Type 1 Diabetes
Conditions
Keywords
Control-IQ Technology, Insulin Pump, Closed Loop Control (CLC), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI)
Brief summary
The purpose of this study is to learn whether an investigational automated insulin delivery system (study system) for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.
Detailed description
Participants will be randomized to closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) or to standard of care where the children will continue to use his or her personal insulin pump or multiple daily injections. Both groups will use a continuous glucose monitor (CGM) throughout the study. The study system will also use a study insulin pump and a software algorithm to automatically give insulin and control blood glucose. This system is also sometimes called a closed-loop system. This study will take about 6-7 months for the child to complete. Study visits can be completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person at the clinic. A subset of participants will be asked to join an ancillary study with Meal Bolus and Exercise challenges during the extension phase. Data collected from the start of each of these challenges until the following morning will be excluded from the analysis of the extension phase.
Interventions
DEVICETandem t:slim X2 with Control-IQ Technology Pro
The Tandem t:slim X2 with Control-IQ Technology Pro is an artificial pancreas (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population.
DEVICEStandard Care (SC)
Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted).
DEVICETandem t:slim X2 with Control-IQ Technology V1.5
The Tandem t:slim X2 with Control-IQ Technology V1.5 is an artificial pancreas (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Tandem Diabetes Care, Inc.
Marc Breton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 71 Months
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 6 months and using insulin for at least 6 months 2. Familiarity and use of a carbohydrate ratio for meal boluses. 3. Age ≥2 and \<6 years old 4. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff. 5. Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol 6. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study-provided Tandem pump during the study. • Study will not be providing insulin; therefore, participants will need to have access to either lispro or aspart 7. Total daily insulin dose (TDD) at least 5 U/day 8. Body weight at least 20 lbs. 9. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3) 10. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. 11. Parent/guardian proficient in reading and writing English.
Exclusion criteria
1. Concurrent use of any non-insulin glucose-lowering agent (including Glucagon-like peptide-1 \[GLP-1\] agonists, Symlin, Dipeptidyl peptidase-4 \[DPP-4\] inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors, sulfonylureas). 2. Hemophilia or any other bleeding disorder 3. History of \>1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months 4. History of \>1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis 5. History of chronic renal disease or currently on hemodialysis 6. History of adrenal insufficiency 7. Hypothyroidism that is not adequately treated 8. Use of oral or injectable steroids within the last 8 weeks 9. Known, ongoing adhesive intolerance 10. Plans to receive blood transfusions or erythropoietin injections during the course of the study 11. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk (specified in the study procedure manual) 12. Currently using any closed-loop system, or using an insulin pump that is incompatible with use of the study CGM 13. Participation in another pharmaceutical or device trial at the time of enrollment or during the study 14. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | 13 weeks | Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM-measured Percent Above 250 mg/dL | 13 weeks | Percentage of time with a glucose above 250 mg/dL as measured by CGM |
