Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: University of Virginia

UVA CENTER FOR DIABETES TECHNOLOGY 
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Safety of the Tandem t:slim X2 with Control-IQ 
Automated Insulin Delivery System in 
Preschoolers, age 2-6 Years Old 
Study Sponsor 
Marc D. Breton, Ph.D. 
University of Virginia 
Center for Diabetes Technology 
 Protocol Chair 
R. Paul Wadwa, MD
Barbara Davis Center
University of Colorado
Participating Institutions 
University of Virginia, Charlottesville, Virginia 
Barbara Davis Center, University of Colorado, Colorado 
Stanford University, California 
NCT04084171
Version Number: v1.3 
30-Aug-2019
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Key Roles 
22 
 
Sponsor Chair / IDE Chair 
 
Name, degree 
Marc D. Breton, Ph.D. 
Institution Name 
University of Virginia, Center for Diabetes Technology 
 
 
Protocol Chair/Director 
 
Name, degree 
R. Paul Wadwa, MD 
Institution Name 
Barbara Davis Center, University of Colorado  
 
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Protocol Version History 
24 
Version 
Number 
Author(s) 
Approver 
Effective 
Date 
Revision Description 
1.0 
Marc Breton 
Marc Breton 
 
Original Protocol 
1.1 
Mary Oliveri  
Mary Oliveri 
22-Aug-2019 
FDA revisions 
• Exclusion criteria added: use of 
diluted insulin 
• A phone with the Dexcom Follow 
app will be near the child 
participant during the home 
study. 
• Participant 
Stopping 
Criteria 
redefined 
IRB revisions  
• Parent/child enrollment required 
since parent is completing 
questionnaire;  
• Questionnaire to occur after 
home use of equipment; 
• Added Other Risks: Photographs 
taken by the study team may be 
shared at conference; 
presentations, study brochures, 
or potential research donors 
• Revised ‘Timing of Event’ 
section; 
• Revisions throughout document 
to improve clarity 
1.2 
Mary Oliveri 
Mary Oliveri  
29-Aug-2019 
FDA revisions 
• Clarified exclusion criteria 
• Added SMBG pre-meal on day 1 
open-loop & every bedtime 
during At-Home use  
• Added caregivers 
• Physical activity restricted if 
CGM is below 90 mg/dL 
1.3 
Mary Oliveri 
Mary Oliveri 
30-Aug-2019 
FDA revisions 
• If > 1 serious hypoglycemia or > 
1 DKA event occurs, the study 
may be paused to determine a 
root cause prior to continuation of 
the study 
• Transition 
back 
to 
personal 
insulin pump will be completed 
under the supervision of a study 
MD 
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Site Principal Investigator Statement of Compliance 
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Protocol Title: Safety of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery 
27 
System in Preschoolers, age 2-6 Years Old. 
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Protocol Version/Date: v1.0/30-Aug-2019 
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I have read the protocol specified above.  In my formal capacity as a Site Principal Investigator, 
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my duties include ensuring the safety of the study participants enrolled under my supervision.  It 
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is understood that all information pertaining to the study will be held strictly confidential and that 
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this confidentiality requirement applies to all study staff at this site. 
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This trial will be carried out in accordance with ICH E6 Good Clinical Practice (GCP) and as 
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required by the following: United States (US) Code of Federal Regulations (CFR) applicable to 
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clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 
36 
CFR Part 812). 
37 
As the Principal Investigator, I will assure that no deviation from, or changes to the protocol 
38 
will take place without prior agreement from the sponsor and documented approval from the 
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Institutional Review Board (IRB), or other approved Ethics Committee, except where necessary 
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to eliminate an immediate hazard(s) to the trial participants. 
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All key personnel (all individuals responsible for the design and conduct of this trial) have 
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completed Human Participants Protection Training and Good Clinical Practice Training.  Further, 
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I agree to ensure that all staff members involved in the conduct of this study are informed about 
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their obligations in meeting the above commitments. 
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Investigator’s Signature __________________________________ Date: _____ / _____ / _____ 
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dd 
mmm yyyy 
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Investigator’s Name: ________________________________ 
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Site Name:  _______________________________________ 
 
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List of Abbreviations 
51 
ABBREVIATION 
DEFINITION 
AP 
Artificial Pancreas 
BG 
Blood Glucose 
BT/BTLE 
Bluetooth, Bluetooth low energy 
CRF 
Case Report Form 
CGM 
Continuous Glucose Monitoring System  
CLC 
Closed-Loop Control 
CSII 
Continuous Subcutaneous Insulin Injection 
CTR 
Control-to-Range 
DiAs 
Diabetes Assistant 
DKA 
Diabetic Ketoacidosis 
EC 
European Commission 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HbA1c 
Hemoglobin A1c 
ID 
Identification 
iDCL 
International Diabetes Closed Loop 
IDE 
Investigational Device Exemption 
IOB 
Insulin-on-Board 
IQR 
Interquartile Range 
JDRF 
Juvenile Diabetes Research Foundation 
LGS 
Low Glucose Suspend 
PLGS 
Predictive Low Glucose Suspend 
POC 
Point-of-Care 
QA 
Quality Assurance 
QC 
Quality Control 
RBM 
Risk-Based Monitoring 
RCT 
Randomized Control Trial 
SC 
Standard of Care group 
SD 
Standard Deviation 
SMBG 
Self-Monitoring Blood Glucose 
TDD 
Total Daily Dose 
UI 
User Interface 
 
 
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Table of Contents 
53 
 
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CHAPTER 1: BACKGROUND INFORMATION .............................................................................. 11 
55 
1.1 
Introduction .................................................................................................................... 11 
56 
1.2 
Study Objective .............................................................................................................. 12 
57 
1.3 
Primary Specific Aim ..................................................................................................... 14 
58 
1.4 
Secondary Specific Aims ............................................................................................... 14 
59 
1.5 
Study Design .................................................................................................................. 15 
60 
CHAPTER 2: STUDY ENROLLMENT AND SCREENING ............................................................... 17 
61 
2.1 
Participant Recruitment and Enrollment ........................................................................ 17 
62 
2.2 
Informed Consent and Authorization Procedures .......................................................... 17 
63 
2.3 
Participant Inclusion Criteria ......................................................................................... 17 
64 
2.4 
Participant Exclusion Criteria ........................................................................................ 17 
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2.5 
Eligibility Screening Procedures .................................................................................... 18 
66 
CHAPTER 3: STUDY DEVICES .................................................................................................... 20 
67 
3.1 
Insulin Pump .................................................................................................................. 20 
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3.2 
Continuous Glucose Monitoring .................................................................................... 20 
69 
3.3 
Blood Glucose Meter and Strips .................................................................................... 20 
70 
3.4 
Ketone Meter and Strips ................................................................................................. 20 
71 
3.5 
Study Device Accountability Procedures ....................................................................... 20 
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CHAPTER 4: STUDY EQUIPMENT TRAINING ............................................................................. 21 
73 
4.1 
Insulin Pump Training .................................................................................................... 21 
74 
4.2 
CGM Training ................................................................................................................ 22 
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4.3 
Blood Glucose and Ketone Testing ................................................................................ 23 
76 
4.4 
Optimization of Insulin Pump Settings .......................................................................... 24 
77 
CHAPTER 5: HOTEL ADMISSION PROCEDURES ........................................................................ 25 
78 
5.1 
General Admission Instructions ..................................................................................... 25 
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5.2 
Hotel Staffing Qualifications ......................................................................................... 25 
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5.3 
Pre-Admission Check-in Visit ....................................................................................... 25 
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5.4 
Admission Check-In (times are approximate) ............................................................... 26 
82 
5.5 
Study Procedures ............................................................................................................ 26 
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5.6 
Hotel Admission Schedule (times are approximate) ...................................................... 26 
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5.7 
Bolus Treatment ............................................................................................................. 27 
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5.8 
Meal Boluses .................................................................................................................. 27 
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5.9 
Group Activities ............................................................................................................. 27 
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5.10 
Procedures Related to Discharge .................................................................................... 27 
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CHAPTER 6: CONTROL-IQ AT HOME ......................................................................................... 28 
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6.1 
At-Home Use .................................................................................................................. 28 
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6.2 
Meal Bolus ..................................................................................................................... 28 
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6.3 
Blood Glucose Checks ................................................................................................... 28 
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6.4 
Activity ........................................................................................................................... 28 
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6.5 
Caregivers ....................................................................................................................... 28 
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6.6 
Post-Study Check-in Visit .............................................................................................. 28 
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6.7 
Questionnaire ................................................................................................................. 29 
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CHAPTER 7: GLYCEMIC TREATMENT GUIDELINES .................................................................. 30 
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7.1 
Hotel Admission Glycemic Guidelines .......................................................................... 30 
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7.2 
At-Home Glycemic Guidelines ...................................................................................... 30 
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CHAPTER 8: REMOTE MONITORING ......................................................................................... 32 
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8.1 
Hotel Admission Monitoring ......................................................................................... 32 
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8.2 
Home Monitoring ........................................................................................................... 32 
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CHAPTER 9: TESTING PROCEDURES ......................................................................................... 33 
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9.1 
Laboratory / Point of Care Testing ................................................................................. 33 
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CHAPTER 10: RISKS ASSOCIATED WITH CLINICAL TRIAL ...................................................... 34 
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10.1 
Potential Risks and Benefits of the Investigational Device ........................................... 34 
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10.2 
Potential Risks and Benefits of the Investigational Device ........................................... 37 
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10.3 
General Considerations .................................................................................................. 37 
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CHAPTER 11: ADVERSE EVENTS, DEVICE ISSUES, AND STOPPING RULES .............................. 39 
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11.1 
Adverse Events ............................................................................................................... 39 
110 
11.2 
Reportable Device Issues ............................................................................................... 43 
111 
11.3 
Timing of Event Reporting ............................................................................................ 43 
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11.4 
Stopping Criteria ............................................................................................................ 44 
113 
11.5 
Independent Safety Oversight ........................................................................................ 44 
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CHAPTER 12: MISCELLANEOUS CONSIDERATIONS .................................................................. 45 
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12.1 
Prohibited Medications, Treatments, and Procedures .................................................... 45 
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12.2 
Participant Withdrawal ................................................................................................... 45 
117 
12.3 
Confidentiality ................................................................................................................ 45 
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CHAPTER 13: STATISTICAL CONSIDERATION .......................................................................... 46 
119 
13.1 
Statistical and Analytical Plans ...................................................................................... 46 
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13.2 
Statistical Hypotheses .................................................................................................... 46 
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CHAPTER 14: DATA COLLECTION AND MONITORING ............................................................. 48 
122 
14.1 
Case Report Forms and Device Data ............................................................................. 48 
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14.2 
Study Records Retention ................................................................................................ 48 
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14.3 
Protocol Deviations ........................................................................................................ 48 
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CHAPTER 15: ETHICS/PROTECTION OF HUMAN PARTICIPANTS ............................................. 49 
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15.1 
Ethical Standard ............................................................................................................. 49 
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15.2 
Institutional Review Boards ........................................................................................... 49 
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15.3 
Informed Consent Process .............................................................................................. 49 
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Protocol Summary 
131 
PARTICIPANT AREA 
DESCRIPTION 
Title 
Safety of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery 
System in Preschoolers, age 2-6 Years Old. 
Investigational Device 
Tandem Control-IQ with G6 Continuous Glucose Monitor  
Objectives 
To assess study the safety profile of the Tandem t:slim X2 with Control-IQ system 
in children with T1D aged 2-6 years old under free living condition 
Study Design 
A single-arm, multi-center, clinical study 
Number of Sites 
3 independent clinical sites – sharing IDE and regulatory documentation only  
Endpoint 
Number of subjects with less than 6% time below 70 mg/dL and less than 40% time 
above 180 mg/dL.  
Population 
Key Inclusion Criteria 
 Age ≥ 2 and < 6 years old at the time of visit 1 
 Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at 
least 3 months and using insulin at the time of enrollment 
 Use of an insulin pump in the past 3 months 
 Use of Dexcom G6 for at least 11 out of the last 14 days 
Key Exclusion Criteria  
 Hypoglycemia induced seizure or loss of consciousness in the past 3 months 
 Concurrent use of any non-insulin glucose-lowering agent 
 A condition, which in the opinion of the investigator or designee, would put the 
participant or study at risk. 
Sample Size 
Up to 15 participants 
Participant Duration 
About 14 days  
Protocol Overview/Synopsis 
48 hour hotel stay with 24/7 study team supervision followed by parental remote 
monitoring for 72 hours of at-home use 
 
