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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DK127551-01 | U.S. NIH Grant/Contract | View source | |
| RFA-DK-19-036 | Other Grant/Funding Number | NIDDK |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Jaeb Center for Health Research | OTHER |
| Tandem Diabetes Care, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLC Group | Experimental | 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). |
|
| SC Group | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem t:slim X2 with Control-IQ Technology Pro | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGM-measured Percent Above 250 mg/dL | Percentage of time with a glucose above 250 mg/dL as measured by CGM | 13 weeks |
| CGM-measured Mean Glucose | Average glucose value measured by CGM |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Above 180 mg/dL | percent above 180 mg/dL | 13 weeks |
| Percent in Range 70-140 mg/dL | percent in range 70-140 mg/dL | 13 weeks |
Inclusion Criteria:
Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 6 months and using insulin for at least 6 months
Familiarity and use of a carbohydrate ratio for meal boluses.
Age ≥2 and <6 years old
Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
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
Total daily insulin dose (TDD) at least 5 U/day
Body weight at least 20 lbs.
Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3)
Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.
Parent/guardian proficient in reading and writing English.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lum, MS | Jaeb Center for Health Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States | ||
| Barbara Davis Center, University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36920756 | Background | Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834. | |
| 37067353 | Derived | Beck RW, Kanapka LG, Breton MD, Brown SA, Wadwa RP, Buckingham BA, Kollman C, Kovatchev B. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558. Epub 2023 Apr 12. |
| Label | URL |
|---|---|
| Study Results | View source |
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Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Generally, data will be made available after the primary publications of each study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2021 | Aug 24, 2022 |
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| Standard Care (SC) | Device | 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). |
|
| Tandem t:slim X2 with Control-IQ Technology V1.5 | Device | 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. |
|
| 13 weeks |
| HbA1c at 13 Weeks | HbA1c at 13 weeks | 13 weeks |
| CGM-measured Percent Below 70 mg/dL | Percentage of time with glucose below 70 mg/dL as measured by CGM | 13 weeks |
| CGM-measured Percent Below 54 mg/dL | Percentage of time with glucose below 54 mg/dL as measured by CGM | 13 weeks |
| Glucose Variability Measured With the Coefficient of Variation (CV) | glucose variability measured with the coefficient of variation (CV) | 13 weeks |
| Glucose Variability Measured With the Standard Deviation (SD) | glucose variability measured with the standard deviation (SD) | 13 weeks |
| CGM-measured Percent <60 mg/dL | CGM-measured percent <60 mg/dL | 13 weeks |
| Low Blood Glucose Index (LBGI)* | low blood glucose index (LBGI)* | 13 weeks |
| Hypoglycemic Events (Defined as at Least 15 Consecutive Minutes <54 mg/dL) | hypoglycemic events (defined as at least 15 consecutive minutes <54 mg/dL) | 13 weeks |
| Hyperglycemic Events (Defined as at Least 90 Consecutive Minutes >300 mg/dL) | hyperglycemic events (defined as at least 90 consecutive minutes >300 mg/dL) | 13 weeks |
| Percent >300 mg/dL | percent >300 mg/dL | 13 weeks |
| High Blood Glucose Index (HBGI)* | high blood glucose index (HBGI)* | 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 ≥5 percent | 13 weeks |
| 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 | 13 weeks |
| 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 | 13 weeks |
| HbA1c <7.0 Percent at 13 Weeks | HbA1c <7.0 percent at 13 weeks | 13 weeks |
| HbA1c <7.5 Percent at 13 Weeks | HbA1c <7.5 percent at 13 weeks | 13 weeks |
| HbA1c Improvement From Baseline to 13 Weeks >0.5 Percent | HbA1c improvement from baseline to 13 weeks >0.5 percent | 13 weeks |
| HbA1c Improvement From Baseline to 13 Weeks >1.0 Percent | HbA1c improvement from baseline to 13 weeks >1.0 percent | 13 weeks |
| HbA1c Relative Improvement From Baseline to 13 Weeks >10 Percent | HbA1c relative improvement from baseline to 13 weeks >10 percent | 13 weeks |
| 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 | 13 weeks |
| 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 | 13 weeks |
| 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 | 13 weeks |
| Number of Other Serious Adverse Events | Number of other serious adverse events (SAEs other than SH events and DKA events) | 13 weeks |
| Any Adverse Event Rate | Any adverse event rate | 13 weeks |
