Randomized Controlled Trial to Demonstrate the Efficacy of the Omnipod® 5 System When Compared to Multiple Daily Injections for Treatment of Type 1 Diabetes (RADIANT)
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Sponsor: Insulet Corporation

 
Omnipod 5 RADIANT Study 
Statistical Analysis Plan 
 
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Insulet Corporation 
Statistical Analysis Plan 
for 
RAndomized Controlled Trial to Demonstrate the 
Efficacy of the Omnipod® 5 with FreeStyle Libre 2 
Compared to Multiple Daily Injections for TreAtmeNT of 
Type 1 Diabetes (Omnipod 5 RADIANT Study) 
 
 
 
 
 
 
SAP:   
Version 2.0, dated 16 Jan 2025 
 
Protocol:  
OP5-004 Protocol V3.0 Dated 06 Nov 2024 (UK) 
 
OP5-004 Protocol V4.0 Dated 06 Nov 2024 (BE)  
 
OP5-004 Protocol V4.0 Dated 06 Nov 2024 (FR)  
 
 

 
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Document Approval 
 
 
Approval 
Approved By 
Anderson Leão, PhD 
Signature/Date 
Role 
Biostatistician II, Fortrea 
 
 
Approval 
Approved By 
Trang Ly, MBBS, FRACP, PhD 
Signature/Date 
Role 
Senior Vice President, Clinical and 
Medical Director, Insulet Corporation 
 
 
 
 

 
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Table of Contents 
1 
Purpose ................................................................................................................... 5 
2 
Study Design ........................................................................................................... 5 
2.1 
Study Design Overview ..................................................................................... 5 
2.2 
Investigational Device ....................................................................................... 6 
2.3 
Study Schedule ................................................................................................. 6 
2.4 
Study Success................................................................................................... 6 
2.5 
Randomization .................................................................................................. 7 
2.6 
Point of Enrollment ............................................................................................ 7 
2.7 
Sample Size ...................................................................................................... 7 
3 
Study Objectives and Endpoints ............................................................................. 8 
3.1 
Primary Objective and Endpoint ........................................................................ 8 
3.2 
Secondary Objectives and Endpoints ................................................................ 8 
3.3 
Exploratory Endpoints ....................................................................................... 9 
4 
Analysis of Primary Endpoint ................................................................................ 12 
4.1 
Primary Analysis.............................................................................................. 12 
4.1.1 
Change from Baseline in HbA1c ............................................................... 13 
4.1.2 
Handling of Missing Data .......................................................................... 14 
4.2 
Sensitivity analysis .......................................................................................... 14 
4.2.1 
Complete Cases Only ............................................................................... 14 
4.2.2 
Worst-Case and Tipping Point Analysis .................................................... 14 
4.2.3 
Covariate Adjustment ............................................................................... 15 
4.3 
Poolability ........................................................................................................ 15 
4.3.1 
Poolability by Country ............................................................................... 15 
4.3.2 
Poolability by Site ..................................................................................... 15 
4.4 
Subgroup and Stratified Analyses ................................................................... 16 
5 
Analysis of Other Endpoints .................................................................................. 17 
5.1 
Analysis of Secondary Endpoints .................................................................... 17 
5.1.1 
Analysis of Change from Baseline Endpoints ........................................... 17 
5.1.2 
Analysis of CGM-Derived Endpoints ......................................................... 17 
5.1.3 
Binary Secondary Endpoints..................................................................... 18 
5.1.4 
Hierarchy of Secondary Endpoints ........................................................... 18 
5.2 
Analysis of Exploratory Endpoints ................................................................... 24 

 
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5.2.1 
Analysis Methods for Exploratory Endpoints ............................................ 24 
5.2.2 
Episodes of Severe Hypoglycemia and Diabetic Ketoacidosis ................. 28 
6 
Analysis of Safety .................................................................................................. 29 
6.1 
Medical Monitor ............................................................................................... 29 
6.2 
Relationship to Study Device and Procedure .................................................. 29 
6.3 
Severity ........................................................................................................... 29 
6.4 
Outcome .......................................................................................................... 30 
6.5 
Analysis of Adverse Events ............................................................................. 31 
6.6 
Evaluation of Device Deficiencies ................................................................... 31 
7 
General Statistical Considerations ........................................................................ 31 
7.1 
Visit and Analysis Windows ............................................................................. 31 
7.2 
Analysis Sets ................................................................................................... 31 
7.2.1 
ITT (Intention to Treat) Analysis Set ......................................................... 31 
7.2.2 
mITT (modified Intention to Treat) Analysis Set ........................................ 31 
7.2.3 
PP (Per Protocol) Analysis Set ................................................................. 32 
7.3 
Control of Systematic Bias .............................................................................. 32 
7.4 
Calculation of Endpoint Outcomes .................................................................. 33 
7.4.1 
Change from Baseline in HbA1c ............................................................... 33 
7.4.2 
Calculation of Percentage of Time ............................................................ 33 
7.4.3 
Change from Baseline in Body Mass Index (BMI) .................................... 33 
7.4.4 
Change from Baseline in Total Daily Insulin (TDI) .................................... 34 
7.4.5 
Additional CGM-Derived Endpoints .......................................................... 34 
7.4.6 
Hypoglycemia and Hyperglycemia Events ................................................ 35 
7.5 
Length of Study Periods .................................................................................. 36 
7.5.1 
CGM Endpoints ........................................................................................ 36 
7.5.2 
Non-CGM Endpoints ................................................................................. 37 
7.6 
Handling of Missing Data ................................................................................ 38 
7.7 
Patient-Reported Outcomes ............................................................................ 39 
7.8 
Other Data Summaries .................................................................................... 42 
7.9 
Statistical Software .......................................................................................... 43 
 
 

 
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1 
PURPOSE 
The purpose of this Statistical Analysis Plan (SAP) is to describe the statistical 
methodology that is used to confirm the safety and effectiveness of the “RAndomized 
Controlled Trial to Demonstrate the Efficacy of the Omnipod® 5 with FreeStyle Libre 2 
Compared to Multiple Daily Injections for TreAtmeNT of Type 1 Diabetes” (RADIANT) 
study. Should there be a discrepancy between the study protocol and this SAP, the 
content of the SAP shall prevail. 
2 
STUDY DESIGN 
2.1 STUDY DESIGN OVERVIEW 
This is a prospective, randomized, parallel-group multicenter trial, followed by an 
extension period during which both groups use the Omnipod 5 System. 
A total of up to 250 pediatric and adult participants will be screened for this study. Up to 
200 participants across up to 20 investigational sites in France, Belgium, and the United 
Kingdom, comprised of 120 children (aged 4-17.9 years old) and 80 adults (aged 18-70 
years old) with type 1 diabetes currently on multiple daily injections (MDI) and sensor 
therapy with an HbA1c between 7.5-11% (58-97 mmol/mol), inclusive, will be enrolled. 
Subjects will be randomized in a 2:1 allocation to Intervention Arm (Omnipod 5 System 
with FreeStyle Libre 2 sensor) or Control Arm (MDI with FreeStyle Libre 2 sensor). 
Following a two-week standard therapy period where sensor data will be collected, 
participants will be randomized (2:1 ratio [Intervention:Control]) to either: 
• Intervention group: Omnipod 5 System with FreeStyle Libre 2 Sensor or 
• Control group: MDI with FreeStyle Libre 2 Sensor 
Period 1: 
Both groups will participate for a total of 26 weeks after completion of standard therapy. 
During the first 13-week randomized period, participants in the Control group will continue 
using MDI therapy with their glucose sensor. Participants in the Intervention group will 
onboard onto the Omnipod 5 System. At the conclusion of the 13-week randomized 
period, the Control group will onboard and use the Omnipod 5 System for an additional 
13 weeks. Both groups will continue using the Omnipod 5 System for the remainder of 
the 26 weeks. 
Period 2: 
Following Period 1, participants in France and Belgium will be offered the option to 
continue use of the Omnipod 5 System through commercialization. 
All participants will use the FreeStyle Libre 2 Sensor for the duration of the study. 

