Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Marc Breton

 
UVA CENTER FOR DIABETES TECHNOLOGY 
 
 
 
 
 
 
Evaluation of The Postprandial Impact of 
Automated Priming Bolus for Full Closed Loop 
Insulin Delivery 
 
 
Protocol Chair 
Sue A. Brown, MD 
 
 
University of Virginia 
Center for Diabetes Technology 
 
 
NCT#05528770 
Version Number: v1.7 
06-Oct-2022 
 

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KEY ROLES 
 
Protocol Principal Investigator 
 
Name, degree 
Sue Brown, MD 
Institution Name 
University of Virginia Center for Diabetes Technology  
 
 

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PROTOCOL VERSION HISTORY 
Version 
Number 
Author(s) 
Approver 
Effective Date 
Revision Description 
1.0 
Mark DeBoer,  
Mary Oliveri  
Sue Brown 
29-Jul-2022 
Original Protocol 
1.1 
Mary Oliveri 
Mark DeBoer 
15-Aug-2022 
FDA requested mods:  
• 
Figure 1 was updated  
• 
BPS 
transitions 
described 
(section 7.6) 
1.2 
Mark DeBoer 
Mark DeBoer 
16-Aug-2022 
FDA requested mods:  
• 
Inclusion & exclusion criteria 
(section 3.5 & 3.6) 
• 
Pilot study BPS corrections 
(section 6.3 & 6.4) 
• 
Exercise termination criteria 
(section 7.8) 
• 
Discharge criteria (section 
7.9) 
• 
Individual stopping criteria 
(section 11.10.1) 
1.3 
Mary Oliveri 
Sue Brown 
23-Aug-2022 
FDA requested mods:  
• 
Pilot study will complete a 
minimum of 2-3 participants 
(section 1.3, 3.2 & Chapter 6) 
• 
A H&P within 9 months of 
screening appointments may 
be used (section 3.4 & 3.7) 
• 
Further modified Exercise 
termination criteria (section 
7.8)  
• 
Discharge criteria (section 
6.6) 
1.4 
Mary Oliveri 
Sue Brown 
12-Sep-2022 
IRB Pre-Review mods (07-Sep-
2022):  
• 
Clarified enrollment numbers 
(section 3.2 & 13.2) 
• 
Edited 
inclusion 
criteria 
(section 3.5). 
• 
Edited 
Screening 
Process 
(section 3.4 &  3.7) 
• 
Deleted 
references 
to 
questionnaires (section 5.1, 
7.2, & 7.10) 
• 
Added 5-minute low intensity 
warm up (section 7.7) 
• 
Clarified 
Covid 
testing 
(section 9.1.3) 
• 
Deleted Covid vaccination 
record (section 10.3) 

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• 
Edited 
pre-screening 
description (section 3.7) 
1.5 
Sue Brown 
Sue Brown 
25-Sep-2022 
IRB FB Review request: 
• 
SAP description (Chapter 13). 
1.6 
Mary Oliveri 
Mary Oliveri 
27-Sep-2022 
IRB FB Review request: 
• 
Remove screening remote 
references 
1.7 
Mary Oliveri 
Mary Oliveri 
06-Oct-2022 
IRB FB Review request: 
• 
Clarified 
Part 
11 
identification process (section 
15.3.1)  
 
 
 

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SITE PRINCIPAL INVESTIGATOR STATEMENT OF COMPLIANCE 
 
Protocol Title: Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed 
Loop Insulin Delivery 
Protocol Version/Date: v1.7  06-Oct-2022 
I have read the protocol specified above.  In my formal capacity as a Site Principal Investigator, 
my duties include ensuring the safety of the study participants enrolled under my supervision.  It 
is understood that all information pertaining to the study will be held strictly confidential and that 
this confidentiality requirement applies to all study staff at this site. 
This trial will be carried out in accordance with ICH E6 Good Clinical Practice (GCP) and as 
required by the following: United States (US) Code of Federal Regulations (CFR) applicable to 
clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 
CFR Part 812). 
As the Principal Investigator, I will assure that no deviation from, or changes to the protocol 
will take place without prior agreement from the sponsor and documented approval from the 
Institutional Review Board (IRB), or other approved Ethics Committee, except where necessary 
to eliminate an immediate hazard(s) to the trial participants. 
All key personnel (all individuals responsible for the design and conduct of this trial) have 
completed Human Participants Protection Training and Good Clinical Practice Training.  Further, 
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments. 
 
Investigator’s Signature __________________________________Date: _____ / _____ / _____ 
Investigator’s Name: ________________________________ 
Site Name:  University of Virginia 
 
 

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LIST OF ABBREVIATIONS 
ABBREVIATION 
DEFINITION 
ADRR 
Average Daily Risk Range 
AP 
Artificial Pancreas 
BG 
Blood Glucose 
BT/BTLE 
Bluetooth, Bluetooth low energy 
BPS 
Bolus Priming System 
CGM 
Continuous Glucose Monitoring 
CLC 
Closed-Loop Control 
CSII 
Continuous Subcutaneous Insulin Injection 
DKA 
Diabetic Ketoacidosis 
DSMB 
Data Safety Monitoring Board 
FCL 
Fully Closed Loop 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HbA1c 
Hemoglobin A1c 
HBGI 
High Blood Glucose Index  
HIIT 
High-intensity interval training  
HCL 
Hybrid Closed Loop 
IDE 
Investigational Device Exemption 
IOB 
Insulin-on-Board 
LBGI 
Low Blood Glucose Index  
POC 
Point-of-Care 
QC 
Quality Control 
UI 
User Interface 
 
 

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PROTOCOL SUMMARY 
PARTICIPANT AREA 
DESCRIPTION 
Title 
Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop 
Insulin Delivery 
Investigational Device 
UVA Model Predictive Control Artificial Pancreas (RocketAP) with and without use of the 
Bolus Priming System (BPS) 
Objectives 
The purpose of this study is to show the safety and feasibility of a new fully automated AP 
controller with and without the Bolus Priming System 
Study Design 
A randomized cross-over trial assessing glycemic responses to a fully automated AP system 
using two approaches:  
1) using the Bolus Priming System (which detects shifts in glucose level to trigger a priming 
dose of insulin) 
2) without the Bolus Priming System 
We will also have structured meal and exercise challenges of the fully closed loop system. 
Number of Sites 
One 
Endpoint 
The primary outcome will be time in range 70-180 mg/dL for a 24-hour period. 
Population 
Key Inclusion Criteria 
• 
Age 18 and ≤65 years of age 
• 
Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one 
year  
• 
Currently using insulin for at least six months 
• 
Currently using insulin pump for at least three months  
Sample Size  
• 
Pilot Study: complete a minimum of 2-3 participants  
• 
Main Study: complete up to 20 participants 
Treatment Groups 
Randomized crossover:  Participants will be randomized to the order that they experience 
the use of the BPS in fully automated closed loop (FCL) (for 24 hours each, with a 24-hour 
washout in between): 1) with the BPS active, 2) without BPS.   
Participant Duration 
Pilot Study:  Participants will be admitted to a local hotel or rental house for up to 
approximately 24 hours and will have a dinner with the RocketAP without the BPS 
Main Study: Participants will be admitted to a local hotel for approximately 96 hours.  
Protocol Overview/Synopsis 
Main Study participants will be admitted to the hotel for a 4-night study, receiving the two 
sessions in random order: 1) FCL with BPS activated, 2) FCL without the BPS, with a 24-
hour washout period in between. During the admission, participants will receive structured 
meals and have blood glucose control followed to compare time in range 70-180 mg/dL 
between Controller sessions.  After the first 24 hour period on the first FCL approach (BPS 
vs. no BPS,) that the participant has been randomized to, there will be a 24 hour challenge 
period before shifting to the other randomized approach; during this session participants will 
undergo further testing of the control algorithm, including meal challenges and a high-
intensity interval training bout.  

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STUDY VISITS AND PROCEDURES SCHEDULE  
 
Screening 
Study Equipment 
Training 
Pre-Admission 
Check-In 
Study Admission 
Post-Admission 
Check-In 
Location 
Clinic 
Clinic/ Remote 
Phone/ Email/ 
Text 
Hotel/Rental 
House 
Phone/ Email/ 
Text 
Visit 
1 
2 
3 
4 
5 
Informed Consent 
X 
 
 
 
 
Eligibility Assessment 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
HbA1c 
X 
 
 
 
 
Pregnancy test (if applicable) 
X 
X 
 
X 
 
Physical Exam 
X 
 
 
 
 
Vital Signs (height/weight) 
X 
 
 
X 
 
Electrocardiogram (ECG) 
X 
 
 
 
 
Demographic Survey 
X 
 
 
 
 
Randomization 
 
 
 
X 
 
COVID-19 Testing 
 
 
X 
 
 
CGM Use 
 
 
 
X 
 
Survey  
X 
 
 
 
 
Review diabetes management and AEs 
 
 
 
X 
X 

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TABLE OF CONTENTS 
1 
Chapter 1 Background ..........................................................................................13 
2 
1.1 Introduction ......................................................................................................................... 13 
3 
1.2 Study Objective ................................................................................................................... 14 
4 
1.3 Study Design ....................................................................................................................... 14 
5 
1.4 Study Device Download ..................................................................................................... 16 
6 
1.5 Study System Issues ............................................................................................................ 16 
7 
Chapter 2 Study Devices .......................................................................................18 
8 
2.1 Insulin Pump ....................................................................................................................... 18 
9 
2.2 Continuous Glucose Monitor .............................................................................................. 18 
10 
2.3 Blood Glucose Meter and Strips ......................................................................................... 18 
11 
2.4 Ketone Meter and Strips ..................................................................................................... 18 
12 
2.5 Study Devices Accountability Procedures .......................................................................... 18 
13 
Chapter 3 Study Screening ...................................................................................19 
14 
3.1 Clinical Sites ....................................................................................................................... 19 
15 
3.2 Participant Recruitment and Enrollment ............................................................................. 19 
16 
3.3 Informed Consent and Authorization Procedures ............................................................... 19 
17 
3.4 Screening Procedures .......................................................................................................... 19 
18 
3.5 Participant Inclusion Criteria .............................................................................................. 19 
19 
3.6 Participant Exclusion Criteria ............................................................................................. 20 
20 
3.7 Visit 1: Screening Procedures ............................................................................................. 21 
21 
3.8 Demographic Data Survey .................................................................................................. 23 
22 
Chapter 4 Randomization .....................................................................................25 
23 
4.1 Pilot Study Participants ....................................................................................................... 25 
24 
4.2 Main Study Participants ...................................................................................................... 25 
25 
Chapter 5 Visit 2: Study Equipment Training ....................................................26 
26 

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5.1 CGM Training ..................................................................................................................... 26 
27 
5.2 Activity Tracker .................................................................................................................. 26 
28 
5.3 Study Insulin Pump ............................................................................................................. 27 
29 
Chapter 6 Pilot Study ............................................................................................28 
30 
6.1 Qualifications and Role of the Staff.................................................................................... 28 
31 
6.2 Visit 3: Pre-Admission Check-In Visit ............................................................................... 28 
32 
6.3 Visit 4: Admission Check-In .............................................................................................. 28 
33 
6.4 Study Meals ........................................................................................................................ 29 
34 
6.5 Admission Activities ........................................................................................................... 29 
35 
6.6 Admission Discharge .......................................................................................................... 29 
36 
6.7 Visit 5: Post Admission Check-In Visit .............................................................................. 30 
37 
Chapter 7 Main Study ...........................................................................................31 
38 
7.1 Hotel Admission ................................................................................................................. 31 
39 
7.2 Qualifications and Role of the Staff.................................................................................... 31 
40 
7.3 Visit 3: Pre-Admission Check-In Visit ............................................................................... 31 
41 
7.4 Visit 4: Admission Check-In .............................................................................................. 31 
42 
7.5 System Transitions .............................................................................................................. 32 
43 
7.6 Study Meals ........................................................................................................................ 32 
44 
7.7 Admission Activities ........................................................................................................... 33 
45 
7.8 Admission Discharge .......................................................................................................... 34 
46 
7.9 Visit 5: Post Admission Check-In Visit .............................................................................. 34 
47 
7.10 Medical Monitor Review .................................................................................................. 34 
48 
Chapter 8 Medical Monitor Review .....................................................................35 
49 
8.1 Medical Monitor Study Safety Data Review ...................................................................... 35 
50 
8.2 Medical Monitor Main Study Safety Data Review ............................................................ 35 
51 
Chapter 9 Testing Procedures ..............................................................................36 
52 
9.1 Laboratory / Point of Care Testing ..................................................................................... 36 
53 