| 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) | 13 weeks |
| Worsening of HbA1c From Baseline to 13 Weeks by >0.5 Percent | Worsening of HbA1c from baseline to 13 weeks by >0.5 percent | 13 weeks |
| Adverse Device Effects (ADE) | Adverse device effects (ADE) in intervention group only | 13 weeks |
| Serious Adverse Device Events (SADE) | Serious adverse device events (SADE) in intervention group only | 13 weeks |
| Unanticipated Adverse Device Effects (UADE) | Unanticipated adverse device effects (UADE) in intervention group only | 13 weeks |
| Total Daily Insulin (Units/kg) | Total daily insulin (units/kg) | 13 weeks |
| Percentage of Total Insulin Delivered Via Basal | Percentage of total insulin delivered via basal | 13 weeks |
| Weight | Weight | 13 weeks |
| Body Mass Index (BMI) | Body Mass Index (BMI) | 13 weeks |
| PedsQL Diabetes Module - Total Score and 5 Subscales | PedsQL Diabetes Module - total score and 5 subscales: Diabetes, Treatment 1, Treatment 2, Worry, Communication | 13 weeks |
| 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) | 13 weeks |
| 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. | 13 weeks |
| 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. | 13 weeks |
| 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) | 13 weeks |
| 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 | Up to 24 hour period |
| 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 | Up to 24 hour period |
| CGM-measured % <54 mg/dL Overnight (All Challenge Types) | CGM-measured % <54 mg/dL overnight (all challenge types) | 8 hours |
| CGM-measured % <70 mg/dL Overnight (All Challenge Types) | CGM-measured % <70 mg/dL overnight (all challenge types) | 8 hours |
| CGM-measured % >180 mg/dL Overnight (All Challenge Types) | CGM-measured % >180 mg/dL overnight (all challenge types) | 8 hours |
| 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 | 2 hours |
| 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 | 2 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 | 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 % >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 | 4 hours |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| FG001 | 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). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diabetes Duration | Count of Participants | Participants |
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| Glycosylated Hemoglobin (HbA1c) at Randomization | Missing data (CLC/SC): HbA1c 4/2 | Mean | Standard Deviation | Percentage of glycosylated hemoglobin |
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| Insulin Modality | Count of Participants | Participants |
| ||||||||||||||||
| Prior Continuous Glucose Monitor (CGM) Use | Count of Participants | Participants |
| ||||||||||||||||
| Annual Household Income | Missing data (CLC/SC): annual household income 4/2 | Count of Participants | Participants |
| |||||||||||||||
| Parent Education | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | One participant in the CLC group was missing baseline CGM data. | Posted | Mean | Standard Deviation | Percent of time | 13 weeks |
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| Secondary | CGM-measured Percent Above 250 mg/dL | Percentage of time with a glucose above 250 mg/dL as measured by CGM | One participant in the CLC group was missing baseline CGM data. | Posted | Mean | Standard Deviation | Percent of time | 13 weeks |
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| Secondary | CGM-measured Mean Glucose | Average glucose value measured by CGM | One participant in the CLC group was missing baseline CGM data. | Posted | Mean | Standard Deviation | mg/dL | 13 weeks |
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| Secondary | HbA1c at 13 Weeks | HbA1c at 13 weeks | 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. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | 13 weeks |
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| Secondary | CGM-measured Percent Below 70 mg/dL | Percentage of time with glucose below 70 mg/dL as measured by CGM | One participant in the CLC group was missing baseline CGM data. | Posted | Mean | Standard Deviation | Percent of time | 13 weeks |
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| Secondary | CGM-measured Percent Below 54 mg/dL | Percentage of time with glucose below 54 mg/dL as measured by CGM | One participant in the CLC group was missing baseline CGM data. | Posted | Mean | Standard Deviation | Percent of time | 13 weeks |