 
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2.2 INVESTIGATIONAL DEVICE 
The devices used in the Intervention group include: 
• Omnipod 5 System, comprised of the following components:  
o Omnipod 5 Pod  
o Omnipod 5 App (on the Insulet-provided Controller)  
• Abbott FreeStyle Libre 2 Glucose Sensor (“FreeStyle Libre 2”)  
The devices used in the Control group include: 
• Participant’s own MDI supplies 
• Abbott FreeStyle Libre 2 Glucose Sensor 
2.3 STUDY SCHEDULE 
The study is expected to be completed in approximately 32 months, which includes 
clinical site initiation to completion of all data entry, monitoring procedures, and report 
finalization. Each participant is expected to participate for approximately 6 months 
(Period 1). Participants that agree to take part in Period 2 (France and Belgium only) may 
participate until the Omnipod 5 System is commercially available (approximately an 
additional 6-12 months). 
Briefly, the study will consist of: 
1. A Baseline 14-day standard therapy period (Period 1) 
2. A 13-week randomized period (Period 1), followed by 
3. 13-week extension period with both groups using the Omnipod 5 System (Period 
1). 
4. An optional extension period with both groups using the Omnipod 5 System until 
the Omnipod 5 System is commercially available(Period 2, for France and Belgium 
only). 
 
Figure 1. Study Schematic 
 
2.4 STUDY SUCCESS 
The study will be deemed successful if the primary endpoint is met.  

 
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2.5 RANDOMIZATION 
This is a prospective, randomized, parallel-group multicenter trial followed by an 
extension period during which both groups use the Omnipod 5 System.  
After completing the 14-day standard therapy period, all participants will transition to the 
13-week randomized period. At the conclusion of the standard therapy period, 
participants who meet all eligibility criteria, have completed all screening assessments, 
and have met the sensor device usage and data criteria will be randomized 2:1 
(Intervention:Control) using a computer-generated randomization scheme stratified by 
site and by age group (<18 years, ≥18 years). A permuted-block randomization scheme 
will be implemented to balance group assignments. Randomization will be assigned via 
study database access during Visit 3 to one of the two study groups: Intervention group 
(Omnipod 5 System with FreeStyle Libre 2 Sensor) or Control group (Multiple daily 
injections therapy with FreeStyle Libre 2 Sensor)). 
Participants randomized to the Intervention group will onboard onto the Omnipod 5 
System during Visit 4. Participants randomized to the Control group will continue their 
usual MDI and sensor therapy during the 13 weeks. 
2.6 POINT OF ENROLLMENT 
A subject is considered enrolled into the study when the participant commences the 14-
day standard therapy period (at Visit 2) or when the participant shares their sensor data 
for an abbreviated standard therapy period. Participants who do not meet the eligibility 
criteria will not continue in the study and will be considered screen failures. 
2.7 SAMPLE SIZE 
The study is powered at 90% to detect a between-group difference of 0.5% in change 
from baseline in HbA1c at 13 weeks and assuming a standard deviation of 0.7% in each 
group for children (aged 4-17.9 years old) or 0.5% for adults (aged 18-70 years old). 
Under these assumptions and with 2:1 (Intervention:Control) randomization, a total 
sample size of 96 children (64 Intervention, 32 Control) and 51 adults (34 Intervention, 
17 Control) is required. To allow for attrition of up to 20% for children and 35% for adults, 
a total sample size of up to 200 will be enrolled (120 children, 80 adults) to obtain a 
minimum of 147 (96 children and 51 adults) completing the primary 13-week 
randomization period. A maximum of 250 participants will be screened. 
The anticipated difference and standard deviations were projected from the Omnipod 5 
Pivotal study (NCT04196140). PASS 2022 was used for sample size calculations. 

 
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3 
STUDY OBJECTIVES AND ENDPOINTS 
3.1 PRIMARY OBJECTIVE AND ENDPOINT 
The primary objective is to demonstrate superior efficacy of the Omnipod 5 System 
compared to MDI and sensor therapy in children and adults with type 1 diabetes. The 
primary endpoint is defined as follows. 
• Per-participant change from baseline in HbA1c at 13 weeks of randomized period 
between Intervention and Control group. 
3.2 SECONDARY OBJECTIVES AND ENDPOINTS 
The secondary objective is to demonstrate additional measures of efficacy and safety of 
the Omnipod 5 System compared to MDI and sensor therapy in children and adults with 
type 1 diabetes.  
The following secondary per-participant endpoints will be evaluated and compared in the 
Intervention group vs. Control group at the end of 13-week randomized period. Unless 
otherwise indicated, these endpoints will be analyzed for the total cohort. The secondary 
endpoints will be tested hierarchically for statistical significance in the following order: 
1. Percentage of time in range 70-180 mg/dL (3.9-10.0 mmol/L)  
2. Percentage of time <54 mg/dL (3.0 mmol/L) (non-inferior)  
3. Percentage of time >180 mg/dL (10.0 mmol/L)  
4. Percentage of time >300 mg/dL (16.7 mmol/L)  
5. Percentage of time <70 mg/dL (3.9 mmol/L) (non-inferior)  
6. Change from baseline in HbA1c for participants ≥18 years of age at baseline  
7. Change from baseline in HbA1c for participants <18 years of age at baseline  
8. Percentage of time in range 70-180 mg/dL (3.9-10.0 mmol/L) for participants ≥18 
years of age at baseline  
9. Percentage of time in range 70-180 mg/dL (3.9-10.0 mmol/L) for participants <18 
years of age at baseline  
10. Change from baseline in HbA1c in participants with baseline HbA1c ≥8% (64 
mmol/mol)  
11. Change from baseline in PSQI total score 
12. Change from baseline in T1-DDS total score for participants ≥18 years of age at 
baseline  
13. Change from baseline in HCS total score for participants ≥18 years of age at 
baseline  
14. Percentage of time <70 mg/dL (3.9 mmol/L)  
15. Percentage of participants achieving HbA1c <7% (53 mmol/mol)  
16. Change from baseline in EQ-5D-3L index score  
17. Change from baseline in total daily insulin (TDI) (units/kg) for participants ≥18 
years of age at baseline  
18. Percentage of time <54 mg/dL (3.0 mmol/L) 
 

 
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3.3 EXPLORATORY ENDPOINTS 
Period 1 – 13-week Randomized Period 
 
The following exploratory endpoints will be evaluated and compared in the Intervention 
group vs. Control group at the end of the 13-week randomized period. Unless otherwise 
indicated, these endpoints will be analyzed for the total cohort, for participants < 18 years 
of age, and for participants ≥18 years of age (as applicable): 
CGM-Derived Outcomes 
• Percentage of time <54 mg/dL (3.0 mmol/L)  
• Percentage of time <70 mg/dL (3.9 mmol/L)  
• Percentage of time >180 mg/dL (10.0 mmol/L)  
• Percentage of time >300 mg/dL (16.7 mmol/L) 
• Percentage of time >250 mg/dL (13.9 mmol/L)  
• Mean glucose (mg/dL and mmol/L)  
• Coefficient of variation (%)  
 
 
Glycemic Targets 
• Percentage of participants achieving HbA1c <7% (53 mmol/mol) 
• Percentage of participants achieving <6.5% (48 mmol/mol)  
• Percentage of participants in range 70-180 mg/dL (3.9-10.0 mmol/L) >70% of 
time  
• Percentage of participants in range 70-180 mg/dL (3.9-10.0 mmol/L) >70% of 
time and below range <70 mg/dL (3.9 mmol/L) (TBR) <4% of time  
 