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Chapter 10 Risks Associated with Clinical Trial ................................................37 
54 
10.1 Potential Risks and Benefits of the Investigational Device .............................................. 37 
55 
10.2 General Considerations ..................................................................................................... 40 
56 
10.3 COVID-19 Risk Mitigation Plan and Justification ........................................................... 41 
57 
Chapter 11 Adverse Events, Device Issues, and Stopping Rules.......................42 
58 
11.1 Definitions......................................................................................................................... 42 
59 
11.2 Reportable Events ............................................................................................................. 43 
60 
11.3 Relationship of Adverse Event to Study Device............................................................... 44 
61 
11.4 COVID-19 Transmission .................................................................................................. 44 
62 
11.5 Intensity of Adverse Event................................................................................................ 45 
63 
11.6 Coding of Adverse Events ................................................................................................ 45 
64 
11.7 Outcome of Adverse Events ............................................................................................. 45 
65 
11.8 Reportable Device Issues .................................................................................................. 46 
66 
11.9 Timing of Event Reporting ............................................................................................... 46 
67 
11.10 Stopping Criteria ............................................................................................................. 47 
68 
11.11 Independent Safety Oversight ......................................................................................... 48 
69 
11.12 Definition of a Data Breach ............................................................................................ 48 
70 
Chapter 12 Miscellaneous Considerations ..........................................................49 
71 
12.1 Prohibited Medications, Treatments, and Procedures ....................................................... 49 
72 
12.2 Participant Withdrawal ..................................................................................................... 49 
73 
12.3 Confidentiality .................................................................................................................. 49 
74 
Chapter 13 Statistical Consideration ...................................................................50 
75 
13.1 Design and Randomization ............................................................................................... 50 
76 
13.2 Sample Size ....................................................................................................................... 51 
77 
13.3 Outcome Measures............................................................................................................ 51 
78 
13.4 Safety Analyses ................................................................................................................. 52 
79 
13.5 Baseline Descriptive Statistics .......................................................................................... 52 
80 

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13.6 Device Issues .................................................................................................................... 52 
81 
Chapter 14 Data Collection and Monitoring .......................................................53 
82 
14.1 Case Report Forms and Device Data ................................................................................ 53 
83 
14.2 Study Records Retention................................................................................................... 53 
84 
14.3 Protocol Deviations ........................................................................................................... 53 
85 
Chapter 15 Ethics/Protection of Human Participants .......................................54 
86 
15.1 Ethics Standard ................................................................................................................. 54 
87 
15.2 Institutional Review Boards .............................................................................................. 54 
88 
15.3 Informed Consent Process ................................................................................................ 54 
89 
Chapter 16 References ...........................................................................................56 
90 
 
91 
 
 
92 

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Chapter 1 Background 
93 
 
94 
A major impediment to maintaining blood glucose (BG) control in Type 1 diabetes (T1D) is missed 
95 
meal boluses, which has been associated with significantly higher HbA1c levels.1  While the 
96 
advent of the artificial pancreas (AP) offers promise of safe reductions in HbA1c, our research 
97 
group previously found that current AP systems only partly compensates for missed prandial 
98 
insulin.2 We thus designed a new system called RocketAP to be fully automated, utilizing a Bolus 
99 
Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin 
100 
prior to extreme blood sugar excursions. When used as a fully automated closed loop (FCL) system 
101 
(without any meal announcements to the controller), this system improves time-in-range compared 
102 
to a current commercially available system (Control-IQ). However, we have not previously 
103 
determined whether the BPS provides improved blood sugar control over what the RocketAP 
104 
controller could without the BPS.  Indeed, when the BPS provides a bolus, it reduces the amount 
105 
of insulin the controller can provide in response to high blood sugars—leaving open the possibility 
106 
that the RocketAP controller could provide a similar degree of blood sugar control after 
107 
unannounced meals.  In addition, this system needs to be further tested under challenging 
108 
conditions of exercise and food intake.  This is particularly true for the BPS, given the potential 
109 
that the BPS could detect spurious changes in blood sugar and provide a priming dose of insulin 
110 
in the absence of a meal.   
111 
In the current study, the maximum amount of insulin that the BPS injects (which varies based on 
112 
the system’s calculation of the probability that a meal has been ingested) is 6% of the person’s 
113 
total daily insulin for any individual meal. This system is equipped with a novel hypoglycemia 
114 
anti-rebound system, which constrains insulin infusion after CGM/SMBG readings<70 mg/dL. 
115 
The BPS system is also silenced at night (23:00 – 6:00h). 
116 
In the current study, we are testing this RocketAP system for BG levels using two approaches:  
117 
A randomized cross-over trial where each participant will experience FCL for two 24-hour study 
118 
periods in random order (referred to as FCL1 and FCL2) with: 
119 
• 
The BPS functioning 
120 
• 
The BPS inactivated 
121 
During the washout period between FCL1 and FCL2, we will test the RocketAP system in FCL 
122 
with further challenges, both before and after the change in BPS treatment arm—i.e., not as a 
123 
cross-over assessment but a comparison between participants randomized to start with or without 
124 
BPS.  These challenges will include: 
125 
• 
A session of high-intensity interval training (assessing the safety of the BPS when BG’s 
126 
may spike during bursts of anaerobic activity) 
127 

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• 
A high-carbohydrate, high-fat meal (assessing how the system responds to prolonged 
128 
carbohydrate absorption) 
129 
• 
Ingestion of a bolus of simple sugar (assessing the safety of the BPS when the user’s 
130 
blood sugar spikes from a relatively low amount of carbohydrate)    
131 
Participants will be admitted to a hotel and started on the RocketAP for the purpose of comparing 
132 
FCL use with and without BPS as described above, all implemented on the DiAs platform (MAF 
133 
2109).  As an assessment of the efficacy of the system in maintaining BG control, participants will 
134 
be followed for approximately 24 hours in the randomized phase (FCL1 vs. FCL2) and during the 
135 
24-hour cross-over phase. Our primary outcome will be one of efficacy in assessing BG control 
136 
(TIR 70-180 mg/dL) between the two 24-hour FCL1/FCL2 periods.  
137 
We hypothesize that performances of RocketAP without BPS in FCL will provide similar glycemic 
138 
control as FCL with BPS.  We expect that this will constitute an important step toward having a 
139 
fully automated AP system because it may remove the need for a BPS system that itself could 
140 
increase risk of episodes of hypoglycemia.  
141 
 
142 
The purpose of this study is to test the performance of the RocketAP in FCL both with and without 
143 
the BPS, assessing efficacy and safety. We will target completion of up to 20 adults in a 
144 
randomized cross-over trial, comparing blood glucose time in range 70-180 mg/dL for two 24-
145 
hour periods and assessing TIR during an additional challenge period, which will be compared 
146 
between those who started on BPS vs. those who did not.    
147 
 
148 
We will consent up to 30 participants, ages ≥18.0 and ≤65 years, with a goal to have up to 20 
149 
participants complete the trial. The study will be performed overnight at a local hotel/rental house 
150 
(heretofore referred to as “hotel”). Enrollment in the Pilot Study will proceed with the goal of 
151 
completing a minimum of 2-3 participants. This admission will be about 24 hours at a hotel/rented 
152 
house. Enrollment in the Main Study will proceed with the goal of completing 20 participants.   
153 
1.3.1 Study Hardware/Software 
154 
The study itself will involve use of the DiAs prototyping platform (MAF 2109), connected to a 
155 
Tandem t:AP research pump and a Dexcom G6 sensor, and implementing RocketAP with and 
156 
without BPS.  Upon arrival at the hotel, participants will be instructed in how to use the Tandem 
157 
research pump as well as the UVa AP system, including stopping the system.  
158 
1.3.2 Timing of UVa Artificial Pancreas Use 
159 
The participants will arrive to hotel the evening before starting the experimental system to allow 
160 
for a settling of blood glucose in an unfamiliar environment. The next morning, participants will 
161 
be connected to a Tandem research pump connected to the UVa DiAs platform and their Dexcom 
162 

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G6 Transmitter will be linked with DiAs. Participants will then be taught how to use DiAs in this 
163 
configuration. The research pump will be programmed with the individual’s usual insulin 
164 
parameters. Once started, the participants will have their blood sugar managed through this system 
165 
during the entirety of the time at hotel. 
166 
1.3.3 Study Controller Sessions 
167 
Order and timing of controller sessions: During the hotel stay, participants will have two separate 
168 
24-hour periods during which they will receive FCL control with and without the BPS active.  
169 
These will be separated by a 24-hour challenge period which will involve further challenges.  The 
170 
timing and potential order of these sessions is shown in Figure 1. 
171 
 
172 
Figure 1:  Timeline and randomized order of the Study Controller Sessions 
173 
During these 24-hour periods participants will be followed for the experimental meals as part of 
174 
the Study Controller Sessions to compare blood glucose control with and without the BPS (Figure 
175 
1). The study meals and activities will be standardized between study sessions (see Figure 2).  
176 

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177 
Figure 2:  Timeline of Study Controller Sessions and Study Meals and activities.  There will be two identical 24-
178 
hour periods (FCL1 in green and FCL2 in orange), separated by a 24-hour challenge period (FCL1 in green-hatched) 
179 
that will first involve the BPS activation assignment the participant was randomized to (the treatment approach used 
180 
in FCL1) and then involve the alternate assignment (the treatment approach to be used in FCL2), with the system 
181 
switch at the end of the challenge day. Arrows represent meals with Blue Arrows representing meals in which the 
182 
participants are using their personal devices. 
183 
The primary outcome will compare the percent time CGM is between 70 and 180 mg/dL during 
184 
daytime for FCL1 and FCL2 sessions with and without BPS.  During the time between arrival at 
185 
the hotel and being started on the experimental system, participants will use their home diabetes 
186 
management approach, including insulin dosing via normal carbohydrate announcement.  Starting 
187 
the first morning of the study (Day 2 of study), study staff who will be present will include nursing 
188 
staff and technical staff; a study physician will be available either on-site or nearby off-site at all 
189 
times. Hyperglycemia and hypoglycemia treatment protocols will be followed per guidelines. We 
190 
anticipate more significant cases of hyperglycemia during meals on the study system because of 
191 
the lack of carbohydrate announcement; participants will be encouraged to drink large amounts of 
192 
non-caloric beverages, particularly after these meals. UVa CDT study staff will monitor CGM 
193 
output continuously and manage glucose control issues.  At the end of the hotel stay, the participant 
194 
will return to their home insulin management.  
195 
 
196 
Before discharge from the hotel, all study devices will be turned in to study staff for device 
197 
download, and the participants will return to their usual diabetes management. 
198 
 
199 
If the CGM signal becomes unavailable for more than 20 minutes consecutively, closed loop will 
200 
not operate to automatically adjust insulin.  If the CGM is not connected, the system will revert to 
201 
usual function of the pump and deliver insulin with the insulin dosing parameters programmed in 
202 

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the system for that individual. Resumption of closed-loop control will occur automatically once 
203 
CGM signal is available again. 
204 
If the study system is unable to maintain pump connectivity, the pump will automatically revert to 
205 
pre-programmed basal insulin delivery after 30 minutes without any need for instruction from the 
206 
user. 
 
