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| Name | Class |
|---|---|
| Tandem Diabetes Care, Inc. | INDUSTRY |
| DexCom, Inc. | INDUSTRY |
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An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.
This proposal aims to demonstrate the superiority of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named Tandem t:slim X2 with Control-IQ Technology and assess usability in a supervised setting in a controlled environment compared with state-of-the-art Sensor-Augmented Pump (SAP) therapy for the treatment of type 1 diabetes (T1D) in adolescents. Phase 1 participants (13-18 years old) and Phase 2 participants (6-12 years old) will be assessed during a ~48 hour ski camp; Upon completion of the ski camp, Phase 2 participants (6-12 years old) will also be assessed during a ~78 hour home use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Pancreas Therapy | Experimental | Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety. |
|
| Sensor Augmented Pump Therapy | Placebo Comparator | Subjects will use a Dexcom CGM G5 and their Continuous Subcutaneous Insulin Infusion devices (insulin pumps) to modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 | Device | Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM]. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time Spent Between 70 and 180 mg/dL | The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission. | Overall [48hr study admission] |
| Percent Time Spent Between 70 and 180 mg/dL | This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Daytime, defined as 7am-11pm. | Daytime [7am - 11pm] |
| Percent Time Spent Between 70 and 180 mg/dL | This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Overnight, defined as 11pm-7am. | Overnight [11pm - 7am] |
| Percent Time Spent Between 70 and 180 mg/dL | This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Skiing periods, defined as 9:30am-noon and 1:30pm-4pm. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time Spent <50 mg/dL | The percentage of time spent below 50 mg/dL during the Overall period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. | Overall [48hr study admission] |
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Inclusion Criteria:
Criteria for documented hyperglycemia (at least 1 must be met):
Criteria for requiring insulin at diagnosis (both criteria must be met):
Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years
Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
Not being pregnant at the start of the trial. All female subjects of childbearing potential will be screened for pregnancy.
8. If the participant is less than 13 years of age and the parents or the study team request it, at least one parent commit to stay with the study subject at the camp site 9. A parent/caregiver is available for system training and will commit to be the main responsible person for the use of the AP system at home
Exclusion Criteria:
Diabetic ketoacidosis in the past 6 months
Hypoglycemic seizure or loss of consciousness in the past 6 months
History of seizure disorder (except for hypoglycemic seizure)
History of any heart disease including coronary artery disease, heart failure, or arrhythmias
History of altitude sickness
Chronic pulmonary conditions that could impair oxygenation
Cystic fibrosis
Current use of oral 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).
Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
Pregnancy
Presence of a febrile illness within 24 hours of start ski camp or acetaminophen use while wearing the CGM. The camp study subject will not participate in the trial if these conditions are met.
Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as (for parent and/or child):
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| Name | Affiliation | Role |
|---|---|---|
| Marc Breton, PhD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States | ||
| Barbara Davis Center, University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31099946 | Result | Ekhlaspour L, Forlenza GP, Chernavvsky D, Maahs DM, Wadwa RP, Deboer MD, Messer LH, Town M, Pinnata J, Kruse G, Kovatchev BP, Buckingham BA, Breton MD. Closed loop control in adolescents and children during winter sports: Use of the Tandem Control-IQ AP system. Pediatr Diabetes. 2019 Sep;20(6):759-768. doi: 10.1111/pedi.12867. Epub 2019 May 23. |
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Randomization occurred at the ski camp after check In. Forty-eight were randomized, participated, and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford).
