Type 1 Diabetes Mellitus
Conditions
Keywords
Artificial Pancreas (AP), Insulin Pump, Continuous Glucose Monitor (CGM), MyTDI, Hybrid Closed Loop (HCL), Total Daily Insulin (TDI)
Brief summary
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.
Detailed description
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes. Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.
Interventions
DEVICEHybrid Closed Loop (HCL)
Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
DEVICEControl-IQ with MyTDI
Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
Sponsors
Tandem Diabetes Care, Inc.
DexCom, Inc.
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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) * Diagnosis of type 1 diabetes is based on the investigator's judgement * Criteria for requiring insulin at diagnosis (both criteria must be met): * Daily insulin therapy for ≥ 6 months * Insulin pump therapy for ≥ 3 months * Age 12-18 years * Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart. * Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month. * Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study. * For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study. * Total daily insulin dose (TDD) at least 10 U/day.
Exclusion criteria
* Diabetic ketoacidosis in the past 6 months * Hypoglycemic seizure or loss of consciousness in the past 6 months * History of seizure disorder * 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 judgement 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). * Pregnancy * Presence of a febrile illness within 24 hours of the Ski Admission * Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as: * Inpatient psychiatric treatment in the past 6 months * Uncontrolled adrenal insufficiency * Alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time in Range at Home Pre/Post Intervention at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average CGM at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) | average of CGM values within time frame |
| Percentage of CGM Values Below 50mg/dL at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | the percentage of CGM values falling below 50mg/dL, calculated as the number of CGM values \<50mg/dL within the time frame divided by the total number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Below 50mg/dL at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) | the percentage of CGM values falling below 50mg/dL, computed as the number of CGM values \<50mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Below 54mg/dL at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) | the percentage of CGM values falling below 54mg/dL. computed as the number of CGM values \<54mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Below 60mg/dL at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values \<60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Below 60mg/dL at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) | the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values \<60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Below 70mg/dL at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values \<70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Below 70mg/dL at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) | the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values \<70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) | the percentage of CGM values falling between 70mg/dL and 180mg/dL, computed as the number of CGM values \<=180mg/dL and \>70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Above 180mg/dL at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values \>180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Above 180mg/dL at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) | the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values \>180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Average CGM at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | Average of available CGM values within time frame |
| Percentage of CGM Values Above 250mg/dL at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) | the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values \>250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Above 300mg/dL at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values \>300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Percentage of CGM Values Above 300mg/dL at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) | the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values \>300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
| Change in Total Daily Insulin at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | sum of the recorded insulin injection over the time frame in units |
| Change in Total Daily Insulin at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) | sum of the recorded insulin injection over the time frame in units |
| Change in Total Meal Carbohydrates at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | sum of the meal sized recorded over the time frame |
| Change in Total Meal Carbohydrates at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) | sum of the meal sized recorded over the time frame |
| Change in Number of Hypoglycemic Events at Camp | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) | Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL) |
| Number of Hypoglycemia Treatment at Camp | 2 days during camp admission (Camp) | Sum of the number of CHO treatments recorded over the time frame |
| Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp | 2 days during camp admission (Camp) | Sum of the amount of carbohydrates used for treatments recorded over the time frame |
| Change in Hypoglycemia Events at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | change in number of hypoglycemia between baseline and home |
| Percentage of CGM Values Above 250mg/dL at Home | 5 days post camp (home) compared to 5 days before camp (baseline) | the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values \>250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. |
Countries
United States
Participant flow
Recruitment details
Of 22 enrolled participants, 20 were randomized to treatment. One participant was dropped after meeting stopping criteria.
Pre-assignment details
1 participant dropped prior to randomization for personal reasons (travel issues); 1 participant dropped prior to randomization as they didn't attend screening appointment.