Insulin and Weight Change 
• Change from baseline in total daily insulin (TDI) (units/kg) for participants <18 
years of age at baseline  
• Change from baseline in total daily insulin (TDI) (units)  
• Change from baseline in Body Mass Index (BMI) (kg/m2) or BMI z-score as 
appropriate.  
• Change from baseline in weight (kg) 
 
Safety 
• Number of hypoglycemic events as measured by the glucose sensor (<70 
mg/dL for ≥15 minutes; <54 mg/dL for ≥15 minutes)  
• Number of hyperglycemia events as measured by the glucose sensor (≥300 
mg/dL for ≥1 hour)  
• Number of episodes of severe hypoglycemia  
• Number of episodes of DKA  
 
Patient Reported Outcomes (PROs) 
• T1 Diabetes Distress Scale (T1-DDS)  
• Hypoglycemic Confidence Scale (HCS)  
• Pittsburgh Sleep Quality Index (PSQI)  
• EQ-5D-3L, EQ-5D-3L proxy version 1  

 
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• Diabetes Quality of Life Brief (DQOLBrief)  
• System Usability Scale (SUS)  
• Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations 
(INSPIRE)  
• Patient Health Questionnaire-2 (PHQ-2)  
• Clarke Hypoglycemia Awareness  
• System opinion questions  
• Time away from school/work 
• Proportion of participants achieving a Total Score > 5 (Poor Sleepers) on the 
PSQI questionnaire at 13 weeks1. 
• Proportion of participants achieving a minimally clinically important difference 
(MCID) of ≥0.19 points (improvement) on the T1-DDS questionnaire total score 
at 13 weeks2. 
• Proportion of participants achieving MCID score of ≥3 on the HCS 
questionnaire at 13 weeks3 for participants ≥18 years of age at baseline  
• Proportion of participants achieving a Minimally Detectable Difference (MDC) 
improvement of Change from Baseline > 0.5*Standard Deviation (SD) on the 
EQ-5D-3L questionnaire index score at 13 weeks 4. 
 
Device Use 
• Percentage of time spent in Automated Mode and in Manual Mode  
• Number of boluses delivered per day 
• Cumulative number of person-days spent at each available glucose target 
setting 
The following outcomes will be assessed separately during the day (06:00–23:59 hours) 
and during the night (00:00–05:59) compared in the Intervention group vs. Control group 
at the end of 13-week randomized period. 
• Percentage of time in range 70-180 mg/dL (3.9-10.0 mmol/L)  
• Percentage of time <54 mg/dL (3.0 mmol/L)  
• Percentage of time <70 mg/dL (3.9 mmol/L)  
• Percentage of time >180mg/dL (10.0 mmol/L)  
• Percentage of time >300 mg/dL (16.7 mmol/L)  
 
 
1 Buysse, Daniel J, Charles F. Reynolds, Timothy H. Monk, Susan R. Berman and David J. Kupfer. The 
Pittsburgh sleep quality index: A new instrument for psychiatric practice and research. Psychiatry 
Research 28 (1989): 193-213. 
2 Fisher L, Hessler D, Polonsky W, Strycker L, Masharani U, Peters A. Diabetes distress in adults with 
type 1 diabetes: Prevalence, incidence and change over time. J Diabetes Complications. 2016 
Aug;30(6):1123-8. doi: 10.1016/j.jdiacomp.2016.03.032. Epub 2016 Apr 4. PMID: 27118163; PMCID: 
PMC4949147. 
3 Polonsky WH, Fisher L, Hessler D, Edelman SV. Investigating Hypoglycemic Confidence in Type 1 and 
Type 2 Diabetes. Diabetes technology & therapeutics. 2017;19(2):131-6. 
4 Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the 
remarkable universality of half a standard deviation. Med Care 2003;41:582e92. 

 
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• Percentage of time >250 mg/dL (13.9 mmol/L)  
 
Period 1 – 13-week Extension Period 
The following exploratory endpoints will be evaluated at the end of the Omnipod 5 System 
use and compared to the start of the Omnipod 5 System use (either at the end of 26 
weeks for the Intervention group as compared to baseline, or at the end of 26 weeks 
compared to the end of 13-week randomized period for the Control group). These 
endpoints will be analyzed for the total cohort, for participants <18 years of age, and for 
participants ≥18 years of age. 
Glycemic Outcomes 
• HbA1c at 13 weeks extension of Period 1 
 
CGM-Derived Outcomes 
• Percentage of time in range 70–180 mg/dL (3.9-10.0 mmol/L)  
• Percentage of time <54 mg/dL (3.0 mmol/L)  
• Percentage of time <70 mg/dL (3.9 mmol/L)  
• Percentage of time >180mg/dL (10.0 mmol/L)  
• Percentage of time >300 mg/dL (16.7 mmol/L)  
• Percentage of time >250 mg/dL (13.9 mmol/L) 
 
Glycemic Targets 
• Percentage of participants achieving HbA1c <7% (53 mmol/mol)  
 
Patient Reported Outcomes (PROs) 
• T1 Diabetes Distress Scale (T1-DDS)  
• Hypoglycemic Confidence Scale (HCS)  
• Pittsburgh Sleep Quality Index (PSQI)  
• EQ-5D-3L, EQ-5D-3L proxy version 1  
• Diabetes Quality of Life Brief (DQOLBrief)  
• System Usability Scale (SUS)  
• Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations 
(INSPIRE)  
• Patient Health Questionnaire-2 (PHQ-2)  
• Clarke Hypoglycemia Awareness  
• System opinion questions  
• Time away from school/work  
 
Device Use 
• Percentage of time spent in Automated Mode and in Manual Mode  
• Number of boluses delivered per day 
• Cumulative number of person-days spent at each available glucose target 
setting 
 
Period 2 Extension 

 
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The following exploratory endpoints will be evaluated for the participants in France and 
Belgium only at the end of the Omnipod 5 System use and compared to the start of the 
Omnipod 5 System use (either at the end of the extension for the Intervention group as 
compared to baseline, or at the end of the extension compared to the end of 13-week 
randomized period for the Control group). These endpoints will be analyzed for the total 
cohort, for participants <18 years of age, and for participants ≥18 years of age. 
Glycemic Outcomes 
• HbA1c at 3, 6, and 9 months of Period 2 
• Change from baseline in HbA1c at 3, 6, and 9 months of Period 2 
 
CGM-Derived Outcomes 
• Percentage of time <54 mg/dL (3.0 mmol/L)  
• Percentage of time <70 mg/dL (3.9 mmol/L)  
• Percentage of time >180mg/dL (10.0 mmol/L) 
• Percentage of time in range 70–180 mg/dL (3.9-10.0 mmol/L)  
• Mean Glucose 
 
Glycemic Targets 
• Percentage of patients having time in range 70-180 mg/dL (3.9-10.0mmol/L) 
>70% of time 
• Percentage of patients having time below range <70 mg/dL (3.9 mmol/L) <4% 
of time 
 
Insulin and Weight Change 
• Insulin usage (units, units/kg) 
• Change from baseline in BMI, or BMI z-score as appropriate, at the end of 
Period 2 
Safety  
• Incidence rate of severe hypoglycemia 
• Incidence rate of diabetic ketoacidosis (DKA)  
Patient Reported Outcomes (PROs) 
• T1 Diabetes Distress Scale (T1-DDS) 
• Hypoglycemic Confidence Scale (HCS) 
• Diabetes Quality of Life Brief (DQOLBrief) 
 