| CGM-measured Mean Glucose | 13 weeks | Average glucose value measured by CGM |
| HbA1c at 13 Weeks | 13 weeks | HbA1c at 13 weeks |
| CGM-measured Percent Below 70 mg/dL | 13 weeks | Percentage of time with glucose below 70 mg/dL as measured by CGM |
| CGM-measured Percent Below 54 mg/dL | 13 weeks | Percentage of time with glucose below 54 mg/dL as measured by CGM |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic Events (Defined as at Least 15 Consecutive Minutes <54 mg/dL) | 13 weeks | hypoglycemic events (defined as at least 15 consecutive minutes \<54 mg/dL) |
| Hyperglycemic Events (Defined as at Least 90 Consecutive Minutes >300 mg/dL) | 13 weeks | hyperglycemic events (defined as at least 90 consecutive minutes \>300 mg/dL) |
| Percent >300 mg/dL | 13 weeks | percent \>300 mg/dL |
| High Blood Glucose Index (HBGI)* | 13 weeks | high blood glucose index (HBGI)\* |
| Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5 Percent | 13 weeks | percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5 percent |
| Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10 Percent | 13 weeks | percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10 percent |
| Percent Time in Range 70-180 mg/dL >70 Percent and Percent Time <70 mg/dL <4 Percent | 13 weeks | percent time in range 70-180 mg/dL \>70 percent and percent time \<70 mg/dL \<4 percent |
| HbA1c <7.0 Percent at 13 Weeks | 13 weeks | HbA1c \<7.0 percent at 13 weeks |
| HbA1c <7.5 Percent at 13 Weeks | 13 weeks | HbA1c \<7.5 percent at 13 weeks |
| HbA1c Improvement From Baseline to 13 Weeks >0.5 Percent | 13 weeks | HbA1c improvement from baseline to 13 weeks \>0.5 percent |
| HbA1c Improvement From Baseline to 13 Weeks >1.0 Percent | 13 weeks | HbA1c improvement from baseline to 13 weeks \>1.0 percent |
| HbA1c Relative Improvement From Baseline to 13 Weeks >10 Percent | 13 weeks | HbA1c relative improvement from baseline to 13 weeks \>10 percent |
| HbA1c Absolute Improvement From Baseline to 13 Weeks >1.0 Percent or HbA1c <7.0 Percent at 13 Weeks | 13 weeks | HbA1c absolute improvement from baseline to 13 weeks \>1.0 percent or HbA1c \<7.0 percent at 13 weeks |
| Number of Severe Hypoglycemic (SH) Events and SH Event Rate Per 100 Person-years | 13 weeks | Number of SH events and SH event rate per 100 person-years |
| Number of Diabetic Ketoacidosis (DKA) Events and DKA Event Rate Per 100 Person-years | 13 weeks | Number of DKA events and DKA event rate per 100 person-years |
| Number of Other Serious Adverse Events | 13 weeks | Number of other serious adverse events (SAEs other than SH events and DKA events) |
| Any Adverse Event Rate | 13 weeks | Any adverse event rate |
| Number of Calendar Days With Any Ketone Level ≥1.0 mmol/L (if ≥5 Total Calendar Days Combined) | 13 weeks | Number of calendar days with any ketone level ≥1.0 mmol/L (if ≥5 total calendar days combined) |
| Worsening of HbA1c From Baseline to 13 Weeks by >0.5 Percent | 13 weeks | Worsening of HbA1c from baseline to 13 weeks by \>0.5 percent |
| Adverse Device Effects (ADE) | 13 weeks | Adverse device effects (ADE) in intervention group only |
| Serious Adverse Device Events (SADE) | 13 weeks | Serious adverse device events (SADE) in intervention group only |
| Unanticipated Adverse Device Effects (UADE) | 13 weeks | Unanticipated adverse device effects (UADE) in intervention group only |
| Total Daily Insulin (Units/kg) | 13 weeks | Total daily insulin (units/kg) |
| Percentage of Total Insulin Delivered Via Basal | 13 weeks | Percentage of total insulin delivered via basal |
| Weight | 13 weeks | Weight |
| Body Mass Index (BMI) | 13 weeks | Body Mass Index (BMI) |
| PedsQL Diabetes Module - Total Score and 5 Subscales | 13 weeks | PedsQL Diabetes Module - total score and 5 subscales: Diabetes, Treatment 1, Treatment 2, Worry, Communication |