Participants by arm
| Arm | Count |
|---|---|
| Hybrid Closed Loop (HCL) Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity. | 10 |
| Control-IQ With MyTDI Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
* A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
* A single correction factor (CF) of 1650/TDI will be implemented across the whole day
* Carbohydrate ratios (CR) will be set at:
* 00:00-04:00 CR=450/TDI
* 04:00-11:00 CR=360/TDI
* 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Family Obligation | 1 | 0 |
Baseline characteristics
| Characteristic | Control-IQ With MyTDI | Total | Hybrid Closed Loop (HCL) |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.7 years STANDARD_DEVIATION 1.6 | 14.5 years STANDARD_DEVIATION 1.65 | 14.3 years STANDARD_DEVIATION 1.7 |
| 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 | 0 Participants | 0 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 | 10 Participants | 20 Participants | 10 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Percent Time in Range at Home Pre/Post Intervention at Home
The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percent Time in Range at Home Pre/Post Intervention at Home | Baseline | 77.8 percentage of time spent in range | Standard Deviation 6.2 |
| Hybrid Closed Loop (HCL) | Percent Time in Range at Home Pre/Post Intervention at Home | Home | 68.9 percentage of time spent in range | Standard Deviation 8.9 |
| Control-IQ With MyTDI | Percent Time in Range at Home Pre/Post Intervention at Home | Baseline | 70.7 percentage of time spent in range | Standard Deviation 12.4 |
| Control-IQ With MyTDI | Percent Time in Range at Home Pre/Post Intervention at Home | Home | 70.1 percentage of time spent in range | Standard Deviation 14.4 |
p-value: 0.178ANOVA
Secondary
Average CGM at Camp
average of CGM values within time frame
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Average CGM at Camp | Baseline | 142.4 mg/dL | Standard Deviation 13.6 |
| Hybrid Closed Loop (HCL) | Average CGM at Camp | Camp | 144.3 mg/dL | Standard Deviation 24.6 |
| Control-IQ With MyTDI | Average CGM at Camp | Baseline | 152.2 mg/dL | Standard Deviation 19.2 |
| Control-IQ With MyTDI | Average CGM at Camp | Camp | 141.3 mg/dL | Standard Deviation 13.1 |
p-value: 0.304ANOVA
Secondary
Average CGM at Home
Average of available CGM values within time frame
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Average CGM at Home | Baseline | 142.4 mg/dL | Standard Deviation 13.6 |
| Hybrid Closed Loop (HCL) | Average CGM at Home | Week 2-Home Portion | 156.5 mg/dL | Standard Deviation 14.9 |
| Control-IQ With MyTDI | Average CGM at Home | Baseline | 152.2 mg/dL | Standard Deviation 19.2 |
| Control-IQ With MyTDI | Average CGM at Home | Week 2-Home Portion | 152.9 mg/dL | Standard Deviation 21.2 |
p-value: 0.145ANOVA
Secondary
Change in Hypoglycemia Events at Home
change in number of hypoglycemia between baseline and home
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Change in Hypoglycemia Events at Home | Baseline | 1 events per day |
| Hybrid Closed Loop (HCL) | Change in Hypoglycemia Events at Home | Home | 0.3 events per day |
| Control-IQ With MyTDI | Change in Hypoglycemia Events at Home | Baseline | 0.6 events per day |
| Control-IQ With MyTDI | Change in Hypoglycemia Events at Home | Home | 0.7 events per day |
Secondary
Change in Number of Hypoglycemic Events at Camp
Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Change in Number of Hypoglycemic Events at Camp | Baseline | 1 events per day |
| Hybrid Closed Loop (HCL) | Change in Number of Hypoglycemic Events at Camp | Camp | 1 events per day |
| Control-IQ With MyTDI | Change in Number of Hypoglycemic Events at Camp | Baseline | 0.5 events per day |
| Control-IQ With MyTDI | Change in Number of Hypoglycemic Events at Camp | Camp | 1 events per day |
Secondary
Change in Total Daily Insulin at Camp
sum of the recorded insulin injection over the time frame in units
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Change in Total Daily Insulin at Camp | Baseline | 39.0 Units | Standard Deviation 7.3 |
| Hybrid Closed Loop (HCL) | Change in Total Daily Insulin at Camp | Camp | 38.8 Units | Standard Deviation 11.3 |
| Control-IQ With MyTDI | Change in Total Daily Insulin at Camp | Baseline | 48.7 Units | Standard Deviation 18.4 |
| Control-IQ With MyTDI | Change in Total Daily Insulin at Camp | Camp | 50.9 Units | Standard Deviation 27.5 |
p-value: 0.69ANOVA
Secondary
Change in Total Daily Insulin at Home
sum of the recorded insulin injection over the time frame in units
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Change in Total Daily Insulin at Home | Baseline | 39.0 Units | Standard Deviation 7.3 |
| Hybrid Closed Loop (HCL) | Change in Total Daily Insulin at Home | Home | 48.2 Units | Standard Deviation 11.2 |
| Control-IQ With MyTDI | Change in Total Daily Insulin at Home | Baseline | 48.7 Units | Standard Deviation 18.4 |
| Control-IQ With MyTDI | Change in Total Daily Insulin at Home | Home | 54.9 Units | Standard Deviation 29 |
