Trial Outcomes & Findings for The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes (NCT NCT04796779)

Results Overview

Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

13 weeks

Results posted on

2023-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	68	34
Overall Study COMPLETED	67	34
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing data (CLC/SC): HbA1c 4/2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CLC Group n=68 Participants 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 n=34 Participants 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).	Total n=102 Participants Total of all reporting groups
Age, Continuous	3.84 Years STANDARD_DEVIATION 1.23 • n=68 Participants	4.06 Years STANDARD_DEVIATION 1.25 • n=34 Participants	3.92 Years STANDARD_DEVIATION 1.24 • n=102 Participants
Age, Customized 2 to <4 years	31 Participants n=68 Participants	16 Participants n=34 Participants	47 Participants n=102 Participants
Age, Customized 4 to <6 years	37 Participants n=68 Participants	18 Participants n=34 Participants	55 Participants n=102 Participants
Sex: Female, Male Female	33 Participants n=68 Participants	19 Participants n=34 Participants	52 Participants n=102 Participants
Sex: Female, Male Male	35 Participants n=68 Participants	15 Participants n=34 Participants	50 Participants n=102 Participants
Race/Ethnicity, Customized White non-Hispanic	50 Participants n=68 Participants	25 Participants n=34 Participants	75 Participants n=102 Participants
Race/Ethnicity, Customized Black/African American	4 Participants n=68 Participants	2 Participants n=34 Participants	6 Participants n=102 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 Participants n=68 Participants	5 Participants n=34 Participants	16 Participants n=102 Participants
Race/Ethnicity, Customized Asian	1 Participants n=68 Participants	1 Participants n=34 Participants	2 Participants n=102 Participants
Race/Ethnicity, Customized More than one race	2 Participants n=68 Participants	1 Participants n=34 Participants	3 Participants n=102 Participants
Region of Enrollment United States	68 participants n=68 Participants	34 participants n=34 Participants	102 participants n=102 Participants
Diabetes Duration 0.5 to <1 years	29 Participants n=68 Participants	10 Participants n=34 Participants	39 Participants n=102 Participants
Diabetes Duration 1 to <2 years	24 Participants n=68 Participants	15 Participants n=34 Participants	39 Participants n=102 Participants
Diabetes Duration 2 to <4 years	11 Participants n=68 Participants	7 Participants n=34 Participants	18 Participants n=102 Participants
Diabetes Duration ≥4 years	4 Participants n=68 Participants	2 Participants n=34 Participants	6 Participants n=102 Participants
Glycosylated Hemoglobin (HbA1c) at Randomization	7.5 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.2 • n=64 Participants • Missing data (CLC/SC): HbA1c 4/2	7.7 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.9 • n=32 Participants • Missing data (CLC/SC): HbA1c 4/2	7.6 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.1 • n=96 Participants • Missing data (CLC/SC): HbA1c 4/2
Insulin Modality Insulin pump	42 Participants n=68 Participants	24 Participants n=34 Participants	66 Participants n=102 Participants
Insulin Modality Multiple daily injections	26 Participants n=68 Participants	10 Participants n=34 Participants	36 Participants n=102 Participants
Prior Continuous Glucose Monitor (CGM) Use In past, but not current	2 Participants n=68 Participants	0 Participants n=34 Participants	2 Participants n=102 Participants
Prior Continuous Glucose Monitor (CGM) Use Current	66 Participants n=68 Participants	34 Participants n=34 Participants	100 Participants n=102 Participants
Annual Household Income $25,000 - <$35,000	2 Participants n=64 Participants • Missing data (CLC/SC): annual household income 4/2	2 Participants n=32 Participants • Missing data (CLC/SC): annual household income 4/2	4 Participants n=96 Participants • Missing data (CLC/SC): annual household income 4/2
Annual Household Income $35,000 - <$50,000	6 Participants n=64 Participants • Missing data (CLC/SC): annual household income 4/2	4 Participants n=32 Participants • Missing data (CLC/SC): annual household income 4/2	10 Participants n=96 Participants • Missing data (CLC/SC): annual household income 4/2
Annual Household Income $50,000 - <$75,000	8 Participants n=64 Participants • Missing data (CLC/SC): annual household income 4/2	5 Participants n=32 Participants • Missing data (CLC/SC): annual household income 4/2	13 Participants n=96 Participants • Missing data (CLC/SC): annual household income 4/2
Annual Household Income $75,000 - <$100,000	11 Participants n=64 Participants • Missing data (CLC/SC): annual household income 4/2	7 Participants n=32 Participants • Missing data (CLC/SC): annual household income 4/2	18 Participants n=96 Participants • Missing data (CLC/SC): annual household income 4/2
Annual Household Income $100,000 - <$200,000	22 Participants n=64 Participants • Missing data (CLC/SC): annual household income 4/2	10 Participants n=32 Participants • Missing data (CLC/SC): annual household income 4/2	32 Participants n=96 Participants • Missing data (CLC/SC): annual household income 4/2
Annual Household Income ≥ $200,000	15 Participants n=64 Participants • Missing data (CLC/SC): annual household income 4/2	4 Participants n=32 Participants • Missing data (CLC/SC): annual household income 4/2	19 Participants n=96 Participants • Missing data (CLC/SC): annual household income 4/2
Parent Education ≤High School Diploma	6 Participants n=68 Participants	3 Participants n=34 Participants	9 Participants n=102 Participants
Parent Education Associates Degree or Some College but no Degree	2 Participants n=68 Participants	1 Participants n=34 Participants	3 Participants n=102 Participants
Parent Education Bachelor's Degree	6 Participants n=68 Participants	5 Participants n=34 Participants	11 Participants n=102 Participants
Parent Education Master's Degree	22 Participants n=68 Participants	13 Participants n=34 Participants	35 Participants n=102 Participants
Parent Education Doctoral or Prof Degree	32 Participants n=68 Participants	12 Participants n=34 Participants	44 Participants n=102 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: One participant in the CLC group was missing baseline CGM data.

Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM

Outcome measures

Outcome measures
Measure	CLC Group n=68 Participants 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 n=34 Participants 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).
Time in Range Baseline	56.7 Percent of time Standard Deviation 18.0	54.9 Percent of time Standard Deviation 14.7
Time in Range Week 13	69.3 Percent of time Standard Deviation 11.1	55.9 Percent of time Standard Deviation 12.6

SECONDARY outcome

Timeframe: 13 weeks

Population: One participant in the CLC group was missing baseline CGM data.

Percentage of time with a glucose above 250 mg/dL as measured by CGM

Outcome measures

Outcome measures
Measure	CLC Group n=68 Participants 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 n=34 Participants 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).
CGM-measured Percent Above 250 mg/dL Baseline	14.8 Percent of time Standard Deviation 15.5	16.0 Percent of time Standard Deviation 13.9
CGM-measured Percent Above 250 mg/dL Week 13	8.4 Percent of time Standard Deviation 7.2	15.0 Percent of time Standard Deviation 10.9

SECONDARY outcome

Timeframe: 13 weeks

Population: One participant in the CLC group was missing baseline CGM data.

Average glucose value measured by CGM

Outcome measures

Outcome measures
Measure	CLC Group n=68 Participants 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 n=34 Participants 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).
CGM-measured Mean Glucose Baseline	173 mg/dL Standard Deviation 36	176 mg/dL Standard Deviation 26
CGM-measured Mean Glucose Week 13	155 mg/dL Standard Deviation 20	174 mg/dL Standard Deviation 22

SECONDARY outcome

Timeframe: 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.

HbA1c at 13 weeks

Outcome measures

Outcome measures
Measure	CLC Group n=68 Participants 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 n=34 Participants 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).
HbA1c at 13 Weeks Week 13	7.0 Percentage of glycosylated hemoglobin Standard Deviation 0.8	7.5 Percentage of glycosylated hemoglobin Standard Deviation 0.9
HbA1c at 13 Weeks Baseline	7.5 Percentage of glycosylated hemoglobin Standard Deviation 1.2	7.7 Percentage of glycosylated hemoglobin Standard Deviation 0.9

SECONDARY outcome

Timeframe: 13 weeks

Population: One participant in the CLC group was missing baseline CGM data.

Percentage of time with glucose below 70 mg/dL as measured by CGM

Outcome measures

Outcome measures
Measure	CLC Group n=68 Participants 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 n=34 Participants 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).
CGM-measured Percent Below 70 mg/dL Baseline	3.0 Percent of time Standard Deviation 2.2	2.7 Percent of time Standard Deviation 2.0
CGM-measured Percent Below 70 mg/dL Week 13	3.0 Percent of time Standard Deviation 1.8	3.0 Percent of time Standard Deviation 2.2

SECONDARY outcome

Timeframe: 13 weeks

Population: One participant in the CLC group was missing baseline CGM data.