 
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Study Visits and Procedures Schedule 
133 
 
 
134 
` 
SCREENING 
OPEN LOOP 
AT-HOME 
USE 
PRE-
ADMISSION 
CHECK-IN 
HOTEL 
ADMISSION 
CLOSED 
LOOP AT-
HOME USE  
POST-
ADMISSION 
CHECK-IN 
DURATION 
ABOUT 3 
HOURS  
 
ABOUT 30 
MINUTES 
 ABOUT 48 
HOURS 
ABOUT 72 
HOURS 
ABOUT 30 
MINUTES 
COMMENT 
SCREEN / 
ENROLL 
 
PHONE, 
EMAIL, TEXT 
HOTEL 
HOME 
PHONE, 
EMAIL, TEXT 
Informed Consent 
X 
 
 
 
 
 
Eligibility Assessment 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
HbA1c  
X 
 
 
 
 
 
Physical Exam 
X 
 
 
X 
 
 
Vital Signs  
X 
 
 
X 
 
 
Equipment Training 
X 
 
 
X 
 
 
Use of Study Equipment 
 
X 
X 
X 
X 
 
Blood Glucose & Ketone 
Measurement 
 
 
 
X 
 
 
CGM Placement 
 
X 
X 
 
 
 
Review diabetes 
management and AEs 
 
 
 
X 
X 
X 
Review Medical Changes  
 
 
X 
X 
 
 
Questionnaire 
 
 
 
X 
 
 
Return study equipment  
 
 
 
 
 
X 

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Chapter 1: BACKGROUND INFORMATION 
135 
1.1 
Introduction 
136 
The Tandem X2 insulin pump with Control-IQ Technology is a third-generation closed-loop 
137 
control (CLC) system retaining the same control algorithm that was initially tested by UVA’s DiAs 
138 
system and then implemented in the inControl system. DiAs is described in 13 IDEs (see IDEs 1-
139 
12 and 14 in the list below) and inControl is described in IDEs G160097, G160181, G150240, 
140 
G140169/S010. IDE 17-20 below are specific to the implementation proposed here. For complete 
141 
algorithmic and clinical background, we refer to these IDEs and to a number of scientific 
142 
publications that describe glycemic control outcomes and clinical impressions from the use of 
143 
these systems (see list of 25 peer-reviewed papers and scientific presentations under Bibliography). 
144 
Overall, this control algorithm has been implemented in two mobile platforms (DiAs and 
145 
inControl) and an embedded system (Tandem t:slim X2 with Control IQ) which have been tested 
146 
in 35 clinical trials by over 700 adults and children with type 1 diabetes (T1D) for over 1,200,000 
147 
hours of use to date in the U.S. and overseas.  
148 
As described above, this project is a result of a sequence of clinical trials that have tested 
149 
extensively. The following 20 IDEs reflect this progress: 
150 
1. IDE #G110095: Feasibility study of closed loop control in type 1 diabetes using heart 
151 
rate monitoring as an exercise marker, approved 10/08/2011; 
152 
2. IDE #G120032: Early feasibility (pilot) study of outpatient control-to-range; 3/2/2012; 
153 
3. IDE #G120210: Early feasibility study 2 of outpatient control-to-range; 10/12/2012; 
154 
4. IDE #G130118: DiAs control-to-range nocturnal closed-loop camp study; 6/19/2013;  
155 
5. IDE #G130121: Optimizing closed-loop control of type 1 diabetes mellitus in 
156 
adolescents; 6/19/2013; 
157 
6. IDE# G130142:  Closed loop control in adolescents using heart rate as exercise 
158 
indicator; 7/16/13; 
159 
7. IDE #G130143: Early feasibility study of adaptive advisory/automated (AAA) control 
160 
of type 1 diabetes; 7/19/2013; 
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8. IDE #G140066:  Full day and night closed-loop with DiAs platform; 5/9/14. 
162 
9. IDE #G140068: Unified Safety System (USS) Virginia Closed Loop versus sensor 
163 
augmented pump therapy overnight in type 1 diabetes; 5/14/2014; 
164 
10. IDE #G140089: Outpatient control-to-range: Safety and efficacy with day-and-night 
165 
in-home use; 6/6/2014; 
166 
11. IDE #G140169: Unified Safety System (USS) Virginia Closed-Loop versus Sensor 
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Augmented Pump (SAP) therapy for hypoglycemia reduction in type 1 diabetes; 
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10/3/2014. 
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12. IDE #G150221: Reducing risks and improving glucose control during extended 
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exercise in youth with T1DM: The AP Ski Camp; 11/09/2015;  
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13. IDE #G150240: Project Nightlight: Efficacy and system acceptance of dinner/night vs. 
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24 hr closed loop control; 11/12/2015; 
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14. IDE #G160047: Closed-loop in school-age children 5-8 years old using DiAs platform; 
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03/29/2016;  
175 
15. IDE #G160097: Clinical Acceptance of the Artificial Pancreas: The International 
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Diabetes Closed-Loop (iDCL) Trial/Research Site Training Protocol; 06/03/16. 
177 
16. IDE#G160181: PROTOCOL 1 for “Clinical Acceptance of the Artificial Pancreas: The 
178 
International Diabetes Closed Loop (iDCL) Trial; 09/21/16 
179 
17. IDE#G170267: Real-Time Monitoring and Glucose Control During Winter-Sport 
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Exercise in Youth with Type 1 Diabetes: The AP Ski Camp Continued. 12/01/2017 
181 
18. IDE#G180053: Protocol 3: Clinical Acceptance of the Artificial Pancreas (DCLP3) 
182 
19. IDE#G180279: Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas 
183 
System Using Total Daily Insulin, 11/21/2018 
184 
20. IDE#G180053/S008: Protocol 5: Clinical Acceptance of the Artificial Pancreas in 
185 
Pediatrics. A Study of t:slim X2 with Control-IQ Technology, currently enrolling, 
186 
12/17/2018 
187 
1.2 
Study Objective  
188 
The closed-loop system, also called Artificial Pancreas (AP), modulates insulin infusion according 
189 
to computed real-time needs. It has proven to be successful in maintaining blood glucose in 
190 
euglycemic ranges during the day and even more efficiently during overnight hours where it was 
191 
shown that the system can keep glycemic values in the euglycemic range (70-180 mg/dL) for 70% 
192 
to 75% of the time. 
193 
The biggest challenges for glycemic control in young children with diabetes are frequent meals 
194 
and snacks as well as unpredictable activity/exercise routines. Meal variability has the benefit that 
195 
meals are typically announced and quantified. Glucose control around exercise, on the other hand, 
196 
is more complicated if the patient doesn’t announce a change in activity level. 
197 
Over the last 5 years, our teams have developed and tested different version of closed-loop systems 
198 
and remote monitoring systems conducting clinical trials in summer and winter camp settings 
199 
demonstrating significantly improved glycemic control and hypoglycemia avoidance in young 
200 
adult and pediatric patients with T1D.  
201 
There is a new wearable version of a closed-loop control system that is proposed to be tested in 
202 
this clinical trial.  The Closed-Loop Control System contained in t-slim X2 with Control-IQ 
203 
Technology that is described in Master File MAF-2032/A003. Control-IQ Technology is derived 
204 
from inControl previously described in IDE# G160097, G160181, G150240 and G140169/S010. 
205 
The CLC is an “artificial pancreas” (AP) application that uses advanced closed loop control 
206 
algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The 
207 
system modulates insulin to keep blood glucose in a targeted range. The system components 
208 
include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6 ( 
Figure 1). 
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Figure 1: t:slim X2 with Control-IQ and DexCom G6 system 
210 
This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known 
211 
as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a 
212 
supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old). It 
213 
is important to note that the system under study has been shown safe in efficacious in a large 
214 
(N=168) RCT clinical trial in subjects 14 and up (results presented at ADA 2019), which 
215 
Compared the system with sensor-augmented pump therapy, CLC system (Control-IQ) use for 6 
216 
months improved: 
217 
 Time in target range 70-180 mg/dL (+11%; p<0.0001) 
218 
 HbA1c (-0.33%; p=0.0014) 
219 
 Mean Glucose by CGM (-13 mg/dL; p<0.0001) 
220 
 Hyperglycemia >180 mg/dL (-10%; p<0.0001) 
221 
 Hypoglycemia <70 mg/dL (-0.88%; p<0.0001) 
222 
 Hypoglycemia <54 mg/dL (-0.10%; p=0.02) 
223 
The same system is also currently the subject of a similar trial down to 6 years old (IDE#20 above).  
224 
Finally, preliminary analysis of a clinical trial in France using the same system in prepubertal 
225 
children (6-10 yo) comparing 24/7 vs overnight use has shown very promising performances as 
226 
well (Table 1). 
227 
Table 1: Interim analysis of FREELIFEKIDS AP (N=30 for 3 months) 
228 
Overall 
CLC at night 
CLC 24/7 
Stats 
baseline 
CLC 
baseline 
CLC 
base vs 
Tx 
Night vs 
24/7 
% time below 50mg/dL 
0.4 ± 
0.3% 
0.3 ± 
0.2% 
0.5 ± 
0.7% 
0.3 ± 
0.2% 
ns 
ns 
% time below 54mg/dL 
0.7 ± 
0.6% 
0.6 ± 
0.3% 
0.9 ± 1% 
0.5 ± 
0.4% 
0.081 
ns 

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% time below 60mg/dL 
1.5 ± 1% 
1.1 ± 
0.5% 
1.7 ± 
1.6% 
1.1 ± 
0.8% 
0.041 
ns 
% time below 70 mg/dL 
4.1 ± 
1.9% 
2.8 ± 1% 
3.9 ± 
2.8% 
2.8 ± 
1.9% 
0.006 
ns 
% time between 70-
140mg/dL 
42 ± 8.6% 
45.6 ± 
7.4% 
37.9 ± 
8.2% 
49.3 ± 
4.9% 
<0.001 
0.009 
% time between 70-
180mg/dL 
63.2 ± 
9.1% 
67.5 ± 
6.5% 
59.7 ± 
8.4% 
71.8 ± 4% 
<0.001 
0.009 
% time above 180mg/dL 
32.8 ± 
9.2% 
29.6 ± 
6.7% 
36.4 ± 
9.5% 
25.4 ± 
4.8% 
<0.001 
0.010 
% time above 250mg/dL 
9.6 ± 
4.3% 
8.6 ± 
3.7% 
11.8 ± 
5.6% 
6.1 ± 
2.2% 
0.001 
0.010 
% time above 300mg/dL 
2.8 ± 
1.7% 
2.7 ± 
1.8% 
3.9 ± 
3.7% 
1.7 ± 1% 
0.030 
0.046 
  
