Type 1 Diabetes Mellitus
Conditions
Keywords
Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump
Brief summary
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.
Detailed description
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.
Interventions
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 \[CGM\].
DEVICEDexcom CGM G5
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
Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.
Sponsors
Tandem Diabetes Care, Inc.
DexCom, Inc.
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Criteria for documented hyperglycemia (at least 1 must be met): * Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required) * The diagnosis of type 1 diabetes is based on the investigator's judgment 2. Criteria for requiring insulin at diagnosis (both criteria must be met): * Daily insulin therapy for ≥ 6 months * Insulin pump therapy for ≥ 3 months (note: must be willing to disable any glucose suspend, predictive suspend, or artificial pancreas functionality on insulin pump during study) 3. Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years 4. Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor. 5. Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study 6. 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
1. Diabetic ketoacidosis in the past 6 months 2. Hypoglycemic seizure or loss of consciousness in the past 6 months 3. History of seizure disorder (except for hypoglycemic seizure) 4. History of any heart disease including coronary artery disease, heart failure, or arrhythmias 5. History of altitude sickness 6. Chronic pulmonary conditions that could impair oxygenation 7. Cystic fibrosis 8. 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. 9. History of ongoing renal disease (other than microalbuminuria). 10. Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine). 11. Subjects requiring other anti-diabetic medications other than insulin (oral or injectable). 12. Pregnancy 13. 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. 14. 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): * Inpatient psychiatric treatment in the past 6 months * Uncontrolled adrenal insufficiency * Alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time Spent Between 70 and 180 mg/dL | Overall [48hr study admission] | The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time Spent <54 mg/dL | Overall [48hr study admission] | 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. |
| Percent Time Spent <60 mg/dL | Overall [48hr study admission] | 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. |
| Percent Time Spent <70 mg/dL | Overall [48hr study admission] | 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. |
| Percent Time Spent >180 mg/dL | Overall [48hr study admission] | 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. |
| Percent Time Spent >250 mg/dL | Overall [48hr study admission] | 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. |
| Percent Time Spent >300 mg/dL | Overall [48hr study admission] | 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. |
| Percent Time Spent <50 mg/dL | Overall [48hr study admission] | 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. |
| Glucose Variability | Overall [48hr study admission] | Variability of glucose during the Overall period |
| Insulin | Overall [48hr study admission] | Amount (U/kg) of insulin administered during the Overall period |
| Carbohydrate (CHO) Treatment | Overall [48hr study admission] | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overall period. |
| CHO Treatment | Daytime [7am - 11pm] | The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Daytime period. |
| Percent Time Spent Between 70 and 150 mg/dL | Overnight [11pm - 7am] | This outcome looks at the percentage of time spent between 70 and 150 mg/dL during the Overnight, defined as 11pm-7am. |
| Mean Glucose | Overall [48hr study admission] | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 24 |
| 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). | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Experimental AP Group | Control SAP Group | Total |
|---|---|---|---|
| Age, Continuous BDC-UColorado | 9.2 years STANDARD_DEVIATION 1.6 | 8.8 years STANDARD_DEVIATION 0.4 | 9 years STANDARD_DEVIATION 1.1 |
| Age, Continuous Stanford | 10.8 years STANDARD_DEVIATION 2.4 | 9.7 years STANDARD_DEVIATION 1.4 | 10.25 years STANDARD_DEVIATION 2.3 |
| Age, Continuous UVA | 15.0 years STANDARD_DEVIATION 1.4 | 14.8 years STANDARD_DEVIATION 1.8 | 14.9 years STANDARD_DEVIATION 1.6 |
| Body Mass Index (BMI) BDC-UColorado | 18.9 kg/m^2 STANDARD_DEVIATION 3.8 | 16.6 kg/m^2 STANDARD_DEVIATION 1.6 | 17.8 kg/m^2 STANDARD_DEVIATION 3 |
| Body Mass Index (BMI) Stanford | 19.6 kg/m^2 STANDARD_DEVIATION 1.5 | 18.9 kg/m^2 STANDARD_DEVIATION 0.8 | 19.2 kg/m^2 STANDARD_DEVIATION 3.3 |
