biomedical outcomes (HbA1C; severe hypoglycemia; glycemic variability; proportion of glucose readings in the normal range) and behavioral outcomes (treatment adherence; parent adolescent teamwork; diabetes-related family conflict; quality of life; fear of hypoglycemia; and treatment satisfaction). After the 9 month randomized trial, all youths will be allowed to use the CGS device during an additional 3-month continuation phase. Statistical analyses will be based on individual growth modeling techniques. The application capitalizes on the Principal Investigator's prior and ongoing funded research on family management of T1DM, including trials of family-focused behavioral interventions, intensive therapy regimens, and clinical evaluations of continuous glucose sensors. The proposed study will determine whether a targeted behavioral intervention improves CGS benefits among adolescents with previously inadequate glycemic control. These results could demonstrate that adolescents with previously suboptimal diabetic control could realize multiple benefits from CGS use if they are provided with a specialized behavioral intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments. |
|
| Continuous Glucose Sensor | Active Comparator | Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms. |
|
| CGS + Behavior Therapy | Experimental | Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Sensor | Device | Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose. | Baseline, 3, 6, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Technology Questionnaire-Adolescents | Adolescent's total score on the DTQ-Current items. Range 30-150. Higher scores indicate more favorable satisfaction with and impact of the package of diabetes technology (e.g. pump, meter, CGM, etc.) in use by the patient during the prior 3 months. | Baseline, 3 6, 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Wysocki, Ph.D. | Nemours Children's Clinic Jacksonville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments. Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses. |
| FG001 | Continuous Glucose Sensor | Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms. Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management. |
| FG002 | CGS + Behavior Therapy | Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care. CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments. Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Adolescent Age in Years |
| 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 | Glycated Hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose. | Posted | Mean | Standard Deviation | percentage of hemoglobin molecules | Baseline, 3, 6, 9 months |
|
9 months for each participant
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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 | Standard Care | Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments. Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Wysocki, PhD | Nemours Foundation: Dept. of Biomedical Research | 904-697-3483 | twysocki@nemours.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2018 | Jul 13, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 26, 2012 | Jul 13, 2018 | ICF_001.pdf |
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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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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3 group (Standard Care: Continuous Glucose Monitor; Continuous Glucose Monitor + Behavior Therapy) X 4 time points (0, 3, 6, and 9 months) Repeated measures randomized treatments design.
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| Standard Care | Other | Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses. |
|
| CGS + Behavior Therapy | Behavioral | Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care. |
|
| Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items |
Parents' ratings of impact and satisfaction with the diabetes devices currently in use (e.g. pump, meter, CGM etc.) Score range from 30-150. Higher score signify greater satisfaction and impact. |
| Baseline, 3, 6, 9 months |
| Blood Glucose Monitoring Communication Questionnaire-Adolescent | Adolescent report of communication with parents about blood glucose monitoring and results. Range 8-24. Higher scores indicate more negative communication about BG results. | Baseline, 3, 6, 9 months |
| Blood Glucose Monitoring Communication Questionnaire-Parents | Parents perspectives of communication with adolescent around blood glucose monitoring and results. Score range 8-24. Higher scores signify more negative communication about BG results. | Baseline, 3, 6, 9 months |
| Diabetes Family Conflict Scale-Adolescent | Adolescent ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more frequent family conflict around diabetes. | Baseline, 3, 6, 9 months |
| Diabetes Family Conflict Scale-Parent | Parents' ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more family conflict around diabetes. | Baseline, 3, 6, 9 months |
| Diabetes Family Responsibility Questionnaire-Adolescent | Adolescent's self-ratings of their degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate greater adolescent responsibility for diabetes care. | Baserline, 3, 6, 9 months |
| Diabetes Family Responsibility Questionnaire-Parent | Parent ratings of adolescent's degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate great adolescent responsibility for diabetes care tasks. | Baseline, 3, 6, 9 months |
| Diabetes Self Management Profile-Adolescent | Adolescent self-report of diabetes management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence. | Baseline, 3, 6, 9 months |
| Diabetes Self Management Profile-Parent | Parent report of adolescent's diabetes self-management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence. | Baseline, 3, 6, 9 months |
| Hypoglycemia Fear Survey-Adolescent | Adolescent worry and behavior related to apprehension of low BG episodes. Score range 24-72. Higher scores indicate greater fear and avoidance of hypoglycemia | Baseline, 3, 6, 9 months |
| Hypoglycemia Fear Survey-Parent | Parental worry and behavior related to apprehension of low BG events. Score range 24-72. Higher scores indicate greater parental fear and avoidance of hypoglycemia. | Baseline, 3, 6, 9 months |