Average CGM [mg/dL] 
158.1 ± 
13.6 
156.7 ± 
10.5 
165.4 ± 
15.8 
150.2 ± 
7.4 
0.001 
0.006 
We propose to use the Control-IQ System during a supervised 48 hours hotel stay with planned 
229 
activities and meals; in addition, child participants will continue to use the system for another 3 
230 
days at home under the parent/guardian(s) supervision. 
231 
1.3 
Primary Specific Aim 
232 
Study the safety profile of the Tandem t:slim X2 with Control-IQ System in children with type 1 
233 
diabetes aged 2-6 years old. 
234 
1.4 
Secondary Specific Aims 
235 
 Assess the safety profile of the system at home under parental/legal guardian(s) 
236 
supervision 
237 
 Compare system performance to normative data from a 6-12 years old cohort 
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1.5 
Study Design  
239 
1.5.1 Purpose/Objectives of Clinical Study  
240 
The purpose of this study is to demonstrate the safety and efficacy the Artificial Pancreas system 
241 
(Tandem t:slim X2 with Control IQ Technology) in T1D participants, aged 2-6 y.o.  
242 
1.5.2 Study Participants 
243 
Approximately 15 participants with Type 1 Diabetes Mellitus, currently managed with insulin 
244 
pump therapy, will participate in the trial for approximately 14 days. The study will be performed 
245 
at the University of Virginia, Stanford University, and the Barbara Davis Center at the University 
246 
of Colorado. Children and a parent/guardian(s) will use the system at home in Open Loop until the 
247 
start of the Hotel Admission. The child participant will then use the Control-IQ System during a 
248 
~48 hours study hotel/house admission. The child participant will then use the Control-IQ System 
249 
at home for 72 hours under parental supervision and remote monitoring by the study team. 
250 
1.5.3 Clinical Sites 
251 
Each clinical site will perform the trial independently, seeking their own local IRB approval.   
252 
 The University of Virginia-Center for Diabetes Technology  
253 
 560 Ray Hunt Drive, Charlottesville VA 22903 
254 
 
255 
 Stanford University 
256 
 300 Pasteur Drive, # S302, Palo Alto, CA 94304 
257 
 
258 
 Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus: 
259 
 1775 Aurora Court, Aurora, CO 80045 
 
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1.5.4 Study Diagram 
261 
 
262 
 
263 
 
 
264 
Figure 2: Study Diagram 

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Chapter 2: STUDY ENROLLMENT AND SCREENING 
265 
2.1 
Participant Recruitment and Enrollment 
266 
Enrollment will proceed with the goal of completing 15 participants in this trial, approximately 5 
267 
participants per clinical site.   
268 
Enrollment at the University of Virginia will be defined as a parent/child dyad as the parent is 
269 
completing the questionnaire at the conclusion of the study.  
270 
Up to 25 participants may sign the consent form.  
271 
2.2 
Informed Consent and Authorization Procedures 
272 
Consenting procedures and documentation is defined in section 15.3.  
273 
2.3 
Participant Inclusion Criteria 
274 
Child participants must meet all of the following inclusion criteria in order to be eligible to 
275 
participate in the study. 
276 
 Age ≥ 2 and < 6 years old at the time of consent 
277 
 Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months 
278 
and using insulin at the time of enrollment 
279 
 Use of an insulin pump in the past 3 months 
280 
 Use of Dexcom G6 for at least 11 out of the last 14 days 
281 
 Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses 
282 
 Living with one or more parent/guardian knowledgeable about emergency procedures for 
283 
severe hypoglycemia and able to contact emergency services and study staff 
284 
 At least one parent/guardian is willing to stay with the child during the hotel/house portion of 
285 
the study on the dates selected by the study team 
286 
 Investigator has confidence that the parent/guardian(s) can successfully operate all study 
287 
devices and is capable of adhering to the protocol 
288 
 Willingness to switch to lispro (Humalog) or aspart (Novolog) if not already, and to use no 
289 
other insulin besides lispro (Humalog) or aspart (Novolog) during the study 
290 
 Total daily insulin dose (TDD) of at least 5 U/day 
291 
 Willingness not to start any new non-insulin glucose-lowering agent during the course of the 
292 
trial 
293 
 Child participant and parent/guardian(s) willingness to participate in all training sessions as 
294 
directed by study staff 
295 
 Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study 
296 
 Willingness to wear a Dexcom G6 sensor during the entire study 
297 
 An understanding and willingness to follow the protocol and sign informed consent 
298 
 
299 
2.4 
Participant Exclusion Criteria 
300 
Individuals meeting any of the following exclusion criteria at baseline will be excluded from study 
301 
participation.  
302 

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 Hypoglycemia induced seizure or loss of consciousness in the past 3 months  
303 
 Diabetes Ketoacidosis in the past 3 months 
304 
 Use of diluted insulin 
305 
 Concurrent use of any non-insulin glucose-lowering agent 
306 
 Hemophilia or any other bleeding disorder 
307 
 A condition, which in the opinion of the investigator or designee, would put the participant 
308 
or study at risk. These conditions may include: 
309 
 Acute illness at the time of  the enrollment visit (fever of 101 or higher, vomiting, diarrhea) 
310 
 Addison’s disease 
311 
 Diagnosed at less than 1 year of age without positive antibodies 
312 
 Decreased renal function 
313 
 Cystic fibrosis 
314 
 Other chronic conditions, such as an underlying seizure disorder 
315 
 Participation in another pharmaceutical or device trial at the time of enrollment or during the 
316 
study.  
317 
 Having a family member(s) employed by Tandem Diabetes Care, Inc. or having a direct 
318 
supervisor at place of employment who is also directly involved in conducting the clinical 
319 
trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is 
320 
directly involved in conducting the clinical trial. 
321 
2.5 
Eligibility Screening Procedures 
322 
After informed consent has been signed, the child participant will be evaluated for study inclusion 
323 
and exclusion eligibility and documented: 
324 
 Demographics (date of birth, gender, race and ethnicity) 
325 
 Medical history 
326 
 Details of the diabetes history: duration of disease (number of years), diagnosis details, current 
327 
insulin pump model, history of CGM use, current treatment (including basal rates, 
328 
carbohydrate ratios, insulin sensitivity factors, target glucose, average daily insulin, history 
329 
of diabetic ketoacidosis, history of severe hypoglycemia, history of seizures or loss of 
330 
consciousness, and average number of blood tests performed daily).  
331 
 Surgical history  
332 
 Allergies 
333 
 Medications and supplements 
334 
 Short Physical examination – A historical history and physical report within 52 weeks of 
335 
screening appointment may be used  
336 
 Weight and height 
337 
 Vital signs 
338 
 Hemoglobin HbA1c assessment (blood draw or point of care per study physician discretion) 
339 
– A historical lab value dated within the last 30 days from screening date may be used 
340 
 Use of Dexcom G6 for at least 11 out of the last 14 days 
341 
 
342 

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Once all results of the screening evaluations are available, a decision will be made to determine 
343 
the subject’s eligibility for the study or if one or more parts of the screening will have to be 
344 
repeated. If at the first screening or repeat screening an exclusionary condition is identified, the 
345 
study subject will be excluded from participation in the study.  The participants will be referred to 
346 
their primary care physician as needed. Subjects may be re-screened at a later date if their clinical 
347 
situation changes at the discretion of the study physician during an acceptable timeline. 
348 
Parent/guardian(s) will be instructed to contact the study team in the event of a febrile illness 
349 
anytime during the study.  
 
350 

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Chapter 3: STUDY DEVICES 
351 
3.1 
Insulin Pump 
352 
The study system will include the Tandem t:slim X2 with Control-IQ technology. 
353 
3.2 
Continuous Glucose Monitoring 
354 
The study CGM will include Dexcom G6 transmitter and sensors.  The CGM sensor is viable for 
355 
10 days. 
356 
3.3 
Blood Glucose Meter and Strips 
357 
Blood glucose levels will be measured using the Accu-Chek Guide blood glucose meter 
358 
(glucometer).  The CGM device will be calibrated, if needed, using the study glucometer and strips 
359 
in accordance with the manufacturer’s labeling. 
360 
3.4 
Ketone Meter and Strips 
361 
Blood ketone levels will be measured using the Abbott Precision Xtra meter and strips in 
362 
accordance with the manufacturer’s labeling.  The blood glucose meter component of the Precision 
363 
Xtra device will not be used. 
364 
3.5 
Study Device Accountability Procedures 
365 
Device serial numbers will be recorded and use of equipment will be tracked.  
 
366 

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Chapter 4: STUDY EQUIPMENT TRAINING 
367 
Equipment training may begin immediately after screening eligibility has been met or may be 
368 
deferred for a maximum of 14 days but should not be less than 48 hours prior to the start of the 
369 
study to allow for a CGM warmup period. The purpose of this training is to introduce the study 
370 
insulin pump and study CGM to the parent/guardian(s) and child participant.  
371 
The subject’s insulin parameters will be programmed into their Tandem t:slim X2 with Control-
372 
IQ pump by two research staff. Subjects will then switch to the study insulin pump. The subject’s 
373 
personal pump and infusion site will be removed. 
374 
At the conclusion of the study equipment training session, the child participant will use the system 
375 
in pump only (open loop) configuration where no closed loop algorithms are activated until the 
376 
start of the Hotel Admission. 
377 
Child participants will have the insulin pump and sensor on them at all times. Parent/guardian(s) 
378 
will monitor their child using the Dexcom App. Parent/guardian(s) will also be required to carry 
379 
the study glucometer and ketone meter with them at all times and must be within BLE connection 
380 
distance of their child (same room) or equip the child with a Clarity enabled cellphone. Study 
381 
supplied phones will be available upon request.   
382 
4.1 
Insulin Pump Training  
383 
Insulin pump training will include: 
384 
 The parent/guardian(s) will be fully instructed on the study insulin pump. A qualified 
385 
system trainer will conduct the training and in particular discuss differences from their 
386 
home pump in important aspects such as calculation of insulin on board and correction 
387 
boluses. Additional topics not limited to but may include: infusion site initiation, 
388 
cartridge/priming procedures, setting up the pump, charging the pump, navigation through 
389 
menus, bolus procedures including stopping a bolus, etc. 
390 
 The study team will assist the parent/guardian(s) in study pump infusion site initiation and 
391 
will start the participant on the study pump. The study pump will be programmed with the 
392 
child participant’s usual basal rates and pump parameters. The child participant’s personal 
393 
pump will be removed. 
394 
 The parent/guardian(s) will be supervised with the study pump during at least one meal or 
395 
snack bolus to ensure participant understanding of the pump features. 
396 
 The parent/guardian(s) will be encouraged to review the literature provided with the pump 
397 
and infusion sets after the training is completed. Infusion sets manufactured by Tandem 
398 
will be provided to the study subject and a sample list is below and may be provided in 
399 
different cannula lengths (e.g. 6mm or 9mm) and tubing lengths (e.g. 23 or 43 inch): 
400 
 Tandem Autosoft Line  (e.g. Autosoft 30, Autosoft 90, Autosoft XC) 
401 
 Tandem Varisoft 
402 
 Tandem TruSteel  
403 