207 

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Chapter 2 Study Devices 
208 
 
209 
The study systems will utilize the Tandem t:AP research pump connected to the UVa DiAs system 
210 
run on a dedicated external smart phone, running the RocketAP control algorithm with either the 
211 
BPS system active or not, with the order of these sessions determined randomly. 
212 
 
213 
The study CGM will include Dexcom G6 transmitter and sensors. The CGM sensor is viable for 
214 
10 days. 
215 
 
216 
Blood glucose levels will be measured during the hotel admission with the use of a study 
217 
glucometer. The CGM device will be calibrated, if needed, using the study glucometer and strips 
218 
in accordance with the manufacturer’s labelling.  
219 
 
220 
Blood ketone levels will be measured during the hotel admission with the use of the Abbott 
221 
Precision Xtra meters and strips in accordance with the manufacturer’s labelling. The blood 
222 
glucose meter component of the Precision Xtra Device will not be used.   
223 
 
224 
Device serial numbers will be recorded, and use of equipment will be tracked. 
 
225 

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Chapter 3 Study Screening  
226 
 
227 
The study will be performed at the University of Virginia, with screening procedures taking place 
228 
either virtually, at the Clinical Research Unit, or at local hotel. 
229 
 
230 
Pilot Study:  Enrollment goal in the Pilot Study will be to complete  a minimum of 2-3 participants. 
231 
Up to 6 participants may sign consent forms.  
232 
Main Study:  Enrollment in the study will proceed with the goal of completing up to 20 
233 
participants.  Participants will initially be randomized for the order of using FCL with or without 
234 
BPS.  Up to 30 participants may sign the consent form. 
235 
 
236 
Before consent has been obtained, participants will be asked inclusion/exclusion criteria questions 
237 
during pre-screening to determine study eligibility. Before completing any procedures or 
238 
collecting any data that are not part of usual care, written informed consent, when applicable) will 
239 
be obtained. Potential eligibility may be assessed as part of a routine-care examination.   
240 
A participant is considered enrolled when the informed consent form has been signed by the 
241 
participant and the study team. 
242 
Consenting procedures and documentation is defined in section 15.3.  
243 
 
244 
After informed consent has been signed, a potential participant will be evaluated for study 
245 
eligibility through the elicitation of a medical history, performance of a physical examination 
246 
by licensed personnel, an ECG, and pregnancy testing (if applicable) to screen for exclusionary 
247 
medical conditions.   
248 
A physical exam documented in the prior 9 months can suffice for the physical exam but will not 
249 
serve as an exclusionary criterion if not available. Participants may self-report height,  weight, 
250 
blood pressure, temperature, and heart rate . Individuals who do not initially meet study eligibility 
251 
requirements may be rescreened at a later date per investigator discretion. 
252 
 
253 
The participants must meet all of the following inclusion criteria in order to be eligible to 
254 
participate in the study. 
255 
1. Age ≥18.0 and ≤65 years old at time of consent 
256 
2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year  
257 

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3. Currently using insulin for at least six months 
258 
4. Currently using insulin pump for at least three months  
259 
5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on 
260 
their pump in order to dose insulin for meals or corrections  
261 
6. Current regular exercise (e.g. walk, bike, jog) and be able to participate in a high intensity 
262 
interval training activity. 
263 
7. Access to internet and willingness to upload data during the study as needed  
264 
8. For females, not currently known to be pregnant or breastfeeding 
265 
9. If female and sexually active, must agree to use a form of contraception to prevent pregnancy 
266 
while a participant in the study.  A negative serum or urine pregnancy test will be required for 
267 
all females of childbearing potential. Participants who become pregnant will be discontinued 
268 
from the study. Also, participants who during the study develop and express the intention to 
269 
become pregnant within the timespan of the study will be discontinued. 
270 
10. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the 
271 
study CGM is in use 
272 
11. Willingness to use the UVa closed-loop system throughout study admission 
273 
12. Willingness to use personal lispro (Humalog) or aspart (Novolog) during the study admission.  
274 
13. Willingness not to start any new non-insulin glucose-lowering agent during the course of the 
275 
trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 
276 
inhibitors, sulfonylureas and naturaceuticals) 
277 
14. Willingness to eat at least 1 g/kg of carbohydrate per day during the hotel admission 
278 
15. Willingness to reschedule if placed on oral steroids 
279 
16. An understanding and willingness to follow the protocol and signed informed consent  
280 
17. Willingness to follow COVID-19 protocols in place at the time of study.  
281 
 
282 
The participant must not have any exclusion criteria in order to be eligible to participate in the 
283 
study.  
284 
1. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment 
285 
2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to 
286 
enrollment 
287 
3. Pregnancy or intent to become pregnant during the trial 
288 
4. Currently being treated for a seizure disorder 
289 
5. Planned surgery during study duration. 
290 
6. Treatment with meglitinides/sulfonylureas at the time of hotel study. 
291 

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7. Use of metformin/biguanides, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 
292 
inhibitors, or naturaceuticals with a change in dose in the past month.  
293 
8. Coronary artery disease or heart failure, unless written clearance is received from a   
294 
cardiologist or personal health care provider allowing clearance for high-intensity interval 
295 
training and documentation of a negative stress test within the year 
296 
9. History of cardiac arrhythmia (except for benign premature atrial contractions and benign 
297 
premature ventricular contractions which are permitted or previous ablation of arrhythmia 
298 
without recurrence which may be permitted) 
299 
10. Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the 
300 
study medical physician. 
301 
11. A known medical condition that in the judgment of the investigator might interfere with the 
302 
completion of the protocol such as the following examples: 
303 
a. Inpatient psychiatric treatment in the past 6 months  
304 
b. Presence of a known adrenal disorder 
305 
c. Abnormal liver function test results (Transaminase >2 times the upper limit of 
306 
normal); testing required for subjects taking medications known to affect liver 
307 
function or with diseases known to affect liver function 
308 
d. Uncontrolled thyroid disease 
309 
e. Musculoskeletal or other condition that limits participation in exercise portion of 
310 
study 
311 
12. A known medical condition that in the judgment of the investigator might interfere with the 
312 
completion of the protocol. 
313 
13. Positive Covid-19 test result  
314 
 
315 
The participant will be evaluated for study inclusion and exclusion eligibility after the informed 
316 
consent form has been signed by the participant and the study team.  
317 
Individuals who do not initially meet study eligibility requirements may be rescreened at a later 
318 
date per investigator discretion. 
319 
Screening procedures will last approximately 1-2 hours. The visit may occur in-person or by 
320 
telecommunication. The following procedures may be performed/data collected/eligibility criteria 
321 
checked and documented:  
322 
1. Inclusion and Exclusion criteria assessed 
323 
2. Demographics, including: 
324 
a. Date of birth 
325 
b. Gender  
326 
c. Race 
327 
d. Ethnicity 
328 
3. Medical History, including diabetes history  
329 

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a. Duration of disease (number of years) 
330 
b. Current insulin pump model 
331 
c. History of CGM use 
332 
d. Current treatment 
333 
e. Severe hypoglycemia history 
334 
f. Severe hyperglycemia history 
335 
g. History of seizures  
336 
h. Loss of consciousness 
337 
4. Basal rates 
338 
5. Carbohydrate ratios 
339 
6. Insulin sensitivity factors 
340 
7. Target glucose 
341 
8. Average daily insulin 
342 
9. Surgical history 
343 
10. Allergies 
344 
11. Concomitant medications 
345 
12. Electrocardiogram (ECG)  
346 
13. Physical Examination – Aa historical history and physical report within 9 months of 
347 
screening appointments may be used but is not required for eligibility. If vitals are not 
348 
available, may include self-reported values.  
349 
a. Weight (may be self-reported) 
350 
b. Height (may be self-reported) 
351 
c. Blood pressure 
352 
d. Temperature 
353 
e. Heart Rate 
354 
14. Screening Labs 
355 
a. Hemoglobin A1c point of care  
356 
b. Urine or serum pregnancy test for all women of childbearing potential (this test can 
357 
be done remotely with results sent to the study team) 
358 
If needed based on medical history, investigators may include baseline chemistry panel, liver 
359 
function tests, hematocrit, and thyroid stimulating hormone (lab results within one year of 
360 
screening appointment may be used). 
361 
Up to 6 months of historical data from the participant’s personal insulin pump, glucometer, or 
362 
continuous glucose monitor may be downloaded or recorded. Data will be obtained from the 
363 
participant’s personal insulin pump and CGM. This data may be obtained through the commercial 
364 
applications (e.g. t:connect and Dexcom G6).  
365 
If participants are on-site, the participant’s glucometer may be uploaded to ensure that the 
366 
participant can successfully upload the equipment.  
367 
Any labs required may be obtained at a local laboratory (e.g. LabCorp) convenient to the 
368 
participant. 
369 

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This study is not meant to find out if the participant has any other disease or problem. The study 
370 
leaders will alert the participant if any of the research results are important to his/her health during 
371 
the study. The participant may have a copy of the screening tests to discuss with the personal 
372 
physician. When the blood tests are completed, any blood left over will be thrown away. It will 
373 
not be stored for any future testing. 
374 
For potential subjects who live out of state and or a significant distance from UVA to facilitate the 
375 
consent process, e-consent will be used. Note: For potential participants who are not able to use 
376 
DocuSign, email, fax, or mail will be an option for receipt of the signed consent. The consenting 
377 
process will involve discussing the study at length in a phone call/HIPAA compliant 
378 
telecommunication method with the interested potential participant. The potential participant will 
379 
be asked permission to review inclusion/exclusion criteria to assess if they are eligible to 
380 
participate in the study.  If permission is granted, the study team will review the pre-screening 
381 
questionnaire which contains the inclusion/exclusion criteria.  If eligible, the study team member 
382 
will provide a copy of the informed consent form (i.e. in person, email, or mail) to the potential 
383 
participant for their review. Potential participants may also elect to choose to review the informed 
384 
consent form prior to discussing pre-screening questions.  
385 
The potential participant will be given an opportunity to ask the study team questions or may speak 
386 
directly with the study physician. After ample time to make an informed decision, the potential 
387 
participant may sign the consent form at home and provide it to the study team (e.g. in person, 
388 
electronically, email, fax, or mail).  The potential participant’s understanding of the information, 
389 
presented in the process of consent will be assessed by asking open-ended questions, may occur 
390 
during the phone call or at the screening appointment. Once consent is obtained, study procedures 
391 
may begin (e.g. LabCorp).  
392 
The study physician or physician designee will have the discretion to repeat screening tests. The 
393 
repeat screening tests may be conducted locally (e.g. LabCorp). The participant may request a 
394 
copy of any of the results from the screening evaluation to review with their primary care provider.  
395 
If an exclusionary condition is identified, the study participant will be excluded from participation 
396 
with follow up and referral to their primary care physician as needed.  
397 
If the study participant is pregnant, the study physician will discuss the results of the blood test 
398 
with the participant and the participant will be asked to seek confirmation of the test and the 
399 
appropriate medical care.  
400 
Participants may be re-screened at a later date if their clinical situation changes as determined by 
401 
the study physician. 
402 
 
403 
Research in diabetes technology has revealed significant disparities in minoritized population’s 
404 
representation in clinical trials and access to devices that improve diabetes outcomes.  Collection 
405 

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of detailed demographic data regarding participants in technology trials has become essential.  This 
406 
includes data on race/ethnicity, income levels and insurance status, as well as education and other 
407 
variables that describe the study population.  
408 
The Demographic Data Survey will be electronically administered once eligibility has been met.  
409 
a. Gender 
410 
b. Race 
411 
c. Ethnicity 
412 
d. Marital status  
413 
e. Level of education 
414 
f. Employment status  
415 
g. Household income 
416 
h. Health insurance status 
417 
i. Monthly insulin costs  
 
418 

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Chapter 4 Randomization  
419 
Participants will receive the two different experimental conditions (FCL with and without BPS) in 
420 
random order as described below. 
421 
 
422 
Pilot participants will not be randomized and will use the RocketAP system with and without BPS. 
423 
 
424 
Once eligibility is met and screening procedures are completed, the participant may continue to 
425 
randomization. Screening failures and study dropout participants may be replaced. Randomization 
426 
will occur via permuted blocks of 4.   
 
