## Protocol Section
### Identification Module
**NCT ID:** NCT04796779

**Brief Title:** The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes

**Official Title:** The Pediatric Artificial Pancreas (PEDAP) Trial: A Randomized Controlled Comparison of the Control-IQ Technology Versus Standard of Care in Young Children in Type 1 Diabetes

#### Organization Study ID Info
**ID:** 200433
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
#### Secondary ID Infos
**ID:** 1U01DK127551-01
**Link:** https://reporter.nih.gov/quickSearch/1U01DK127551-01
**Type:** NIH
**Domain:** NIDDK
**ID:** RFA-DK-19-036
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2022-07-31

**Type:** ACTUAL

#### Last Update Post Date
**Date:** 2023-06-28

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-04-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-06-28

**Type:** ACTUAL

**Results First Submit Date:** 2023-04-10

**Results First Submit QC Date:** 2023-06-05

#### Start Date
**Date:** 2021-04-21

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2021-03-15
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-15
**Study First Submit QC Date:** 2021-03-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

**Class:** OTHER

**Name:** Jaeb Center for Health Research

**Class:** INDUSTRY

**Name:** Tandem Diabetes Care, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** Marc Breton

#### Responsible Party

**Investigator Affiliation:** University of Virginia

**Investigator Full Name:** Marc Breton

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Type 1 Diabetes

**Keywords:**

- Control-IQ Technology

- Insulin Pump

- Closed Loop Control (CLC)

- Continuous Glucose Monitor (CGM)

- Multiple Daily Injections (MDI)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 102

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Device: Tandem t:slim X2 with Control-IQ Technology Pro

- Device: Tandem t:slim X2 with Control-IQ Technology V1.5

**Label:** CLC Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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).

**Intervention Names:**

- Device: Standard Care (SC)