| Pediatric Inventory for Parents (PIP) 2 Domains Each With a Total Score and 4 Subscales for (5x2=10 Difference Scores) | 13 weeks | Pediatric Inventory for Parents (PIP) 2 domains each with a total score and 4 subscales for (5x2=10 difference scores): Frequency (Total Score, Communication, Medical Care, Role Function, Emotional Functioning), Difficulty ( Same total + 4 subscales as above for frequency) |
| INSPIRE Survey (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) (CLC Arm Only) | 13 weeks | INSPIRE (CLC arm only) 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. |
| Pittsburgh Sleep Quality Index (PSQI) Global Score | 13 weeks | An abbreviated 9-question version of the Pittsburgh Sleep Quality Index (PSQI), a validated tool for assessing self-reported sleep quantity and quality, will be completed by parents. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
| Fear of Hypoglycemia Survey for Parents (HFS-P) - Total Score, 2 Subscales and 4 Factor Scores | 13 weeks | Fear of Hypoglycemia Survey for Parents (HFS-P) - total score, 2 subscales and 4 factor scores: Behavior (avoidance, Maintain high BG), Worry (Helplessness, Social consequences) |
| Number of SH Events During, Immediately After and Overnight From the Study Challenges | Up to 24 hour period | Number of SH events during, immediately after and overnight from the study challenges |
| Number of Adverse Events During, Immediately After and Overnight From the Study Challenges | Up to 24 hour period | Number of adverse events during, immediately after and overnight from the study challenges |
| CGM-measured % <54 mg/dL Overnight (All Challenge Types) | 8 hours | CGM-measured % \<54 mg/dL overnight (all challenge types) |
| CGM-measured % <70 mg/dL Overnight (All Challenge Types) | 8 hours | CGM-measured % \<70 mg/dL overnight (all challenge types) |
| CGM-measured % >180 mg/dL Overnight (All Challenge Types) | 8 hours | CGM-measured % \>180 mg/dL overnight (all challenge types) |
| CGM-measured % <54 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge | 2 hours | CGM-measured % \<54 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge |
| CGM-measured % <70 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge | 2 hours | CGM-measured % \<70 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge |
| CGM-measured % >180 mg/dL During the Four Hours Following the Announced Meal, or Until the Next Meal Bolus is Given, for the Missed Meal Bolus Challenge | 4 hours | CGM-measured % \>180 mg/dL during the four hours following the announced meal, or until the next meal bolus is given, for the missed meal bolus challenge |
| Percent Above 180 mg/dL | 13 weeks | percent above 180 mg/dL |
| CGM-measured % >300 mg/dL During the Four Hours Following the Announced Meal, or Until the Next Meal Bolus is Given, for the Missed Meal Bolus Challenge | 4 hours | CGM-measured % \>300 mg/dL during the four hours following the announced meal, or until the next meal bolus is given, for the missed meal bolus challenge |
| Percent in Range 70-140 mg/dL | 13 weeks | percent in range 70-140 mg/dL |
| Glucose Variability Measured With the Coefficient of Variation (CV) | 13 weeks | glucose variability measured with the coefficient of variation (CV) |
| Glucose Variability Measured With the Standard Deviation (SD) | 13 weeks | glucose variability measured with the standard deviation (SD) |
| CGM-measured Percent <60 mg/dL | 13 weeks | CGM-measured percent \<60 mg/dL |
| Low Blood Glucose Index (LBGI)* | 13 weeks | low blood glucose index (LBGI)\* |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CLC Group Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the intervention group will use the Tandem t:slim X2 with Control-IQ Technology v1.0 during the first 13 weeks of the study (RCT phase, weeks 1-13) and then use Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 for the remaining 13 weeks of the study (extension phase, weeks 14-26). | 68 |