| Body Mass Index (BMI) UVA | 21.5 kg/m^2 STANDARD_DEVIATION 2.4 | 25.7 kg/m^2 STANDARD_DEVIATION 4.7 | 23.6 kg/m^2 STANDARD_DEVIATION 4.2 |
| Daily Insulin Dose BDC-UColorado | 0.7 U/kg STANDARD_DEVIATION 0.3 | 0.7 U/kg STANDARD_DEVIATION 0.2 | 0.7 U/kg STANDARD_DEVIATION 0.2 |
| Daily Insulin Dose Stanford | 0.8 U/kg STANDARD_DEVIATION 0.1 | 0.7 U/kg STANDARD_DEVIATION 0 | 0.7 U/kg STANDARD_DEVIATION 0.2 |
| Daily Insulin Dose UVA | 0.8 U/kg STANDARD_DEVIATION 0.2 | 0.8 U/kg STANDARD_DEVIATION 0.2 | 0.8 U/kg STANDARD_DEVIATION 0.2 |
| Diabetes Duration BDC-UColorado | 4.7 years STANDARD_DEVIATION 2.8 | 4.8 years STANDARD_DEVIATION 1.6 | 4.75 years STANDARD_DEVIATION 2.2 |
| Diabetes Duration Stanford | 4.7 years STANDARD_DEVIATION 0.2 | 4.0 years STANDARD_DEVIATION 0.7 | 4.3 years STANDARD_DEVIATION 1.6 |
| Diabetes Duration UVA | 6.7 years STANDARD_DEVIATION 3.2 | 5.6 years STANDARD_DEVIATION 2.4 | 6.1 years STANDARD_DEVIATION 2.8 |
| Glycated hemoglobin BDC-UColorado | 7.3 % STANDARD_DEVIATION 0.8 | 7.6 % STANDARD_DEVIATION 0.7 | 7.4 % STANDARD_DEVIATION 0.7 |
| Glycated hemoglobin Stanford | 7.4 % STANDARD_DEVIATION 0.7 | 7.2 % STANDARD_DEVIATION 0.3 | 7.3 % STANDARD_DEVIATION 0.6 |
| Glycated hemoglobin UVA | 8.3 % STANDARD_DEVIATION 1.5 | 8.0 % STANDARD_DEVIATION 1.1 | 8.2 % STANDARD_DEVIATION 1.3 |
| Height BDC-UColorado | 137.9 cm STANDARD_DEVIATION 8.9 | 136.5 cm STANDARD_DEVIATION 2.4 | 137.2 cm STANDARD_DEVIATION 6.3 |
| Height Stanford | 143.9 cm STANDARD_DEVIATION 12 | 138.4 cm STANDARD_DEVIATION 13.4 | 141.15 cm STANDARD_DEVIATION 14 |
| Height UVA | 166.6 cm STANDARD_DEVIATION 10.2 | 168.9 cm STANDARD_DEVIATION 8.7 | 167.8 cm STANDARD_DEVIATION 9.3 |
| Pump use BDC-UColorado | 4 years STANDARD_DEVIATION 2.3 | 3.7 years STANDARD_DEVIATION 2 | 3.8 years STANDARD_DEVIATION 2 |
| Pump use Stanford | 4.2 years STANDARD_DEVIATION 1.7 | 3.3 years STANDARD_DEVIATION 0.7 | 3.75 years STANDARD_DEVIATION 1.7 |
| Pump use UVA | 6.5 years STANDARD_DEVIATION 3.5 | 4.9 years STANDARD_DEVIATION 2.1 | 5.7 years STANDARD_DEVIATION 2.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 23 Participants | 47 Participants |
| Sex: Female, Male BDC-UColorado Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male BDC-UColorado Male | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Stanford Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Stanford Male | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male UVA Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male UVA Male | 6 Participants | 8 Participants | 14 Participants |
| Site CA | 6 Participants | 6 Participants | 12 Participants |
| Site CO | 6 Participants | 6 Participants | 12 Participants |
| Site VA | 12 Participants | 12 Participants | 24 Participants |
| Weight BDC-UColorado | 36.5 kg STANDARD_DEVIATION 10.7 | 31 kg STANDARD_DEVIATION 3.1 | 33.7 kg STANDARD_DEVIATION 8 |
| Weight Stanford | 41.2 kg STANDARD_DEVIATION 9.2 | 36.7 kg STANDARD_DEVIATION 4.4 | 38.9 kg STANDARD_DEVIATION 10.3 |
| Weight UVA | 60.1 kg STANDARD_DEVIATION 10.9 | 73.6 kg STANDARD_DEVIATION 16.8 | 66.9 kg STANDARD_DEVIATION 15.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | All | 57.8 percentage of time | Standard Deviation 27.3 |
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | School-age [6-12 years old] | 50 percentage of time | Standard Deviation 30.7 |
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | Teens [13-18 years old] | 66.4 percentage of time | Standard Deviation 21.1 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | All | 55.9 percentage of time | Standard Deviation 31.1 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | School-age [6-12 years old] | 65.2 percentage of time | Standard Deviation 24 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | Teens [13-18 years old] | 46.6 percentage of time | Standard Deviation 35.5 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: 0.063ANOVA
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.
Time frame: Overall [48hr study admission]
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | All | 66.4 percentage of time | Standard Deviation 16.4 |
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | School-age [6-12 years old] | 59.9 percentage of time | Standard Deviation 19.5 |
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | Teens [13-18 years old] | 73.5 percentage of time | Standard Deviation 8.4 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | All | 53.9 percentage of time | Standard Deviation 24.8 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | School-age [6-12 years old] | 57.7 percentage of time | Standard Deviation 23.1 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | Teens [13-18 years old] | 50 percentage of time | Standard Deviation 26.8 |
p-value: 0.01ANOVA
p-value: 0.089ANOVA
p-value: 0.024ANOVA
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.