- Device: Tandem t:slim X2 with Control-IQ Technology V1.5

**Label:** SC Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CLC Group

**Description:** 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.

**Name:** Tandem t:slim X2 with Control-IQ Technology Pro

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- SC Group

**Description:** 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).

**Name:** Standard Care (SC)

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- CLC Group

- SC Group

**Description:** 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.

**Name:** Tandem t:slim X2 with Control-IQ Technology V1.5

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** percent above 180 mg/dL

**Measure:** Percent Above 180 mg/dL

**Time Frame:** 13 weeks

**Description:** percent in range 70-140 mg/dL

**Measure:** Percent in Range 70-140 mg/dL

**Time Frame:** 13 weeks

**Description:** glucose variability measured with the coefficient of variation (CV)

**Measure:** Glucose Variability Measured With the Coefficient of Variation (CV)

**Time Frame:** 13 weeks

**Description:** glucose variability measured with the standard deviation (SD)

**Measure:** Glucose Variability Measured With the Standard Deviation (SD)

**Time Frame:** 13 weeks

**Description:** CGM-measured percent \<60 mg/dL

**Measure:** CGM-measured Percent <60 mg/dL

**Time Frame:** 13 weeks

**Description:** low blood glucose index (LBGI)\*

**Measure:** Low Blood Glucose Index (LBGI)*

**Time Frame:** 13 weeks

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

**Measure:** Hypoglycemic Events (Defined as at Least 15 Consecutive Minutes <54 mg/dL)

**Time Frame:** 13 weeks

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

**Measure:** Hyperglycemic Events (Defined as at Least 90 Consecutive Minutes >300 mg/dL)

**Time Frame:** 13 weeks

**Description:** percent \>300 mg/dL

**Measure:** Percent >300 mg/dL

**Time Frame:** 13 weeks

**Description:** high blood glucose index (HBGI)\*

**Measure:** High Blood Glucose Index (HBGI)*

**Time Frame:** 13 weeks

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

**Measure:** Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5 Percent

**Time Frame:** 13 weeks

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

**Measure:** Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10 Percent

**Time Frame:** 13 weeks

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

**Measure:** Percent Time in Range 70-180 mg/dL >70 Percent and Percent Time <70 mg/dL <4 Percent

**Time Frame:** 13 weeks

**Description:** HbA1c \<7.0 percent at 13 weeks

**Measure:** HbA1c <7.0 Percent at 13 Weeks

**Time Frame:** 13 weeks

**Description:** HbA1c \<7.5 percent at 13 weeks

**Measure:** HbA1c <7.5 Percent at 13 Weeks

**Time Frame:** 13 weeks

**Description:** HbA1c improvement from baseline to 13 weeks \>0.5 percent

**Measure:** HbA1c Improvement From Baseline to 13 Weeks >0.5 Percent

**Time Frame:** 13 weeks

**Description:** HbA1c improvement from baseline to 13 weeks \>1.0 percent

**Measure:** HbA1c Improvement From Baseline to 13 Weeks >1.0 Percent

**Time Frame:** 13 weeks

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

**Measure:** HbA1c Relative Improvement From Baseline to 13 Weeks >10 Percent

**Time Frame:** 13 weeks

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

**Measure:** HbA1c Absolute Improvement From Baseline to 13 Weeks >1.0 Percent or HbA1c <7.0 Percent at 13 Weeks

**Time Frame:** 13 weeks

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

**Measure:** Number of Severe Hypoglycemic (SH) Events and SH Event Rate Per 100 Person-years

**Time Frame:** 13 weeks

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

**Measure:** Number of Diabetic Ketoacidosis (DKA) Events and DKA Event Rate Per 100 Person-years

**Time Frame:** 13 weeks

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

**Measure:** Number of Other Serious Adverse Events

**Time Frame:** 13 weeks

**Description:** Any adverse event rate

**Measure:** Any Adverse Event Rate

**Time Frame:** 13 weeks

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

**Measure:** Number of Calendar Days With Any Ketone Level ≥1.0 mmol/L (if ≥5 Total Calendar Days Combined)

**Time Frame:** 13 weeks

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

**Measure:** Worsening of HbA1c From Baseline to 13 Weeks by >0.5 Percent

**Time Frame:** 13 weeks

**Description:** Adverse device effects (ADE) in intervention group only

**Measure:** Adverse Device Effects (ADE)

**Time Frame:** 13 weeks

**Description:** Serious adverse device events (SADE) in intervention group only

**Measure:** Serious Adverse Device Events (SADE)

**Time Frame:** 13 weeks

**Description:** Unanticipated adverse device effects (UADE) in intervention group only

**Measure:** Unanticipated Adverse Device Effects (UADE)

**Time Frame:** 13 weeks

**Description:** Total daily insulin (units/kg)

**Measure:** Total Daily Insulin (Units/kg)

**Time Frame:** 13 weeks

**Description:** Percentage of total insulin delivered via basal

**Measure:** Percentage of Total Insulin Delivered Via Basal

**Time Frame:** 13 weeks

**Description:** Weight

**Measure:** Weight

**Time Frame:** 13 weeks

**Description:** Body Mass Index (BMI)

**Measure:** Body Mass Index (BMI)

**Time Frame:** 13 weeks

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

**Measure:** PedsQL Diabetes Module - Total Score and 5 Subscales

**Time Frame:** 13 weeks

**Description:** 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)

**Measure:** Pediatric Inventory for Parents (PIP) 2 Domains Each With a Total Score and 4 Subscales for (5x2=10 Difference Scores)