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental AP Group | The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA). |
| FG001 | Control SAP Group | The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental AP Group | The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA). |
| BG001 | Control SAP Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). |
| 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 | Percent Time Spent Between 70 and 180 mg/dL | The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results. | Posted | Mean | Standard Deviation | percentage of time | Overall [48hr study admission] |
|
48 hours
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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 | Control SAP Group | The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ). |
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Data for 3 participants were excluded. Subject 1: a software error resulted in prolonged AP system downline. The error was identified in data analysis; Subject 2: repeated pump occlusion resulted in prolonged system downtime; Subject 3: study pump initialized with siblings pump settings resulting in strong biased results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Breton, PhD | University of Virginia Center for Diabetes Technology | 434-982-6484 | mb6nt@virginia.edu |
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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 | Jan 2, 2018 | Jun 28, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2018 | Feb 18, 2022 | 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 |
|---|---|
| D019397 | Pancreas, Artificial |
| D000095583 | Continuous Glucose Monitoring |
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D001774 | Blood Chemical Analysis |
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| Dexcom CGM G5 | Device | The Dexcom G5 CGM is a subcutaneous glucose sensor that provides an estimate of the prevailing blood glucose concentration approximately every 5 minutes.The Dexcom G5 sensor alerts the user if the prevailing glucose concentration is higher or lower than predetermined thresholds, or if it is changing too fast. In addition, the Share/Follow functionality of the Dexcom G5 allows up to 5 people ("followers") to receive in real-time information about the current blood glucose concentration and rate of change. The Dexcom G5 system will be used by participants and clinical study staff to monitor glucose levels 24h/day during the camp, ensure participants safety, and compute glycemic control outcomes |
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| Continuous Subcutaneous Insulin Infusion | Device | Subjects will use a subcutaneous pump to deliver insulin and control their glycemia. |
|
|
| Percent Time Spent <54 mg/dL |
The percentage of time spent below 54 mg/dL during the Overall period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. |
| Overall [48hr study admission] |
| Percent Time Spent <60 mg/dL | The percentage of time spent below 60 mg/dL during the Overall period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. | Overall [48hr study admission] |
| Percent Time Spent <70 mg/dL | The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. | Overall [48hr study admission] |
| Percent Time Spent >180 mg/dL | The percentage of time spent above 180 mg/dL during the overall period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome. | Overall [48hr study admission] |
| Percent Time Spent >250 mg/dL | The percentage of time spent above 250 mg/dL during the Overall period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome. | Overall [48hr study admission] |
| Percent Time Spent >300 mg/dL | The percentage of time spent above 300 mg/dL. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome. | Overall [48hr study admission] |
| Mean Glucose | Mean glucose is a measure of the average CGM value in mg/dL during the Overall period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. | Overall [48hr study admission] |
| Glucose Variability | Variability of glucose during the Overall period | Overall [48hr study admission] |
| Insulin | Amount (U/kg) of insulin administered during the Overall period | Overall [48hr study admission] |
| Carbohydrate (CHO) Treatment | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overall period. | Overall [48hr study admission] |
| Percent Time Spent <50 mg/dL | The percentage of time spent below 50 mg/dL during the Daytime period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. | Daytime [7am - 11pm] |
| Percent Time Spent <54 mg/dL | The percentage of time spent below 54 mg/dL during the Daytime period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. | Daytime [7am - 11pm] |
| Percent Time Spent <60 mg/dL | The percentage of time spent below 60 mg/dL during the Daytime period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. | Daytime [7am - 11pm] |
| Percent Time Spent <70 mg/dL | The percentage of time spent below 70 mg/dL during the Daytime period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. | Daytime [7am - 11pm] |
| Percent Time Spent >180 mg/dL | The percentage of time spent above 180 mg/dL during the Daytime period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome. | Daytime [7am - 11pm] |
| Percent Time Spent >250 mg/dL | The percentage of time spent above 250 mg/dL during the Daytime period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome. | Daytime [7am - 11pm] |
| Percent Time Spent >300 mg/dL | The percentage of time spent above 300 mg/dL during the Daytime period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome. | Daytime [7am - 11pm] |
| Mean Glucose | Mean glucose is a measure of the average CGM value in mg/dL during the Daytime period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. | Daytime [7am - 11pm] |
| Glucose Variability | Variability of glucose during the Daytime period | Daytime [7am - 11pm] |
| Insulin | Amount (U/kg) of insulin administered during the Daytime period | Daytime [7am - 11pm] |
| CHO Treatment | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Daytime period. | Daytime [7am - 11pm] |
| Percent Time Spent <50 mg/dL | The percentage of time spent below 50 mg/dL during the Overnight period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. | Overnight [11pm - 7am] |
| Percent Time Spent <54 mg/dL | The percentage of time spent below 54 mg/dL during the Overnight period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. | Overnight [11pm - 7am] |
| Percent Time Spent <60 mg/dL | The percentage of time spent below 60 mg/dL during the Overnight period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. | Overnight [11pm - 7am] |
| Percent Time Spent <70 mg/dL | The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. | Overnight [11pm - 7am] |
| Percent Time Spent Between 70 and 150 mg/dL | This outcome looks at the percentage of time spent between 70 and 150 mg/dL during the Overnight, defined as 11pm-7am. | Overnight [11pm - 7am] |
| Percent Time Spent >180 mg/dL | The percentage of time spent above 180 mg/dL during the Overnight period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome. | Overnight [11pm - 7am] |
| Percent Time Spent >250 mg/dL | The percentage of time spent above 250 mg/dL during the Overnight period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome. | Overnight [11pm - 7am] |
| Percent Time Spent >300 mg/dL | The percentage of time spent above 300 mg/dL during the Overnight period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome. | Overnight [11pm - 7am] |