Time frame: Daytime [7am - 11pm]
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | All | 62.4 percentage of time | Standard Deviation 18.8 |
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | School-age [6-12 years old] | 56.4 percentage of time | Standard Deviation 22.7 |
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | Teens [13-18 years old] | 68.9 percentage of time | Standard Deviation 11.1 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | All | 54.8 percentage of time | Standard Deviation 24.9 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | School-age [6-12 years old] | 59.6 percentage of time | Standard Deviation 22.3 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | Teens [13-18 years old] | 50 percentage of time | Standard Deviation 27.3 |
p-value: 0.095ANOVA
p-value: 0.104ANOVA
p-value: 0.042ANOVA
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.
Time frame: Overnight [11pm - 7am]
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | All | 78.6 percentage of time | Standard Deviation 20.3 |
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | School-age [6-12 years old] | 70.6 percentage of time | Standard Deviation 24 |
| Experimental AP Group | Percent Time Spent Between 70 and 180 mg/dL | Teens [13-18 years old] | 87.3 percentage of time | Standard Deviation 10.8 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | All | 50.9 percentage of time | Standard Deviation 34.2 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | School-age [6-12 years old] | 52 percentage of time | Standard Deviation 34.3 |
| Control SAP Group | Percent Time Spent Between 70 and 180 mg/dL | Teens [13-18 years old] | 49.9 percentage of time | Standard Deviation 35.6 |
p-value: <0.001ANOVA
p-value: >0.2ANOVA
p-value: 0.065ANOVA
Secondary
Carbohydrate (CHO) Treatment
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overall period.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Carbohydrate (CHO) Treatment | All | 45.5 grams | Standard Deviation 27.8 |
| Experimental AP Group | Carbohydrate (CHO) Treatment | School-age [6-12 years old] | 42.1 grams | Standard Deviation 27.3 |
| Experimental AP Group | Carbohydrate (CHO) Treatment | Teens [13-18 years old] | 49.3 grams | Standard Deviation 29.2 |
| Control SAP Group | Carbohydrate (CHO) Treatment | All | 57.7 grams | Standard Deviation 57.8 |
| Control SAP Group | Carbohydrate (CHO) Treatment | School-age [6-12 years old] | 55.8 grams | Standard Deviation 36.1 |
| Control SAP Group | Carbohydrate (CHO) Treatment | Teens [13-18 years old] | 59.6 grams | Standard Deviation 75.4 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
Secondary
CHO Treatment
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Daytime period.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | CHO Treatment | All | 38.5 grams | Standard Deviation 25.2 |
| Experimental AP Group | CHO Treatment | School-age [6-12 years old] | 35.1 grams | Standard Deviation 23.6 |
| Experimental AP Group | CHO Treatment | Teens [13-18 years old] | 42.3 grams | Standard Deviation 27.6 |
| Control SAP Group | CHO Treatment | All | 47.5 grams | Standard Deviation 50.2 |
| Control SAP Group | CHO Treatment | School-age [6-12 years old] | 46.8 grams | Standard Deviation 29.1 |
| Control SAP Group | CHO Treatment | Teens [13-18 years old] | 48.2 grams | Standard Deviation 66.5 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
Secondary
CHO Treatment
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overnight period.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | CHO Treatment | All | 2.8 grams | Standard Deviation 8.3 |
| Experimental AP Group | CHO Treatment | School-age [6-12 years old] | 3.4 grams | Standard Deviation 10 |
| Experimental AP Group | CHO Treatment | Teens [13-18 years old] | 2.1 grams | Standard Deviation 6.5 |
| Control SAP Group | CHO Treatment | All | 5.5 grams | Standard Deviation 12.4 |
| Control SAP Group | CHO Treatment | School-age [6-12 years old] | 4 grams | Standard Deviation 9.7 |
| Control SAP Group | CHO Treatment | Teens [13-18 years old] | 7 grams | Standard Deviation 14.9 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
Secondary
CHO Treatment
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Skiing period.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | CHO Treatment | All | 13.4 grams | Standard Deviation 14.8 |
| Experimental AP Group | CHO Treatment | School-age [6-12 years old] | 10.1 grams | Standard Deviation 9 |
| Experimental AP Group | CHO Treatment | Teens [13-18 years old] | 17.1 grams | Standard Deviation 19.3 |
| Control SAP Group | CHO Treatment | All | 14.6 grams | Standard Deviation 19.3 |
| Control SAP Group | CHO Treatment | School-age [6-12 years old] | 14.3 grams | Standard Deviation 14.7 |
| Control SAP Group | CHO Treatment | Teens [13-18 years old] | 14.9 grams | Standard Deviation 23.7 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
Secondary
Glucose Variability
Variability of glucose during the Overall period