427 

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Chapter 5 Visit 2: Study Equipment Training 
428 
Equipment training may begin at the hotel after UVa AP system has been put in place.  The purpose 
429 
of this training is to introduce the study insulin pump and study CGM to the participant.  
430 
The participant’s insulin parameters will be programmed into their study insulin pump and 
431 
confirmed by two research staff. Subjects will then switch to the study insulin pump. The 
432 
participant’s personal pump and infusion site will be removed. 
433 
The participant will have the insulin pump and sensor on them at all times.  
434 
 
435 
A study CGM will be provided to all participants at the training session. The participants will be 
436 
provided with CGM equipment and instructed to use the study CGM on a daily basis. If the 
437 
participant has prior use of the CGM, re-training will be specific to the individual. The study team 
438 
may elect to have less frequent CGM users watch the Dexcom online training videos 
439 
(https://www.dexcom.com/training-videos) to assist in the training session.  Study staff training 
440 
may include review of study CGM in real-time to make management decisions and how to review 
441 
the data after an upload for retrospective review. Study staff will specifically identify how alarms 
442 
are set using the app and the frequency that these alarms will repeat. 
443 
The participants personal CGM will be discontinued. The participants will be observed placing the 
444 
sensor and will learn/review how to access the CGM trace via the DiAs phone or the Tandem 
445 
research pump, as needed. The participants will be asked to perform fingerstick blood glucose 
446 
measurements (if needed) in accordance with the labelling of the study CGM device.  
447 
An electronic copy of the CGM user’s guide will be provided for the participants to read. The 
448 
study team will be sure that the participants will leave the training session knowing how to properly 
449 
use the CGM. The study team will be available for any questions. 
450 
Participants will have the option of using their personal smartphone or receive a study smartphone 
451 
to use in order to collect the data from the devices. If the participant elects to use a personal device, 
452 
the Dexcom app will be downloaded to their phone in order to monitor the participant’s CGM 
453 
values and alerts in real-time may be used. 
454 
 
455 
All participants may be asked to wear an activity tracker (e.g. Fitbit) during the entire study (home 
456 
and hotel admissions) to record information about movement and heart rate though not an endpoint 
457 
in this study. 
458 

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459 
The study team will be responsible for monitoring and managing the study insulin pump during 
460 
the hotel admissions. The participants may be provided a quick overview on its functionality to 
461 
understand the equipment. 
462 
5.3.1 Study Insulin Pump Topics  
463 
The study team will assist the participant in study pump infusion site initiation and will start the 
464 
participant on the study pump. The study pump will be programmed with the participant’s usual 
465 
basal rates and pump parameters. The participant’s personal pump will be removed. The 
466 
investigator may elect to use an existing personal pump infusion site at their discretion at the start 
467 
of the study. 
468 
The participant will be instructed on charging the pump, navigation through menus, bolus 
469 
procedures including stopping a bolus, etc. 
470 
5.3.2 Other Issues  
471 
The participant will be instructed to notify study staff if they experience any issues with the study 
472 
devices during the hotel admission. Staff will be present in the event that if insulin is delivered by 
473 
any means other than the study pump (e.g. injection of subcutaneous insulin via syringe in the 
474 
event of infusion site failure). If insulin is delivered by any means other than the study pump, the 
475 
study team will be instructed to turn off closed-loop mode for approximately four hours. 
476 
The participant will also be asked to alert the study clinical staff for technical issues with the 
477 
Tandem research pump and/or the DiAs system, including use of the study pump and study CGM 
478 
(open loop mode) during periods of component disconnections or technical difficulties.  
479 
A glucagon emergency kit will be available at the hotel once the investigational system is in place.  
480 
Glycemic Treatment Guidelines will be available for staff use during the study admissions. 
481 
5.3.3 Optimization of Insulin Pump Settings 
482 
Data-driven optimization of pump settings can occur any time prior to the hotel admission, 
483 
particularly if the participant contacts the study physician due to concerns about their pump 
484 
settings due to recurring hypo- or hyperglycemia. No pump settings changes can occur during 
485 
closed loop testing. 
 
486 

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Chapter 6  Pilot Study  
487 
In order to optimize the flow of the study visits during the Main Study, we will perform a Pilot 
488 
Study at a local hotel or rental house. The duration of the pilot admission will be approximately 
489 
24 hours with the intent of testing the logistics of our study procedures.  The goal will be to 
490 
complete 2-3 participants. Pilot study participants are eligible to enroll in the Main Study.  
491 
Participants and staff will adhere to the Covid-19 Mitigation Plan as outlined in Section 10.3   
492 
 
493 
For the pilot study, there will be at least two study staff present at all times at the study site, at least 
494 
one of whom will be clinical staff (e.g. nurse, physician, nurse practitioner, physician assistant). 
495 
There will be a physician available either on-site or off-site within an approximate 20-minute drive 
496 
at all times.  In addition, one of the study medical physicians and one senior engineer will be on 
497 
call during the entire admission. Glucagon for the emergency treatment of hypoglycemia will be 
498 
available on-site. 
499 
 
500 
Pilot participants will be contacted by the study team approximately 24-48 hours prior to the hotel 
501 
admission to verify the following information: 
502 
• Inquire about any changes to the participant’s medical history  
503 
• Study equipment (e.g. CGM and activity tracker) initiation has occurred 
504 
• Determine pump profile(s) the participant uses on certain days 
505 
• New CGM sensor has been placed approximately 24-72 hours prior to admission for proper 
506 
warm-up 
507 
• Verify with the participant that the goal CGM reading on  day 2 is less than 200 mg/dL; 
508 
this may require contact with the study physician prior today 2 of the hotel study.  
509 
• Should any concerns regarding medical history, pump information, or unforeseen issues 
510 
arise, the admission will be cancelled for that participant at the discretion of the investigator 
511 
 
512 
For the pilot study, one to three  participants will be assessed at a time.  The participant will arrive 
513 
at the hotel on the first day of the admission.  The study team will perform vital signs and inquire 
514 
about any changes to the participant’s medical history.  Any changes to medical history will be 
515 
communicated to the medical physician to ensure continued eligibility and participation.   
516 
A urine pregnancy test will be collected if relevant. The test must be negative for the participant 
517 
to continue with the study.  
518 
The subject’s CGM reading, and ketone concentration will be recorded. In the event that the 
519 
participant’s CGM reading is not between 80-250 mg/dL or ketone concentration is ≥0.6 mmol/L 
520 
prior to initiation of the UVa AP system, the study physician may recommend additional insulin 
521 

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dosing according to the participants’ usual doses. Study physician may elect to cancel participant’s 
522 
participation in the hotel admission if concerned about their medical safety.  This participant will 
523 
not be replaced.  
524 
The participant’s home insulin pump will be discontinued, and the study Tandem research insulin 
525 
pump will be initiated using the RocketAP system with BPS activated.  The study team will ensure 
526 
the proper function of the CGM, insulin pump, and activity tracker. The goal will be to initiate 
527 
Closed-Loop Control by approximately lunch time, running the RocketAP system on the DiAs 
528 
platform.  
529 
The CGM used in the study is FDA-approved for the non-adjunctive measurement of blood 
530 
glucose (i.e. the CGM reading can be used for insulin dosing decisions). The CGM readings will 
531 
be the primary source of blood glucose values.  There are no protocol fingerstick blood glucose 
532 
measurements other than at times of CGM calibration (if necessary) and if directed by the study 
533 
team. Fingerstick blood glucose measurements may be taken whenever participants experience 
534 
symptoms, if the CGM glucose is suspected to be erroneous, or any time the participant would like 
535 
to be reassured. 
536 
 
537 
Participants will eat a structured dinner at approximately 6-7 pm during the admission. The 
538 
participant will not announce carbohydrate ingestion, allowing testing of the RocketAP controller 
539 
with BPS following dinner. Breakfast in the morning will be with the BPS system engaged. 
540 
Throughout the Pilot study, the participant will remain in closed loop mode.  
541 
 
542 
In the afternoon after admission, participants will participate in a supervised bout of high-intensity 
543 
interval training (see details in Section 7.8). During this time, the system will have BPS activated. 
544 
Apart from the programmed exercise portions, participants will be free to engage in low-intensity 
545 
activity (i.e. walking) during the admission. Participants will enjoy quiet activities in the evening. 
546 
 
547 
Discharge will be at approximately noon. Discharge criteria is CGM value 80-300 mg/dL with 
548 
stable trend and ketones <=0.6 mmol/L. If the CGM values are above 300 mg/dL and ketone values 
549 
are >0.6 mmol/L, the study team will check the insulin pump infusion site and correction insulin 
550 
will be administered per study physician judgement via the subject’s insulin pump.   A qualified 
551 
clinical study team member (e.g. MD, NP, PA, CDE) will assess and discuss the transition back to 
552 
usual care with the study participant.    
553 
Participants will be asked to continue monitoring ketone levels for 24-48 hours after the hotel 
554 
admission if ketones were >0.6 mmol/L at time of discharge. Urine ketone supplies may be 
555 
provided for this testing.  
556 

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557 
Approximately 24-48 hours after the hotel admission, the study team will contact the participant 
558 
via phone/email/text/text to assess adverse events, adverse device effects, and device issues. 
559 

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Chapter 7  Main Study  
560 
 
561 
Main Study participants will participate in hotel admission. Each admission will be up to 
562 
approximately 96 hours in duration.  
563 
Participants and staff will adhere to the Covid-19 Mitigation Plan as outlined in Section 10.3.   
564 
 
565 
There will be at least two study staff present at all times at the study site, at least one of whom will 
566 
be clinical staff (e.g. nurse, physician, nurse practitioner, physician assistant). There will be a 
567 
physician at the hotel or nearby on call during the study at all times.  In addition, at least one senior 
568 
engineer will be on call during the entire admission. Participants will be remotely monitored by at 
569 
least one study team member using a web-based remote monitoring system that has been 
570 
previously established for DiAs.  The web-based remote monitoring system will display real-time 
571 
insulin delivery, CGM and other system information to allow for patient safety monitoring.    In 
572 
addition, study team members will be trained in all protocol and glycemic treatment guideline 
573 
procedures. The closed-loop system will be managed by the participant with study-staff 
574 
supervision, particularly at the time of insulin boluses.  Glucagon for the emergency treatment of 
575 
hypoglycemia will be available on-site. 
576 
 
577 
Participants will be contacted by the study team approximately 24-48 hours prior to each hotel 
578 
admission if most recent contact with the study participant exceeds 10 days. The study team will 
579 
verify the following information: 
580 
• Inquire about any changes to the participant’s medical history 
581 
• Study equipment (e.g. CGM and activity tracker) initiation has occurred 
582 
• Determine pump profile(s) the participant uses on certain days 
583 
• New CGM sensor has been placed approximately 24-72 hours prior to admission for proper 
584 
warm-up 
585 
• Verify with the subject that the goal CGM reading at time of arrival is less than 200 mg/dL; 
586 
this may require contact with the study physician prior to arrival on the day of the study 
587 
visit  
588 
• Should any concerns regarding medical history, pump information, or unforeseen issues 
589 
arise, the admission will be cancelled for that participant at the discretion of the investigator 
590 
 
591 
Participants will arrive at the hotel on the first day of the admission.  As described in section 10.3, 
592 
all participants will receive a test for COVID-19 after arriving for the study.  The study team will 
593 
perform vital signs and inquire about any changes to the participant’s medical history.  Any 
594 