**Time Frame:** 13 weeks

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

**Measure:** INSPIRE Survey (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) (CLC Arm Only)

**Time Frame:** 13 weeks

**Description:** 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.

**Measure:** Pittsburgh Sleep Quality Index (PSQI) Global Score

**Time Frame:** 13 weeks

**Description:** 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)

**Measure:** Fear of Hypoglycemia Survey for Parents (HFS-P) - Total Score, 2 Subscales and 4 Factor Scores

**Time Frame:** 13 weeks

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

**Measure:** Number of SH Events During, Immediately After and Overnight From the Study Challenges

**Time Frame:** Up to 24 hour period

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

**Measure:** Number of Adverse Events During, Immediately After and Overnight From the Study Challenges

**Time Frame:** Up to 24 hour period

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

**Measure:** CGM-measured % <54 mg/dL Overnight (All Challenge Types)

**Time Frame:** 8 hours

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

**Measure:** CGM-measured % <70 mg/dL Overnight (All Challenge Types)

**Time Frame:** 8 hours

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

**Measure:** CGM-measured % >180 mg/dL Overnight (All Challenge Types)

**Time Frame:** 8 hours

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

**Measure:** CGM-measured % <54 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge

**Time Frame:** 2 hours

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

**Measure:** CGM-measured % <70 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge

**Time Frame:** 2 hours

**Description:** 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

**Measure:** 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

**Description:** 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

**Measure:** 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

#### Primary Outcomes

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

**Measure:** Time in Range

**Time Frame:** 13 weeks

#### Secondary Outcomes

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

**Measure:** CGM-measured Percent Above 250 mg/dL

**Time Frame:** 13 weeks

**Description:** Average glucose value measured by CGM

**Measure:** CGM-measured Mean Glucose

**Time Frame:** 13 weeks

**Description:** HbA1c at 13 weeks

**Measure:** HbA1c at 13 Weeks

**Time Frame:** 13 weeks

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

**Measure:** CGM-measured Percent Below 70 mg/dL

**Time Frame:** 13 weeks

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

**Measure:** CGM-measured Percent Below 54 mg/dL

**Time Frame:** 13 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 71 Months

**Minimum Age:** 24 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stanford

**Country:** United States

**Facility:** Stanford University

**State:** California

**Zip:** 94304

**Location 2:**

**City:** Aurora

**Country:** United States

**Facility:** Barbara Davis Center, University of Colorado

**State:** Colorado

**Zip:** 80045

**Location 3:**

**City:** Charlottesville

**Country:** United States

**Facility:** University of Virginia Center for Diabetes Technology

**State:** Virginia

**Zip:** 22903

#### Overall Officials

**Official 1:**

**Affiliation:** Jaeb Center for Health Research

**Name:** John Lum, MS

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** Generally, data will be made available after the primary publications of each study.

### References Module

#### References

**Citation:** 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.

**PMID:** 36920756

#### See Also Links

**Label:** Study Results

**URL:** https://pubmed.ncbi.nlm.nih.gov/36920756/

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-12-03

- Filename: Prot_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1679569

- Type Abbrev: Prot

- Upload Date: 2022-08-24T14:21

- Date: 2022-05-18

- Filename: SAP_003.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 773158

- Type Abbrev: SAP

- Upload Date: 2022-10-06T21:33

- Date: 2021-07-22

- Filename: ICF_004.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 282881

- Type Abbrev: ICF

- Upload Date: 2023-05-04T11:21

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Intervention Browse Module - Ancestors

- ID: D000014131

- Term: Trace Elements

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M22554

- Name: Pancrelipase

- Relevance: LOW

- As Found: Unknown

- ID: M13114

- Name: Pancreatin

- Relevance: LOW

- As Found: Unknown

- ID: M225448

- Name: Ferrous fumarate

- Relevance: HIGH

- As Found: Blunt

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000031621

- Term: Ferrous fumarate

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2023-05-06

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** CLC Group

**Deaths Num At Risk:** 68

**Description:** 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).

**ID:** EG000

**Other Num Affected:** 40

**Other Num at Risk:** 68

**Serious Number Affected:** 3

**Serious Number At Risk:** 68

**Title:** CLC Group

**Group ID:** EG001

**Title:** SC Group

**Deaths Num At Risk:** 34

**Description:** 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).

**ID:** EG001

**Other Num Affected:** 9

**Other Num at Risk:** 34

**Serious Number Affected:** 2

**Serious Number At Risk:** 34

**Title:** SC Group

**Frequency Threshold:** 0

#### Other Events

**Term:** Hyperglycemia with or without Ketosis Related to Study Device

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Term:** Hyperglycemia with or without Ketosis Not Related to Study Device

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Term:** Hypoglycemia (not severe)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Term:** Burn

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** COVID-19

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Fractured Finger

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Hematuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Medical Device Site Bleeding

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Skin Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Streptococcal Sore Throat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Upper Respiratory Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Severe hypoglycemic event

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 68

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 34

**Num Events:** 1

**Term:** Diabetic ketoacidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 68

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 34

**Term:** Other serious adverse event

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** One participant in the SC group was hospitalized for an asthma flare