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| Other Pre-specified | Percent Above 180 mg/dL | percent above 180 mg/dL | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent in Range 70-140 mg/dL | percent in range 70-140 mg/dL | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Glucose Variability Measured With the Coefficient of Variation (CV) | glucose variability measured with the coefficient of variation (CV) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Glucose Variability Measured With the Standard Deviation (SD) | glucose variability measured with the standard deviation (SD) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | CGM-measured Percent <60 mg/dL | CGM-measured percent <60 mg/dL | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Low Blood Glucose Index (LBGI)* | low blood glucose index (LBGI)* | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent >300 mg/dL | percent >300 mg/dL | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | High Blood Glucose Index (HBGI)* | high blood glucose index (HBGI)* | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | HbA1c <7.0 Percent at 13 Weeks | HbA1c <7.0 percent at 13 weeks | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | HbA1c <7.5 Percent at 13 Weeks | HbA1c <7.5 percent at 13 weeks | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | HbA1c Improvement From Baseline to 13 Weeks >0.5 Percent | HbA1c improvement from baseline to 13 weeks >0.5 percent | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | HbA1c Improvement From Baseline to 13 Weeks >1.0 Percent | HbA1c improvement from baseline to 13 weeks >1.0 percent | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | HbA1c Relative Improvement From Baseline to 13 Weeks >10 Percent | HbA1c relative improvement from baseline to 13 weeks >10 percent | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Other Serious Adverse Events | Number of other serious adverse events (SAEs other than SH events and DKA events) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Any Adverse Event Rate | Any adverse event rate | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adverse Device Effects (ADE) | Adverse device effects (ADE) in intervention group only | Not Posted | No | 13 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Serious Adverse Device Events (SADE) | Serious adverse device events (SADE) in intervention group only | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Unanticipated Adverse Device Effects (UADE) | Unanticipated adverse device effects (UADE) in intervention group only | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Total Daily Insulin (Units/kg) | Total daily insulin (units/kg) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Total Insulin Delivered Via Basal | Percentage of total insulin delivered via basal | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Weight | Weight | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Body Mass Index (BMI) | Body Mass Index (BMI) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | Not Posted | 13 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Up to 24 hour period | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Up to 24 hour period | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | CGM-measured % <54 mg/dL Overnight (All Challenge Types) | CGM-measured % <54 mg/dL overnight (all challenge types) | Not Posted | 8 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | CGM-measured % <70 mg/dL Overnight (All Challenge Types) | CGM-measured % <70 mg/dL overnight (all challenge types) | Not Posted | 8 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | CGM-measured % >180 mg/dL Overnight (All Challenge Types) | CGM-measured % >180 mg/dL overnight (all challenge types) | Not Posted | 8 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 2 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 2 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 4 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 4 hours | Participants |
Baseline to Week 13
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 68 | 3 | 68 | 40 | 68 |
| EG001 | 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). | 0 | 34 | 2 | 34 | 9 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycemic event | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Other serious adverse event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | One participant in the SC group was hospitalized for an asthma flare |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia with or without Ketosis Related to Study Device | Endocrine disorders | Systematic Assessment |
| ||
| Hyperglycemia with or without Ketosis Not Related to Study Device | Endocrine disorders | Systematic Assessment |
| ||
| Hypoglycemia (not severe) | Endocrine disorders | Systematic Assessment |
| ||
| Burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fractured Finger | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Medical Device Site Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skin Infection | Infections and infestations | Systematic Assessment |
| ||
| Streptococcal Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Breton, PhD | University of Virginia | 434-982-6484 | mb6nt@virginia.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2022 | Oct 6, 2022 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2021 | May 4, 2023 | ICF_004.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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