Device Use 
• Percentage of time spent in Automated Mode 
4 
ANALYSIS OF PRIMARY ENDPOINT 
4.1 PRIMARY ANALYSIS 
The primary endpoint will be tested for statistical significance in the modified intention to 
treat (mITT) analysis set (defined in Section 7.2.2) at a two-sided significance level of 
5%. Hypothesis testing for the secondary endpoints will commence if and only if the 
primary endpoint is found to be statistically significant (two-sided p-value ≤0.05). Strict 

 
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control of Type I error will be maintained with a hierarchical testing procedure, with 
secondary endpoints tested in the order listed above. 
Each secondary endpoint with a two-sided p-value ≤0.05 (or one-sided p-value of ≤0.025, 
as appropriate) is considered to be met until a secondary endpoint with a two-sided p-
value >0.05 (or one-sided p-value of >0.025, as appropriate) is encountered. That 
secondary endpoint, and all subsequent secondary endpoints, are considered to not be 
met irrespective of their observed p-values. 
Hypothesis testing for the exploratory endpoints may be performed based on the clinical 
interest or relevance of the outcome for future study hypothesis generation. Methods for 
exploratory endpoints analysis are described in Section 5.2.1. 
The primary and secondary endpoints will be summarized for the mITT and per protocol 
(PP) analysis sets (defined in Section 7.2). If the PP analysis set does not differ from the 
mITT analysis set, separate analyses will not be presented. 
4.1.1 Change from Baseline in HbA1c 
The primary endpoint is the change from baseline in HbA1c at 13 weeks between the 
Intervention and Control groups. The null hypothesis states that the mean change from 
baseline in HbA1c at 13 weeks in the Intervention group is equal to the mean change 
from baseline in HbA1c at 13 weeks in the Control group. The alternative hypothesis 
states that the mean change from baseline in HbA1c at 13 weeks in the Intervention 
group is not equal to the mean change from baseline in HbA1c at 13 weeks in the Control 
group. 
Formally, the hypotheses associated with primary endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of change from baseline in 
HbA1c at 13 weeks in the Intervention and Control groups, respectively. 
The calculation of change from baseline in HbA1c is described in Section 7.4.1 of this 
document.  
The primary endpoint will be analyzed with a linear mixed effects model (LMM) with 
change from baseline in HbA1c at 13 weeks as the outcome, and randomized treatment 
group as a fixed effect. The following variables will be included in the model as fixed 
effects: age, sex, duration of diagnosis, and baseline HbA1c value. Country and/or site 
may be included in the model as random effects, depending on the results of the 
poolability assessment described in Section 4.3 of this document. The assessment of 
significance will be based on the least squares means estimate of the difference between 
treatment groups produced by the model. 

 
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Standard residual diagnostics will be performed for all analyses associated with the 
primary endpoint. It is expected that the primary outcome will follow an approximately 
normal distribution, however, residual values will be examined to confirm an approximate 
normal distribution. If values are highly skewed, then robust regression using M-
estimation will be used instead. In this case, the model will include HbA1c at 13 weeks 
as the dependent variable, baseline HbA1c, age, sex, and duration of diagnosis as the 
covariates, and missing data will be handled using multiple imputation as described in 
Section 7.6. 
The primary analysis will utilize the mITT analysis set and will be tested at a two-sided 
significance level of 5%. If there is evidence of heterogeneity either across countries or 
study sites based on the poolability analysis, a random effect for country or site, as 
appropriate, will also be included. The study will be assumed to be successful if the 
primary endpoint is considered to be met; that is, the treatment group fixed effect in the 
LMM is significant at a two-sided significance level of 5%. 
4.1.2 Handling of Missing Data 
Handling of missing data for the primary endpoint is described in Section 7.6 of this 
document. 
4.2 SENSITIVITY ANALYSIS 
The following sensitivity analysis will be performed for the primary endpoint. 
4.2.1 Complete Cases Only 
The primary analysis will be replicated including only participants with non-missing 
HbA1c at baseline and follow-up. This assumes missing completely at random (MCAR). 
4.2.2 Worst-Case and Tipping Point Analysis 
The Worst-Case Scenario sensitivity analysis will be applied to subjects with missing 
values for change from baseline in HbA1c at 13 weeks, assuming the following: 
• Subjects randomized to Omnipod 5 arm: Missing values at baseline will be 
imputed with the lowest observed non-missing baseline HbA1c value for the 
Omnipod 5 group, and missing values at 13 weeks will be imputed with the highest 
observed non-missing HbA1c value for the Omnipod 5 group at 13 weeks. This 
will result in the worst possible outcome (i.e., smallest change in HbA1c) for the 
subjects randomized to the Omnipod 5 arm. 
• Subjects randomized to Control arm: Missing values at baseline will be imputed 
with the highest observed non-missing baseline HbA1c value for the Control 
group, and missing values at 13 weeks will be imputed with the lowest observed 
on-missing HbA1c value for the Control group at 13 weeks. This will result in the 
best possible outcome (i.e., greatest change in HbA1c) for the subjects 
randomized to the Control arm. 

 
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If the results of the worst-case analysis greatly differ from the primary analysis of the 
endpoint, a two-way tipping point sensitivity analysis will be performed to evaluate the 
possibility of missing not at random (MNAR).  
First, multiple imputation will be applied to missing HbA1c assuming MAR, as described 
above. This procedure will then be repeated applying various shifts to the imputed values. 
Since the reasons for missing data may vary by treatment group, a separate shift will be 
applied for each treatment group. A shift of zero for both treatment groups is equivalent 
to the model assuming MAR. A positive shift indicates that we expect HbA1c to be worse 
in that treatment group for those with missing values than those with observed data. The 
range of shifts that are considered will include scenarios where the outcomes for patients 
missing data are worse among patients randomized to the treatment arm than those 
randomized to the control arm. The goal is to examine how far one needs to shift for the 
results of the study to tip from significant to not significant for between-treatment 
comparison. Tipping points that change the significance will be reported and clinically 
evaluated for whether such points are considered plausible.  
4.2.3 Covariate Adjustment 
The primary analysis includes a pre-specified list of covariates. As an additional 
sensitivity analysis, any baseline demographic or clinical characteristics observed to be 
imbalanced between treatment groups will be added as covariates to the model for the 
primary endpoint. The determination of a meaningful baseline imbalance will be based 
on clinical judgement and not a p-value. 
4.3 POOLABILITY 
As the study plans to enroll sites in multiple countries (France, Belgium and the United 
Kingdom), the poolability will be assessed first by country, and then by site. 
4.3.1 Poolability by Country 
A linear model with treatment group and country as fixed effects for change in HbA1c at 
13 weeks from baseline will be fit for the comparison of treatment groups. The model will 
also include treatment group by country interaction term. A p-value for the interaction 
term of <0.15 will be considered to indicate heterogeneity, and a random effect for country 
will be included in the primary analysis model as described in Section 4.1 of this 
document. If the p-value for the interaction term is ≥0.15, random effect for country will 
not be included in any analyses. 
4.3.2 Poolability by Site 
If the p-value for the interaction term from the poolability by country assessment is ≥0.15, 
a linear model with treatment group and site as fixed effects for change in HbA1C at 13 
weeks from baseline will be fit for the comparison of treatment groups. The model will 
also include treatment group by site interaction term. A p-value for the interaction term of 
<0.15 will be considered to indicate heterogeneity, and a random effect for site will be 
included in the primary analysis model as described in Section 4.1 of this document. If 