| BG001 | Continuous Glucose Sensor | Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms. Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management. |
| BG002 | CGS + Behavior Therapy | Patients in this group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care. CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care. |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Glycated Hemoglobin Level (%) | Glycated hemoglobin level expressed as percentage of hemoglobin molecules bound to glucose molecules. | Mean | Standard Deviation | Percentage of hemoglobin |
|
| Continuous Glucose Sensor |
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms. Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management. |
| OG002 | CGS + Behavior Therapy | Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care. CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care. |
|
|
|
| Secondary | Diabetes Technology Questionnaire-Adolescents | Adolescent's total score on the DTQ-Current items. Range 30-150. Higher scores indicate more favorable satisfaction with and impact of the package of diabetes technology (e.g. pump, meter, CGM, etc.) in use by the patient during the prior 3 months. | Posted | Mean | Standard Deviation | Total score | Baseline, 3 6, 9 months |
|
|
|
|
| Secondary | Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items | Parents' ratings of impact and satisfaction with the diabetes devices currently in use (e.g. pump, meter, CGM etc.) Score range from 30-150. Higher score signify greater satisfaction and impact. | Posted | Mean | Standard Deviation | Total scores | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Blood Glucose Monitoring Communication Questionnaire-Adolescent | Adolescent report of communication with parents about blood glucose monitoring and results. Range 8-24. Higher scores indicate more negative communication about BG results. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Blood Glucose Monitoring Communication Questionnaire-Parents | Parents perspectives of communication with adolescent around blood glucose monitoring and results. Score range 8-24. Higher scores signify more negative communication about BG results. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Diabetes Family Conflict Scale-Adolescent | Adolescent ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more frequent family conflict around diabetes. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Diabetes Family Conflict Scale-Parent | Parents' ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more family conflict around diabetes. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Diabetes Family Responsibility Questionnaire-Adolescent | Adolescent's self-ratings of their degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate greater adolescent responsibility for diabetes care. | Posted | Mean | Standard Deviation | units on a scale | Baserline, 3, 6, 9 months |
|
|
|
|
| Secondary | Diabetes Family Responsibility Questionnaire-Parent | Parent ratings of adolescent's degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate great adolescent responsibility for diabetes care tasks. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Diabetes Self Management Profile-Adolescent | Adolescent self-report of diabetes management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Diabetes Self Management Profile-Parent | Parent report of adolescent's diabetes self-management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Hypoglycemia Fear Survey-Adolescent | Adolescent worry and behavior related to apprehension of low BG episodes. Score range 24-72. Higher scores indicate greater fear and avoidance of hypoglycemia | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| Secondary | Hypoglycemia Fear Survey-Parent | Parental worry and behavior related to apprehension of low BG events. Score range 24-72. Higher scores indicate greater parental fear and avoidance of hypoglycemia. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 9 months |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Continuous Glucose Sensor | Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms. Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management. | 0 | 39 | 0 | 39 | 0 | 39 |
| EG002 | CGS + Behavior Therapy | Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care. CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
|
| 6-Months |
|
| 9-Months |
|
| 0.88 |
| Mean Difference (Net) |
| -0.82 |
| Standard Deviation |
| 5.47 |
| 2-Sided |
| 95 |
| -11.54 |
| 9.9 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.66 |
| Mean Difference (Net) |
| 2.53 |
| Standard Deviation |
| 5.76 |
| 2-Sided |
| 95 |
| Superiority |
|
| 6-Months |
|
| 9-months |
|
| 0.65 |
| Mean Difference (Net) |
| -0.41 |
| Standard Deviation |
| 0.92 |
| 2-Sided |
| 95 |
| -2.22 |
| 1.39 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.93 |
| Mean Difference (Net) |
| -1.22 |
| Standard Deviation |
| 13.81 |
| 2-Sided |
| 95 |
| -28.26 |
| 25.83 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.08 |
| Mean Difference (Net) |
| -2.59 |
| Standard Deviation |
| 1.87 |
| 2-Sided |
| 95 |
| -5.50 |
| 0.32 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| .007 |
| Mean Difference (Net) |
| -3.71 |
| Standard Deviation |
| 1.36 |
| 2-Sided |
| 95 |
| -6.38 |
| -1.04 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.78 |
| Mean Difference (Net) |
| -0.39 |
| Standard Deviation |
| 1.38 |
| 2-Sided |
| 95 |
| -3.09 |
| 2.32 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.41 |
| Mean Difference (Net) |
| -0.93 |
| Standard Deviation |
| 1.14 |
| 2-Sided |
| 95 |
| -3.17 |
| 1.3 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.24 |
| Mean Difference (Net) |
| -3.01 |
| Standard Deviation |
| 2.54 |
| 2-Sided |
| 95 |
| -7.99 |
| 1.96 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.45 |
| Mean Difference (Net) |
| -2.21 |
| Standard Deviation |
| 2.95 |
| 2-Sided |
| 95 |
| -8.01 |
| 3.57 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.72 |
| Mean Difference (Net) |
| 0.99 |
| Standard Deviation |
| 2.63 |
| 2-Sided |
| 95 |
| -4.11 |
| 6.08 |
| Superiority |
|
| 6-Months |
|
| 9-Months |
|
| 0.68 |
| Mean Difference (Net) |
| -1.16 |
| Standard Deviation |
| 2.85 |
| 2-Sided |
| 95 |
| -6.74 |
| 4.43 |
| Superiority |