| SC Group Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the SC group will use their existing insulin therapy in conjunction with study Dexcom G6 CGM during the first 13 weeks of the study (RCT phase, weeks 1-13). The SC group will then transition to using the Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 and study Dexcom G6 CGM for the remaining 13 weeks of the study (weeks 14-26). | 34 |
| Total | 102 |
Baseline characteristics
| Characteristic | CLC Group | SC Group | Total |
|---|---|---|---|
| Age, Continuous | 3.84 Years STANDARD_DEVIATION 1.23 | 4.06 Years STANDARD_DEVIATION 1.25 | 3.92 Years STANDARD_DEVIATION 1.24 |
| Age, Customized 2 to <4 years | 31 Participants | 16 Participants | 47 Participants |
| Age, Customized 4 to <6 years | 37 Participants | 18 Participants | 55 Participants |
| Annual Household Income $100,000 - <$200,000 | 22 Participants | 10 Participants | 32 Participants |
| Annual Household Income ≥ $200,000 | 15 Participants | 4 Participants | 19 Participants |
| Annual Household Income $25,000 - <$35,000 | 2 Participants | 2 Participants | 4 Participants |
| Annual Household Income $35,000 - <$50,000 | 6 Participants | 4 Participants | 10 Participants |
| Annual Household Income $50,000 - <$75,000 | 8 Participants | 5 Participants | 13 Participants |
| Annual Household Income $75,000 - <$100,000 | 11 Participants | 7 Participants | 18 Participants |
| Diabetes Duration 0.5 to <1 years | 29 Participants | 10 Participants | 39 Participants |
| Diabetes Duration 1 to <2 years | 24 Participants | 15 Participants | 39 Participants |
| Diabetes Duration 2 to <4 years | 11 Participants | 7 Participants | 18 Participants |
| Diabetes Duration ≥4 years | 4 Participants | 2 Participants | 6 Participants |
| Glycosylated Hemoglobin (HbA1c) at Randomization | 7.5 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.2 | 7.7 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.9 | 7.6 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.1 |
| Insulin Modality Insulin pump | 42 Participants | 24 Participants | 66 Participants |
| Insulin Modality Multiple daily injections | 26 Participants | 10 Participants | 36 Participants |
| Parent Education Associates Degree or Some College but no Degree | 2 Participants | 1 Participants | 3 Participants |
| Parent Education Bachelor's Degree | 6 Participants | 5 Participants | 11 Participants |
| Parent Education Doctoral or Prof Degree | 32 Participants | 12 Participants | 44 Participants |
| Parent Education ≤High School Diploma | 6 Participants | 3 Participants | 9 Participants |
| Parent Education Master's Degree | 22 Participants | 13 Participants | 35 Participants |
| Prior Continuous Glucose Monitor (CGM) Use Current | 66 Participants | 34 Participants | 100 Participants |
| Prior Continuous Glucose Monitor (CGM) Use In past, but not current | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 50 Participants | 25 Participants | 75 Participants |
| Region of Enrollment United States | 68 participants | 34 participants | 102 participants |
| Sex: Female, Male Female | 33 Participants | 19 Participants | 52 Participants |
| Sex: Female, Male Male | 35 Participants | 15 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 34 |
| other Total, other adverse events | 40 / 68 | 9 / 34 |
| serious Total, serious adverse events | 3 / 68 | 2 / 34 |
Outcome results
Primary
Time in Range
Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
Time frame: 13 weeks
Population: One participant in the CLC group was missing baseline CGM data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLC Group | Time in Range | Baseline | 56.7 Percent of time | Standard Deviation 18 |
| CLC Group | Time in Range | Week 13 | 69.3 Percent of time | Standard Deviation 11.1 |
| SC Group | Time in Range | Baseline | 54.9 Percent of time | Standard Deviation 14.7 |
| SC Group | Time in Range | Week 13 | 55.9 Percent of time | Standard Deviation 12.6 |