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changes to medical history will be communicated to the medical physician to ensure continued 
595 
eligibility and participation.   
596 
A urine pregnancy test will be collected for female participants of childbearing age. The test must 
597 
be negative for the participant to continue with the study.  
598 
The subject’s CGM reading, and ketone concentration will be recorded. In the event that the 
599 
participant’s CGM reading is not between 80-250 mg/dL or ketone concentration is ≥0.6 mmol/L 
600 
prior to initiation of the UVa artificial pancreas system, the study physician may recommend 
601 
additional insulin dosing according to the participants’ usual doses. Study physician may elect to 
602 
cancel participant’s participation in the hotel admission if concerned about their medical safety.  
603 
This participant will not be replaced.  
604 
The participant’s home insulin pump will be discontinued, and the study insulin pump will be 
605 
initiated.  The study team will ensure the proper function of the CGM, insulin pump, and activity 
606 
tracker.  
607 
The CGM used in the study is FDA-approved for the non-adjunctive measurement of blood 
608 
glucose (i.e. the CGM reading can be used for insulin dosing decisions). The CGM readings will 
609 
be the primary source of blood glucose values.  There are no protocol fingerstick blood glucose 
610 
measurements other than at times of CGM calibration (if necessary) and if directed by the study 
611 
team.  Fingerstick blood glucose measurements may be taken whenever participants experience 
612 
symptoms, if the CGM glucose is suspected to be erroneous, or any time the participant would like 
613 
to be reassured. Glycemic Treatment Guidelines to be used during the hotel admission are defined 
614 
in a separate document.  
615 
 
616 
Participants will be informed beforehand and at the time of the transfer from one BPS state to 
617 
another.  Participants will be told what this transition means with respect to insulin dosing.  The 
618 
transfer from one treatment to another will proceed as follows: 
619 
• The system is stopped 
620 
• DiAs is plugged into a laptop and ‘parameters.xml’ file (with the corresponding BPS 
621 
condition) will be replaced 
622 
• DiAs is restarted 
623 
• CGM is recovered and pump connections is checked 
624 
• DiAs is transitioned to Closed Loop Control mode  
625 
 
626 
Participants will eat structured study meals during the admission, with the same amount of 
627 
carbohydrate, protein and fat for meals (breakfast, lunch, dinner) on the days for FCL1 and FCL2). 
628 
During the 24-hour challenge period, there will be additional meal challenges that will only be 
629 
performed on that day.  This includes a high carbohydrate high fat meal at dinner (such as pizza) 
630 

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and an early breakfast that consists primarily of fast-acting carbs (e.g.. juice).  In all cases the 
631 
carbohydrate content of the meal will not be announced during the study once the AP system has 
632 
been placed.  Snacks with carbohydrates will not be allowed unless for the treatment of low blood 
633 
sugars. Non-carbohydrates snacks may be allowed throughout the protocol per investigator 
634 
discretion, but the intention is not to have non-carbohydrate snacks.  Blood glucose levels will be 
635 
followed via continuous glucose monitor and glucose values will be managed by the AP system 
636 
as usual.  
637 
 
638 
During the study, we will challenge the participants with exercise sessions that will be supervised 
639 
by study staff.  During FCL1 and FCL2, participants will do a mild to moderate walking or similar 
640 
exercise at approximately 4pm on each of those study days. 
641 
During the challenge phase (the 24-hour period between the FCL1 and FCL2), participants will 
642 
undergo supervised session of high-intensity interval training (HIIT). The HIIT workout will 
643 
consist of a 5-minute low intensity warmup period, a workout of about 1 minute of vigorous 
644 
exercise followed by approximately 2 minutes of light intensity exercise or rest. This 3-minute set 
645 
of intervals may be repeated up to 6 times or until volitional exhaustion, followed by approximately 
646 
5 minutes of light intensity cooldown and stretching. The goal of this will be to assess the safety 
647 
of the AP system in HIIT, given that HIIT has been observed to result in an increase in BG levels, 
648 
which could theoretically lead to activation of the BPS—dosing insulin.  The AP system will be 
649 
monitored for BPS activation during this workout.  If the BPS is activated, participants will 
650 
continue to be monitored for BG excursions, including receiving treatment for hypoglycemia if 
651 
this occurs (as described in the Glycemic Treatment Guidelines).   
652 
Exercise challenges will be terminated early with subjective symptoms such as shortness of breath, 
653 
chest pain, dizziness, palpitations, or any such concerning symptoms reported by participants. 
654 
Participants will stop their participation in the exercise portion of the study if reporting any 
655 
concerning symptoms. Study physicians (or physician’s assistants) will assess the participants for 
656 
their need for additional care outside the study. If symptoms resolve entirely and there is no 
657 
additional requirement for care outside the study, participants will stop participation in the exercise 
658 
portion of the study and will not repeat that portion of the study. Participants however may then 
659 
continue with the remainder of the study per investigator discretion.  
660 
Participants will also be free to engage in low-intensity activity (i.e. walking) during the hotel 
661 
admission but will be asked to have this match between 24-hour study periods as best as possible. 
662 
Participants may leave the hotel to be outside, provided they are accompanied by a study staff 
663 
member and follow COVID precautions in place at the time of study, as described in Section .3. 
664 
Participants will enjoy quiet activities in the evening. 
665 

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666 
Discharge will be at approximately 1 pm. Discharge criteria is CGM value 80-300 mg/dL with 
667 
stable trend and ketones <=0.6 mmol/L. If the CGM values are above 300 mg/dL and ketone values 
668 
are >0.6 mmol/L, the study team will check the insulin pump infusion site and correction insulin 
669 
will be administered per study physician judgement via the subject’s insulin pump. A qualified 
670 
clinical study team member (e.g. MD, NP, PA, CDE) will assess and discuss the transition back to 
671 
usual care with the study participant.    
672 
Participants will be asked to continue monitoring ketone levels for 24-48 hours after the hotel 
673 
admission if ketones were >0.6 mmol/L prior to discharge. Urine ketone supplies may be provided 
674 
for this testing.  
675 
All study equipment will be returned at the time of study end. Per investigator discretion, a 
676 
participant may wear home the study CGM device in use and will be requested to return the study 
677 
transmitter. 
678 
 
679 
Approximately 24-48 hours after the hotel admission, the study team will contact the participant 
680 
via phone/email/text to assess adverse events, adverse device effects, and device issues.  
681 
 
682 
At the conclusion of the Main Study, the medical monitor will review the data as referenced in 
683 
section 8.3.   
 
684 

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Chapter 8  Medical Monitor Review  
685 
 
686 
The Medical Monitor will be provided all adverse event data for review to assess safety.  The 
687 
Medical Monitor will review data related to individual stopping criteria as detailed in the study 
688 
protocol.   
689 
 
690 
A Medical Monitor will review compiled safety data at the conclusion of the trial. In addition, the 
691 
Medical Monitor will review all DKA and severe hypoglycemia irrespective of relatedness to study 
692 
device use, and all serious events (including UADEs) related to study device use at the time of 
693 
occurrence. The Medical Monitor also will be informed of any ADEs not meeting criteria for a 
694 
UADE if the Study PI requests the Medical Monitor review.  The Medical Monitor can request 
695 
modifications to the study protocol or suspension or stoppage of the study if deemed necessary 
696 
based on the totality of safety data available. 
 
697 

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Chapter 9  Testing Procedures 
698 
 
699 
9.1.1 HbA1c  
700 
A blood sample will be obtained at screening to obtain a baseline hemoglobin A1c level. A blood 
701 
test obtained within 2 weeks prior to enrollment may be used. 
702 
HbA1c level may be measured by study team using the DCA2000, a comparable point of care 
703 
device, at time of screening  
704 
Labs may be obtained at a local laboratory (e.g. LabCorp) convenient to the participant. 
705 
9.1.2 Pregnancy Test 
706 
A serum or urine pregnancy test will be required for women of childbearing potential at in person 
707 
visit and admission.  Test must be negative to participate in the study.  
708 
9.1.3  Covid-19 Testing 
709 
All participants and study staff (e.g. on-site research coordinators, technicians, nurses, and 
710 
physicians) will be tested with a COVID-19 test within the first 24 hours of the hotel admission or 
711 
up to 72 hours in advance of being on-site for the Pilot and Main Study.  Individuals with Covid-
712 
19 positive tests will be excluded from the study.   
713 
9.1.4 Demographic Data Survey 
714 
The Demographic Data Survey will be asked after study eligibility has been met.  
 
715 

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Chapter 10 Risks Associated with Clinical Trial 
716 
 
717 
Risks and Benefits are detailed below. Loss of confidentiality is a potential risk; however, data are 
718 
handled to minimize this risk. Hypoglycemia, hyperglycemia and ketone formation are always a 
719 
risk in participants with type 1 diabetes and participants will be monitored for these symptoms.  
720 
10.1.1 Venipuncture Risks 
721 
A hollow needle/plastic tube may be placed in the arm for taking blood samples (e.g. external 
722 
HbA1c measurements for inclusion criteria). Blood draws can cause some common reactions like 
723 
pain, bruising, or redness at the sampling site.  Less common reactions include bleeding from the 
724 
sampling site, formation of a small blood clot or swelling of the vein and surrounding tissues, and 
725 
fainting. 
726 
10.1.2 Fingerstick Risks 
727 
About 1 drop of blood will be removed by fingerstick for measuring blood sugars and sometimes 
728 
HbA1c or other tests. This is a standard method used to obtain blood for routine hospital laboratory 
729 
tests.  Pain is common at the time of lancing.  In about 1 in 10 cases, a small amount of bleeding 
730 
under the skin will produce a bruise. A small scar may persist for several weeks. The risk of local 
731 
infection is less than 1 in 1000. This should not be a significant contributor to risks in this study 
732 
as finger sticks are part of the usual care for people with diabetes. 
733 
10.1.3 Subcutaneous Catheter Risks (CGM) 
734 
Participants using the CGM will be at low risk for developing a local skin infection at the site of 
735 
the sensor needle placement. If a catheter is left under the skin for more than 24 hours it is possible 
736 
to get an infection where it goes into the skin, with swelling, redness and pain.  There may be 
737 
bleeding where the catheter is put in and bleeding under the skin causes a bruise (1 in 10 risk). 
738 
Study staff should verbally alert the participant that on rare occasions, the CGM may break and 
739 
leave a small portion of the sensor under the skin that may cause redness, swelling, or pain at the 
740 
insertion site. The participant should be further instructed to notify the study coordinator 
741 
immediately if this occurs. 
742 
10.1.4 Risks of Hypoglycemia  
743 
As with any person having type 1 diabetes and using insulin, there is always a risk of having a low 
744 
blood sugar (hypoglycemia). The frequency of hypoglycemia should be no more and possibly less 
745 
than it would be as part of daily living. Symptoms of hypoglycemia can include sweating, 
746 
jitteriness, and not feeling well.  Just as at home, there is the possibility of fainting or seizures 
747 
(convulsions) and that for a few days the participant may not be as aware of symptoms of 
748 

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hypoglycemia.  A CGM functioning poorly and significantly over-reading glucose values could 
749 
lead to inappropriate insulin delivery. 
750 
10.1.5 Risks of Hyperglycemia  
751 
Hyperglycemia is likely because of the study design including unannounced carbohydrate 
752 
ingestion.  Also, hyperglycemia and ketonemia could occur if insulin delivery is attenuated or 
753 
suspended for an extended period or if the pump or infusion set is not working properly.  A CGM 
754 
functioning poorly and significantly under-reading glucose values could lead to inappropriate 
755 
suspension of insulin delivery. 
756 
10.1.6 Risks of Device Reuse  
757 
Participant will be informed that FDA or relevant national authorities have approved the insulin 
758 
pump, CGM, glucometer and ketone meter for single use and that by using them among multiple 
759 
patients, bloodborne pathogens (i.e. Hepatitis B) may be spread through the use of multiple users. 
760 
The study CGM system is labelled for single use only. The sensor (the component of the system 
761 
that enters the skin) will be single use only. The transmitter and receiver may be reused during the 
762 
study after cleaning the device using a hospital-approved cleaning procedure. The transmitter is 
763 
attached to the sensor but does not enter the skin and the receiver, if used, is a handheld device.  
764 
The study insulin pumps are labelled for single-patient use. During the study, this device may be 
765 
reused after cleaning adhering to a hospital-approved cleaning procedure. All infusion set 
766 
equipment will be single patient use only (infusion set insertion kits, tubing, cartridges etc.).   
767 
The study blood glucose meter and blood ketone meter are labelled for single-patient use. 
768 
During the study, these devices may be reused after cleaning adhering to a hospital-approved 
769 
cleaning procedure.   
770 
10.1.7 Device Cleaning Instructions 
771 
CGM cleaning instructions are provided in the Dexcom G4 Platinum (Professional) Cleaning and 
772 
Disinfection manual (current edition) and a similar approach will be applied for the G6 version 
773 
used in this study. The transmitter should be cleaned with Clorox Healthcare® Bleach Germicidal 
774 
Cleaner or any disinfectant product in a spray bottle containing a bleach solution of 6500 parts per 
775 
million with the EPA registration number 56392-7.  The transmitter will be submerged in this 
776 
solution and then placed on an absorbent wipe or clean surface.  Two sprays will be dispensed 
777 
from the Clorox cleaner onto each side of the transmitter. A nylon brush will be used to scrub the 
778 
transmitter on all sides for 30 seconds.  The transmitter will be placed in the Clorox Cleaner 
779 
solution for one minute. Transmitter is then rinsed under flowing tap water for ten seconds. The 
780 
transmitter will then be disinfected using a disinfectant product with EPA registration number 
781 
56392-7 using similar procedures as the cleaning process.   
782 