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 68

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 34

**Num Events:** 1

**Time Frame:** Baseline to Week 13

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Units:** Participants

### Group

**ID:** BG000

**Title:** CLC Group

**Description:** 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).

### Group

**ID:** BG001

**Title:** SC Group

**Description:** 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).

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.23

**Value:** 3.84

#### Measurement

**Group ID:** BG001

**Spread:** 1.25

**Value:** 4.06

#### Measurement

**Group ID:** BG002

**Spread:** 1.24

**Value:** 3.92

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 47

**Category Title:** 2 to <4 years

#### Measurement

**Group ID:** BG000

**Value:** 37

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 55

**Category Title:** 4 to <6 years

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 33

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 52

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 35

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 50

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 50

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 75

**Category Title:** White non-Hispanic

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Black/African American

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 16

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** More than one race

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 68

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 102

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 39

**Category Title:** 0.5 to <1 years

#### Measurement

**Group ID:** BG000

**Value:** 24

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 39

**Category Title:** 1 to <2 years

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** 2 to <4 years

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** ≥4 years

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.2

**Value:** 7.5

#### Measurement

**Group ID:** BG001

**Spread:** 0.9

**Value:** 7.7

#### Measurement

**Group ID:** BG002

**Spread:** 1.1

**Value:** 7.6

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 64

**Group ID:** BG001

**Value:** 32

**Group ID:** BG002

**Value:** 96

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 42

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 66

**Category Title:** Insulin pump

#### Measurement

**Group ID:** BG000

**Value:** 26

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 36

**Category Title:** Multiple daily injections

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** In past, but not current

#### Measurement

**Group ID:** BG000

**Value:** 66

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 100

**Category Title:** Current

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** $25,000 - <$35,000

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** $35,000 - <$50,000

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 13

**Category Title:** $50,000 - <$75,000

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** $75,000 - <$100,000

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 32

**Category Title:** $100,000 - <$200,000

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 19

**Category Title:** ≥ $200,000

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 64

**Group ID:** BG001

**Value:** 32

**Group ID:** BG002

**Value:** 96

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 9

**Category Title:** ≤High School Diploma

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Associates Degree or Some College but no Degree