p-value: <0.001Direct likelihood model
Secondary
CGM-measured Mean Glucose
Average glucose value measured by CGM
Time frame: 13 weeks
Population: One participant in the CLC group was missing baseline CGM data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLC Group | CGM-measured Mean Glucose | Week 13 | 155 mg/dL | Standard Deviation 20 |
| CLC Group | CGM-measured Mean Glucose | Baseline | 173 mg/dL | Standard Deviation 36 |
| SC Group | CGM-measured Mean Glucose | Baseline | 176 mg/dL | Standard Deviation 26 |
| SC Group | CGM-measured Mean Glucose | Week 13 | 174 mg/dL | Standard Deviation 22 |
p-value: <0.001Direct likelihood model
Secondary
CGM-measured Percent Above 250 mg/dL
Percentage of time with a glucose above 250 mg/dL as measured by CGM
Time frame: 13 weeks
Population: One participant in the CLC group was missing baseline CGM data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLC Group | CGM-measured Percent Above 250 mg/dL | Baseline | 14.8 Percent of time | Standard Deviation 15.5 |
| CLC Group | CGM-measured Percent Above 250 mg/dL | Week 13 | 8.4 Percent of time | Standard Deviation 7.2 |
| SC Group | CGM-measured Percent Above 250 mg/dL | Baseline | 16.0 Percent of time | Standard Deviation 13.9 |
| SC Group | CGM-measured Percent Above 250 mg/dL | Week 13 | 15.0 Percent of time | Standard Deviation 10.9 |
p-value: <0.001Robust regression using M-estimation
Secondary
CGM-measured Percent Below 54 mg/dL
Percentage of time with glucose below 54 mg/dL as measured by CGM
Time frame: 13 weeks
Population: One participant in the CLC group was missing baseline CGM data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLC Group | CGM-measured Percent Below 54 mg/dL | Baseline | 0.6 Percent of time | Standard Deviation 0.7 |
| CLC Group | CGM-measured Percent Below 54 mg/dL | Week 13 | 0.6 Percent of time | Standard Deviation 0.5 |
| SC Group | CGM-measured Percent Below 54 mg/dL | Baseline | 0.5 Percent of time | Standard Deviation 0.6 |
| SC Group | CGM-measured Percent Below 54 mg/dL | Week 13 | 0.5 Percent of time | Standard Deviation 0.5 |
Secondary
CGM-measured Percent Below 70 mg/dL
Percentage of time with glucose below 70 mg/dL as measured by CGM
Time frame: 13 weeks
Population: One participant in the CLC group was missing baseline CGM data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLC Group | CGM-measured Percent Below 70 mg/dL | Baseline | 3.0 Percent of time | Standard Deviation 2.2 |
| CLC Group | CGM-measured Percent Below 70 mg/dL | Week 13 | 3.0 Percent of time | Standard Deviation 1.8 |
| SC Group | CGM-measured Percent Below 70 mg/dL | Baseline | 2.7 Percent of time | Standard Deviation 2 |
| SC Group | CGM-measured Percent Below 70 mg/dL | Week 13 | 3.0 Percent of time | Standard Deviation 2.2 |
p-value: 0.57Robust regression using M-estimation
Secondary
HbA1c at 13 Weeks
HbA1c at 13 weeks
Time frame: 13 weeks
Population: Baseline HbA1c values were available for n=64/68 in the CLC group and n=32/34 in the SC group. At 13 Weeks, HbA1c data were available for n=62/68 in the CLC group and n=33/34 in the SC group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLC Group | HbA1c at 13 Weeks | Baseline | 7.5 Percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
| CLC Group | HbA1c at 13 Weeks | Week 13 | 7.0 Percentage of glycosylated hemoglobin | Standard Deviation 0.8 |
| SC Group | HbA1c at 13 Weeks | Baseline | 7.7 Percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| SC Group | HbA1c at 13 Weeks | Week 13 | 7.5 Percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
p-value: <0.001Direct likelihood model
Other Pre-specified
Adverse Device Effects (ADE)
Adverse device effects (ADE) in intervention group only
Time frame: 13 weeks
Other Pre-specified
Any Adverse Event Rate
Any adverse event rate
Time frame: 13 weeks
Other Pre-specified
Body Mass Index (BMI)
Body Mass Index (BMI)