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Glucose Variability | All | 34.2 coefficient of variation | Standard Deviation 6.1 |
| Experimental AP Group | Glucose Variability | School-age [6-12 years old] | 32.4 coefficient of variation | Standard Deviation 5.3 |
| Experimental AP Group | Glucose Variability | Teens [13-18 years old] | 36.2 coefficient of variation | Standard Deviation 6.6 |
| Control SAP Group | Glucose Variability | All | 33.9 coefficient of variation | Standard Deviation 8.4 |
| Control SAP Group | Glucose Variability | School-age [6-12 years old] | 33.2 coefficient of variation | Standard Deviation 8 |
| Control SAP Group | Glucose Variability | Teens [13-18 years old] | 34.6 coefficient of variation | Standard Deviation 9 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
Secondary
Glucose Variability
Variability of glucose during the Skiing period
Time frame: Skiing [9:30am-noon and 1:30pm-4pm
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Glucose Variability | All | 30.2 coefficient of variation | Standard Deviation 7.7 |
| Experimental AP Group | Glucose Variability | School-age [6-12 years old] | 30 coefficient of variation | Standard Deviation 9.3 |
| Experimental AP Group | Glucose Variability | Teens [13-18 years old] | 30.3 coefficient of variation | Standard Deviation 6 |
| Control SAP Group | Glucose Variability | Teens [13-18 years old] | 24.5 coefficient of variation | Standard Deviation 7.9 |
| Control SAP Group | Glucose Variability | All | 29.9 coefficient of variation | Standard Deviation 10.5 |
| Control SAP Group | Glucose Variability | School-age [6-12 years old] | 35.2 coefficient of variation | Standard Deviation 10.2 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: 0.198ANOVA
Secondary
Glucose Variability
Variability of glucose during the Overnight period
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Glucose Variability | All | 24.5 coefficient of variation | Standard Deviation 9.9 |
| Experimental AP Group | Glucose Variability | School-age [6-12 years old] | 22.6 coefficient of variation | Standard Deviation 8.9 |
| Experimental AP Group | Glucose Variability | Teens [13-18 years old] | 26.5 coefficient of variation | Standard Deviation 10.9 |
| Control SAP Group | Glucose Variability | Teens [13-18 years old] | 27.6 coefficient of variation | Standard Deviation 9 |
| Control SAP Group | Glucose Variability | All | 24.3 coefficient of variation | Standard Deviation 11.6 |
| Control SAP Group | Glucose Variability | School-age [6-12 years old] | 21 coefficient of variation | Standard Deviation 13.3 |
p-value: >0.2ANOVA
p-value: 0.106ANOVA
p-value: >0.2ANOVA
Secondary
Glucose Variability
Variability of glucose during the Daytime period
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Glucose Variability | All | 33.5 coefficient of variation | Standard Deviation 4.8 |
| Experimental AP Group | Glucose Variability | School-age [6-12 years old] | 32.2 coefficient of variation | Standard Deviation 3.3 |
| Experimental AP Group | Glucose Variability | Teens [13-18 years old] | 34.9 coefficient of variation | Standard Deviation 5.9 |
| Control SAP Group | Glucose Variability | School-age [6-12 years old] | 35.3 coefficient of variation | Standard Deviation 8.1 |
| Control SAP Group | Glucose Variability | All | 34.2 coefficient of variation | Standard Deviation 8.2 |
| Control SAP Group | Glucose Variability | Teens [13-18 years old] | 33.2 coefficient of variation | Standard Deviation 8.5 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
Secondary
Insulin
Amount (U/kg) of insulin administered during the Overnight period
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Insulin | All | 7.5 U/kg | Standard Deviation 3.1 |
| Experimental AP Group | Insulin | School-age [6-12 years old] | 6.1 U/kg | Standard Deviation 3 |
| Experimental AP Group | Insulin | Teens [13-18 years old] | 9 U/kg | Standard Deviation 2.6 |
| Control SAP Group | Insulin | All | 9.4 U/kg | Standard Deviation 10 |
| Control SAP Group | Insulin | School-age [6-12 years old] | 4.1 U/kg | Standard Deviation 2.5 |
| Control SAP Group | Insulin | Teens [13-18 years old] | 14.8 U/kg | Standard Deviation 11.9 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: 0.157ANOVA
Secondary
Insulin
Amount (U/kg) of insulin administered during the Skiing period
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Insulin | All | 6.8 U/kg | Standard Deviation 2.6 |
| Experimental AP Group | Insulin | School-age [6-12 years old] | 6.6 U/kg | Standard Deviation 2.4 |
| Experimental AP Group | Insulin | Teens [13-18 years old] | 6.9 U/kg | Standard Deviation 2.9 |
| Control SAP Group | Insulin | All | 6.6 U/kg | Standard Deviation 5.8 |
| Control SAP Group | Insulin | School-age [6-12 years old] | 5 U/kg | Standard Deviation 3.1 |
| Control SAP Group | Insulin | Teens [13-18 years old] | 8.1 U/kg | Standard Deviation 7.4 |
p-value: 0.105ANOVA
p-value: 0.001ANOVA
p-value: >0.2ANOVA
Secondary
Insulin
Amount (U/kg) of insulin administered during the Overall period