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** Bachelor's Degree

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 35

**Category Title:** Master's Degree

#### Measurement

**Group ID:** BG000

**Value:** 32

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 44

**Category Title:** Doctoral or Prof Degree

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 68

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 102

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Diabetes Duration
**Unit of Measure:** Participants
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Missing data (CLC/SC): HbA1c 4/2
**Title:** Glycosylated Hemoglobin (HbA1c) at Randomization
**Unit of Measure:** Percentage of glycosylated hemoglobin
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Insulin Modality
**Unit of Measure:** Participants
### Measure 9
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Prior Continuous Glucose Monitor (CGM) Use
**Unit of Measure:** Participants
### Measure 10
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Missing data (CLC/SC): annual household income 4/2
**Title:** Annual Household Income
**Unit of Measure:** Participants
### Measure 11
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Parent Education
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** mb6nt@virginia.edu
**Organization:** University of Virginia
**Phone:** 434-982-6484
**Title:** Marc Breton, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.
**Statistical Method:** Direct likelihood model
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** The model was adjusted for baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.
**Statistical Method:** Robust regression using M-estimation
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.
**Statistical Method:** Direct likelihood model
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.
**Statistical Method:** Direct likelihood model
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.57
**P-Value Comment:** To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.
**Statistical Method:** Robust regression using M-estimation
**Tested Non-Inferiority:** 
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
### Outcome Measure 24
### Outcome Measure 25
### Outcome Measure 26
### Outcome Measure 27
### Outcome Measure 28
### Outcome Measure 29
### Outcome Measure 30
### Outcome Measure 31
### Outcome Measure 32
### Outcome Measure 33
### Outcome Measure 34
### Outcome Measure 35
### Outcome Measure 36
### Outcome Measure 37
### Outcome Measure 38
### Outcome Measure 39
### Outcome Measure 40
### Outcome Measure 41
### Outcome Measure 42
### Outcome Measure 43
### Outcome Measure 44
### Outcome Measure 45
### Outcome Measure 46
### Outcome Measure 47
### Outcome Measure 48
### Outcome Measure 49
### Outcome Measure 50
### Outcome Measure 51
### Outcome Measure 52
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.0
- **Upper Limit:** 
- **Value:** 56.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14.7
- **Upper Limit:** 
- **Value:** 54.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.1
- **Upper Limit:** 
- **Value:** 69.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12.6
- **Upper Limit:** 
- **Value:** 55.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 68
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.5
- **Upper Limit:** 
- **Value:** 14.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.9
- **Upper Limit:** 
- **Value:** 16.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.2
- **Upper Limit:** 
- **Value:** 8.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.9
- **Upper Limit:** 
- **Value:** 15.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 68
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 36
- **Upper Limit:** 
- **Value:** 173
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26
- **Upper Limit:** 
- **Value:** 176
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 20
- **Upper Limit:** 
- **Value:** 155
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 22
- **Upper Limit:** 
- **Value:** 174
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 68
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.2
- **Upper Limit:** 
- **Value:** 7.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.9
- **Upper Limit:** 
- **Value:** 7.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 32
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.8
- **Upper Limit:** 
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.9
- **Upper Limit:** 
- **Value:** 7.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 33
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** 3.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.0
- **Upper Limit:** 
- **Value:** 2.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.8
- **Upper Limit:** 
- **Value:** 3.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** 3.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 68
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.7
- **Upper Limit:** 
- **Value:** 0.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.6
- **Upper Limit:** 
- **Value:** 0.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5
- **Upper Limit:** 
- **Value:** 0.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.5
- **Upper Limit:** 
- **Value:** 0.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 68
- **Group ID:** OG001
- **Value:** 34
**Units:** Participants
#### Outcome Measure 7
#### Outcome Measure 8
#### Outcome Measure 9
#### Outcome Measure 10
#### Outcome Measure 11
#### Outcome Measure 12
#### Outcome Measure 13
#### Outcome Measure 14
#### Outcome Measure 15
#### Outcome Measure 16
#### Outcome Measure 17
#### Outcome Measure 18
#### Outcome Measure 19
#### Outcome Measure 20
#### Outcome Measure 21
#### Outcome Measure 22
#### Outcome Measure 23
#### Outcome Measure 24
#### Outcome Measure 25
#### Outcome Measure 26
#### Outcome Measure 27
#### Outcome Measure 28
#### Outcome Measure 29
#### Outcome Measure 30
#### Outcome Measure 31
#### Outcome Measure 32
#### Outcome Measure 33
#### Outcome Measure 34
#### Outcome Measure 35
#### Outcome Measure 36
#### Outcome Measure 37
#### Outcome Measure 38
#### Outcome Measure 39
#### Outcome Measure 40
#### Outcome Measure 41
#### Outcome Measure 42
#### Outcome Measure 43
#### Outcome Measure 44
#### Outcome Measure 45
#### Outcome Measure 46
#### Outcome Measure 47
#### Outcome Measure 48
#### Outcome Measure 49
#### Outcome Measure 50
#### Outcome Measure 51
#### Outcome Measure 52
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One participant in the CLC group was missing baseline CGM data.
**Reporting Status:** POSTED
**Time Frame:** 13 weeks
**Title:** Time in Range
**Type:** PRIMARY
**Unit of Measure:** Percent of time
##### Group
**Description:** 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).
**ID:** OG000
**Title:** CLC Group
##### Group
**Description:** 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).
**ID:** OG001
**Title:** SC Group
#### Outcome Measure 2
**Description:** Percentage of time with a glucose above 250 mg/dL as measured by CGM
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One participant in the CLC group was missing baseline CGM data.