 
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the p-value for the interaction term is ≥0.15, random effect for site will not be included in 
any analyses. 
If the p-value for the interaction term from the poolability by country assessment is <0.15, 
a linear model with treatment and study site as fixed effects for change in HbA1c at 13 
weeks from baseline, and a treatment by site interaction, will be fit for each country 
separately. A p-value for the interaction term of <0.15 will be considered to indicate 
heterogeneity within that country. If the p-value for the interaction term from any of the 
country-specific models is <0.15, both country and site will be included as random effects 
in the primary analysis. If the p-value for all of the interaction terms for the country-specific 
models is ≥0.15, random effect only for country will be included in the primary analysis. 
For the poolability analysis that assesses homogeneity within each country, sites with ≤5 
subjects contributing to analysis will be combined into pseudo-centers of at least 10 
subjects, or combined with existing centers to make sure that each site contributes at 
least 10 subjects. If possible, such grouping will be done within country. If site is included 
in other analyses, e.g., random effect in the analysis of primary endpoint, the same 
approach of combining sites will be used. 
4.4 SUBGROUP AND STRATIFIED ANALYSES 
Regardless of results of poolability analysis of primary endpoint, the primary endpoint will 
be further explored to understand the treatment effect. The general approach for these 
exploratory analyses will be to add an interaction term for the subgroup factor by 
treatment to the primary and secondary endpoint models described above. Factors 
expected to include are: country, sex, age, BMI, and baseline HbA1c.  
Primary and secondary endpoints will be summarized with descriptive statistics at 
baseline, end of 13-week randomized period, and change from baseline at the end of the 
13-week randomized period for the Intervention and Control groups, stratified by the 
following groups.  
• Country (United Kingdom, France, and Belgium) 
• Demographic measures (e.g., sex, age breakdowns) 
• BMI (≤25 vs >25 kg/m2) 
• Baseline TIR (≥70%, 60 to <70%, and <60%) 
• Baseline HbA1c (<8%, 8 to <9%, and ≥9%) 
Additional stratification analysis will be included for the outcomes as described in Section 
3, which will comprise:  
• Day and night (daytime: 6AM to <12AM; nighttime as 12AM to <6AM) 
• Age group (adults and children) 

 
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5 
ANALYSIS OF OTHER ENDPOINTS 
5.1 ANALYSIS OF SECONDARY ENDPOINTS 
If the primary endpoint is found to be statistically significant at a two-sided significance 
level of 5%, testing for the secondary endpoints can commence. Secondary endpoints 
will be tested in a hierarchical fashion at a two-sided significance level of 5% (or one-
sided significance level of 2.5% as appropriate). Strict type I error control will be 
maintained with the hierarchical testing procedure. Each endpoint with a two-sided p-
value ≤0.05 (or one-sided p-value of ≤0.025, as appropriate) is considered to be met until 
a secondary endpoint with a two-sided p-value >0.05 (or one-sided p-value of >0.025, as 
appropriate) is encountered. That secondary endpoint, and all subsequent secondary 
endpoints, are considered to not be met irrespective of their observed p-values. 
The primary analysis for all secondary endpoints will utilize the mITT analysis set and will 
be tested at a two-sided significance level of 5% or a one-sided significance level of 2.5%, 
as appropriate. If there is evidence of heterogeneity either across countries or study sites 
based on the poolability analysis, a random effect for country and/or site, as appropriate, 
will also be included. 
5.1.1 Analysis of Change from Baseline Endpoints 
The change from baseline secondary endpoints will be analyzed using a LMM effects 
model with each of the secondary endpoints as the outcome, and randomized treatment 
group as a fixed effect. This is similar to the method used for the analysis of primary 
endpoint. The following variables will be included in the model: age, sex, duration of 
diagnosis, and baseline value of the outcome being tested. The factors included in the 
model may differ between endpoints. The assessment of significance for each change 
from baseline endpoint will be based on the least squares means estimate of the 
difference between treatment groups produced by the model. 
Standard residual diagnostics will be performed for all secondary endpoint analyses. 
Residual values will be examined to confirm an approximate normal distribution. If values 
are highly skewed, then robust regression using M-estimation will be used instead. In this 
case, the model will include the outcome value at 13 weeks as the dependent variable, 
age, sex, duration of diagnosis, and the baseline value of the outcome being tested as 
the covariates, and missing data will be handled using multiple imputation as in Section 
7.6. 
5.1.2 Analysis of CGM-Derived Endpoints 
The CGM-derived secondary endpoints will be analyzed using a repeated measures 
linear mixed effects model (RLMM) with time in the specified range as the dependent 
variable. The correlation between baseline and follow-up will be modelled using an 
unstructured covariance matrix. The model will include randomized treatment group, age, 
sex, and duration of diagnosis as fixed effects and may include site and/or country as 
random effects (based on the assessment of poolability for the primary endpoint). Visit 
will be included as the repeated effects term for time and an interaction term of visit and 

 
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treatment group will be included in the model. By including both baseline and 13 weeks 
in the predictor vector, the model allows participants to be included even if they do not 
have CGM-derived data at one of the two timepoints. The assessment of significance for 
each CGM-derived endpoint will be based on the least squares means estimate of the 
difference between treatment groups at 13 weeks produced by the model. 
Missing data will be handled by using a direct likelihood approach which will allow 
participants to be included even if they only have data at one of the time points. The direct 
likelihood method approach assumes data are missing at random (MAR).  
Standard residual diagnostics will be performed for all analyses associated with the 
secondary endpoints. It is expected that the primary outcome will follow an approximately 
normal distribution, however, residual values will be examined to confirm an approximate 
normal distribution. If values are highly skewed, then robust regression using M-
estimation will be used instead. In this case, the model will include time in the specified 
range during the 13 weeks randomized period as the dependent variable, baseline time 
in the specified range as a covariate, and missing data will be handled using multiple 
imputation. 
5.1.3 Binary Secondary Endpoints 
Binary endpoints will be presented as the number and percent of participants achieving 
the endpoint with corresponding 95% asymptotic confidence limits in each group. Binary 
endpoints will be analyzed using a logistic mixed effects model using logit link function, 
with the endpoint as the outcome. The following variables will also be included in the 
model as fixed effects: randomized treatment group, age, sex, duration of diagnosis, and 
baseline continuous value of the outcome being tested (if available). A 95% confidence 
interval for the treatment group adjusted risk difference will be produced using parametric 
bootstrapping. The assessment of significance for each binary endpoint will be based on 
the least squares means estimate of the difference between treatment groups at 13 
weeks produced by the model. 
The missing data for the secondary endpoints will be handled according to Section 7.6  
5.1.4 Hierarchy of Secondary Endpoints 
The secondary endpoints will be testing in the following order: 
5.1.4.1 Percentage of Time in Range (TIR) 70-180 mg/dL 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of per-participant means of 
percentage of time in range (TIR) 70-180 mg/dL during the 13 weeks in the 
Intervention and Control groups, respectively. 

 
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The calculation of percentage of time in a specified range is described in Section 7.4.2 
this document. This endpoint will be considered met if the least squares means estimate 
of the difference between treatment groups at 13 weeks in the RLMM is significant at a 
two-sided significance level of 5%. 
5.1.4.2 Percentage of Time <54 mg/dL (Non-Inferiority) 
The hypotheses associated with this endpoint are: 
o H0: μI - μC ≥ 1% 
o HA: μI - μC < 1% 
where μI and μC are the population means of per-participant percentage of 
time <54 mg/dL during the 13 weeks in the Intervention and Control 
groups, respectively 
The non-inferiority margin will be set to 1%. The calculation of percentage of time in a 
specified range is described in Section 7.4.2 of this document. If the upper bound of the 
one-sided 95% confidence interval for the least squares means difference between 
treatment groups at 13 weeks (μI minus μC) is <1%, non-inferiority will be established. 
5.1.4.3 Percentage of Time >180 mg/dL 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of per-participant percentage of 
time >180 mg/dL during the 13 weeks in the Intervention and Control 
groups, respectively. 
The calculation of percentage of time in a specified range is described in Section 7.4.2 
of this document. This endpoint will be considered met if the least squares means 
estimate of the difference between treatment groups at 13 weeks in the RLMM is 
significant at a two-sided significance level of 5%. 
5.1.4.4 Percentage of Time >300 mg/dL 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of per-participant percentage of 
time >300 mg/dL during the 13 weeks in the Intervention and Control 
groups, respectively. 
The calculation of percentage of time in a specified range is described in Section 7.4.2 
of this document. This endpoint will be considered met if the least squares means 
estimate of the difference between treatment groups at 13 weeks in the RLMM is 
significant at a two-sided significance level of 5%. 