| Mean Glucose | Mean glucose is a measure of the average CGM value in mg/dL during the Overnight period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. | Overnight [11pm - 7am] |
| Glucose Variability | Variability of glucose during the Overnight period | Overnight [11pm - 7am] |
| Insulin | Amount (U/kg) of insulin administered during the Overnight period | Overnight [11pm - 7am] |
| CHO Treatment | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overnight period. | Overnight [11pm - 7am] |
| Percent Time Spent <50 mg/dL | The percentage of time spent below 50 mg/dL during the Skiing period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Percent Time Spent <54 mg/dL | The percentage of time spent below 54 mg/dL during the Skiing period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Percent Time Spent <60 mg/dL | The percentage of time spent below 60 mg/dL during the Skiing period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Percent Time Spent <70 mg/dL | The percentage of time spent below 70 mg/dL during the Skiing period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Percent Time Spent >180 mg/dL | The percentage of time spent above 180 mg/dL during the Skiing period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Percent Time Spent >250 mg/dL | The percentage of time spent above 250 mg/dL during the Skiing period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Percent Time Spent >300 mg/dL | The percentage of time spent above 300 mg/dL during the Skiing period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Mean Glucose | Mean glucose is a measure of the average CGM value in mg/dL during the Skiing period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Glucose Variability | Variability of glucose during the Skiing period | Skiing [9:30am-noon and 1:30pm-4pm |
| Insulin | Amount (U/kg) of insulin administered during the Skiing period | Skiing [9:30am-noon and 1:30pm-4pm] |
| CHO Treatment | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Skiing period. | Skiing [9:30am-noon and 1:30pm-4pm] |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Site | Count of Participants | Participants | No |
|
| Height | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). | Mean | Standard Deviation | cm |
|
| Weight | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes Duration | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). | Mean | Standard Deviation | years |
|
| Pump use | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). | Mean | Standard Deviation | years |
|
| Daily Insulin Dose | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). | Mean | Standard Deviation | U/kg |
|
| Glycated hemoglobin | 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation). | Mean | Standard Deviation | % |
|
| OG001 | Control SAP Group | The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ). |
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| Primary | Percent Time Spent Between 70 and 180 mg/dL | This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Daytime, defined as 7am-11pm. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results. | Posted | Mean | Standard Deviation | percentage of time | Daytime [7am - 11pm] |
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| Primary | Percent Time Spent Between 70 and 180 mg/dL | This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Overnight, defined as 11pm-7am. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results. | Posted | Mean | Standard Deviation | percentage of time | Overnight [11pm - 7am] |
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| Primary | Percent Time Spent Between 70 and 180 mg/dL | This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Skiing periods, defined as 9:30am-noon and 1:30pm-4pm. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results. | Posted | Mean | Standard Deviation | percentage of time | Skiing [9:30am-noon and 1:30pm-4pm] |
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| Secondary | Percent Time Spent <50 mg/dL | The percentage of time spent below 50 mg/dL during the Overall period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Overall [48hr study admission] |
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| Secondary | Percent Time Spent <54 mg/dL | The percentage of time spent below 54 mg/dL during the Overall period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Overall [48hr study admission] |
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| Secondary | Percent Time Spent <60 mg/dL | The percentage of time spent below 60 mg/dL during the Overall period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Overall [48hr study admission] |
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| Secondary | Percent Time Spent <70 mg/dL | The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Overall [48hr study admission] |
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|
|
| Secondary | Percent Time Spent >180 mg/dL | The percentage of time spent above 180 mg/dL during the overall period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Overall [48hr study admission] |
|
|
|
|
| Secondary | Percent Time Spent >250 mg/dL | The percentage of time spent above 250 mg/dL during the Overall period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Overall [48hr study admission] |
|
|
|
|
| Secondary | Percent Time Spent >300 mg/dL | The percentage of time spent above 300 mg/dL. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Overall [48hr study admission] |
|
|
|
|
| Secondary | Mean Glucose | Mean glucose is a measure of the average CGM value in mg/dL during the Overall period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | mg/dL | Overall [48hr study admission] |
|
|
|
|
| Secondary | Glucose Variability | Variability of glucose during the Overall period | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | coefficient of variation | Overall [48hr study admission] |
|
|
|
|
| Secondary | Insulin | Amount (U/kg) of insulin administered during the Overall period | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | U/kg | Overall [48hr study admission] |
|
|
|
|
| Secondary | Carbohydrate (CHO) Treatment | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overall period. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | grams | Overall [48hr study admission] |
|
|
|
|
| Secondary | Percent Time Spent <50 mg/dL | The percentage of time spent below 50 mg/dL during the Daytime period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Percent Time Spent <54 mg/dL | The percentage of time spent below 54 mg/dL during the Daytime period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Percent Time Spent <60 mg/dL | The percentage of time spent below 60 mg/dL during the Daytime period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Percent Time Spent <70 mg/dL | The percentage of time spent below 70 mg/dL during the Daytime period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Percent Time Spent >180 mg/dL | The percentage of time spent above 180 mg/dL during the Daytime period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Percent Time Spent >250 mg/dL | The percentage of time spent above 250 mg/dL during the Daytime period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Percent Time Spent >300 mg/dL | The percentage of time spent above 300 mg/dL during the Daytime period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Mean Glucose | Mean glucose is a measure of the average CGM value in mg/dL during the Daytime period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | mg/dL | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Glucose Variability | Variability of glucose during the Daytime period | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | coefficient of variation | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Insulin | Amount (U/kg) of insulin administered during the Daytime period | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | U/kg | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | CHO Treatment | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Daytime period. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | grams | Daytime [7am - 11pm] |