**Reporting Status:** POSTED
**Time Frame:** 13 weeks
**Title:** CGM-measured Percent Above 250 mg/dL
**Type:** SECONDARY
**Unit of Measure:** Percent of time
##### Group
**Description:** 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).
**ID:** OG000
**Title:** CLC Group
##### Group
**Description:** 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).
**ID:** OG001
**Title:** SC Group
#### Outcome Measure 3
**Description:** Average glucose value measured by CGM
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One participant in the CLC group was missing baseline CGM data.
**Reporting Status:** POSTED
**Time Frame:** 13 weeks
**Title:** CGM-measured Mean Glucose
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 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).
**ID:** OG000
**Title:** CLC Group
##### Group
**Description:** 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).
**ID:** OG001
**Title:** SC Group
#### Outcome Measure 4
**Description:** HbA1c at 13 weeks
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 13 weeks
**Title:** HbA1c at 13 Weeks
**Type:** SECONDARY
**Unit of Measure:** Percentage of glycosylated hemoglobin
##### Group
**Description:** 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).
**ID:** OG000
**Title:** CLC Group
##### Group
**Description:** 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).
**ID:** OG001
**Title:** SC Group
#### Outcome Measure 5
**Description:** Percentage of time with glucose below 70 mg/dL as measured by CGM
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One participant in the CLC group was missing baseline CGM data.
**Reporting Status:** POSTED
**Time Frame:** 13 weeks
**Title:** CGM-measured Percent Below 70 mg/dL
**Type:** SECONDARY
**Unit of Measure:** Percent of time
##### Group
**Description:** 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).
**ID:** OG000
**Title:** CLC Group
##### Group
**Description:** 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).
**ID:** OG001
**Title:** SC Group
#### Outcome Measure 6
**Description:** Percentage of time with glucose below 54 mg/dL as measured by CGM
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One participant in the CLC group was missing baseline CGM data.
**Reporting Status:** POSTED
**Time Frame:** 13 weeks
**Title:** CGM-measured Percent Below 54 mg/dL
**Type:** SECONDARY
**Unit of Measure:** Percent of time
##### Group
**Description:** 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).
**ID:** OG000
**Title:** CLC Group
##### Group
**Description:** 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).
**ID:** OG001
**Title:** SC Group
#### Outcome Measure 7
**Description:** percent above 180 mg/dL
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Percent Above 180 mg/dL
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 8
**Description:** percent in range 70-140 mg/dL
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Percent in Range 70-140 mg/dL
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 9
**Description:** glucose variability measured with the coefficient of variation (CV)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Glucose Variability Measured With the Coefficient of Variation (CV)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 10
**Description:** glucose variability measured with the standard deviation (SD)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Glucose Variability Measured With the Standard Deviation (SD)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 11
**Description:** CGM-measured percent \<60 mg/dL
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** CGM-measured Percent <60 mg/dL
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 12
**Description:** low blood glucose index (LBGI)\*
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Low Blood Glucose Index (LBGI)*
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 13
**Description:** hypoglycemic events (defined as at least 15 consecutive minutes \<54 mg/dL)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Hypoglycemic Events (Defined as at Least 15 Consecutive Minutes <54 mg/dL)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 14
**Description:** hyperglycemic events (defined as at least 90 consecutive minutes \>300 mg/dL)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Hyperglycemic Events (Defined as at Least 90 Consecutive Minutes >300 mg/dL)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 15
**Description:** percent \>300 mg/dL
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Percent >300 mg/dL
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 16
**Description:** high blood glucose index (HBGI)\*
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** High Blood Glucose Index (HBGI)*
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 17
**Description:** percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5 percent
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5 Percent
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 18
**Description:** percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10 percent
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10 Percent
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 19
**Description:** percent time in range 70-180 mg/dL \>70 percent and percent time \<70 mg/dL \<4 percent
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Percent Time in Range 70-180 mg/dL >70 Percent and Percent Time <70 mg/dL <4 Percent
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 20
**Description:** HbA1c \<7.0 percent at 13 weeks
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** HbA1c <7.0 Percent at 13 Weeks
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 21
**Description:** HbA1c \<7.5 percent at 13 weeks
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** HbA1c <7.5 Percent at 13 Weeks
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 22
**Description:** HbA1c improvement from baseline to 13 weeks \>0.5 percent
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** HbA1c Improvement From Baseline to 13 Weeks >0.5 Percent
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 23
**Description:** HbA1c improvement from baseline to 13 weeks \>1.0 percent
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** HbA1c Improvement From Baseline to 13 Weeks >1.0 Percent
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 24
**Description:** HbA1c relative improvement from baseline to 13 weeks \>10 percent
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** HbA1c Relative Improvement From Baseline to 13 Weeks >10 Percent
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 25
**Description:** HbA1c absolute improvement from baseline to 13 weeks \>1.0 percent or HbA1c \<7.0 percent at 13 weeks
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** HbA1c Absolute Improvement From Baseline to 13 Weeks >1.0 Percent or HbA1c <7.0 Percent at 13 Weeks