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Per the pump manufacturer, the insulin pump will be cleaned with a damp lint-free cloth. Use of 
783 
household or industrial cleaners, solvents, bleach, scouring pads, chemicals, or sharp instruments 
784 
are prohibited. The pump should never be submerged in water. If needed, use only a very mild 
785 
detergent, such as a bit of liquid soap with warm water. A soft towel will be used to dry the pump.  
786 
The glucometer is cleaned and disinfected with two separate Super Sani-Cloths (EPA number 
787 
9480-4). The entire surface will be cleaned, making sure the surface stays wet for 2 minutes. This 
788 
step is repeated with a clean cloth for disinfecting the device.  
789 
The Precision Xtra User’s Guide suggests that healthcare professionals use 10% bleach, 70% 
790 
alcohol or 10% ammonia to clean the device.  
791 
Equipment that touches intact skin will be cleaned with ethyl or isopropyl alcohol (70-90%), 
792 
quaternary ammonium germicidal detergent (i.e. Cavicide, EPA number 46781) or household 
793 
bleach. The contact time on the surface depends on the method used to clean the equipment. 
794 
Cavicide requires three minutes on the surface of the equipment. Clorox Germicidal Bleach Wipes 
795 
require two minutes on the equipment. The surface should remain wet (i.e. slightly damp) with the 
796 
disinfectant to be considered effective though not wet enough to leave drops of liquid.  
797 
In the event a manufacturer updates cleaning procedures for their device, the study team will 
798 
adhere to the most current recommendations.  
799 
There is the risk of blood sampling collection and contamination from sampling techniques. Hand 
800 
washing with either soap & water or waterless hand sanitizer will be used prior to caring for the 
801 
study subject. Gloves will be worn during blood sample collection and processing. Medical 
802 
personnel will continue to practice hygiene for the subject’s protection (i.e. hand washing, 
803 
changing gloves frequently, disposing needles properly). Gloves will be removed, and hands 
804 
washed or sanitized prior to leaving and upon return to the subject’s room. Soiled linen will be 
805 
changed to minimize the transfer of pathogenic organisms. 
806 
10.1.8 Risk of Exercise 
807 
There is a risk of musculoskeletal symptoms or injury from participating in an exercise regimen. 
808 
There are cardiovascular or cerebrovascular risks (including but not limited to dizziness, 
809 
lightheaded, syncope, arrhythmia or ischemia) associated with participating in an exercise 
810 
regimen. The intention of the eligibility criteria will be to minimize these risks.  
811 
10.1.9 Hb1Ac Risk 
812 
An NGSP Point of Care analyzer (i.e. DCA Vantage Analyzer) will be utilized at the research site 
813 
to obtain the subject’s HbA1c level. 
814 

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10.1.10 Other Risks  
815 
Some participants may develop skin irritation or allergic reactions to the adhesives used to secure 
816 
the CGM, or to secure the insulin infusion sets for the continuous subcutaneous insulin infusion.  
817 
If these reactions occur, different adhesives or “under-taping” (such as with IV 3000, Tegaderm, 
818 
etc.) will be tried, sites will be rotated frequently, and a mild topical steroid cream or other 
819 
medication may be required. 
820 
Whenever the skin is broken there is the possibility of an infection.  The CGM and pump infusion 
821 
sites are inserted under the skin.  It is possible that any part that is inserted under the skin may 
822 
cause an infection.  These occur very infrequently, but, if an infection was to occur, oral and/or 
823 
topical antibiotics can be used.  The risk of skin problems could be greater if you use a sensor for 
824 
longer than it is supposed to be used.  Therefore, participants will be carefully instructed about 
825 
proper use of the sensor. 
826 
Data downloaded from the CGM, pump, glucometer, and ketone meter will be collected for the 
827 
study as measures of diabetes self-management behaviours. Some people may be uncomfortable 
828 
with the researchers' having such detailed information about their daily diabetes habits. 
829 
10.1.11 Known Potential Benefits  
830 
It is expected that this protocol will yield increased knowledge about using an automated closed-
831 
loop system with anticipatory action to control glucose levels. The individual participant may not 
832 
benefit from study participation. 
833 
10.1.12 Risk Assessment 
834 
Based on the facts that (1) adults with diabetes experience mild hypoglycemia and hyperglycemia 
835 
frequently as a consequence of the disease and its management, (2) the study intervention involves 
836 
periodic automated insulin dosing that may increase the likelihood of hypoglycemia, and periodic 
837 
automated attenuation of insulin delivery that may increase the likelihood of hyperglycemia, (3) 
838 
mitigations are in place, and have been tested in prior studies using the investigational device 
839 
system in the home setting, that limit the likelihood of excessive insulin dosing or prolonged 
840 
withdrawal of insulin, and (4) rapid reversal of hypoglycemia and hyperglycemia can be achieved.. 
841 
In addition, it is the belief of the investigators that this study also presents prospect of direct benefit 
842 
to the participants and general benefit to others with diabetes. 
843 
 
844 
The study is being conducted in compliance with the policies described in the study policies 
845 
document, with the ethical principles that have their origin in the Declaration of Helsinki, with the 
846 
protocol described herein, and with the standards of Good Clinical Practice (GCP). 
847 
Whenever possible, data will be directly collected in electronic case report forms, which will be 
848 
considered the source data. 
849 

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The protocol is considered a significant risk device study, due to the fact that the closed-loop 
850 
system is experimental.  Therefore, an investigational device exemption (IDE) from the U.S. Food 
851 
and Drug Administration (FDA) is required to conduct the study. 
852 
 
853 
The study team will follow local guidelines that are in effect at the time of the study admission.  
854 
10.3.1        Participants and Study Personnel 
855 
We will follow a combination of approaches to increase our likelihood of having a COVID-free 
856 
environment:    
857 
• We will follow CDC and local guidelines in effect at the time of the study. 
858 
• All participants and study staff (research coordinators, technicians, nurses, and physicians) 
859 
will be tested with an FDA authorized COVID-19 test with the first 24 hours of  study 
860 
start or up to approximately 72 hours before their participation in the study hotel.  
861 
Those with positive tests will be excluded from the study.   
862 
• Any participants with positive test will be discharged from the study.  Hotel rooms of these 
863 
participants will be restricted from future use. We will limit any personal interaction 
864 
between study personnel and these individuals.  We will follow local guidelines in effect 
865 
at the time of study to guide interactions.   
866 
10.3.2  Environment 
867 
The study team will adhere to current hotel guidelines.  
 
868 

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Chapter 11 Adverse Events, Device Issues, and Stopping Rules 
869 
 
870 
11.1.1 Adverse Events (AE) 
871 
Any untoward medical occurrence in a study participant, irrespective of the relationship between 
872 
the adverse event and the device(s) under investigation (section 11.2) for reportable adverse events 
873 
for this protocol). 
874 
Positive pregnancy test will be not considered adverse event.  
875 
11.1.2 Serious Adverse Event (SAE) 
876 
 Any untoward medical occurrence that: 
877 
• Results in death. 
878 
• Is life-threatening; (a non-life-threatening event which, had it been more severe, might 
879 
have become life-threatening, is not necessarily considered a serious adverse event). 
880 
• Requires inpatient hospitalization or prolongation of existing hospitalization. 
881 
• Results in persistent or significant disability/incapacity or substantial disruption of the 
882 
ability to conduct normal life functions (life threatening). 
883 
• Is a congenital anomaly or birth defect. 
884 
• Is considered a significant medical event by the investigator based on medical judgment 
885 
(e.g., may jeopardize the participant or may require medical/surgical intervention to 
886 
prevent one of the outcomes listed above). 
887 
11.1.3 Unanticipated Adverse Device Effect (UADE) 
888 
Any serious adverse effect on health or safety or any life-threatening problem or death caused by, 
889 
or associated with, a device, if that effect, problem, or death was not previously identified in nature, 
890 
severity, or degree of incidence in the investigational plan or application (including a 
891 
supplementary plan or application), or any other unanticipated serious problem associated with a 
892 
device that relates to the rights, safety, or welfare of participants (21 CFR 812.3(s)). 
893 
11.1.4 Adverse Device Effect (ADE) 
894 
Any untoward medical occurrence in a study participant which the device may have caused or to 
895 
which the device may have contributed. 
896 
11.1.5 Device Complaints and Malfunctions 
897 
A device complication or complaint is something that happens to a device or related to device 
898 
performance, whereas an adverse event happens to a participant. A device complaint may occur 
899 
independently from an AE, or along with an AE. An AE may occur without a device complaint or 
900 
there may be an AE related to a device complaint.  A device malfunction is any failure of a device 
901 

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to meet its performance specifications or otherwise perform as intended.  Performance 
902 
specifications include all claims made in the labelling for the device.  The intended performance 
903 
of a device refers to the intended use for which the device is labelled or marketed. (21 CFR 803.3).   
904 
 
905 
For this protocol, a reportable adverse event includes any untoward medical occurrence that meets 
906 
one of the following criteria: 
907 
• A serious adverse event as defined in section 11.2 
908 
• An Adverse Device Effect as defined in section 11.1.4, unless excluded from reporting in 
909 
section 11.7 
910 
• An Adverse Event as defined in section 11.1.1 occurring in association with a study 
911 
procedure 
912 
• An AE as defined in section 11.1.1 which leads to discontinuation of a study device for 2 
913 
or more hours 
914 
• Hypoglycemia meeting the definition of severe hypoglycemia as defined in section 11.2.1  
915 
• Diabetic ketoacidosis (DKA) as defined in section 11.2.2 or in the absence of DKA, a 
916 
hyperglycemic or ketosis event meeting the criteria defined below 
917 
Hypoglycemia and hyperglycemia not meeting the criteria below will not be recorded as adverse 
918 
events unless associated with an Adverse Device Effect. Skin reactions from sensor placement are 
919 
only reportable if severe and/or required treatment. 
920 
11.2.1 Hypoglycemia Event 
921 
Hypoglycemia not associated with an Adverse Device Effect is only reportable as an adverse event 
922 
when the following definition for severe hypoglycemia is met:   
923 
• The event required assistance of another person due to altered consciousness, and required 
924 
another person to actively administer carbohydrate, glucagon, or other resuscitative actions 
925 
• Impaired cognitively to the point that he/she was unable to treat himself/herself, was unable 
926 
to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced 
927 
seizure or coma. These episodes may be associated with sufficient neuroglycopenia to 
928 
induce seizure or coma 
929 
• If plasma glucose measurements are not available during such an event, neurological 
930 
recovery attributable to the restoration of plasma glucose to normal is considered sufficient 
931 
evidence that the event was induced by a low plasma glucose concentration 
932 
11.2.2 Hyperglycemia Events/Diabetes Ketoacidosis 
933 
Hyperglycemia not associated with an Adverse Device Effect is only reportable as an adverse 
934 
event when one of the following four criteria is met:  
935 
• The event involved DKA, as defined by the Diabetes Control and Complications Trial 
936 
(DCCT) and described below evaluation or treatment was obtained at a health care provider 
937 
facility for an acute event involving hyperglycemia or ketosis 
938 