Time frame: 13 weeks
Other Pre-specified
CGM-measured % >180 mg/dL During the Four Hours Following the Announced Meal, or Until the Next Meal Bolus is Given, for the Missed Meal Bolus Challenge
CGM-measured % \>180 mg/dL during the four hours following the announced meal, or until the next meal bolus is given, for the missed meal bolus challenge
Time frame: 4 hours
Other Pre-specified
CGM-measured % >180 mg/dL Overnight (All Challenge Types)
CGM-measured % \>180 mg/dL overnight (all challenge types)
Time frame: 8 hours
Other Pre-specified
CGM-measured % >300 mg/dL During the Four Hours Following the Announced Meal, or Until the Next Meal Bolus is Given, for the Missed Meal Bolus Challenge
CGM-measured % \>300 mg/dL during the four hours following the announced meal, or until the next meal bolus is given, for the missed meal bolus challenge
Time frame: 4 hours
Other Pre-specified
CGM-measured % <54 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge
CGM-measured % \<54 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge
Time frame: 2 hours
Other Pre-specified
CGM-measured % <54 mg/dL Overnight (All Challenge Types)
CGM-measured % \<54 mg/dL overnight (all challenge types)
Time frame: 8 hours
Other Pre-specified
CGM-measured % <70 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge
CGM-measured % \<70 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge
Time frame: 2 hours
Other Pre-specified
CGM-measured % <70 mg/dL Overnight (All Challenge Types)
CGM-measured % \<70 mg/dL overnight (all challenge types)
Time frame: 8 hours
Other Pre-specified
CGM-measured Percent <60 mg/dL
CGM-measured percent \<60 mg/dL
Time frame: 13 weeks
Other Pre-specified
Fear of Hypoglycemia Survey for Parents (HFS-P) - Total Score, 2 Subscales and 4 Factor Scores
Fear of Hypoglycemia Survey for Parents (HFS-P) - total score, 2 subscales and 4 factor scores: Behavior (avoidance, Maintain high BG), Worry (Helplessness, Social consequences)
Time frame: 13 weeks
Other Pre-specified
Glucose Variability Measured With the Coefficient of Variation (CV)
glucose variability measured with the coefficient of variation (CV)
Time frame: 13 weeks
Other Pre-specified
Glucose Variability Measured With the Standard Deviation (SD)
glucose variability measured with the standard deviation (SD)
Time frame: 13 weeks
Other Pre-specified
HbA1c <7.0 Percent at 13 Weeks
HbA1c \<7.0 percent at 13 weeks
Time frame: 13 weeks
Other Pre-specified
HbA1c <7.5 Percent at 13 Weeks
HbA1c \<7.5 percent at 13 weeks
Time frame: 13 weeks
Other Pre-specified
HbA1c Absolute Improvement From Baseline to 13 Weeks >1.0 Percent or HbA1c <7.0 Percent at 13 Weeks
HbA1c absolute improvement from baseline to 13 weeks \>1.0 percent or HbA1c \<7.0 percent at 13 weeks
Time frame: 13 weeks
Other Pre-specified
HbA1c Improvement From Baseline to 13 Weeks >0.5 Percent
HbA1c improvement from baseline to 13 weeks \>0.5 percent
Time frame: 13 weeks
Other Pre-specified
HbA1c Improvement From Baseline to 13 Weeks >1.0 Percent
HbA1c improvement from baseline to 13 weeks \>1.0 percent
Time frame: 13 weeks
Other Pre-specified
HbA1c Relative Improvement From Baseline to 13 Weeks >10 Percent
HbA1c relative improvement from baseline to 13 weeks \>10 percent
Time frame: 13 weeks
Other Pre-specified
High Blood Glucose Index (HBGI)*
high blood glucose index (HBGI)\*
Time frame: 13 weeks
Other Pre-specified
Hyperglycemic Events (Defined as at Least 90 Consecutive Minutes >300 mg/dL)
hyperglycemic events (defined as at least 90 consecutive minutes \>300 mg/dL)
Time frame: 13 weeks
Other Pre-specified
Hypoglycemic Events (Defined as at Least 15 Consecutive Minutes <54 mg/dL)
hypoglycemic events (defined as at least 15 consecutive minutes \<54 mg/dL)
Time frame: 13 weeks
Other Pre-specified
INSPIRE Survey (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) (CLC Arm Only)
INSPIRE (CLC arm only) 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option.