p-value: 0.584ANOVA
Secondary
Change in Total Meal Carbohydrates at Camp
sum of the meal sized recorded over the time frame
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Change in Total Meal Carbohydrates at Camp | Baseline | 226.3 Grams | Standard Deviation 38.6 |
| Hybrid Closed Loop (HCL) | Change in Total Meal Carbohydrates at Camp | Camp | 280.0 Grams | Standard Deviation 43 |
| Control-IQ With MyTDI | Change in Total Meal Carbohydrates at Camp | Baseline | 204.1 Grams | Standard Deviation 100.4 |
| Control-IQ With MyTDI | Change in Total Meal Carbohydrates at Camp | Camp | 254.6 Grams | Standard Deviation 143.5 |
p-value: 0.904ANOVA
Secondary
Change in Total Meal Carbohydrates at Home
sum of the meal sized recorded over the time frame
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Change in Total Meal Carbohydrates at Home | Baseline | 226.3 Grams | Standard Deviation 38.6 |
| Hybrid Closed Loop (HCL) | Change in Total Meal Carbohydrates at Home | Home | 276.5 Grams | Standard Deviation 94.5 |
| Control-IQ With MyTDI | Change in Total Meal Carbohydrates at Home | Home | 192.6 Grams | Standard Deviation 115.4 |
| Control-IQ With MyTDI | Change in Total Meal Carbohydrates at Home | Baseline | 204.1 Grams | Standard Deviation 100.4 |
p-value: 0.066ANOVA
Secondary
Number of Hypoglycemia Treatment at Camp
Sum of the number of CHO treatments recorded over the time frame
Time frame: 2 days during camp admission (Camp)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hybrid Closed Loop (HCL) | Number of Hypoglycemia Treatment at Camp | 1.5 events per day |
| Control-IQ With MyTDI | Number of Hypoglycemia Treatment at Camp | 2.5 events per day |
Secondary
Percentage of CGM Values Above 180mg/dL at Camp
the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values \>180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 180mg/dL at Camp | Baseline | 18.9 percentage | Standard Deviation 7.7 |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 180mg/dL at Camp | Camp | 20.1 percentage | Standard Deviation 13.4 |
| Control-IQ With MyTDI | Percentage of CGM Values Above 180mg/dL at Camp | Baseline | 26.9 percentage | Standard Deviation 12.7 |
| Control-IQ With MyTDI | Percentage of CGM Values Above 180mg/dL at Camp | Camp | 20.1 percentage | Standard Deviation 7.3 |
p-value: 0.271ANOVA
Secondary
Percentage of CGM Values Above 180mg/dL at Home
the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values \>180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 180mg/dL at Home | Baseline | 18.9 percentage | Standard Deviation 17.7 |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 180mg/dL at Home | Home | 29.1 percentage | Standard Deviation 10.3 |
| Control-IQ With MyTDI | Percentage of CGM Values Above 180mg/dL at Home | Baseline | 26.9 percentage | Standard Deviation 12.7 |
| Control-IQ With MyTDI | Percentage of CGM Values Above 180mg/dL at Home | Home | 27.2 percentage | Standard Deviation 14.4 |
p-value: 0.135ANOVA
Secondary
Percentage of CGM Values Above 250mg/dL at Camp
the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values \>250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 250mg/dL at Camp | Baseline | 16 percentage | Standard Deviation 13.6 |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 250mg/dL at Camp | Camp | 14.88 percentage | Standard Deviation 12.36 |
| Control-IQ With MyTDI | Percentage of CGM Values Above 250mg/dL at Camp | Baseline | 10 percentage | Standard Deviation 11.4 |
| Control-IQ With MyTDI | Percentage of CGM Values Above 250mg/dL at Camp | Camp | 8.04 percentage | Standard Deviation 10.14 |
Secondary
Percentage of CGM Values Above 250mg/dL at Home
the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values \>250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 250mg/dL at Home | Baseline | 3.4 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 250mg/dL at Home | Home | 5.8 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Above 250mg/dL at Home | Baseline | 6.5 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Above 250mg/dL at Home | Home | 3.8 percentage |
p-value: 1ANOVA
Secondary
Percentage of CGM Values Above 300mg/dL at Camp
the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values \>300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 300mg/dL at Camp | Baseline | 0.3 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 300mg/dL at Camp | Camp | 0.0 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Above 300mg/dL at Camp | Baseline | 0.3 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Above 300mg/dL at Camp | Camp | 0.0 percentage |
p-value: 0.294ANOVA
Secondary
Percentage of CGM Values Above 300mg/dL at Home
the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values \>300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 300mg/dL at Home | Baseline | 0.3 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Above 300mg/dL at Home | Home | 0.7 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Above 300mg/dL at Home | Baseline | 0.3 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Above 300mg/dL at Home | Home | 0.9 percentage |