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• Blood ketone level ≥1.5 mmol/L and communication occurred with a health care provider 
939 
at the time of the event 
940 
• Blood ketone level ≥3.0 mmol/L, even if there was no communication with a health care 
941 
provider 
942 
Hyperglycemic events are classified as DKA if the following are present: 
943 
• Symptoms such as polyuria, polydipsia, nausea, or vomiting 
944 
• Serum ketones ≥1.5 mmol/L or large/moderate urine ketones 
945 
• Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15 
946 
• Treatment provided in a health care facility 
947 
All reportable Adverse Events—whether volunteered by the participant, discovered by study 
948 
personnel during questioning, or detected through physical examination, laboratory test, or other 
949 
means—will be reported on an adverse event form online.  Each adverse event form is reviewed 
950 
by the Medical Monitor to verify the coding and the reporting that is required. 
951 
 
952 
The study investigator will assess the relationship of any adverse event to be related or unrelated 
953 
by determining if there is a reasonable possibility that the adverse event may have been caused by 
954 
the study device. 
955 
To ensure consistency of adverse event causality assessments, investigators should apply the 
956 
following general guideline when determining whether an adverse event is related: 
957 
• There is a plausible temporal relationship between the onset of the adverse event and the 
958 
study intervention, and the adverse event cannot be readily explained by the participant’s 
959 
clinical state, intercurrent illness, or concomitant therapies; and/or the adverse event 
960 
follows a known pattern of response to the study intervention; and/or the adverse event 
961 
abates or resolves upon discontinuation of the study intervention or dose reduction and, if 
962 
applicable, reappears upon rechallenge. 
963 
• Evidence exists that the adverse event has an etiology other than the study intervention 
964 
(e.g., pre-existing medical condition, underlying disease, intercurrent illness, or 
965 
concomitant medication); and/or the adverse event has no plausible temporal relationship 
966 
to study intervention. 
967 
 
968 
While we are taking steps to prevent transmission of COVID-19 during this study, there is a 
969 
possibility that participants, based either on exposure before the hotel admission or during the stay, 
970 
are infected with COVID-19.  Any appearance of significant COVID-19 symptoms in participants 
971 
will be cause for repeat COVID-19 testing and possible quarantine until test results are returned.  
972 
If this Covid-19 test is positive, the participant will be discharged from the study.  
973 
In the event of a COVID-19 positive test in a participant, the study team will follow up with the 
974 
participant via phone until conclusion of treatment for the COVID-19 related symptoms. All 
975 

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participants will be asked to follow up via phone with the study team in the event of a positive test 
976 
within 14 days after discharge from the hotel.  
977 
 
978 
The intensity of an adverse event will be rated on a three-point scale: (1) mild, (2) moderate, or (3) 
979 
severe. It is emphasized that the term severe is a measure of intensity: thus, a severe adverse event 
980 
is not necessarily serious. For example, itching for several days may be rated as severe, but may 
981 
not be clinically serious. 
982 
• MILD: Usually transient, requires no special treatment, and does not interfere with the 
983 
participant’s daily activities. 
984 
• MODERATE: Usually causes a low level of inconvenience or concern to the participant 
985 
and may interfere with daily activities but is usually ameliorated by simple therapeutic 
986 
measures. 
987 
• SEVERE: Interrupts a participant’s usual daily activities and generally requires systemic 
988 
drug therapy or other treatment. 
989 
 
990 
Adverse events will be coded per the UVA IRB website instructions (i.e. mild, moderate, severe).  
991 
The Medical Monitor will review the investigator’s assessment of causality and may agree or 
992 
disagree.  Both the investigators and Medical Monitor’s assessments will be recorded.  The 
993 
Medical Monitor will have the final say in determining the causality. 
994 
Adverse events that continue after the participant’s discontinuation or completion of the study will 
995 
be followed until their medical outcome is determined or until no further change in the condition 
996 
is expected. 
997 
 
998 
The outcome of each reportable adverse event will be classified by the investigator as follows: 
999 
• RECOVERED/RESOLVED – The participant recovered from the AE/SAE without 
1000 
sequelae.  Record the AE/SAE stop date. 
1001 
• RECOVERED/RESOLVED WITH SEQUELAE – The event persisted and had stabilized 
1002 
without change in the event anticipated.  Record the AE/SAE stop date. 
1003 
• FATAL – A fatal outcome is defined as the SAE that resulted in death. Only the event that 
1004 
was the cause of death should be reported as fatal.  AEs/SAEs that were ongoing at the 
1005 
time of death; however, were not the cause of death, will be recorded as “resolved” at the 
1006 
time of death. 
1007 
• NOT RECOVERED/NOT RESOLVED (ONGOING) – An ongoing AE/SAE is defined 
1008 
as the event was ongoing with an undetermined outcome. 
1009 
• An ongoing outcome will require follow-up by the site in order to determine the final 
1010 
outcome of the AE/SAE. 
1011 

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• The outcome of an ongoing event at the time of death that was not the cause of death, will 
1012 
be updated and recorded as “resolved” with the date of death recorded as the stop date. 
1013 
• UNKNOWN – An unknown outcome is defined as an inability to access the participant or 
1014 
the participant’s records to determine the outcome (for example, a participant that was lost 
1015 
to follow-up). 
1016 
All clinically significant abnormalities of clinical laboratory measurements or adverse events 
1017 
occurring during the study and continuing at study termination should be followed by the 
1018 
participant’s physician and evaluated with additional tests (if necessary) until diagnosis of the 
1019 
underlying cause, or resolution. Follow-up information should be recorded on source documents. 
1020 
If any reported adverse events are present when a participant completes the study, or if a participant 
1021 
is withdrawn from the study due to an adverse event, the participant will be contacted for re-
1022 
evaluation within 2 weeks.  If the adverse event has not resolved, additional follow-up will be 
1023 
performed as appropriate.  Every effort should be made by the Investigator or delegate to contact 
1024 
the participant until the adverse event has resolved or stabilized. 
1025 
 
1026 
All UADEs, ADEs, device complaints, and device malfunctions will be reported irrespective of 
1027 
whether an adverse event occurred, except in the following circumstances. 
1028 
The following device issues are anticipated and will not be reported but will reported as an Adverse 
1029 
Event if the criteria for AE reporting described above are met: 
1030 
• Component disconnections 
1031 
• CGM sensors lasting fewer than the number of days expected per CGM labelling 
1032 
• CGM tape adherence issues 
1033 
• Pump infusion set occlusion not leading to ketosis 
1034 
• Battery lifespan deficiency due to inadequate charging or extensive wireless 
1035 
communication 
1036 
• Intermittent device component disconnections/communication failures not leading to 
1037 
system replacement 
1038 
• Device issues clearly addressed in the user guide manual that do not require additional 
1039 
troubleshooting 
1040 
• Skin reactions from CGM sensor placement or pump infusion set placement that do not 
1041 
meet criteria for AE reporting 
1042 
 
1043 
• UADEs must be reported within 10 working days to the FDA after the sponsor first receives 
1044 
notice of the adverse effect. 
1045 
• Other reportable adverse events, device malfunctions (with or without an adverse event) 
1046 
and device complaints should be reported promptly, but there is no formal required 
1047 
reporting period. 
1048 

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• The IDE Sponsor will investigate the UADE and if indicated, report the results of the 
1049 
investigation to the IRBs, FDA, and DSMB within 10 working days of the study team 
1050 
becoming aware of the UADE per 21CFR 812.46(b) (2).  
1051 
• The Medical Monitor will determine if the UADE presents an unreasonable risk to 
1052 
participants. If so, the DSMB must ensure that all investigations, or parts of investigations 
1053 
presenting that risk, are terminated as soon as possible but no later than 5 working days 
1054 
after the Medical Monitor makes this determination and no later than 15 working days after 
1055 
first receipt notice of the UADE. 
1056 
• In the case of a device system component malfunction (e.g. pump, CGM, control 
1057 
algorithm), information will be forwarded to the responsible manufacturer by the study 
1058 
personnel. 
1059 
 
1060 
11.10.1 Participant Discontinuation  
1061 
Rules for discontinuing study device use are described below. 
1062 
• The investigator believes it is unsafe for the participant to continue the intervention.  This 
1063 
could be due to the development of a new medical condition or worsening of an existing 
1064 
condition; or participant behaviour contrary to the indications for use of the device that 
1065 
imposes on the participant’s safety 
1066 
• The participant requests that the treatment be stopped 
1067 
• The participant tests positive for COVID-19 (during study testing or otherwise within 14 
1068 
days of study start) or subsequently develops symptoms for COVID-19 and tests positive. 
1069 
• Diagnosis of DKA. Any severe hypoglycemia event meeting the definition in section 
1070 
11.2.1 of the protocol. 
1071 
11.10.2 Suspending/Stopping Overall Study 
1072 
In the case of an unanticipated system malfunction resulting in a severe hypoglycemia or severe 
1073 
hyperglycemia event (as defined in section 11.2.2), use of the study device system will be 
1074 
suspended while the problem is diagnosed. 
1075 
In the event that two distinct episodes of DKA or two distinct severe hypoglycemia events as 
1076 
defined in section 11.2 occur, the overall study would be suspended while the underlying 
1077 
conditions are determined.   
1078 
In addition, study activities could be similarly suspended if the manufacturer of any constituent 
1079 
study device requires stoppage of device use for safety reasons (e.g. product recall).  The affected 
1080 
study activities may resume if the underlying problem can be corrected by a protocol or system 
1081 
modification that will not invalidate the results obtained prior to suspension. The study Medical 
1082 
Monitor will review all adverse events and adverse device events that are reported during the study 
1083 
and will review compiled safety data at periodic intervals . The Medical Monitor may request 
1084 
suspension of study activities or stoppage of the study if deemed necessary based on the totality 
1085 
of safety data available. 
1086 

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1087 
A Medical Monitor will review all DKA and severe hypoglycemia irrespective of relatedness to 
1088 
study device use, and all serious events (including UADEs) related to study device use at the time 
1089 
of occurrence. The Medical Monitor can request modifications to the study protocol or suspension 
1090 
or outright stoppage of the study if deemed necessary based on the totality of safety data available. 
1091 
Details regarding Medical Monitor review will be documented in a separate Medical Monitor 
1092 
document.   
1093 
 
1094 
A data breach is defined in the HITECH Act (43 USC 17932) as an unauthorized acquisition, 
1095 
access, or use of protected health information (PHI) that compromises the security or privacy of 
1096 
such information.  
 
1097 

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Chapter 12 Miscellaneous Considerations  
1098 
 
1099 
Participants using glulisine at the time of enrollment will be asked to contact their personal 
1100 
physician to change their prescribed personal insulin to lispro or aspart for the duration of the trial. 
1101 
The study devices (study insulin pump, study CGM) must be removed before Magnetic Resonance 
1102 
Imaging (MRI), Computed Tomography (CT) or diathermy treatment. Participants may continue 
1103 
in the trial after temporarily discontinuing use if requiring one of the treatments above. 
1104 
 
1105 
Participation in the study is voluntary. Participant may withdraw at any time.  For participants who 
1106 
do withdraw from the study, the study team will determine if their data will be used in analysis.  
1107 
 
1108 
For security and confidentiality purposes, subjects will be assigned an identifier that will be used 
1109 
instead of their name.  Protected health information gathered for this study may be shared with the 
1110 
third-party collaborators.  De-identified subject information may also be provided to collaborators 
1111 
involved in the study after the appropriate research agreement has been executed. 
 