Time frame: 13 weeks
Other Pre-specified
Low Blood Glucose Index (LBGI)*
low blood glucose index (LBGI)\*
Time frame: 13 weeks
Other Pre-specified
Number of Adverse Events During, Immediately After and Overnight From the Study Challenges
Number of adverse events during, immediately after and overnight from the study challenges
Time frame: Up to 24 hour period
Other Pre-specified
Number of Calendar Days With Any Ketone Level ≥1.0 mmol/L (if ≥5 Total Calendar Days Combined)
Number of calendar days with any ketone level ≥1.0 mmol/L (if ≥5 total calendar days combined)
Time frame: 13 weeks
Other Pre-specified
Number of Diabetic Ketoacidosis (DKA) Events and DKA Event Rate Per 100 Person-years
Number of DKA events and DKA event rate per 100 person-years
Time frame: 13 weeks
Other Pre-specified
Number of Other Serious Adverse Events
Number of other serious adverse events (SAEs other than SH events and DKA events)
Time frame: 13 weeks
Other Pre-specified
Number of Severe Hypoglycemic (SH) Events and SH Event Rate Per 100 Person-years
Number of SH events and SH event rate per 100 person-years
Time frame: 13 weeks
Other Pre-specified
Number of SH Events During, Immediately After and Overnight From the Study Challenges
Number of SH events during, immediately after and overnight from the study challenges
Time frame: Up to 24 hour period
Other Pre-specified
Pediatric Inventory for Parents (PIP) 2 Domains Each With a Total Score and 4 Subscales for (5x2=10 Difference Scores)
Pediatric Inventory for Parents (PIP) 2 domains each with a total score and 4 subscales for (5x2=10 difference scores): Frequency (Total Score, Communication, Medical Care, Role Function, Emotional Functioning), Difficulty ( Same total + 4 subscales as above for frequency)
Time frame: 13 weeks
Other Pre-specified
PedsQL Diabetes Module - Total Score and 5 Subscales
PedsQL Diabetes Module - total score and 5 subscales: Diabetes, Treatment 1, Treatment 2, Worry, Communication
Time frame: 13 weeks
Other Pre-specified
Percent >300 mg/dL
percent \>300 mg/dL
Time frame: 13 weeks
Other Pre-specified
Percent Above 180 mg/dL
percent above 180 mg/dL
Time frame: 13 weeks
Other Pre-specified
Percentage of Total Insulin Delivered Via Basal
Percentage of total insulin delivered via basal
Time frame: 13 weeks
Other Pre-specified
Percent in Range 70-140 mg/dL
percent in range 70-140 mg/dL
Time frame: 13 weeks
Other Pre-specified
Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10 Percent
percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10 percent
Time frame: 13 weeks
Other Pre-specified
Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5 Percent
percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5 percent
Time frame: 13 weeks
Other Pre-specified
Percent Time in Range 70-180 mg/dL >70 Percent and Percent Time <70 mg/dL <4 Percent
percent time in range 70-180 mg/dL \>70 percent and percent time \<70 mg/dL \<4 percent
Time frame: 13 weeks
Other Pre-specified
Pittsburgh Sleep Quality Index (PSQI) Global Score
An abbreviated 9-question version of the Pittsburgh Sleep Quality Index (PSQI), a validated tool for assessing self-reported sleep quantity and quality, will be completed by parents. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: 13 weeks
Other Pre-specified
Serious Adverse Device Events (SADE)
Serious adverse device events (SADE) in intervention group only
Time frame: 13 weeks
Other Pre-specified
Total Daily Insulin (Units/kg)
Total daily insulin (units/kg)
Time frame: 13 weeks
Other Pre-specified
Unanticipated Adverse Device Effects (UADE)
Unanticipated adverse device effects (UADE) in intervention group only
Time frame: 13 weeks
Other Pre-specified
Weight
Weight
Time frame: 13 weeks
Other Pre-specified
Worsening of HbA1c From Baseline to 13 Weeks by >0.5 Percent
Worsening of HbA1c from baseline to 13 weeks by \>0.5 percent
Time frame: 13 weeks