Percentage of time with glucose below 54 mg/dL as measured by CGM

Outcome measures

Outcome measures
Measure	CLC Group n=68 Participants 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 n=34 Participants 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).
CGM-measured Percent Below 54 mg/dL Baseline	0.6 Percent of time Standard Deviation 0.7	0.5 Percent of time Standard Deviation 0.6
CGM-measured Percent Below 54 mg/dL Week 13	0.6 Percent of time Standard Deviation 0.5	0.5 Percent of time Standard Deviation 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

percent above 180 mg/dL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

percent in range 70-140 mg/dL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

glucose variability measured with the coefficient of variation (CV)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

glucose variability measured with the standard deviation (SD)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

CGM-measured percent \<60 mg/dL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

low blood glucose index (LBGI)\*

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

hypoglycemic events (defined as at least 15 consecutive minutes \<54 mg/dL)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

hyperglycemic events (defined as at least 90 consecutive minutes \>300 mg/dL)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

percent \>300 mg/dL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

high blood glucose index (HBGI)\*

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5 percent

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10 percent

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

percent time in range 70-180 mg/dL \>70 percent and percent time \<70 mg/dL \<4 percent

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

HbA1c \<7.0 percent at 13 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

HbA1c \<7.5 percent at 13 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

HbA1c improvement from baseline to 13 weeks \>0.5 percent

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

HbA1c improvement from baseline to 13 weeks \>1.0 percent

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

HbA1c relative improvement from baseline to 13 weeks \>10 percent

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

HbA1c absolute improvement from baseline to 13 weeks \>1.0 percent or HbA1c \<7.0 percent at 13 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of SH events and SH event rate per 100 person-years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of DKA events and DKA event rate per 100 person-years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of other serious adverse events (SAEs other than SH events and DKA events)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Any adverse event rate

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of calendar days with any ketone level ≥1.0 mmol/L (if ≥5 total calendar days combined)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Worsening of HbA1c from baseline to 13 weeks by \>0.5 percent

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Adverse device effects (ADE) in intervention group only

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Serious adverse device events (SADE) in intervention group only

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Unanticipated adverse device effects (UADE) in intervention group only

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Total daily insulin (units/kg)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Percentage of total insulin delivered via basal

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Weight

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Body Mass Index (BMI)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

PedsQL Diabetes Module - total score and 5 subscales: Diabetes, Treatment 1, Treatment 2, Worry, Communication

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

INSPIRE (CLC arm only) 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 24 hour period

Number of SH events during, immediately after and overnight from the study challenges

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 24 hour period

Number of adverse events during, immediately after and overnight from the study challenges

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours

CGM-measured % \<54 mg/dL overnight (all challenge types)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours

CGM-measured % \<70 mg/dL overnight (all challenge types)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours

CGM-measured % \>180 mg/dL overnight (all challenge types)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

CGM-measured % \<54 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

CGM-measured % \<70 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

CLC Group

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

SC Group

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CLC Group n=68 participants at risk 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 n=34 participants at risk 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).
Metabolism and nutrition disorders Severe hypoglycemic event	2.9% 2/68 • Number of events 2 • Baseline to Week 13	2.9% 1/34 • Number of events 1 • Baseline to Week 13
Metabolism and nutrition disorders Diabetic ketoacidosis	1.5% 1/68 • Number of events 1 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Respiratory, thoracic and mediastinal disorders Other serious adverse event	0.00% 0/68 • Baseline to Week 13	2.9% 1/34 • Number of events 1 • Baseline to Week 13

Other adverse events

Other adverse events
Measure	CLC Group n=68 participants at risk 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 n=34 participants at risk 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).
Endocrine disorders Hyperglycemia with or without Ketosis Related to Study Device	38.2% 26/68 • Number of events 39 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Endocrine disorders Hyperglycemia with or without Ketosis Not Related to Study Device	13.2% 9/68 • Number of events 12 • Baseline to Week 13	20.6% 7/34 • Number of events 8 • Baseline to Week 13
Endocrine disorders Hypoglycemia (not severe)	2.9% 2/68 • Number of events 2 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Injury, poisoning and procedural complications Burn	1.5% 1/68 • Number of events 1 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Infections and infestations COVID-19	4.4% 3/68 • Number of events 3 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Injury, poisoning and procedural complications Fall	1.5% 1/68 • Number of events 1 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Musculoskeletal and connective tissue disorders Fractured Finger	1.5% 1/68 • Number of events 1 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Gastrointestinal disorders Gastroenteritis	2.9% 2/68 • Number of events 2 • Baseline to Week 13	5.9% 2/34 • Number of events 2 • Baseline to Week 13
Renal and urinary disorders Hematuria	1.5% 1/68 • Number of events 1 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Injury, poisoning and procedural complications Medical Device Site Bleeding	1.5% 1/68 • Number of events 1 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Infections and infestations Skin Infection	2.9% 2/68 • Number of events 3 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Respiratory, thoracic and mediastinal disorders Streptococcal Sore Throat	1.5% 1/68 • Number of events 1 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	1.5% 1/68 • Number of events 1 • Baseline to Week 13	0.00% 0/34 • Baseline to Week 13
Gastrointestinal disorders Vomiting	0.00% 0/68 • Baseline to Week 13	2.9% 1/34 • Number of events 2 • Baseline to Week 13

Additional Information

Marc Breton, PhD

University of Virginia

Phone: 434-982-6484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place