 
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5.1.4.5 Percentage of Time <70 mg/dL (Non-inferiority) 
The hypotheses associated with this endpoint are: 
o H0: μI - μC ≥ 1% 
o HA: μI - μC < 1% 
where μI and μC are the population means of per-participant percentage of 
time <70 mg/dL during the 13 weeks in the Intervention and Control 
groups, respectively. 
The non-inferiority margin will be set to 1%. The calculation of percentage of time in a 
specified range is described in Section 7.4.2 of this document. If the upper bound of the 
one-sided 95% confidence interval for the least squares means difference between 
treatment groups at 13 weeks (μI minus μC) is <1%, non-inferiority will be established. 
5.1.4.6 Change from Baseline in HbA1c for Participants ≥18 Years of Age at 
Baseline 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of change from baseline in 
HbA1c at 13 weeks for participants ≥18 years of age at baseline in the 
Intervention and Control groups, respectively. 
The calculation of change from baseline in HbA1c is described in Section 7.4.1 of this 
document. This endpoint will be considered met if the least squares means estimate of 
the difference between treatment groups in the LMM is significant at a two-sided 
significance level of 5%. 
5.1.4.7 Change from Baseline in HbA1c for Participants <18 Years of Age at 
Baseline 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of change from baseline in 
HbA1c at 13 weeks for participants <18 years of age at baseline in the 
Intervention and Control groups, respectively. 
The calculation of change from baseline in HbA1c is described in Section 7.4.1 of this 
document. This endpoint will be considered met if the least squares means estimate of 
the difference between treatment groups in the LMM is significant at a two-sided 
significance level of 5%. 
5.1.4.8 Percentage of Time in Range (TIR) 70-180 mg/dL for Participants ≥18 
Years of Age at Baseline 
The hypotheses associated with this endpoint are: 

 
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o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of percentage of time in range 
(TIR) 70-180 mg/dL during the 13 weeks for participants ≥18 years of age 
at baseline in the Intervention and Control groups, respectively. 
The calculation of percentage of time in a specified range is described in Section 7.4.2 
of this document. This endpoint will be considered met if the least squares means 
estimate of the difference between treatment groups at 13 weeks in the RLMM is 
significant at a two-sided significance level of 5%. 
5.1.4.9 Percentage of Time in Range (TIR) 70-180 mg/dL for Participants <18 
Years of Age at Baseline 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of percentage of time in range 
(TIR) 70-180 mg/dL during the 13 weeks for participants <18 years of age 
at baseline in the Intervention and Control groups, respectively. 
The calculation of percentage of time in a specified range is described in Section 7.4.2 
of this document. This endpoint will be considered met if the least squares means 
estimate of the difference between treatment groups at 13 weeks in the RLMM is 
significant at a two-sided significance level of 5%. 
5.1.4.10 Change from Baseline in HbA1c in Participants with Baseline HbA1c 
≥8% 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of change from baseline in 
HbA1c in participants with baseline HbA1c ≥8% at 13 weeks in the 
Intervention and Control groups, respectively.  
The calculation of change from baseline in HbA1c is described in Section 7.4.1 of this 
document. This endpoint will be considered met if the least squares means estimate of 
the difference between treatment groups in the LMM is significant at a two-sided 
significance level of 5%. 
5.1.4.11 
Change from Baseline in PSQI Total Score 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 

 
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where μI and μC are the population means of change from baseline in PSQI 
total score at 13 weeks in the Intervention and Control groups, respectively; 
change from baseline is calculated as follows: 
The Pittsburgh Sleep Quality Index (PSQI) is further described in Section 7.7 of this 
document. This endpoint will be considered met if the least squares means estimate of 
the difference between treatment groups in the LMM is significant at a two-sided 
significance level of 5%. Change from baseline is calculated as follows: 
𝐶ℎܽ݊݃݁ ݂ݎ݋݉ ܤܽݏ݈݁݅݊݁ ݅݊ ܲܵܳܫ=  ܲܵܳܫ (ܸ݅ݏ݅ݐ 9) −ܲܵܳܫ (ܸ݅ݏ݅ݐ 3) 
 
This endpoint will utilize the following versions of the PSQI questionnaire for the age 
cohorts: 
- 
Children <12 y/o: Caregiver’s version of the PSQI for Children 
- 
Children ≥12 y/o: Self-reported version of the PSQI for Children  
- 
Adults ≥18 y/o: Self-reported version of the PSQI for Adults. 
5.1.4.12 
Change from Baseline in T1-DDS Total Score 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of change from baseline in T1-
DDS total score at 13 weeks in the Intervention and Control groups, 
respectively; change from baseline is calculated as follows: 
The Type-1 Diabetes Distress Scale is further described in Section 7.7 of this document. 
This endpoint will be considered met if the least squares means estimate of the difference 
between treatment groups in the LMM is significant at a two-sided significance level of 
5%. Change from baseline in T1-DDS is calculated as follows: 
𝐶ℎܽ݊݃݁ ݂ݎ݋݉ ܤܽݏ݈݁݅݊݁ ݅݊ ܶ1ܦܦܵ=  ܶ1ܦܦܵ (ܸ݅ݏ݅ݐ 9) −ܶ1ܦܦܵ (ܸ݅ݏ݅ݐ 3) 
5.1.4.13 
Change from Baseline in Hypoglycemia Confidence Scale (HCS) 
Total Score 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of change from baseline in HCS 
total score at 13 weeks in the Intervention and Control groups, respectively. 
The Hypoglycemia Confidence Scale (HCS) is further described in Section 7.7 of this 
document. This endpoint will be considered met if the least squares means estimate of 
the difference between treatment groups in the LMM is significant at a two-sided 
significance level of 5%. Change from baseline is calculated as follows: 

 
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𝐶ℎܽ݊݃݁ ݂ݎ݋݉ ܤܽݏ݈݁݅݊݁ ݅݊ ܪ𝐶ܵ=  ܪ𝐶ܵ (ܸ݅ݏ݅ݐ 9) −ܪ𝐶ܵ (ܸ݅ݏ݅ݐ 3) 
5.1.4.14 
Percentage of Time <70 mg/dL 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of percentage of time <70 mg/dL 
during the 13 weeks in the Intervention and Control groups, respectively. 
The calculation of percentage of time in a specified range is described in Section 7.4.2 
of this document. This endpoint will be considered met if the least squares means 
estimate of the difference between treatment groups at 13 weeks in the RLMM is 
significant at a two-sided significance level of 5%. 
5.1.4.15 
Percentage of Participants Achieving HbA1c <7% 
The hypotheses associated with this endpoint are: 
o H0: πI – πC = 0 
o HA: πI – πC ≠ 0 
where πI and πC are the population proportions of participants achieving 
HbA1c <7% at 13 weeks in the Intervention and Control groups, 
respectively. 
This endpoint will be considered met if the least squares means estimate of the difference 
between treatment groups at 13 weeks in the logistic regression is significant at a two-
sided significance level of 5%.  
5.1.4.16 
Change from Baseline in EQ-5D-3L Index Score 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
Where μI and μC are the population means of change from baseline in EQ-
5D-3L index score at 13 weeks in the Intervention and Control groups, 
respectively. 
The EQ-5D-3L instrument is further described in Section 7.7 of this document. This 
endpoint will be considered met if the least squares means estimate of the difference 
between treatment groups in the LMM is significant at a two-sided significance level of 
5%. Change from baseline is calculated as follows: 
𝐶ℎܽ݊݃݁ ݂ݎ݋݉ ܤܽݏ݈݁݅݊݁ ݅݊ ܧܳ5ܦ=  ܧܳ5ܦ (ܸ݅ݏ݅ݐ 9) −ܧܳ5ܦ (ܸ݅ݏ݅ݐ 3) 
 