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Insulin pump training specific to the Control-IQ Technology functions will include: 
404 
 How to turn on and off Control-IQ technology 
405 
 How to understand when Control-IQ is increasing or decreasing basal rates 
406 
 How to administer a meal or correction bolus on the t:slim X2 with Control-IQ system 
407 
 How to enable the sleep function and set the sleep schedule 
408 
 The participant will be assessed for understanding of the system interface and how to react 
409 
to safety/alert messages 
410 
 The participant will be given a User Guide as a reference 
411 
4.1.1 Closed Loop Training 
412 
The parent/guardian(s) will be instructed to how to use the system if insulin is delivered by any 
413 
means other than the study pump (e.g. injection of subcutaneous insulin via syringe in the event 
414 
of infusion site failure). If insulin is delivered by any means other than the study pump, the 
415 
parent/guardian(s) will be instructed to turn off Control-IQ for approximately four hours. 
416 
The parent/guardian(s) will be provided with contact information and will be asked to call the 
417 
study clinical staff during periods of illness with an elevated temperature >101.5 degrees 
418 
Fahrenheit (38.6 degrees Celsius), periods of significant illness, or during periods of use of 
419 
medications such as epinephrine for the emergency treatment of a severe allergic reaction or 
420 
asthma attack in addition to use of oral or injectable glucocorticoids to determine if closed-loop 
421 
use should be temporarily discontinued. 
422 
The parent/guardian(s) will also be asked to call the study clinical staff for technical issues with 
423 
t:slim X2 with Control-IQ. The study pump without Control-IQ activated and study CGM (open 
424 
loop mode) during periods of component disconnections or technical difficulties.  Study staff 
425 
contact information will be provided to parent/guardian(s) to ask any questions they may have 
426 
during the study. 
427 
Upon completion of the t:slim X2 with Control-IQ training, study staff will document, using a 
428 
checklist, that the participant is familiar with the function/feature and/or capable of performing 
429 
each of the tasks specified. 
430 
Parents/legal guardian(s) will be provided Glycemic Treatment Guidelines (section 7.2) to use at 
431 
home.  
432 
4.2 
 CGM Training 
433 
A study CGM will be provided to all child participants at the training session. The 
434 
parent/guardian(s) will be provided with CGM equipment and instructed to use the study CGM on 
435 
a daily basis. Child participants have prior use of the CGM so re-training will be specific to the 
436 
individual.  Training may include review of study CGM in real-time to make management 
437 
decisions and how to review the data after an upload (if needed) for retrospective review.  
438 

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The child’s personal CGM will be discontinued. The parent/guardian(s) will be observed placing 
439 
the sensor and will learn/review how to access the CGM trace via the t:slim X2 with Control-IQ 
440 
user interface. The parent/guardian(s) will be instructed to perform a fingerstick blood glucose 
441 
measurement prior to meal time for the first open-loop day. The parent/guardian(s) will be asked 
442 
to perform fingerstick blood glucose measurements (if needed) in accordance with the labeling of 
443 
the study CGM device.  
444 
The study CGM user’s guide will be provided for the parent/guardian(s) to take home. The study 
445 
team will be sure that the parent/guardian(s) will leave the clinic knowing how to use proper use 
446 
the CGM. The study team will be available for any questions. 
447 
The use of Dexcom Apps on personal devices to monitor the child participant’s CGM values and 
448 
alerts in real-time may be used.  
449 
Participants will have the option of using their personal smartphone or receive a study smartphone 
450 
to use in order to collect the data from the devices. 
451 
4.3 
Blood Glucose and Ketone Testing 
452 
4.3.1 Blood glucose testing 
453 
Parent/guardian(s) will be provided with a study blood glucose meter and test strips to be used at 
454 
home per manufacturer guidelines. 
455 
All study blood glucose meters will be QC tested by study staff with at least two different 
456 
concentrations of control solution, if available.  A tested meter will not be used in a study if it does 
457 
not read within the target range at each concentration per manufacturer labeling.   
458 
Parent/guardian(s) will be reminded to use the study blood glucose meter for all fingerstick BGs 
459 
during the study. 
460 
4.3.2 Blood ketone testing 
461 
Parent/guardian(s) will be provided with a study blood ketone meter and test strips to be used at 
462 
home per manufacturer guidelines. 
463 
All study blood ketone meters will be QC tested by study staff with at least two different 
464 
concentrations of control solution, if available.  A tested meter will not be used in a study if it does 
465 
not read within the target range at each concentration per manufacturer labeling.   
466 
Parents/legal guardian(s) will be instructed to perform blood ketone testing as described in 
467 
Glycemic Treatment Guidelines (section 7.2). A home glucagon emergency kit will be required. 
468 
Participants who currently do not have one will be given a prescription for the glucagon emergency 
469 
kit. 
470 

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4.4 
Optimization of Insulin Pump Settings 
471 
Data-driven optimization of pump settings can occur any time during the study, particularly if the 
472 
parent/guardian(s) contacts the study physician due to concerns about their pump settings due to 
473 
recurring hypo- or hyperglycemia. 
 
474 

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Chapter 5: HOTEL ADMISSION PROCEDURES 
475 
5.1 
General Admission Instructions 
476 
The Hotel Admission will take place in a hotel or research house for approximately 48 hours. 
477 
Alternately, the clinical trial may occur at a house.  
478 
The CGM used in the study is FDA-approved for the non-adjunctive measurement of blood 
479 
glucose (i.e. the CGM reading can be used for insulin dosing decisions). The CGM readings will 
480 
be the primary source of blood glucose levels.  There are no protocol fingerstick blood glucose 
481 
measurements other than at times of CGM calibration (if necessary) and if directed by the study 
482 
team.  Glycemic Treatment Guidelines to be used during the hotel admission are defined in section 
483 
7.1. 
484 
5.2 
Hotel Staffing Qualifications  
485 
There will be at least one physician, advanced practice provider, registered nurse, and/or other 
486 
medical personnel who are specifically trained in diabetes management and trained technicians 
487 
supervising the Hotel Admission. Certification of their skill is supervised by the clinical site PI. 
488 
All medical personnel who will have direct contact with the child participants will have current 
489 
certification in Basic Life Support including CPR. Study personnel, trained in the use and 
490 
maintenance of the Tandem t:slim X2 with Control-IQ Technology, will be monitoring the system 
491 
during the entire trial.  
492 
There will be a team of at least 3 experienced study personnel in attendance during the day (7 p.m. 
493 
-7 a.m.) and one study staff member during the overnight hours of 7 p.m. – 7 a.m. during the hotel 
494 
admission. These staff members will be proficient with devices, the study protocol and its 
495 
procedures, including the glycemic safety protocols.  
496 
Glucagon for the emergency treatment of hypoglycemia will be available on-site. 
497 
5.3 
Pre-Admission Check-in Visit 
498 
The parent/guardian(s) will be contacted by the study team approximately 48-72 hours prior to the 
499 
hotel admission to verify the following information: 
500 
 Inquire about any changes to the child participant’s health (e.g. illness, medications, etc…)  
501 
 Inquire about current use of the study equipment 
502 
 Remind parent/guardian(s) to bring all current medications for use during the study.  
503 
 Determine what pump profile(s) the subject uses on certain days 
504 
 Verify that a new CGM sensor will be placed approximately 48 hours prior to the admission 
505 
for proper warm up 
506 
 Verify with the subject that the goal CGM reading at time of arrival is less than 250 mg/dL  
507 
Should any concerns regarding medical history, pump information, or unforeseen issues arise, the 
508 
admission may be cancelled for that participant at the discretion of the investigator. 
509 

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Additional phone contact(s) can occur at the study team’s discretion.  
510 
5.4 
Admission Check-In (times are approximate) 
511 
On day 1 of the admission, parent/guardian(s) and child participants will arrive to the hotel at 
512 
approximately 3-5 pm. The study team will perform vital signs and inquire about any changes to 
513 
the participant’s medical history.  The study team will confirm that the child participant has 
514 
brought his/her insulin and regular medications. Any changes to medical history will be 
515 
communicated to the medical physician to ensure continued eligibility and participation. The study 
516 
team will ensure the proper function of the CGM and insulin pump.  Insulin parameters will be 
517 
reviewed by the study medical team 
518 
A SMBG and a ketone value will be collected on the study equipment. In the event that the child 
519 
participant’s CGM reading is not between 80 – 300 mg/dL or ketone concentration is ≤0.6 mmol/L 
520 
prior to the Control-IQ initiation, the study physician may recommend corrective action as outlined 
521 
in the Hotel Admission Glycemic Guidelines (section 7.1). Study physician may elect to cancel 
522 
participant’s participation in the hotel admission if concerned about their medical safety.   
523 
Data from subjects’ insulin pumps will be reviewed and/or downloaded for a review of pump 
524 
settings and average of daily insulin delivery.  
525 
5.5 
Study Procedures 
526 
Parent/guardian(s) will be retrained on the study equipment as needed. During system use, subjects 
527 
will be remotely monitored and will have immediate access to medical personnel and technical 
528 
personnel.  Child participants will be accompanied by at least one parent/guardian during the 
529 
supervised stay and trained on the Control-IQ System. A trained parent/caregiver or study team 
530 
member must remain in the immediate vicinity of the subjects as long as the AP system is active. 
531 
The parent/guardian(s) will be primarily responsible for using the system at this time, with the 
532 
study team serving as a back-up when needed. Re-education will be provided as needed. Study 
533 
staff will be available at all times to assure proper use of all study equipment.  
534 
CGM sensors last up to 10 days; therefore, there should be no need to change CGM sensors. All 
535 
sensor changes during camp will be handled by the study team, but caregivers of subjects will be 
536 
trained on how to change sensors in case of sensor failure during the 72 hours home use. 
537 
5.6 
Hotel Admission Schedule (times are approximate) 
538 
Parent/guardian(s) and child participants will be provided dinner at approximately 6 – 7 p.m. 
539 
Parent/guardian(s) and child participants will be permitted to retire to their personal rooms after 
540 
dinner, if desired.  Bedtime for the child participant is encouraged to be no later than 9 p.m. Devices 
541 
should be charged overnight while subjects are sleeping.  
542 
On day 2 of the admission, breakfast will be provided at approximately 7 – 8 a.m. Group activities 
543 
will occur from approximately 9 – 11 a.m. An optional snack will be available at approximately 
544 
10 a.m.  
545 

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Lunch will be provided at approximately 11:30 – 12:30 p.m.  Parent/guardian(s) and child 
546 
participants will retire to their personal rooms for quiet time. An optional snack will be available 
547 
at approximately 3 p.m. Group activities will occur from approximately 3:30 – 5:30 p.m. 
548 
Parent/guardian(s) and child participants will be provided dinner at approximately 6-7 p.m. 
549 
Parent/guardian(s) and child participants will be permitted to retire to their personal rooms after 
550 
dinner, if desired.  Bedtime for the child participant is encouraged to be no later than 9 p.m. Devices 
551 
should be charged overnight while subjects are sleeping. 
552 
On day 3 of the admission, breakfast will be provided at approximately 7 – 8 a.m. Group activities 
553 
will occur from approximately 9 – 11 a.m. An optional snack will be available at approximately 
554 
10 a.m. Lunch will be provided at approximately 11:30 – 12:30 p.m.   
555 
Discharge will occur after lunch.   
556 
5.7 
Bolus Treatment 
557 
Use of a temporary basal rate will be permitted during the hotel admission.  
558 
5.8 
Meal Boluses  
559 
The time and size of the meal bolus will be determined by parent/guardian(s) and will be 
560 
supervised by the study team.      
561 
5.9 
Group Activities 
562 
Planned group activities may be managed by the study team or a specialized service provider (e.g. 
563 
preschool professionals) with study staff supervision. These activities may include transporting 
564 
parent/guardian(s) and child participants to off-site locations (e.g. museums, amusement parks, 
565 
etc…).  One medical personnel per car will be required. Parents and their children are expected to 
566 
participate in all activities of the supervised phase, unless excused by the study team.  
567 
5.10 Procedures Related to Discharge  
568 
Parent/guardian(s) will show proficiency of using the system before leaving for the home portion 
569 
of the trial. 
570 
Parent/guardian(s) will show proficiency on how to change CGM before leaving for the home use 
571 
portion of the trial.  
572 
The child participant’s SMBG value needs to be between 70-300 mg/dL and ketone concentration 
573 
is ≤ 0.6 mmol/L prior to discharge. The parent/guardian(s) and child will be offered a snack prior 
574 
to discharge. The study team will verify that parent/guardian(s) have study team’s contact 
575 
information.  
 