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Insulin | All | 40.5 U/kg | Standard Deviation 16.7 |
| Experimental AP Group | Insulin | School-age [6-12 years old] | 29.5 U/kg | Standard Deviation 10.9 |
| Experimental AP Group | Insulin | Teens [13-18 years old] | 52.7 U/kg | Standard Deviation 13.1 |
| Control SAP Group | Insulin | All | 43.9 U/kg | Standard Deviation 28.4 |
| Control SAP Group | Insulin | School-age [6-12 years old] | 21.4 U/kg | Standard Deviation 8.4 |
| Control SAP Group | Insulin | Teens [13-18 years old] | 66.3 U/kg | Standard Deviation 22.8 |
p-value: >0.2ANOVA
p-value: 0.081ANOVA
p-value: >0.2ANOVA
Secondary
Insulin
Amount (U/kg) of insulin administered during the Daytime period
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Insulin | All | 30.9 U/kg | Standard Deviation 13.1 |
| Experimental AP Group | Insulin | School-age [6-12 years old] | 22.1 U/kg | Standard Deviation 8 |
| Experimental AP Group | Insulin | Teens [13-18 years old] | 40.7 U/kg | Standard Deviation 10.5 |
| Control SAP Group | Insulin | All | 32.7 U/kg | Standard Deviation 20.4 |
| Control SAP Group | Insulin | School-age [6-12 years old] | 16.3 U/kg | Standard Deviation 6.2 |
| Control SAP Group | Insulin | Teens [13-18 years old] | 49 U/kg | Standard Deviation 15.8 |
p-value: >0.2ANOVA
p-value: 0.044ANOVA
p-value: >0.2ANOVA
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.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Mean Glucose | All | 161 mg/dL | Standard Deviation 29.9 |
| Experimental AP Group | Mean Glucose | School-age [6-12 years old] | 175.9 mg/dL | Standard Deviation 33.9 |
| Experimental AP Group | Mean Glucose | Teens [13-18 years old] | 144.5 mg/dL | Standard Deviation 11.7 |
| Control SAP Group | Mean Glucose | All | 176.8 mg/dL | Standard Deviation 36.5 |
| Control SAP Group | Mean Glucose | School-age [6-12 years old] | 174.5 mg/dL | Standard Deviation 30.7 |
| Control SAP Group | Mean Glucose | Teens [13-18 years old] | 179 mg/dL | Standard Deviation 42.7 |
p-value: 0.023ANOVA
p-value: >0.2ANOVA
p-value: 0.016ANOVA
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.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Mean Glucose | All | 166.9 mg/dL | Standard Deviation 34 |
| Experimental AP Group | Mean Glucose | School-age [6-12 years old] | 180.3 mg/dL | Standard Deviation 40.6 |
| Experimental AP Group | Mean Glucose | Teens [13-18 years old] | 152 mg/dL | Standard Deviation 16.4 |
| Control SAP Group | Mean Glucose | All | 177.2 mg/dL | Standard Deviation 37.6 |
| Control SAP Group | Mean Glucose | School-age [6-12 years old] | 170.4 mg/dL | Standard Deviation 30.1 |
| Control SAP Group | Mean Glucose | Teens [13-18 years old] | 183.9 mg/dL | Standard Deviation 44.1 |
p-value: 0.111ANOVA
p-value: 0.13ANOVA
p-value: 0.017ANOVA
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Mean Glucose | All | 173.2 mg/dL | Standard Deviation 44.7 |
| Experimental AP Group | Mean Glucose | School-age [6-12 years old] | 185.3 mg/dL | Standard Deviation 53.8 |
| Experimental AP Group | Mean Glucose | Teens [13-18 years old] | 159.8 mg/dL | Standard Deviation 29 |
| Control SAP Group | Mean Glucose | All | 178 mg/dL | Standard Deviation 47.4 |
| Control SAP Group | Mean Glucose | School-age [6-12 years old] | 167.5 mg/dL | Standard Deviation 33.3 |
| Control SAP Group | Mean Glucose | Teens [13-18 years old] | 188.5 mg/dL | Standard Deviation 57.8 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: 0.104ANOVA
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Mean Glucose | All | 142.9 mg/dL | Standard Deviation 36 |
| Experimental AP Group | Mean Glucose | School-age [6-12 years old] | 162.4 mg/dL | Standard Deviation 37 |
| Experimental AP Group | Mean Glucose | Teens [13-18 years old] | 121.6 mg/dL | Standard Deviation 19.7 |
| Control SAP Group | Mean Glucose | All | 175.4 mg/dL | Standard Deviation 52.7 |
| Control SAP Group | Mean Glucose | School-age [6-12 years old] | 187.1 mg/dL | Standard Deviation 39.9 |
| Control SAP Group | Mean Glucose | Teens [13-18 years old] | 163.8 mg/dL | Standard Deviation 62.6 |
p-value: 0.005ANOVA
p-value: >0.2ANOVA
p-value: 0.193ANOVA
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.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >180 mg/dL | All | 31.4 percentage of time | Standard Deviation 17.6 |
| Experimental AP Group | Percent Time Spent >180 mg/dL | School-age [6-12 years old] | 39 percentage of time | Standard Deviation 20.5 |
| Experimental AP Group | Percent Time Spent >180 mg/dL | Teens [13-18 years old] | 22.9 percentage of time | Standard Deviation 8.2 |
| Control SAP Group | Percent Time Spent >180 mg/dL | All | 43 percentage of time | Standard Deviation 24.5 |
| Control SAP Group | Percent Time Spent >180 mg/dL | School-age [6-12 years old] | 40.5 percentage of time | Standard Deviation 23.1 |
| Control SAP Group | Percent Time Spent >180 mg/dL | Teens [13-18 years old] | 45.5 percentage of time | Standard Deviation 26.7 |
p-value: 0.015ANOVA
p-value: 0.199ANOVA
p-value: 0.025ANOVA