This endpoint will utilize the following versions of the EQ-5D-3L questionnaire for the age 
cohorts: 
- 
Children <16 y/o: Proxy version of the EQ-5D-3L for Children 

 
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- 
Children ≥16 y/o: Self-reported version of the EQ-5D-3L for Children  
- 
Adults ≥18 y/o: Self-reported version of the EQ-5D-3L for Adults. 
5.1.4.17 
Change from Baseline in Total Daily Insulin (TDI) (units/kg) for 
Participants ≥18 Years of Age at Baseline 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
Where μI and μC are the population means of change from baseline in total 
daily insulin (units/kg) during the 13 weeks in the Intervention and Control 
groups, respectively. 
The calculation of change from baseline in TDI is described in Section 7.4.4 of this 
document. This endpoint will be considered met if the least squares means estimate of 
the difference between treatment groups in the LMM is significant at a two-sided 
significance level of 5%. 
5.1.4.18 
Percentage of Time <54 mg/dL 
The hypotheses associated with this endpoint are: 
o H0: μI - μC = 0 
o HA: μI - μC ≠ 0 
where μI and μC are the population means of percentage of time <54 mg/dL 
during the 13 weeks in the Intervention and Control groups, respectively. 
The calculation of percentage of time in a specified range is described in Section 7.4.2 
of this document. This endpoint will be considered met if the least squares means 
estimate of the difference between treatment groups in the LMM is significant at a two-
sided significance level of 5%. 
5.2 ANALYSIS OF EXPLORATORY ENDPOINTS 
List of exploratory endpoints is provided in Section 3.3 of this document. 
5.2.1 Analysis Methods for Exploratory Endpoints 
The mITT analysis set will be the main analysis set used to analyze these endpoints. 
Summary statistics will be presented for all endpoints and may be stratified by time points 
(e.g., day, night, overall) and age cohort (e.g., total, participants <18 years of age, and 
participants ≥18 years of age) of interest if appropriate. 
5.2.1.1 Period 1 – 13-week Randomized Period 
Exploratory endpoints will be analyzed as in Section 5.1 for the Period 1 – 13-week 
Randomized Period. 
False Discovery Rate for Multiple Testing of Exploratory Endpoints 

 
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To control for False Discovery Rate (FDR) among the randomized period exploratory 
endpoints the Benjamini-Yekutieli (2001)5 method for multiple testing will be implemented 
to the groups of exploratory endpoints below.  
Briefly, the Benjamini-Yekutieli procedure is a step-up testing procedure that do not 
assume any hierarchy among the tested null hypotheses. The procedure ranks the p-
values and compares the largest p-value to the largest endpoint-specific critical value (α). 
If the largest p-value does not show statistical significance, testing proceeds to compare 
the second-largest p-value to the second-largest adjusted alpha value. Sequential testing 
continues in this manner until a p-value for an endpoint is statistically significant, 
whereupon the provides a conclusion of statistically significant treatment effects for that 
endpoint and all endpoints with smaller p-values. 
Each family of endpoints listed below will be analyzed separately so that FDR is 
controlled at 5% within each family.  
Family #1: Glycemic Measures; Reduction of Hypoglycemia 
1. Percentage of time <54 mg/dL (3.0 mmol/L) for participants <18 years of age at 
baseline    
2. Percentage of time <54 mg/dL (3.0 mmol/L) for participants ≥18 years of age at 
baseline    
3. Percentage of time <70 mg/dL (3.9 mmol/L) for participants <18 years of age at 
baseline    
4. Percentage of time <70 mg/dL (3.9 mmol/L) for participants ≥18 years of age at 
baseline    
5. Percentage of time <70 mg/dL (3.9 mmol/L) during Daytime 
6. Percentage of time <70 mg/dL (3.9 mmol/L) during Nighttime 
7. Coefficient of variation (%) 
8. Coefficient of variation (%) for participants <18 years of age at baseline 
9. Coefficient of variation (%) for participants ≥18 years of age at baseline 
10. Number of hypoglycemic events as measured by the glucose sensor (<70 mg/dL 
for 15 minutes) 
11. Number of hypoglycemic events as measured by the glucose sensor (<70 mg/dL 
for 15 minutes) for participants <18 years of age at baseline   
12. Number of hypoglycemic events as measured by the glucose sensor (<70 mg/dL 
for 15 minutes) for participants ≥18 years of age at baseline   
13. Number of hypoglycemic events as measured by the glucose sensor (<54 mg/dL 
for 15 minutes) 
14. Number of hypoglycemic events as measured by the glucose sensor (<54 mg/dL 
for 15 minutes) for participants <18 years of age at baseline   
 
 
5 Benjamini, Y., & Yekutieli, D. (2001). The Control of the False Discovery Rate in Multiple 
Testing under Dependency. The Annals of Statistics, 29(4), 1165–1188. 
http://www.jstor.org/stable/2674075. 

 
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15. Number of hypoglycemic events as measured by the glucose sensor (<54 mg/dL 
for 15 minutes) for participants ≥18 years of age at baseline   
 
Family #2: Glycemic Measures; Reduction of Hyperglycemia  
1. Change from baseline in A1c in France participants  
2. Change from baseline in A1c in United Kingdom participants 
3. Percentage of time in range 70-180 mg/dL (3.9-10.0 mmol/L) during Daytime 
4. Percentage of time in range 70-180 mg/dL (3.9-10.0 mmol/L) during Nighttime 
5. Mean glucose (mg/dL and mmol/L) 
6. Mean glucose (mg/dL and mmol/L) for participants <18 years of age at baseline 
7. Mean glucose (mg/dL and mmol/L) for participants ≥18 years of age at baseline 
8. Percentage of time >180 mg/dL (10.0 mmol/L) for participants <18 years of age 
at baseline 
9. Percentage of time >180 mg/dL (10.0 mmol/L) for participants ≥18 years of age 
at baseline 
10. Percentage of time >250 mg/dL (13.9 mmol/L) 
11. Percentage of time >250 mg/dL (13.9 mmol/L) for participants <18 years of age 
at baseline 
12. Percentage of time >250 mg/dL (13.9 mmol/L) for participants ≥18 years of age 
at baseline 
13. Percentage of time >300 mg/dL (16.7 mmol/L) for participants <18 years of age 
at baseline 
14. Percentage of time >300 mg/dL (16.7 mmol/L) for participants ≥18 years of age 
at baseline 
15. Number of hyperglycemia events as measured by the glucose sensor (≥300 
mg/dL for 1 hour) 
16. Number of hyperglycemia events as measured by the glucose sensor (≥300 
mg/dL for 1 hour) for participants <18 years of age at baseline 
17. Number of hyperglycemia events as measured by the glucose sensor (≥300 
mg/dL for 1 hour) for participants ≥18 years of age at baseline 
18. Percentage of participants in range 70-180 mg/dL (3.9-10.0 mmol/L) >70% of 
time  
19. Percentage of children (<18 years of age at baseline) participants in range 70-
180 mg/dL (3.9-10.0 mmol/L) >70% of time  
20. Percentage of adult (≥18 years of age at baseline) participants in range 70-180 
mg/dL (3.9-10.0 mmol/L) >70% of time  
21. Percentage of participants in range 70-180 mg/dL (3.9-10.0 mmol/L) >70% of 
time and below range <70 mg/dL (3.9 mmol/L) (TBR) <4% of time 
22. Percentage of children (<18 years of age at baseline) participants in range 70-
180 mg/dL (3.9-10.0 mmol/L) >70% of time and below range <70 mg/dL (3.9 
mmol/L) (TBR) <4% of time   
23. Percentage of adult (≥18 years of age at baseline) participants in range 70-180 
mg/dL (3.9-10.0 mmol/L) >70% of time and below range <70 mg/dL (3.9 mmol/L) 
(TBR) <4% of time 
24. Percentage of participants achieving A1c <6.5% (48 mmol/mol) 