|
|
|
|
| Secondary | Percent Time Spent <50 mg/dL | The percentage of time spent below 50 mg/dL during the Overnight period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Percent Time Spent <54 mg/dL | The percentage of time spent below 54 mg/dL during the Overnight period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Percent Time Spent <60 mg/dL | The percentage of time spent below 60 mg/dL during the Overnight period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Percent Time Spent <70 mg/dL | The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Percent Time Spent Between 70 and 150 mg/dL | This outcome looks at the percentage of time spent between 70 and 150 mg/dL during the Overnight, defined as 11pm-7am. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Percent Time Spent >180 mg/dL | The percentage of time spent above 180 mg/dL during the Overnight period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Percent Time Spent >250 mg/dL | The percentage of time spent above 250 mg/dL during the Overnight period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Percent Time Spent >300 mg/dL | The percentage of time spent above 300 mg/dL during the Overnight period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Mean Glucose | Mean glucose is a measure of the average CGM value in mg/dL during the Overnight period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | mg/dL | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Glucose Variability | Variability of glucose during the Overnight period | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | coefficient of variation | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Insulin | Amount (U/kg) of insulin administered during the Overnight period | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | U/kg | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | CHO Treatment | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overnight period. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | grams | Overnight [11pm - 7am] |
|
|
|
|
| Secondary | Percent Time Spent <50 mg/dL | The percentage of time spent below 50 mg/dL during the Skiing period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | Percent Time Spent <54 mg/dL | The percentage of time spent below 54 mg/dL during the Skiing period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | Percent Time Spent <60 mg/dL | The percentage of time spent below 60 mg/dL during the Skiing period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | Percent Time Spent <70 mg/dL | The percentage of time spent below 70 mg/dL during the Skiing period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Median | Inter-Quartile Range | percentage of time | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | Percent Time Spent >180 mg/dL | The percentage of time spent above 180 mg/dL during the Skiing period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | Percent Time Spent >250 mg/dL | The percentage of time spent above 250 mg/dL during the Skiing period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | Percent Time Spent >300 mg/dL | The percentage of time spent above 300 mg/dL during the Skiing period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | percentage of time | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | Mean Glucose | Mean glucose is a measure of the average CGM value in mg/dL during the Skiing period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | mg/dL | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | Glucose Variability | Variability of glucose during the Skiing period | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | coefficient of variation | Skiing [9:30am-noon and 1:30pm-4pm |
|
|
|
|
| Secondary | Insulin | Amount (U/kg) of insulin administered during the Skiing period | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | U/kg | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| Secondary | CHO Treatment | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Skiing period. | The "All" row is the combined total of participants in the following rows "School-age" and "Teens." | Posted | Mean | Standard Deviation | grams | Skiing [9:30am-noon and 1:30pm-4pm] |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Experimental AP Group | The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA). | 0 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019963 |
| Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
| Male |
|
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| VA |
|
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.104 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.042 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.065 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.063 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.062 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.199 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.025 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6 -12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.064 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.017 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.074 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.034 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.016 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.081 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.187 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.040 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.053 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.010 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.038 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.016 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.130 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.017 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.044 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.141 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | 0.149 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.094 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.033 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.111 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.193 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.106 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.157 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| Wilcoxon (Mann-Whitney) | >0.2 | Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.073 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.064 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.104 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | 0.198 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| 0.001 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |
| School-age [6-12 years old] |
|
|
| Teens [13-18 years old] |
|
|
| >0.2 |
Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value <0.05 was considered significant. |
| Other |
| ANOVA | >0.2 | Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value <0.05 was considered significant. | Other |