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.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >180 mg/dL | All | 35.7 percentage of time | Standard Deviation 19.8 |
| Experimental AP Group | Percent Time Spent >180 mg/dL | School-age [6-12 years old] | 42.6 percentage of time | Standard Deviation 23.7 |
| Experimental AP Group | Percent Time Spent >180 mg/dL | Teens [13-18 years old] | 28.1 percentage of time | Standard Deviation 11.3 |
| Control SAP Group | Percent Time Spent >180 mg/dL | All | 42.5 percentage of time | Standard Deviation 24.9 |
| Control SAP Group | Percent Time Spent >180 mg/dL | School-age [6-12 years old] | 38.4 percentage of time | Standard Deviation 22.4 |
| Control SAP Group | Percent Time Spent >180 mg/dL | Teens [13-18 years old] | 46.5 percentage of time | Standard Deviation 27.6 |
p-value: 0.124ANOVA
p-value: 0.187ANOVA
p-value: 0.04ANOVA
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >180 mg/dL | All | 41.4 percentage of time | Standard Deviation 27.8 |
| Experimental AP Group | Percent Time Spent >180 mg/dL | School-age [6-12 years old] | 49.3 percentage of time | Standard Deviation 31.4 |
| Experimental AP Group | Percent Time Spent >180 mg/dL | Teens [13-18 years old] | 32.8 percentage of time | Standard Deviation 21.5 |
| Control SAP Group | Percent Time Spent >180 mg/dL | All | 41.5 percentage of time | Standard Deviation 30.3 |
| Control SAP Group | Percent Time Spent >180 mg/dL | School-age [6-12 years old] | 33.4 percentage of time | Standard Deviation 23.4 |
| Control SAP Group | Percent Time Spent >180 mg/dL | Teens [13-18 years old] | 49.5 percentage of time | Standard Deviation 35 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: 0.073ANOVA
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >180 mg/dL | All | 18.2 percentage of time | Standard Deviation 21.4 |
| Experimental AP Group | Percent Time Spent >180 mg/dL | School-age [6-12 years old] | 28.2 percentage of time | Standard Deviation 23.3 |
| Experimental AP Group | Percent Time Spent >180 mg/dL | Teens [13-18 years old] | 7.1 percentage of time | Standard Deviation 12.5 |
| Control SAP Group | Percent Time Spent >180 mg/dL | All | 44.5 percentage of time | Standard Deviation 37 |
| Control SAP Group | Percent Time Spent >180 mg/dL | School-age [6-12 years old] | 46.7 percentage of time | Standard Deviation 34.1 |
| Control SAP Group | Percent Time Spent >180 mg/dL | Teens [13-18 years old] | 42.3 percentage of time | Standard Deviation 41.1 |
p-value: 0.001ANOVA
p-value: >0.2ANOVA
p-value: 0.111ANOVA
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.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >250 mg/dL | All | 10.4 percentage of time | Standard Deviation 11.4 |
| Experimental AP Group | Percent Time Spent >250 mg/dL | School-age [6 -12 years old] | 14.8 percentage of time | Standard Deviation 14 |
| Experimental AP Group | Percent Time Spent >250 mg/dL | Teens [13-18 years old] | 5.6 percentage of time | Standard Deviation 4.9 |
| Control SAP Group | Percent Time Spent >250 mg/dL | All | 16 percentage of time | Standard Deviation 13.6 |
| Control SAP Group | Percent Time Spent >250 mg/dL | School-age [6 -12 years old] | 13.2 percentage of time | Standard Deviation 12.5 |
| Control SAP Group | Percent Time Spent >250 mg/dL | Teens [13-18 years old] | 18.8 percentage of time | Standard Deviation 14.5 |
p-value: 0.059ANOVA
p-value: 0.064ANOVA
p-value: 0.017ANOVA
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >250 mg/dL | Teens [13-18 years old] | 8.5 percentage of time | Standard Deviation 10.6 |
| Experimental AP Group | Percent Time Spent >250 mg/dL | All | 14.4 percentage of time | Standard Deviation 17.3 |
| Experimental AP Group | Percent Time Spent >250 mg/dL | School-age [6-12 years old] | 19.8 percentage of time | Standard Deviation 20.7 |
| Control SAP Group | Percent Time Spent >250 mg/dL | All | 18.2 percentage of time | Standard Deviation 20.4 |
| Control SAP Group | Percent Time Spent >250 mg/dL | School-age [6-12 years old] | 14.4 percentage of time | Standard Deviation 16.4 |
| Control SAP Group | Percent Time Spent >250 mg/dL | Teens [13-18 years old] | 22 percentage of time | Standard Deviation 23.8 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: 0.064ANOVA
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >250 mg/dL | All | 5.3 percentage of time | Standard Deviation 13.5 |
| Experimental AP Group | Percent Time Spent >250 mg/dL | School-age [6-12 years old] | 7.7 percentage of time | Standard Deviation 17 |
| Experimental AP Group | Percent Time Spent >250 mg/dL | Teens [13-18 years old] | 2.7 percentage of time | Standard Deviation 8.4 |
| Control SAP Group | Percent Time Spent >250 mg/dL | All | 13.2 percentage of time | Standard Deviation 19 |
| Control SAP Group | Percent Time Spent >250 mg/dL | School-age [6-12 years old] | 12.7 percentage of time | Standard Deviation 20.2 |
| Control SAP Group | Percent Time Spent >250 mg/dL | Teens [13-18 years old] | 13.7 percentage of time | Standard Deviation 18.6 |