1112 

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Chapter 13 Statistical Consideration 
1113 
 
1114 
The main study is itself an early exploratory study to assess glycemic responses of a fully closed-
1115 
loop system (Rocket AP).  This information is detailed in Table 1.  
1116 
Randomization will occur via selection from the above list using permuted blocks in groups of 4.   
1117 
13.1.1 Planned Analysis 
1118 
Our primary objective is to assess the impact of priming bolus on post prandial FCL control therefore we 
1119 
will test the following statistical hypotheses 
1120 
 
1121 
a. Null Hypothesis: There is no difference in the means of time spent in the 70-180mg/dL range during 
1122 
daytime between FCL with and without prandial priming bolus (BPS at 6% and 0% of TDI respectively) 
1123 
 
1124 
b. Alternative Hypothesis: There is a difference in the means of time spent in the 70-180mg/dL range during 
1125 
daytime between FCL with and without prandial priming bolus (BPS at 6% and 0% of TDI respectively) 
1126 
 
1127 
To do so we will use repeated measure ANOVA models to predict daytime time in range with the BPS 
1128 
status a fixed effect and baseline HbA1c and gender as covariates. 
1129 
 
1130 
Secondary outcomes: 
1131 
All secondary outcomes will be similarly analyzed. If an outcomes distribution is not suited for mixed 
1132 
model analysis (e.g. profound skewness, or large atom at boundary) we will perform paired Wilcoxon 
1133 
signed rank test (and loose the capacity to use covariate) to test difference in the median instead of the 
1134 
mean; this is expected for time below 70mg/dL, number of hypoglycemia, and possibly time above 
1135 
250mg/dL. 
1136 
 
1137 
We do not plan to correct for multiple comparisons. 
1138 
 
1139 
We do not expect substantial missing values in this highly supervised study, but if more than 3 subjects 
1140 
have one or more missing admissions, we will consider switching from RANOVA to mixed model repeated 
1141 
measures. 
1142 
 
1143 

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1144 
As a early exploratory Study, the goal will be to complete up to 20 participants in the main study 
1145 
to provide data from a variety of individuals.  This number was chosen out of feasibility and not 
1146 
from a formal power calculation.  (The Pilot Study for this proposal will assess ease of system and 
1147 
will be completed in a minimum of 2-3 individuals prior to the beginning of the Main Study.) With 
1148 
N=20 and our randomized crossover design (allowing for paired comparison), we can hope to detect a 
1149 
minimum effect size of 0.66 at a power of 80%. Based of prior FCL study, the standard deviation of daytime 
1150 
TIR is approximately 12%, leading to a detectable difference in daytime TIR of 8%. 
1151 
 
1152 
13.3.1 Primary Efficacy Endpoint  
1153 
The study design allows for multiple comparisons of blood glucose control during the study meals 
1154 
and exercise sessions, with for the primary comparison of interest being between the RocketAP 
1155 
with and without BPS. Our primary endpoint is CGM time-in-range 70-180 mg/dL for the daytime 
1156 
period 6 am – 12 am when on each treatment modality (BPS vs. no BPS).  
1157 
13.3.2 Secondary Outcomes 
1158 
Each admission is separated into windows of analysis: 
1159 
• 
The entirety of the admission (24h: 4pm to 4pm) 
1160 
• 
The 4 hours following each of the meals. 
1161 
• 
The overnight period (12 am to 6 am) 
1162 
For each of these periods we will compute the following outcomes: 
1163 
• 
Number of hypoglycemia events defined as at least two consecutive CGM values 
1164 
<70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are 
1165 
counted as one). 
1166 
• 
Percent CGM time <70 mg/dL 
1167 
• 
Percent CGM time between 80-140mg/dL 
1168 
• 
Percent CGM time between 70-180mg/dL 
1169 
• 
Percent CGM time >180 mg/dL 
1170 
• 
Percent CGM time >250 mg/dL 
1171 
• 
Units of insulin injected  
1172 
• 
Area under the curve when accounting for starting BG  
1173 
• 
Low Blood Glucose Index 
1174 
• 
High Blood Glucose Index 
1175 
• CGM coefficient of variation 
1176 
• 
Mean CGM 
1177 
 
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13.3.3  CGM data treatment 
1179 
• 
Saturated CGM values “High” and “Low” will be replaced by 401mg/dL and 39mg/dL 
1180 
respectively.  
1181 
• 
Any CGM gaps shorter than 1 hour will be interpolated  
1182 
• 
CGM data during recorded occlusion event will be removed from analysis as follow: 
1183 
any measurement less than 2h before or after the time of record will be removed. 
1184 
• 
CGM data following a pump/DiAs communication interruption >1h by less than 2h 
1185 
will be removed 
1186 
13.3.4 Outcome computation conditions 
1187 
Outcomes will only be computed if at least 80% of the analysis window CGM measurements (after data 
1188 
treatment) are available 
1189 
 
1190 
We will assess for the system’s functionality, including the ability of the system to run its code 
1191 
without error (delivering insulin safely, as planned), as well as its ability to avoid low BG <70 
1192 
mg/dL. 
1193 
 
1194 
Baseline demographic and clinical characteristics of the cohort of all randomized participants will 
1195 
be summarized in a table using summary statistics appropriate to the distribution of each variable. 
1196 
Descriptive statistics will be displayed overall and by treatment group. 
1197 
Will include: 
1198 
• 
Age 
1199 
• 
HbA1c 
1200 
• 
Gender 
1201 
• 
Race/ethnicity 
1202 
• 
CGM use before enrollment 
1203 
• 
AID use before enrollment 
1204 
• 
Diabetes duration 
1205 
• 
BMI 
1206 
• 
Total Daily Insulin 
1207 
 
1208 
The following tabulations and analyses will be performed during time on the UVa AP systems to 
1209 
assess device issues: 
1210 
• 
Device malfunctions requiring study team contact and other reported device issues 
1211 
• 
% time CGM data available 
1212 
• 
% time with closed loop control 
 
1213 

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Chapter 14  Data Collection and Monitoring 
1214 
 
1215 
The study data are collected through a combination of case report forms (electronic and paper) and 
1216 
electronic device data files obtained from the software and individual hardware components. These 
1217 
electronic device files and electronic CRFs are considered the primary source documentation. 
1218 
When data are directly collected in electronic case report forms, this will be considered the source 
1219 
data.  Records will be maintained in accordance with ICH E6 and institutional regulatory 
1220 
requirements for the protection of confidentiality of participants. 
1221 
 
1222 
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
1223 
application in an ICH region and until there are no pending or contemplated marketing applications 
1224 
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
1225 
development of the investigational product.  These documents should be retained for a longer 
1226 
period, however, if required by local regulations. No records will be destroyed without the written 
1227 
consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform the investigator 
1228 
when these documents no longer need to be retained. 
1229 
 
1230 
A protocol deviation is any noncompliance with the clinical trial protocol, Good Clinical Practices 
1231 
(GCP), or procedure requirements.  The noncompliance may be either on the part of the participant, 
1232 
the investigator, or the study site staff. As a result of deviations, corrective actions may be 
1233 
developed by the site and implemented as appropriate.  Major deviations will be reported to the 
1234 
IRB-HSR within 7 calendar days of when the study team becomes aware of the event.  
1235 

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Chapter 15  Ethics/Protection of Human Participants 
1236 
 
1237 
The investigator will ensure that this study is conducted in full conformity with Regulations for 
1238 
the Protection of Human Participants of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 
1239 
CFR Part 56, and/or the ICH E6. 
1240 
 
1241 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
1242 
be submitted to the IRB for review and approval.  Approval of both the protocol and the consent 
1243 
form must be obtained before any participant is enrolled.  Any amendment to the protocol will 
1244 
require review and approval by the IRB before the changes are implemented to the study.  All 
1245 
changes to the consent form will be IRB approved; a determination will be made regarding whether 
1246 
previously consented participants need to be re-consented. 
1247 
 
1248 
15.3.1 Consent Procedures and Documentation 
1249 
Informed consent is a process that is initiated prior to an individual’s agreement to participate in 
1250 
the study and continues throughout the individual’s study participation.  Extensive discussion of 
1251 
risks and possible benefits of participation will be provided.  Consent forms will be IRB approved 
1252 
and the participant will be asked to read and review the document.  The investigator or their 
1253 
delegate will explain the research study to the participant and answer any questions that may arise.  
1254 
All participants will receive a verbal explanation in terms suited to their comprehension of the 
1255 
purposes, procedures, and potential risks of the study and of their rights as research participants.  
1256 
Participant will have the opportunity to carefully review the written consent form and ask questions 
1257 
prior to signing. 
1258 
The consenting process will involve discussing the study at length in a phone call/HIPAA 
1259 
compliant telecommunication method for consenting that is not face to face. The participant will 
1260 
sign the informed consent document prior to any procedures being done specifically for the study. 
1261 
The consent form may be signed electronically with the use of the Part 11 compliant version of 
1262 
DocuSign for both in-person and telecommunication screening visits. The study team will follow 
1263 
the FDA part 11 compliant process of verification of reviewing two forms of identification if 
1264 
signing electronically off site. A HIPAA compliant video conferencing tool will be utilized during 
1265 
the consenting process of the telecommunication screening visit to facilitate review of the 
1266 
participant’s identification.  A copy of the informed consent document will be given to the 
1267 
participant for their records.  The rights and welfare of the participants will be protected by 
1268 

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emphasizing to them that the quality of their medical care will not be adversely affected if they 
1269 
decline to participate in this study. 
1270 
15.3.2 Participant and Data Confidentiality 
1271 
The study monitor, representatives of the IRB or device company supplying study product may 
1272 
inspect all documents and records required to be maintained by the investigator, including but not 
1273 
limited to, medical records (office, clinic, or hospital) for the participants in this study.   
1274 
The study participant’s contact information will be securely stored at the clinical site for internal 
1275 
use during the study.  At the end of the study, all records will continue to be kept in a secure 
1276 
location for as long a period as dictated by local IRB and Institutional regulations. 
1277 
 Participant
1278 
The study monitor, representatives of the IRB or device company supplying study product may 
1279 
inspect all documents and records required to be maintained by the investigator, including but not 
1280 
limited to, medical records (office, clinic, or hospital) for the participants in this study.   
1281 
The study participant’s contact information will be securely stored at the clinical site for internal 
1282 
use during the study. At the end of the study, all records will continue to be kept in a secure location 
1283 
for as long a period as dictated by local IRB and Institutional regulations. 
1284 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, 
1285 
will be transmitted to and stored at the University of Virginia Center for Diabetes Technology.  
1286 
The study data entry and study management systems used by research staff will be secured and 
1287 
password protected.  At the end of the study, all study databases may be de-identified and archived 
1288 
at the University of Virginia Center for Diabetes Technology. 
 
1289 

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Chapter 16 References  
1290 
1. Burdick J, Chase HP, Slover RH, et al. Missed insulin meal boluses and elevated hemoglobin 
1291 
A(1c) levels in children receiving insulin pump therapy. Pediatrics. Mar 2004;113(3):E221-E224. 
1292 
doi:10.1542/peds.113.3.e221 
1293 
2. Cherñavvsky DR, DeBoer MD, Keith-Hynes P, et al. Use of an artificial pancreas among 
1294 
adolescents for a missed snack bolus and an underestimated meal bolus. Pediatr Diabetes. Feb 
1295 
2016;17(1):28-35. doi:10.1111/pedi.12230 
1296 
3. Garcia-Tirado J, Brown SA, Laichuthai N, et al. Anticipation of Historical Exercise Patterns 
1297 
by a Novel Artificial Pancreas System Reduces Hypoglycemia During and After Moderate-
1298 
Intensity Physical Activity in People with Type 1 Diabetes. Diabetes Technol Ther. Dec 
1299 
2020;doi:10.1089/dia.2020.0516 
1300 
4. Voysey, Merryn and Costa Clemens, Sue Ann and Madhi, Shabir A. et al and Group, Oxford 
1301 
COVID Vaccine Trial, Single Dose Administration, And The Influence Of The Timing Of The 
1302 
Booster Dose On Immunogenicity and Efficacy Of ChAdOx1 nCoV-19 (AZD1222) Vaccine. 
1303 
Available at SSRN: https://ssrn.com/abstract=3777268 
1304