576 

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Chapter 6: CONTROL-IQ AT HOME  
577 
6.1 
At-Home Use 
578 
Child participants will continue to use the Control-IQ System for another 72 hours at home under 
579 
parental/legal guardian(s) supervision. The study team will continue remote monitoring as 
580 
described in section 8.2. Study staff will be available 24/7 by phone to answer any questions or 
581 
concerns or to help resolve any technical problems. 
582 
At the conclusion of 72 hours, the parent/guardian(s) will remove the study equipment under the 
583 
supervision of a study physician which may occur at home or in the presence of study staff. 
584 
Participants who discontinue use of the study devices at home will return study devices by standard 
585 
shipping (e.g. FedEx) provided by the research team. 
586 
Parent/guardian(s) will be asked to download the child participant’s personal pump to ensure the 
587 
child’s personal equipment is working properly.  
588 
6.2 
Meal Bolus  
589 
Child participants may consume meals and snacks of their own choice with no restrictions. Meal 
590 
size will be estimated by the parent/guardian(s). The timing of the bolus will be per each child 
591 
participant’s typical dosing routine. 
592 
6.3 
Blood Glucose Checks 
593 
Parent/guardian(s) will be advised to obtain their child’s fingerstick blood glucose value prior to 
594 
bedtime each night of at-home use.  
595 
6.4 
Activity  
596 
The child should refrain from activity (e.g. sports) if their CGM value is below 90 mg/dL.  
597 
6.5 
Caregivers 
598 
In the event that the child is in the care of someone other than the parent/guardian(s), the child 
599 
must be routinely cared for by this individual (i.e. more than once per week for more than one 
600 
month).  This individual must be trained on the use of the study devices and safety guidelines by 
601 
study staff prior to the child using the device at home.   
602 
6.6 
Post-Study Check-in Visit 
603 
Approximately 48 hours after the home use of the equipment, the study team will contact the 
604 
parent/guardian(s) via phone/email/text to assess: 
605 
 adverse events, adverse device effects, and device issues 
606 
 blood glucose values <60 mg/dL and >300 mg/dL 
607 
 verify collection of ketone measurement data 
608 
 answer any questions related to device use 
609 

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 unscheduled calls during the study period may be recommended for additional device 
610 
training or other unanticipated needs 
611 
6.7 
Questionnaire 
612 
Parent/Guardian(s) will be asked to complete a Technology Acceptance Questionnaire (Parent 
613 
Version) asking them their perceptions and feeling about the technology used during the Hotel 
614 
Admission.   
 
615 

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Chapter 7: GLYCEMIC TREATMENT GUIDELINES 
616 
7.1 
Hotel Admission Glycemic Guidelines  
617 
Upon arrival, the subject will be asked to check the CGM reading and ketone concentration using 
618 
the study ketone meter.  If CGM is <70 mg/dL or >300 mg/dL, or ketone test is >0.6 mmol/L, the 
619 
study physician will suggest appropriate treatment.  The study team may request fingersticks as 
620 
needed. The study subject may continue participation in the trial once CGM is between 70-300 mg 
621 
/dL and ketone concentration is ≤0.6 mmol/L. 
622 
If CGM < 80 mg/dL during the day, the patient will be treated until CGM reads >80 mg/dL. If 
623 
CGM < 70 mg/dL during the night, hypoglycemia treatment will be provided until CGM reads > 
624 
80 mg/dL. SMBG may be performed if the MD on-call deems it necessary.  
625 
If CGM >300 mg/dL for more than 60 minutes, SMBG will be performed every 60 minutes. If 
626 
SMBG >300 mg/dL, the Glycemic Treatment Guidelines will be applied. 
627 
If CGM <80 mg/dL at any time, subjects will be given approximately 16 grams of fast-acting 
628 
rescue carbohydrates.  Study team will monitor CGM rise and will consider treating again if CGM 
629 
<80 mg/dL after approximately 20 minutes.  Hypoglycemic treatments can occur at any time per 
630 
study physician request. 
631 
Parent/guardian(s) will be asked to respond to both hypoglycemia and hyperglycemia alarms 
632 
during the Hotel Admission.  If they do not respond to the alarms within 10 minutes, study 
633 
personnel will assist as per the Glycemic Treatment Guidelines.  
634 
Medical personnel and emergency supplies (e.g. glucagon) will be available on site. 
635 
7.2 
At-Home Glycemic Guidelines 
636 
7.2.1 CGM Measurements 
637 
CGM values are updated every 5 minutes and parents will be able to see it on the pump and 
638 
Dexcom App. 
639 
CGM alarms on the study team controlled Dexcom App will be set at 70 mg/dl for 30 minutes and 
640 
300 mg/dl for 60 minutes. 
641 
If CGM < 80 mg/dL during the day, the patient will be treated until CGM reads >80 mg/dL. If 
642 
CGM < 70 mg/dL during the night. Hypoglycemia treatment will be provided until CGM reads > 
643 
80 mg/dL. SMBG may be performed if the MD on-call deems it necessary.  
644 
If CGM >300 mg/dL for more than 60 minutes, SMBG will be performed every 60 minutes. If 
645 
SMBG >300 mg/dL, the Glycemic Treatment Guidelines will be applied. 
646 
A study team member will contact the family if either of the above conditions is triggered and 
647 
confirm treatment per provided guidelines. 
648 

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7.2.2 Ketone Measurements  
649 
Parent/guardian(s) will be advised to test for ketones any time the CGM is above 300 mg/dL for 
650 
more than 2 hours.  
651 
If ketones are 0.6-3.0 mmol/L, the following guidelines should be followed until SMBG < 250 
652 
mg/dL.  
653 
 Notify MD as soon as possible 
654 
 Consider taking correction dose of insulin by syringe or pen 
655 
 Change insulin in reservoir and tubing and change pump site 
656 
 Drink sugar-free beverages 
657 
 Once BG is 100-250 mg/dL, restart pump treatment in appropriate mode. Record the 
658 
amount of insulin that was given when prompted 
659 
If ketones are >3.0 mmol/L, the following guidelines should occur:  
660 
 The participant will stop the study 
661 
 Notify MD as soon as possible 
662 
 Disconnect the STUDY insulin pump and start HOME insulin pump once instructed by 
663 
MD 
664 
 Take correction dose of insulin by syringe or pen 
665 
 Drink sugar-free beverages 
 
666 

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Chapter 8: REMOTE MONITORING 
667 
8.1 
Hotel Admission Monitoring 
668 
Parent/guardian(s) will remotely monitor the subjects in real-time using the DexCom G6 App 
669 
capabilities provided by Dexcom Inc. during the Hotel Admission.   
670 
Staff will remotely monitor the subjects in real-time using the DexCom G6 capabilities provided 
671 
by Dexcom Inc. . Notification will be set for CGM readings below 80mg/dl during the day and 
672 
70mg/dl at night or above 250mg/dl to alert study staff of the need treatment or SMBG 
673 
confirmation. In case of remote monitoring failure, CGM alarms will be activated at low=70 
674 
mg/dL and high=250 mg/dL for the study personnel to act if alarms are set off. 
675 
8.2 
Home Monitoring 
676 
Parent/guardian(s) will remotely monitor the subjects in real-time using the DexCom G6 App 
677 
capabilities provided by Dexcom Inc. Alerts will be setup for values below 70mg/dL and above 
678 
250mg/dL; families may choose to use more conservative thresholds (i.e. higher than 70 and/or 
679 
lower than 250) as well as supplemental alerts. 
680 
Additionally, a smart phone with the Dexcom Share app will always be in the vicinity of the child 
681 
during the home study.  This app may be on a parent’s phone or the study team will provide a 
682 
phone that will be used with parents or caretakers. 
683 
In addition, the study staff will include the staff remote monitoring for threshold alerts but with 
684 
alerts adapted to the existence of a first tier remote monitor (parent/legal guardian(s)) and the fact 
685 
that they are not one site. Therefore, the study staff (Tier 2) alerts will be <70mg/dL for more than 
686 
15 minutes and >300 mg/dL for more than 60 minutes. 
 
687 

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Chapter 9:   TESTING PROCEDURES  
688 
9.1 
Laboratory / Point of Care Testing 
689 
9.1.1 HbA1c 
690 
 Performed locally at the Screening visit. Blood test may be obtained within 30 days prior 
691 
to enrollment. 
692 
 HbA1c level will be measured using the DCA Vantage Analyzer, a comparable point of 
693 
care device or local laboratory 
694 
 
 
695 

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Chapter 10:  RISKS ASSOCIATED WITH CLINICAL TRIAL 
696 
10.1 Potential Risks and Benefits of the Investigational Device 
697 
Risks and Benefits are detailed below. Loss of confidentiality is a potential risk; however, data are 
698 
handled to minimize this risk.  Hypoglycemia, hyperglycemia and ketone formation are always a 
699 
risk in participants with type 1 diabetes and participants will be monitored for these symptoms.  
700 
10.1.1 Known Potential Risks 
701 
10.1.1.1 Venipuncture Risks 
702 
A hollow needle/plastic tube will be placed in the arm for taking blood samples. Blood draws can 
703 
cause some common reactions like pain, bruising, or redness at the sampling site.  Less common 
704 
reactions include bleeding from the sampling site, formation of a small blood clot or swelling of 
705 
the vein and surrounding tissues, and fainting. 
706 
10.1.1.2 Fingerstick Risks 
707 
About 1 drop of blood will be removed by fingerstick for measuring blood sugars and sometimes 
708 
HbA1c or other tests. This is a standard method used to obtain blood for routine hospital laboratory 
709 
tests.  Pain is common at the time of lancing.  In about 1 in 10 cases, a small amount of bleeding 
710 
under the skin will produce a bruise.  A small scar may persist for several weeks.  The risk of local 
711 
infection is less than 1 in 1000.  This should not be a significant contributor to risks in this study 
712 
as finger sticks are part of the usual care for people with diabetes. 
713 
10.1.1.3 Subcutaneous Catheter Risks (CGM) 
714 
Participants using the CGM will be at low risk for developing a local skin infection at the site of 
715 
the sensor needle placement.  If a catheter is left under the skin for more than 24 hours it is possible 
716 
to get an infection where it goes into the skin, with swelling, redness and pain.  There may be 
717 
bleeding where the catheter is put in and bleeding under the skin causes a bruise (1 in 10 risk). 
718 
Study staff should verbally alert the participant that on rare occasions, the CGM may break and 
719 
leave a small portion of the sensor under the skin that may cause redness, swelling, or pain at the 
720 
insertion site.  The participant should be further instructed to notify the study coordinator 
721 
immediately if this occurs. 
722 
10.1.1.4 Risk of Hypoglycemia 
723 
As with any person having type 1 diabetes and using insulin, there is always a risk of having a low 
724 
blood sugar (hypoglycemia).  The frequency of hypoglycemia should be no more and possibly less 
725 
than it would be as part of daily living.  Symptoms of hypoglycemia can include sweating, 
726 
jitteriness, and not feeling well.  Just as at home, there is the possibility of fainting or seizures 
727 
(convulsions) and that for a few days the participant may not be as aware of symptoms of 
728 
hypoglycemia.  A CGM functioning poorly and significantly over-reading glucose values could 
729 
lead to inappropriate insulin delivery. 
730 