p-value: 0.118ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
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.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >250 mg/dL | All | 12.1 percentage of time | Standard Deviation 13.6 |
| Experimental AP Group | Percent Time Spent >250 mg/dL | School-age [6-12 years old] | 17.1 percentage of time | Standard Deviation 16.3 |
| Experimental AP Group | Percent Time Spent >250 mg/dL | Teens [13-18 years old] | 6.6 percentage of time | Standard Deviation 6.9 |
| Control SAP Group | Percent Time Spent >250 mg/dL | All | 16.9 percentage of time | Standard Deviation 14.4 |
| Control SAP Group | Percent Time Spent >250 mg/dL | School-age [6-12 years old] | 13.3 percentage of time | Standard Deviation 12 |
| Control SAP Group | Percent Time Spent >250 mg/dL | Teens [13-18 years old] | 20.4 percentage of time | Standard Deviation 16.3 |
p-value: 0.108ANOVA
p-value: 0.053ANOVA
p-value: 0.01ANOVA
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.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >300 mg/dL | All | 4.6 percentage of time | Standard Deviation 7.2 |
| Experimental AP Group | Percent Time Spent >300 mg/dL | School-age [6-12 years old] | 7.6 percentage of time | Standard Deviation 9 |
| Experimental AP Group | Percent Time Spent >300 mg/dL | Teens [13-18 years old] | 1.3 percentage of time | Standard Deviation 1.7 |
| Control SAP Group | Percent Time Spent >300 mg/dL | All | 7.3 percentage of time | Standard Deviation 7.5 |
| Control SAP Group | Percent Time Spent >300 mg/dL | School-age [6-12 years old] | 6.5 percentage of time | Standard Deviation 6.4 |
| Control SAP Group | Percent Time Spent >300 mg/dL | Teens [13-18 years old] | 8.1 percentage of time | Standard Deviation 8.7 |
p-value: 0.08ANOVA
p-value: 0.038ANOVA
p-value: 0.016ANOVA
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >300 mg/dL | All | 1.8 percentage of time | Standard Deviation 7.8 |
| Experimental AP Group | Percent Time Spent >300 mg/dL | School-age [6-12 years old] | 3.2 percentage of time | Standard Deviation 10.8 |
| Experimental AP Group | Percent Time Spent >300 mg/dL | Teens [13-18 years old] | 0.2 percentage of time | Standard Deviation 0.6 |
| Control SAP Group | Percent Time Spent >300 mg/dL | All | 5.8 percentage of time | Standard Deviation 9.5 |
| Control SAP Group | Percent Time Spent >300 mg/dL | School-age [6-12 years old] | 6.7 percentage of time | Standard Deviation 11.7 |
| Control SAP Group | Percent Time Spent >300 mg/dL | Teens [13-18 years old] | 4.8 percentage of time | Standard Deviation 7 |
p-value: 0.116ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >300 mg/dL | All | 5.9 percentage of time | Standard Deviation 11.1 |
| Experimental AP Group | Percent Time Spent >300 mg/dL | School-age [6-12 years old] | 9.2 percentage of time | Standard Deviation 14.6 |
| Experimental AP Group | Percent Time Spent >300 mg/dL | Teens [13-18 years old] | 2.3 percentage of time | Standard Deviation 3.2 |
| Control SAP Group | Percent Time Spent >300 mg/dL | All | 7.5 percentage of time | Standard Deviation 10.9 |
| Control SAP Group | Percent Time Spent >300 mg/dL | School-age [6-12 years old] | 8.1 percentage of time | Standard Deviation 10.5 |
| Control SAP Group | Percent Time Spent >300 mg/dL | Teens [13-18 years old] | 6.9 percentage of time | Standard Deviation 11.7 |
p-value: >0.2ANOVA
p-value: >0.2ANOVA
p-value: >0.2ANOVA
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.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent >300 mg/dL | All | 3.9 percentage of time | Standard Deviation 5.9 |
| Experimental AP Group | Percent Time Spent >300 mg/dL | School-age [6-12 years old] | 6.5 percentage of time | Standard Deviation 7.2 |
| Experimental AP Group | Percent Time Spent >300 mg/dL | Teens [13-18 years old] | 1 percentage of time | Standard Deviation 1.3 |
| Control SAP Group | Percent Time Spent >300 mg/dL | All | 6.9 percentage of time | Standard Deviation 6.7 |
| Control SAP Group | Percent Time Spent >300 mg/dL | School-age [6-12 years old] | 6.6 percentage of time | Standard Deviation 6.6 |
| Control SAP Group | Percent Time Spent >300 mg/dL | Teens [13-18 years old] | 7.3 percentage of time | Standard Deviation 7 |
p-value: 0.034ANOVA
p-value: 0.074ANOVA
p-value: 0.034ANOVA