p-value: 1ANOVA
Secondary
Percentage of CGM Values Below 50mg/dL at Camp
the percentage of CGM values falling below 50mg/dL, computed as the number of CGM values \<50mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 50mg/dL at Camp | Baseline | 0.0 percentage | Standard Deviation 0 |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 50mg/dL at Camp | Camp | 0.3 percentage | Standard Deviation 0.7 |
| Control-IQ With MyTDI | Percentage of CGM Values Below 50mg/dL at Camp | Baseline | 0.0 percentage | Standard Deviation 0 |
| Control-IQ With MyTDI | Percentage of CGM Values Below 50mg/dL at Camp | Camp | 0.16 percentage | Standard Deviation 0.36 |
Secondary
Percentage of CGM Values Below 50mg/dL at Home
the percentage of CGM values falling below 50mg/dL, calculated as the number of CGM values \<50mg/dL within the time frame divided by the total number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 50mg/dL at Home | Baseline | 0.0 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 50mg/dL at Home | Home | 0.0 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 50mg/dL at Home | Baseline | 0.0 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 50mg/dL at Home | Home | 0.6 percentage |
p-value: 0.131ANOVA
Secondary
Percentage of CGM Values Below 54mg/dL at Camp
the percentage of CGM values falling below 54mg/dL. computed as the number of CGM values \<54mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 54mg/dL at Camp | Baseline | 0.1 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 54mg/dL at Camp | Camp | 0.0 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 54mg/dL at Camp | Camp | 0.0 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 54mg/dL at Camp | Baseline | 0.1 percentage |
p-value: 0.206ANOVA
Secondary
Percentage of CGM Values Below 60mg/dL at Camp
the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values \<60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 60mg/dL at Camp | Baseline | 0.7 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 60mg/dL at Camp | Camp | 0.5 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 60mg/dL at Camp | Baseline | 0.7 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 60mg/dL at Camp | Camp | 0.9 percentage |
p-value: 0.637ANOVA
Secondary
Percentage of CGM Values Below 60mg/dL at Home
the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values \<60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 60mg/dL at Home | Baseline | 0.7 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 60mg/dL at Home | Home | 0.5 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 60mg/dL at Home | Baseline | 0.7 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 60mg/dL at Home | Home | 1.3 percentage |
p-value: 0.335ANOVA
Secondary
Percentage of CGM Values Below 70mg/dL at Camp
the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values \<70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 70mg/dL at Camp | Baseline | 1.9 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 70mg/dL at Camp | Camp | 1.4 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 70mg/dL at Camp | Baseline | 2.1 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 70mg/dL at Camp | Camp | 3.8 percentage |
p-value: 0.057ANOVA
Secondary
Percentage of CGM Values Below 70mg/dL at Home
the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values \<70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 70mg/dL at Home | Baseline | 1.9 percentage |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Below 70mg/dL at Home | Home | 0.9 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 70mg/dL at Home | Baseline | 2.1 percentage |
| Control-IQ With MyTDI | Percentage of CGM Values Below 70mg/dL at Home | Home | 2.4 percentage |
p-value: 0.347ANOVA
Secondary
Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp
the percentage of CGM values falling between 70mg/dL and 180mg/dL, computed as the number of CGM values \<=180mg/dL and \>70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp | Camp Portion | 78.4 percentage | Standard Deviation 12.8 |
| Hybrid Closed Loop (HCL) | Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp | Baseline | 77.8 percentage | Standard Deviation 6.2 |
| Control-IQ With MyTDI | Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp | Baseline | 70.7 percentage | Standard Deviation 12.4 |
| Control-IQ With MyTDI | Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp | Camp Portion | 76.5 percentage | Standard Deviation 8 |
p-value: 0.435ANOVA
Secondary
Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp
Sum of the amount of carbohydrates used for treatments recorded over the time frame
Time frame: 2 days during camp admission (Camp)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp | 35.9 grams per day | Standard Deviation 37 |
| Control-IQ With MyTDI | Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp | 43.6 grams per day | Standard Deviation 35.2 |