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10.1.1.5 Risk of Hyperglycemia 
731 
Hyperglycemia and ketonemia could occur if insulin delivery is attenuated or suspended for an 
732 
extended period or if the pump or infusion set is not working properly.  A CGM functioning poorly 
733 
and significantly under-reading glucose values could lead to inappropriate suspension of insulin 
734 
delivery. 
735 
10.1.1.6 Risk of Device Reuse 
736 
The study CGM system is labeled for single use only. The sensor (the component of the system 
737 
that enters the skin) will be single use only. The transmitter and receiver may be reused during the 
738 
study after cleaning the device using a hospital-approved cleaning procedure. The transmitter is 
739 
attached to the sensor but does not enter the skin and the receiver, if used, is a hand held device. 
740 
Participants will be informed that FDA or relevant national authorities have approved these devices 
741 
for single use and that by using them among multiple patients, bloodborne pathogens (i.e. Hepatitis 
742 
B) may be spread through the use of multiple users. 
743 
The study insulin pump is labeled for single-patient use. During the study, this device may be 
744 
reused after cleaning adhering to a hospital-approved cleaning procedure. All infusion set 
745 
equipment will be single patient use only (infusion set insertion kits, tubing, cartridges etc.)  
746 
Participants will be informed that FDA or relevant national authorities typically approve the insulin 
747 
pump device for single use and that by using them among multiple patients, bloodborne pathogens 
748 
(i.e. Hepatitis B) may be spread through the use of multiple users. 
749 
The study blood glucose meter and blood ketone meter are labeled for single-patient use. 
750 
During the study, these devices may be reused after cleaning adhering to a hospital-approved 
751 
cleaning procedure.  Participants will be informed that FDA or relevant national authorities 
752 
typically approve the glucose and ketone meters for single use and that by using them among 
753 
multiple patients, bloodborne pathogens (i.e. Hepatitis B) may be spread through the use of 
754 
multiple users. 
755 
10.1.1.7 Device Cleaning Instructions 
756 
CGM cleaning instructions are provided in the Dexcom G4 PLATINUM (Professional) Cleaning 
757 
and Disinfection manual (current edition). The transmitter should be cleaned with Clorox 
758 
Healthcare® Bleach Germicidal Cleaner or any disinfectant product in a spray bottle containing a 
759 
bleach solution of 6500 parts per million with the EPA registration number 56392-7.  The 
760 
transmitter will be submerged in this solution and then placed on an absorbent wipe or clean 
761 
surface.  Two sprays will be dispensed from the Clorox cleaner onto each side of the transmitter. 
762 
A nylon brush will be used to scrub the transmitter on all sides for 30 seconds.  The transmitter 
763 
will be placed in the Clorox Cleaner solution for one minute. Transmitter is then rinsed under 
764 
flowing tap water for ten seconds. The transmitter will then be disinfected using a disinfectant 
765 
product with EPA registration number 56392-7 using similar procedures as the cleaning process.   
766 
Per the pump manufacturer, the insulin pump will be cleaned with a damp lint-free cloth. Use of 
767 
household or industrial cleaners, solvents, bleach, scouring pads, chemicals, or sharp instruments 
768 
are prohibited. The pump should never be submerged in water. If needed, use only a very mild 
769 
detergent, such as a bit of liquid soap with warm water. A soft towel will be used to dry the pump. 
770 

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The outside of the transmitter will be wiped with a damp lint-free cloth or isopropyl alcohol wipe 
771 
between uses.  
772 
The Accu-Chek Guide glucometer is cleaned and disinfected with two separate Super Sani-Cloths 
773 
(EPA number 9480-4). The entire surface will be cleaned, making sure the surface stays wet for 2 
774 
minutes. This step is repeated with a clean cloth for disinfecting the device.  
775 
The Precision Xtra User’s Guide suggests that healthcare professionals use 10% bleach, 70% 
776 
alcohol or 10% ammonia to clean the device.  
777 
Equipment that touches intact skin will be cleaned with ethyl or isopropyl alcohol (70-90%), 
778 
quaternary ammonium germicidal detergent (i.e. Cavicide, EPA number 46781) or household 
779 
bleach. The contact time on the surface depends on the method used to clean the equipment. 
780 
Cavicide requires three minutes on the surface of the equipment. Clorox Germicidal Bleach Wipes 
781 
require two minutes on the equipment. The surface should remain wet (i.e. slightly damp) with the 
782 
disinfectant to be considered effective though not wet enough to leave drops of liquid.  
783 
In the event a manufacturer updates cleaning procedures for their device, the study team will 
784 
adhere to the most current recommendations.  
785 
There is the risk of blood sampling collection and contamination from sampling techniques. Hand 
786 
washing with either soap & water or waterless hand sanitizer will be used prior to caring for the 
787 
study subject. Gloves will be worn during blood sample collection and processing. Medical 
788 
personnel will continue to practice hygiene for the subject’s protection (i.e. hand washing, 
789 
changing gloves frequently, disposing needles properly). Gloves will be removed and hands 
790 
washed prior to leaving and upon return to the subject’s room. Soiled linen will be changed to 
791 
minimize the transfer of pathogenic organisms. 
792 
10.1.1.8 Hb1Ac Risk 
793 
An NGSP Point of Care analyzer (i.e. DCA Vantage Analyzer) will be utilized at the research site 
794 
to obtain the subject’s HbA1c level. 
795 
10.1.1.9 Questionnaire 
796 
As part of the study, parent/guardian(s) will complete a Technology Acceptance Questionnaire 
797 
which includes questions about their private attitudes, feelings and behavior related to t:slim X2 
798 
with Control-IQ.  It is possible that some people may find these questionnaires to be mildly 
799 
upsetting. Similar questionnaires have been used in previous research and these types of reactions 
800 
have been uncommon. 
801 
10.1.1.10 Other Risks 
802 
Some participants may develop skin irritation or allergic reactions to the adhesives used to secure 
803 
the CGM, or to secure the insulin infusion sets for the continuous subcutaneous insulin infusion.  
804 
If these reactions occur, different adhesives or “under-taping” (such as with IV 3000, Tegaderm, 
805 
etc.) will be tried, sites will be rotated frequently, and a mild topical steroid cream or other 
806 
medication may be required. 
807 

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Whenever the skin is broken there is the possibility of an infection.  The CGM and pump infusion 
808 
sites are inserted under the skin.  It is possible that any part that is inserted under the skin may 
809 
cause an infection.  These occur very infrequently, but, if an infection was to occur, oral and/or 
810 
topical antibiotics can be used.  The risk of skin problems could be greater if you use a sensor for 
811 
longer than it is supposed to be used.  Therefore, participants will be carefully instructed about 
812 
proper use of the sensor. 
813 
Data downloaded from the CGM, pump, and glucose and ketone meter will be collected for the 
814 
study as measures of diabetes self-management behaviors.  Some people may be uncomfortable 
815 
with the researchers' having such detailed information about their daily diabetes habits. 
816 
The Hotel Admission will have other parents and child participants in attendance. The loss of 
817 
privacy and confidentiality is a likely risk as the study team is not able to restrict other 
818 
participants from sharing photographs (i.e. social media). Photographs taken by the study team 
819 
may be shared at conference presentations, study brochures, or potential research donors.  
820 
10.1.2 Known Potential Benefits 
821 
It is expected that this protocol will yield increased knowledge about using an automated 
822 
closed-loop system with anticipatory action to control glucose levels.  The individual participant 
823 
may not benefit from study participation. 
824 
10.1.3 Risk Assessment 
825 
Based on the facts that (1) adults and adolescents with diabetes experience mild hypoglycemia and 
826 
hyperglycemia frequently as a consequence of the disease and its management, (2) the study 
827 
intervention involves periodic automated insulin dosing that may increase the likelihood of 
828 
hypoglycemia, and periodic automated attenuation of insulin delivery that may increase the 
829 
likelihood of hyperglycemia, (3) mitigations are in place, and have been tested in prior studies 
830 
using the investigational device system in the home setting, that limit the likelihood of excessive 
831 
insulin dosing or prolonged withdrawal of insulin, and (4) rapid reversal of hypoglycemia and 
832 
hyperglycemia can be achieved, it is the assessment of the investigators that this protocol falls 
833 
under DHHS 46.405 which is a minor increase over minimal risk. In addition, it is the belief of the 
834 
investigators that this study also presents prospect of direct benefit to the participants and general 
835 
benefit to others with diabetes. 
836 
10.2 Potential Risks and Benefits of the Investigational Device 
837 
Risks and benefits are detailed below. Loss of confidentiality is a potential risk; however, data are 
838 
handled to minimize this risk.  Hypoglycemia, hyperglycemia and ketone formation are always a 
839 
risk in participants with type 1 diabetes and participants will be monitored for these events. 
840 
10.3 General Considerations 
841 
The study is being conducted in compliance with the policies described in the study policies 
842 
document, with the ethical principles that have their origin in the Declaration of Helsinki, with the 
843 
protocol described herein, and with the standards of Good Clinical Practice (GCP). 
844 

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Whenever possible, data will be directly collected in electronic case report forms, which will be 
845 
considered the source data. 
846 
The protocol is considered a significant risk device study, due to the fact that the closed loop 
847 
system is experimental.  Therefore, an investigational device exemption (IDE) from the U.S. Food 
848 
and Drug Administration (FDA) is required to conduct the study. 
 