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 26
**Description:** Number of SH events and SH event rate per 100 person-years
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Number of Severe Hypoglycemic (SH) Events and SH Event Rate Per 100 Person-years
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 27
**Description:** Number of DKA events and DKA event rate per 100 person-years
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Number of Diabetic Ketoacidosis (DKA) Events and DKA Event Rate Per 100 Person-years
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 28
**Description:** Number of other serious adverse events (SAEs other than SH events and DKA events)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Number of Other Serious Adverse Events
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 29
**Description:** Any adverse event rate
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Any Adverse Event Rate
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 30
**Description:** Number of calendar days with any ketone level ≥1.0 mmol/L (if ≥5 total calendar days combined)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Number of Calendar Days With Any Ketone Level ≥1.0 mmol/L (if ≥5 Total Calendar Days Combined)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 31
**Description:** Worsening of HbA1c from baseline to 13 weeks by \>0.5 percent
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Worsening of HbA1c From Baseline to 13 Weeks by >0.5 Percent
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 32
**Description:** Adverse device effects (ADE) in intervention group only
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Adverse Device Effects (ADE)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 33
**Description:** Serious adverse device events (SADE) in intervention group only
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Serious Adverse Device Events (SADE)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 34
**Description:** Unanticipated adverse device effects (UADE) in intervention group only
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Unanticipated Adverse Device Effects (UADE)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 35
**Description:** Total daily insulin (units/kg)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Total Daily Insulin (Units/kg)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 36
**Description:** Percentage of total insulin delivered via basal
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Percentage of Total Insulin Delivered Via Basal
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 37
**Description:** Weight
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Weight
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 38
**Description:** Body Mass Index (BMI)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Body Mass Index (BMI)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 39
**Description:** PedsQL Diabetes Module - total score and 5 subscales: Diabetes, Treatment 1, Treatment 2, Worry, Communication
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** PedsQL Diabetes Module - Total Score and 5 Subscales
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 40
**Description:** 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)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Pediatric Inventory for Parents (PIP) 2 Domains Each With a Total Score and 4 Subscales for (5x2=10 Difference Scores)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 41
**Description:** INSPIRE (CLC arm only) 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option.
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** INSPIRE Survey (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) (CLC Arm Only)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 42
**Description:** 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.
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Pittsburgh Sleep Quality Index (PSQI) Global Score
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 43
**Description:** 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)
**Reporting Status:** NOT_POSTED
**Time Frame:** 13 weeks
**Title:** Fear of Hypoglycemia Survey for Parents (HFS-P) - Total Score, 2 Subscales and 4 Factor Scores
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 44
**Description:** Number of SH events during, immediately after and overnight from the study challenges
**Reporting Status:** NOT_POSTED
**Time Frame:** Up to 24 hour period
**Title:** Number of SH Events During, Immediately After and Overnight From the Study Challenges
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 45
**Description:** Number of adverse events during, immediately after and overnight from the study challenges
**Reporting Status:** NOT_POSTED
**Time Frame:** Up to 24 hour period
**Title:** Number of Adverse Events During, Immediately After and Overnight From the Study Challenges
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 46
**Description:** CGM-measured % \<54 mg/dL overnight (all challenge types)
**Reporting Status:** NOT_POSTED
**Time Frame:** 8 hours
**Title:** CGM-measured % <54 mg/dL Overnight (All Challenge Types)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 47
**Description:** CGM-measured % \<70 mg/dL overnight (all challenge types)
**Reporting Status:** NOT_POSTED
**Time Frame:** 8 hours
**Title:** CGM-measured % <70 mg/dL Overnight (All Challenge Types)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 48
**Description:** CGM-measured % \>180 mg/dL overnight (all challenge types)
**Reporting Status:** NOT_POSTED
**Time Frame:** 8 hours
**Title:** CGM-measured % >180 mg/dL Overnight (All Challenge Types)
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 49
**Description:** CGM-measured % \<54 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 hours
**Title:** CGM-measured % <54 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 50
**Description:** CGM-measured % \<70 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 hours
**Title:** CGM-measured % <70 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 51
**Description:** 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
**Reporting Status:** NOT_POSTED
**Time Frame:** 4 hours
**Title:** 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
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 52
**Description:** 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
**Reporting Status:** NOT_POSTED
**Time Frame:** 4 hours
**Title:** 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
**Type:** OTHER_PRE_SPECIFIED
### Participant Flow Module
#### Group
**Description:** 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).
**ID:** FG000
**Title:** CLC Group
#### Group
**Description:** 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).
**ID:** FG001
**Title:** SC Group
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 68
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 67
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True