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <50 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <50 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <50 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <50 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <50 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <50 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <50 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <50 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <50 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <50 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <50 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <50 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <50 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <54 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <54 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <54 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <54 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <54 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <54 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <54 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <54 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <54 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <54 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <54 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <54 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <54 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <60 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <60 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <60 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <60 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <60 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <60 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <60 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <60 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <60 mg/dL | Teens [13-18 years old] | 0.5 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: 0.141Wilcoxon (Mann-Whitney)
p-value: 0.149Wilcoxon (Mann-Whitney)
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.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <60 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <60 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <60 mg/dL | Teens [13-18 years old] | 0.5 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <60 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Daytime [7am - 11pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <70 mg/dL | All | 1 percentage of time |
| Experimental AP Group | Percent Time Spent <70 mg/dL | School-age [6-12 years old] | 0.7 percentage of time |
| Experimental AP Group | Percent Time Spent <70 mg/dL | Teens [13-18 years old] | 2.5 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | All | 0.8 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | School-age [6-12 years old] | 1 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | Teens [13-18 years old] | 0.7 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <70 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <70 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <70 mg/dL | Teens [13-18 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <70 mg/dL | All | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <70 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Experimental AP Group | Percent Time Spent <70 mg/dL | Teens [13-18 years old] | 6.1 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | All | 0 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | School-age [6-12 years old] | 0 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | Teens [13-18 years old] | 0 percentage of time |
p-value: >0.2Wilcoxon (Mann-Whitney)
p-value: 0.094Wilcoxon (Mann-Whitney)
p-value: >0.2Wilcoxon (Mann-Whitney)
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.
Time frame: Overall [48hr study admission]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental AP Group | Percent Time Spent <70 mg/dL | All | 2 percentage of time |
| Experimental AP Group | Percent Time Spent <70 mg/dL | School-age [6-12 years old] | 0.8 percentage of time |
| Experimental AP Group | Percent Time Spent <70 mg/dL | Teens [13-18 years old] | 3.3 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | All | 0.8 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | School-age [6-12 years old] | 0.8 percentage of time |
| Control SAP Group | Percent Time Spent <70 mg/dL | Teens [13-18 years old] | 0.9 percentage of time |
p-value: >0.2ANOVA
p-value: 0.062ANOVA
p-value: >0.2ANOVA
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.
Time frame: Overnight [11pm - 7am]
Population: The All row is the combined total of participants in the following rows School-age and Teens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental AP Group | Percent Time Spent Between 70 and 150 mg/dL | All | 60.8 percentage of time | Standard Deviation 26.5 |
| Experimental AP Group | Percent Time Spent Between 70 and 150 mg/dL | School-age [6-12 years old] | 45.5 percentage of time | Standard Deviation 27.7 |
| Experimental AP Group | Percent Time Spent Between 70 and 150 mg/dL | Teens [13-18 years old] | 77.6 percentage of time | Standard Deviation 10.4 |
| Control SAP Group | Percent Time Spent Between 70 and 150 mg/dL | All | 32.1 percentage of time | Standard Deviation 33.2 |
| Control SAP Group | Percent Time Spent Between 70 and 150 mg/dL | School-age [6-12 years old] | 24.7 percentage of time | Standard Deviation 28.5 |
| Control SAP Group | Percent Time Spent Between 70 and 150 mg/dL | Teens [13-18 years old] | 39.5 percentage of time | Standard Deviation 37.1 |
p-value: <0.001ANOVA
p-value: >0.2ANOVA
p-value: 0.033ANOVA