849 

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Chapter 11:  ADVERSE EVENTS, DEVICE ISSUES, AND STOPPING RULES 
850 
11.1 Adverse Events 
851 
11.1.1 Definitions 
852 
Adverse Event (AE): Any untoward medical occurrence in a study participant, irrespective of the 
853 
relationship between the adverse event and the device(s) under investigation (section 11.1.2) for 
854 
reportable adverse events for this protocol). 
855 
Serious Adverse Event (SAE): Any untoward medical occurrence that: 
856 
 Results in death. 
857 
 Is life-threatening; (a non-life-threatening event which, had it been more severe, might 
858 
have become life-threatening, is not necessarily considered a serious adverse event). 
859 
 Requires inpatient hospitalization or prolongation of existing hospitalization. 
860 
 Results in persistent or significant disability/incapacity or substantial disruption of the 
861 
ability to conduct normal life functions (sight threatening). 
862 
 Is a congenital anomaly or birth defect. 
863 
 Is considered a significant medical event by the investigator based on medical judgment 
864 
(e.g., may jeopardize the participant or may require medical/surgical intervention to 
865 
prevent one of the outcomes listed above). 
866 
Unanticipated Adverse Device Effect (UADE): Any serious adverse effect on health or safety or 
867 
any life-threatening problem or death caused by, or associated with, a device, if that effect, 
868 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
869 
investigational plan or application (including a supplementary plan or application), or any other 
870 
unanticipated serious problem associated with a device that relates to the rights, safety, or welfare 
871 
of participants (21 CFR 812.3(s)). 
872 
Adverse Device Effect (ADE): Any untoward medical occurrence in a study participant which the 
873 
device may have caused or to which the device may have contributed (Note that an Adverse Event 
874 
Form is to be completed in addition to a Device Deficiency or Issue Form). 
875 
Device Complaints and Malfunctions: A device complication or complaint is something that 
876 
happens to a device or related to device performance, whereas an adverse event happens to a 
877 
participant.  A device complaint may occur independently from an AE, or along with an AE.  
878 
An AE may occur without a device complaint or there may be an AE related to a device complaint.  
879 
A device malfunction is any failure of a device to meet its performance specifications or otherwise 
880 
perform as intended.  Performance specifications include all claims made in the labeling for the 
881 
device.  The intended performance of a device refers to the intended use for which the device is 
882 
labeled or marketed. (21 CFR 803.3).  Note: for reporting purposes, sites will not be asked to 
883 
distinguish between device complaints and malfunctions. 
884 

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11.1.2 Reportable Adverse Events 
885 
For this protocol, a reportable adverse event includes any untoward medical occurrence that meets 
886 
one of the following criteria: 
887 
a. A serious adverse event 
888 
b. An Adverse Device Effect as defined in section 11.1, unless excluded from reporting in 
889 
section 11.2 
890 
c. An Adverse Event occurring in association with a study procedure 
891 
d. Hypoglycemia meeting the definition of severe hypoglycemia as defined below  
892 
e. Diabetic ketoacidosis (DKA) as defined below or in the absence of DKA, a hyperglycemic 
893 
or ketosis event meeting the criteria defined below 
894 
Hypoglycemia and hyperglycemia not meeting the criteria below will not be recorded as adverse 
895 
events unless associated with an Adverse Device Effect.  Skin reactions from sensor placement are 
896 
only reportable if severe and/or required treatment. 
897 
11.1.2.1 Hypoglycemic Events 
898 
Hypoglycemia not associated with an Adverse Device Effect is only reportable as an adverse event 
899 
when the following definition for severe hypoglycemia is met:  the event required assistance of 
900 
another person due to altered consciousness, and required another person to actively administer 
901 
carbohydrate, glucagon, or other resuscitative actions.  This means that the participant was 
902 
impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to 
903 
verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or 
904 
coma.  These episodes may be associated with sufficient neuroglycopenia to induce seizure or 
905 
coma.  If plasma glucose measurements are not available during such an event, neurological 
906 
recovery attributable to the restoration of plasma glucose to normal is considered sufficient 
907 
evidence that the event was induced by a low plasma glucose concentration. 
908 
11.1.2.2 Hyperglycemic Events/Diabetic Ketoacidosis 
909 
Hyperglycemia not associated with an Adverse Device Effect is only reportable as an adverse 
910 
event when one of the following 4 criteria is met:  
911 
 the event involved DKA, as defined by the Diabetes Control and Complications Trial 
912 
(DCCT) and described below 
913 
 evaluation or treatment was obtained at a health care provider facility for an acute event 
914 
involving hyperglycemia or ketosis 
915 
 blood ketone level ≥1.5 mmol/L and communication occurred with a health care provider 
916 
at the time of the event 
917 
 blood ketone level ≥3.0 mmol/L, even if there was no communication with a health care 
918 
provider 
919 
Hyperglycemic events are classified as DKA if the following are present: 
920 

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 Symptoms such as polyuria, polydipsia, nausea, or vomiting; 
921 
 Serum ketones ≥1.5 mmol/L or large/moderate urine ketones; 
922 
 Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15; and 
923 
 Treatment provided in a health care facility 
924 
All reportable Adverse Events—whether volunteered by the participant, discovered by study 
925 
personnel during questioning, or detected through physical examination, laboratory test, or other 
926 
means—will be reported on an adverse event form online.  Each adverse event form is reviewed 
927 
by the Medical Monitor to verify the coding and the reporting that is required. 
928 
11.1.3 Relationship of Adverse Event to Study Device 
929 
The study investigator will assess the relationship of any adverse event to be related or unrelated 
930 
by determining if there is a reasonable possibility that the adverse event may have been caused by 
931 
the study device. 
932 
To ensure consistency of adverse event causality assessments, investigators should apply the 
933 
following general guideline when determining whether an adverse event is related: 
934 
Yes 
935 
There is a plausible temporal relationship between the onset of the adverse event and the study 
936 
intervention, and the adverse event cannot be readily explained by the participant’s clinical state, 
937 
intercurrent illness, or concomitant therapies; and/or the adverse event follows a known pattern of 
938 
response to the study intervention; and/or the adverse event abates or resolves upon discontinuation 
939 
of the study intervention or dose reduction and, if applicable, reappears upon re-challenge. 
940 
No 
941 
Evidence exists that the adverse event has an etiology other than the study intervention (e.g., 
942 
preexisting medical condition, underlying disease, intercurrent illness, or concomitant 
943 
medication); and/or the adverse event has no plausible temporal relationship to study intervention. 
944 
11.1.4 Intensity of Adverse Event 
945 
The intensity of an adverse event will be rated on a three-point scale: (1) mild, (2) moderate, or (3) 
946 
severe.  It is emphasized that the term severe is a measure of intensity: thus, a severe adverse event 
947 
is not necessarily serious.  For example, itching for several days may be rated as severe, but may 
948 
not be clinically serious. 
949 
 MILD: Usually transient, requires no special treatment, and does not interfere with the 
950 
participant’s daily activities. 
951 
 MODERATE: Usually causes a low level of inconvenience or concern to the participant 
952 
and may interfere with daily activities, but is usually ameliorated by simple therapeutic 
953 
measures. 
954 

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 SEVERE: Interrupts a participant’s usual daily activities and generally requires systemic 
955 
drug therapy or other treatment. 
956 
11.1.5 Coding of Adverse Events 
957 
The Medical Monitor will review the investigator’s assessment of causality and may agree or 
958 
disagree.  Both the investigator’s and Medical Monitor’s assessments will be recorded.  The 
959 
Medical Monitor will have the final say in determining the causality. 
960 
Adverse events that continue after the participant’s discontinuation or completion of the study will 
961 
be followed until their medical outcome is determined or until no further change in the condition 
962 
is expected. 
963 
11.1.6 Outcome of Adverse Event 
964 
The outcome of each reportable adverse event will be classified by the investigator as follows: 
965 
 RECOVERED/RESOLVED – The participant recovered from the AE/SAE without 
966 
sequelae.  Record the AE/SAE stop date. 
967 
 RECOVERED/RESOLVED WITH SEQUELAE – The event persisted and had stabilized 
968 
without change in the event anticipated.  Record the AE/SAE stop date. 
969 
 FATAL – A fatal outcome is defined as the SAE that resulted in death.  Only the event that 
970 
was the cause of death should be reported as fatal.  AEs/SAEs that were ongoing at the 
971 
time of death; however, were not the cause of death, will be recorded as “resolved” at the 
972 
time of death. 
973 
 NOT RECOVERED/NOT RESOLVED (ONGOING) – An ongoing AE/SAE is defined 
974 
as the event was ongoing with an undetermined outcome. 
975 
 An ongoing outcome will require follow-up by the site in order to determine the final 
976 
outcome of the AE/SAE. 
977 
 The outcome of an ongoing event at the time of death that was not the cause of death, will 
978 
be updated and recorded as “resolved” with the date of death recorded as the stop date. 
979 
 UNKNOWN – An unknown outcome is defined as an inability to access the participant or 
980 
the participant’s records to determine the outcome (for example, a participant that was lost 
981 
to follow-up). 
982 
All clinically significant abnormalities of clinical laboratory measurements or adverse events 
983 
occurring during the study and continuing at study termination should be followed by the 
984 
participant’s physician and evaluated with additional tests (if necessary) until diagnosis of the 
985 
underlying cause, or resolution.  Follow-up information should be recorded on source documents. 
986 
If any reported adverse events are present when a participant completes the study, or if a participant 
987 
is withdrawn from the study due to an adverse event, the participant will be contacted for re-
988 
evaluation within 2 weeks.  If the adverse event has not resolved, additional follow-up will be 
989 
performed as appropriate.  Every effort should be made by the Investigator or delegate to contact 
990 
the participant until the adverse event has resolved or stabilized. 
991 

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11.2 Reportable Device Issues 
992 
All UADEs, ADEs, device complaints, and device malfunctions will be reported irrespective of 
993 
whether an adverse event occurred, except in the following circumstances. 
994 
The following device issues are anticipated and will not be reported on a Device Issue Form but 
995 
will reported as an Adverse Event if the criteria for AE reporting described above are met: 
996 
 Component disconnections 
997 
 CGM sensors lasting fewer than the number of days expected per CGM labeling 
998 
 CGM tape adherence issues 
999 
 Pump infusion set occlusion not leading to ketosis 
1000 
 Battery lifespan deficiency due to inadequate charging or extensive wireless 
1001 
communication 
1002 
 Intermittent device component disconnections/communication failures not leading to 
1003 
system replacement 
1004 
 Device issues clearly addressed in the user guide manual that do not require additional 
1005 
troubleshooting 
1006 
 Skin reactions from CGM sensor placement or pump infusion set placement that do not 
1007 
meet criteria for AE reporting 
1008 
11.3 Timing of Event Reporting 
1009 
UADEs must be reported to the FDA by the IDE Sponsor within 10 working days of the study 
1010 
team being notified of the event.  
1011 
Other reportable adverse events, device malfunctions (with or without an adverse event), and 
1012 
device complaints should be reported promptly by completion of an electronic case report form, 
1013 
but there is no formal required reporting period. 
1014 
Clinical sites will notify the IDE Sponsor of any adverse event that is serious, related, and 
1015 
unexpected. Notification will be made within 10 days after becoming aware of the event in order 
1016 
to adhere to FDA regulations.  
1017 
Each principal investigator is responsible for reporting serious study-related adverse events and 
1018 
abiding by any other reporting requirements specific to his/her Institutional Review Board or 
1019 
Ethics Committee. 
1020 
Upon receipt of a UADE report, the Sponsor will investigate the UADE and if indicated, report 
1021 
the results of the investigation to the sites’ IRBs, and the FDA within 10 working days of the 
1022 
Sponsor becoming aware of the UADE per 21CFR 812.46(b) (2). The Medical Monitor must 
1023 
determine if the UADE presents an unreasonable risk to participants. If so, the Medical Monitor 
1024 
must ensure that all investigations, or parts of investigations presenting that risk, are terminated as 
1025 
soon as possible but no later than 5 working days after the Medical Monitor makes this 
1026 
determination and no later than 15 working days after first receipt notice of the UADE. 
1027 

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In the case of a device system component malfunction (e.g. pump, CGM, control algorithm), 
1028 
information will be forwarded to the responsible company by the site personnel, to be handled 
1029 
by its complaint management system. 
1030 
11.4 Stopping Criteria 
1031 
11.4.1 Participant Discontinuation of Study Device 
1032 
Rules for discontinuing study device use are described below. 
1033 
 The investigator believes it is unsafe for the participant to continue on the intervention.  
1034 
This could be due to the development of a new medical condition or worsening of an 
1035 
existing condition; or participant behavior contrary to the indications for use of the device 
1036 
that imposes on the participant’s safety 
1037 
 The participant requests that the treatment be stopped 
1038 
 One distinct episode of DKA 
1039 
 One distinct severe hypoglycemia event as defined in section 11.1.2.1 
1040 
11.4.2 Criteria for Suspending or Stopping Overall Study 
1041 
In the case of an unanticipated system malfunction resulting in a severe hypoglycemia or severe 
1042 
hyperglycemia event (as defined in section 11.1.2.2), use of the study device system will be 
1043 
suspended while the problem is diagnosed. 
1044 
If more than 1 serious hypoglycemia or more than 1 DKA event occurs, the study may be paused 
1045 
to determine a root cause prior to continuation of the study. 
1046 
In addition, study activities could be similarly suspended if the manufacturer of any constituent 
1047 
study device requires stoppage of device use for safety reasons (e.g. product recall).  The affected 
1048 
study activities may resume if the underlying problem can be corrected by a protocol or system 
1049 
modification that will not invalidate the results obtained prior to suspension. The study Medical 
1050 
Monitor will review all adverse events and adverse device events that are reported during the study 
1051 
and will review compiled safety data at periodic intervals (generally timed to the review of 
1052 
compiled safety data by the DSMB). The Medical Monitor may request suspension of study 
1053 
activities or stoppage of the study if deemed necessary based on the totality of safety data available. 
1054 
11.5 Independent Safety Oversight 
1055 
A Medical Monitor will review all DKA and severe hypoglycemia irrespective of relatedness to 
1056 
study device use, and all serious events (including UADEs) related to study device use at the time 
1057 
of occurrence. The Medical Monitor also will be informed of any ADEs not meeting criteria for a 
1058 
UADE. 
1059 

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Chapter 12:  MISCELLANEOUS CONSIDERATIONS 
1060 
12.1 Prohibited Medications, Treatments, and Procedures 
1061 
Child participants using glulisine at the time of enrollment will be asked to contact their personal 
1062 
physician to change their prescribed personal insulin to lispro or aspart for the duration of the trial. 
1063 
The study devices (study insulin pump, study CGM) must be removed before Magnetic Resonance 
1064 
Imaging (MRI), Computed Tomography (CT) or diathermy treatment. Participants may continue 
1065 
in the trial after temporarily discontinuing use if requiring one of the treatments above. 
1066 
12.2 Participant Withdrawal 
1067 
Participation in the study is voluntary, and a participant may withdraw at any time.  For participants 
1068 
who withdraw, their data will be used up until the time of withdrawal. 
1069 
12.3 Confidentiality 
1070 
For security and confidentiality purposes, subjects will be assigned an identifier that will be used 
1071 
instead of their name.  Protected health information gathered for this study may be shared with the 
1072 
third party collaborators.  De-identified subject information may also be provided to collaborators 
1073 
involved in the study after the appropriate research agreement has been executed.  
 
1074 

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Chapter 13:  STATISTICAL CONSIDERATION 
1075 
13.1 Statistical and Analytical Plans 
1076 
This trial is single-armed and not powered to detect differences between groups. The study is 
1077 
designed to obtain a primary safety profile on patients in this age-group. 
1078 
This study is an early feasibility study that will test the safety of t:slim X2 with Control-IQ 
1079 
Technology in an outpatient setting. These studies would generate up to 75 days of closed-loop 
1080 
data. This sample size allows for subject withdrawal.  
1081 
13.2 Statistical Hypotheses 
1082 
13.2.1 Primary Outcome  
1083 
Number of subject with less than 6% time below 70mg/dL and less than 40% time above 
1084 
180mg/dL. 
1085 
13.2.2 Secondary Outcome 
1086 
1. % time spent <70 mg/dl, <60mg/dl, <54mg/dL, and <50mg/dL 
1087 
2. % time spent >180mg/dl, and >250mg/dl, >300 mg/dl 
1088 
3. % time spent between 70-180mg/dl 
1089 
4. % time spent between 70-150mg/dl 
1090 
5. Number of hypoglycemia below 70 mg/dL 
1091 
6. Number of carbohydrate treatments, as well as total amount of carbohydrates used for  
1092 
treatments. 
1093 
7. Time spent in closed loop 
1094 
8. Time with available CGM 
1095 
9. Number of subject with more than 70% time in 70-180mg/dL range with less than 4% 
1096 
time below 70mg/dL 
1097 
13.2.3 Success Criteria / Goal 
1098 
As a general rule, a session will be considered useful for data analysis if the subject completes 
1099 
close to 80% of the active study protocol. Sessions are considered separate: (i) Supervised 
1100 
Phase=complete at least 38 hours of AP; (ii) at home use=complete at least 56 hours of AP.  
1101 
The primary goal will be considered met is the primary outcome is achieved for 65% or more of 
1102 
the subjects. 
1103 
13.2.4 Statistical Analysis Plan 
1104 
Proportions of subject matching primary criteria will be computed and directly compared to 65% 
1105 
(considered baseline). Further analysis will be performed using a chi2 test of goodness of fit. Based 
1106 
on prior data in 6-12 year olds we anticipate an possible effect size of 0.64, which would allow to 
1107 
detect a difference with 70% power considering our sample size. 
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Overall outcomes will be compared to the normative data below (values derived from the analysis 
1109 
of 30 6-12 year old T1D subjects using pumps and CGM and rounded for ease of use): 
1110 
Baseline 
mean 
std 
% time below 50mg/dL 
0.5% 0.5% 
% time below 54mg/dL 
1% 0.8% 
% time below 60mg/dL 
2% 
1% 
% time below 70 mg/dL 
4% 2.5% 
% time between 70-140mg/dL 
40% 
9% 
% time between 70-180mg/dL 
60% 
9% 
% time above 180mg/dL 
35% 
9% 
% time above 250mg/dL 
11% 
5% 
% time above 300mg/dL 
4% 
3% 
  
  
Average CGM [mg/dL] 
162.0 
15.0 
This analysis will be performed using a single group one sided t-test for mean comparison for 
1111 
outcomes that can be assumed normally distributed and One-Sample Wilcoxon Signed Rank test 
1112 
for median comparison for the others, this analysis is not powered. 
1113 
Secondary outcomes will be reported for the entire period and for the supervised and home phases 
1114 
separately. Outcomes by phase will be compared to each other to assess possible loss of 
1115 
performances during the transition at home. For this purpose, McNemar’s tests will be used to 
1116 
compare the supervised phase to the home phase for the primary outcome and secondary outcome 
1117 
# 6, 7, and 8. All other outcomes will be analyzed using repeated measure ANOVA. Significance 
1118 
of 0.05 will be used. 
1119 
This analysis is not powered. 
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Chapter 14:  DATA COLLECTION AND MONITORING 
1121 
14.1 Case Report Forms and Device Data 
1122 
The study data are collected through a combination of case report forms (electronic and paper) and 
1123 
electronic device data files obtained from the software and individual hardware components.  
1124 
These electronic device files and electronic CRFs are considered the primary source 
1125 
documentation. 
1126 
When data are directly collected in electronic case report forms, this will be considered the source 
1127 
data.  Records will be maintained in accordance with ICH E6 and institutional regulatory 
1128 
requirements for the protection of confidentiality of participants. 
1129 
14.2 Study Records Retention 
1130 
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
1131 
application in an ICH region and until there are no pending or contemplated marketing applications 
1132 
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
1133 
development of the investigational product.  These documents should be retained for a longer 
1134 
period, however, if required by local regulations.  No records will be destroyed without the written 
1135 
consent of the sponsor, if applicable.  It is the responsibility of the sponsor to inform the 
1136 
investigator when these documents no longer need to be retained. 
1137 
14.3 Protocol Deviations 
1138 
A protocol deviation is any noncompliance with the clinical trial protocol, Good Clinical Practices 
1139 
(GCP), or procedure requirements.  The noncompliance may be either on the part of the participant, 
1140 
the investigator, or the study site staff.  As a result of deviations, corrective actions may be 
1141 
developed by the site and implemented as appropriate.  Major deviations will be reported to the 
1142 
IRB-HSR within 7 calendar days of when the study team becomes aware of the event. 
1143 

UNIVERSITY OF VIRGINIA 
 
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Page 49 of 50 
Chapter 15:  ETHICS/PROTECTION OF HUMAN PARTICIPANTS 
1144 
15.1 Ethical Standard 
1145 
The investigator will ensure that this study is conducted in full conformity with Regulations for 
1146 
the Protection of Human Participants of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 
1147 
CFR Part 56, and/or the ICH E6. 
1148 
15.2 Institutional Review Boards 
1149 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
1150 
be submitted to the IRB for review and approval.  Approval of both the protocol and the consent 
1151 
form must be obtained before any participant is enrolled.  Any amendment to the protocol will 
1152 
require review and approval by the IRB before the changes are implemented to the study.  All 
1153 
changes to the consent form will be IRB approved; a determination will be made regarding whether 
1154 
previously consented participants need to be re-consented. 
1155 
15.3 Informed Consent Process 
1156 
15.3.1 Consent Procedures and Documentation 
1157 
Informed consent is a process that is initiated prior to an individual’s agreement to participate in 
1158 
the study and continues throughout the individual’s study participation.  Extensive discussion of 
1159 
risks and possible benefits of participation will be provided.  Consent forms will be IRB approved 
1160 
and the participant will be asked to read and review the document.  The investigator or their 
1161 
delegate will explain the research study to the parent/guardian(s) and answer any questions that 
1162 
may arise.  All participants will receive a verbal explanation in terms suited to their comprehension 
1163 
of the purposes, procedures, and potential risks of the study and of their rights as research 
1164 
participants.  Parent/guardian(s) will have the opportunity to carefully review the written consent 
1165 
form and ask questions prior to signing. 
1166 
The parent/guardian(s) will sign the informed consent document prior to any procedures being 
1167 
done specifically for the study.  The parent/guardian(s) may withdraw their child’s consent at any 
1168 
time throughout the course of the trial.  A copy of the informed consent document will be given to 
1169 
the parent/guardian(s) for their records.  The rights and welfare of the participants will be protected 
1170 
by emphasizing to them that the quality of their medical care will not be adversely affected if they 
1171 
decline to participate in this study. 
1172 
A child participant is considered enrolled when the informed consent form has been signed. 
1173 
15.3.2 Participant and Data Confidentiality 
1174 
The study monitor, representatives of the IRB or device company supplying study product may 
1175 
inspect all documents and records required to be maintained by the investigator, including but not 
1176 
limited to, medical records (office, clinic, or hospital) for the participants in this study.   
1177 

UNIVERSITY OF VIRGINIA 
 
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The study participant’s contact information will be securely stored at the clinical site for internal 
1178 
use during the study.  At the end of the study, all records will continue to be kept in a secure 
1179 
location for as long a period as dictated by local IRB and Institutional regulations. 
1180 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, 
1181 
will be transmitted to and stored at the University of Virginia Center for Diabetes Technology.  
1182 
This will not include the participant’s contact or identifying information.  Rather, individual 
1183 
participants and their research data will be identified by a unique study identification number.  The 
1184 
study data entry and study management systems used by research staff will be secured and 
1185 
password protected.  At the end of the study, all study databases may be de-identified and archived 
1186 
at the University of Virginia Center for Diabetes Technology.   
1187