 
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25. Percentage of children (<18 years of age at baseline) participants achieving A1c 
<6.5% (48 mmol/mol)  
26. Percentage of adults (≥18 years of age at baseline) participants achieving A1c 
<6.5% (48 mmol/mol)  
27. Percentage of children (<18 years of age at baseline) participants achieving A1c 
<7% (53 mmol/mol) 
28. Percentage of adults (≥18 years of age at baseline) participants achieving A1c 
<7% (53 mmol/mol) 
 
Family #3: Clinical Metrics (Insulin, BMI) 
1. Change from baseline in total daily insulin (TDI) (units/kg) for participants <18 
years of age at baseline    
2. Change from baseline in total daily insulin (TDI) (units) for participants <18 years 
of age at baseline     
3. Change from baseline in total daily insulin (TDI) (units) for participants ≥18 years 
of age at baseline    
4. Change from baseline in Body Mass Index (BMI) z-score for participants <18 
years of age at baseline   
5. Change from baseline in Body Mass Index (BMI) (kg/m²) for participants ≥18 
years of age at baseline    
 
Family #4: Questionnaires  
1. Change from baseline in PSQI total score for caregivers of pediatric subjects 
2. Change from baseline in PSQI total score for caregivers of teen subjects 
3. Change from baseline in PSQI total score for teen subjects 
4. Change from baseline in PSQI total score for adult subjects 
5. Change from baseline in PSQI overall sleep quality subscale for caregivers of 
pediatric subjects 
6. Change from baseline in PSQI overall sleep quality subscale for caregivers of 
teen subjects 
7. Change from baseline in PSQI overall sleep quality subscale for teen subjects 
8. Change from baseline in PSQI overall sleep quality subscale for adult subjects 
9. Change from baseline in PSQI sleep duration subscale for caregivers of pediatric 
subjects 
10. Change from baseline in PSQI sleep duration subscale for caregivers of teen 
subjects 
11. Change from baseline in PSQI sleep duration subscale for teen subjects 
12. Change from baseline in PSQI sleep duration subscale for adult subjects 
13. Change from baseline in HCS total score for caregivers of pediatric subjects 
14. Change from baseline in HCS total score for caregivers of teen subjects 
15. Change from baseline in HCS total score for teen subjects 
16. Change from baseline in EQ-5D-3L VAS score      
17. Change from baseline in DQOL Brief for adult subjects 
18. Change from Baseline in SUS for caregivers of pediatric subjects (Omnipod 5 
Only) 
19. Change from Baseline in SUS for caregivers of teen subjects (Omnipod 5 Only) 
20. Change from Baseline in SUS for teen subjects (Omnipod 5 Only) 

 
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21. Change from Baseline in SUS for adult subjects (Omnipod 5 Only) 
22. Days missed from work or left early/late for adults 
23. Days missed from school or left early/late for teenagers 
24. Days missed from work or left early/late for caregivers of teenagers 
25. Days missed from work or left early/late for caregivers of children 
26. Proportion of participants achieving a Total Score > 5 (Poor Sleepers) on the 
PSQI questionnaire at 13 weeks. 
27. Proportion of participants achieving a minimally clinically important difference 
(MCID) of ≥0.19 points (improvement) on the T1-DDS questionnaire total score 
at 13 weeks. 
28. Proportion of participants achieving MCID score of ≥ 3 on the HCS questionnaire 
at 13 weeks for participants ≥18 years of age at baseline    
 
5.2.1.2 Period 1 – 13-week Extension Period 
Exploratory endpoints for Extension Period 1 will be evaluated at the end of the 13-week 
Extension Period and compared to the start of the Omnipod 5 System use, either at the 
end of 26 weeks for the Intervention group as compared to baseline, or at the end of 26 
weeks compared to the end of 13-week randomized period for the Control group. 
Continuous endpoints will be analyzed using a paired t-test between the start and end of 
Omnipod 5 System use within each group separately. Normality of the differences will be 
assessed, and if the data are highly skewed, the Wilcoxon Signed-Rank Test will be 
employed as a non-parametric alternative. Binary endpoints will be evaluated using 
McNemar’s Test to assess paired proportions.  
No imputation for missing data will be performed for the analysis of 13-week extension 
endpoints. No control for multiplicity testing will be performed; all p-values will be 
considered exploratory. 
5.2.2 Episodes of Severe Hypoglycemia and Diabetic Ketoacidosis 
The number of severe hypoglycemia and DKA (diabetic ketoacidosis) adverse events, 
and the number and percent of subjects with at least one event in each group will be 
summarized. 
As the number of episodes (events) of severe hypoglycemia and DKA are of significant 
interest, statistical testing will be performed for the rate of SH (and DKA) if there are ≥5 
events (of SH or DKA, respectively) combined across both treatment groups. The rates 
will be calculated as the number of events per 100 person years. The rates will be 
compared using a Poisson regression with site as a random effect. The amount of follow-
up will be included as an offset term. If there are concerns with model convergence (e.g., 
due to zero events in one group), Fisher’s exact test for the number of events will be used 
instead.  

 
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6 
ANALYSIS OF SAFETY 
All adverse events reported during the study will be reviewed and adequately reported to 
comply with applicable regulations. All reportable AEs will be assessed by the 
investigator who will determine whether the event is related to the study procedures or 
related to the study device and whether the event meets any of the criteria for 
seriousness. The event will be considered serious if the event meets at least one criterion 
for seriousness. All safety analyses will be based on the mITT analysis set. 
6.1 MEDICAL MONITOR 
A Medical Monitor will be responsible for individual and timely review of adverse events, 
including serious adverse events (SAEs) and adverse device events. The Medical 
Monitor will conduct adjudication of any events of Diabetic Ketoacidosis (DKA) or Severe 
Hypoglycemia (SH) or any additional events as requested by the Sponsor. The specified 
events will be adjudicated to determine event relatedness to the study procedures and/or 
the devices (participant’s own insulin pump, study CGM and Omnipod 5), and whether 
an adverse event is unanticipated. The adjudication decision of the Medical Monitor will 
be used for the final classification of events, including relatedness to the study 
procedures and/or the devices, for the determination of safety endpoints and for all 
regulatory reports, product labeling, and publications or presentations. 
6.2 RELATIONSHIP TO STUDY DEVICE AND PROCEDURE 
The causal relationship to the study procedures and the investigational device for each 
adverse event will be rated as follows: 
• Unrelated: The event is not related to the procedures or the investigational device.  
• Possibly Related: The temporal sequence is such that the relationship is not 
unlikely or there is no contradicting evidence that can reasonably explain the 
participant’s condition. There is a possibility of any relation between the event and 
the procedures or the devices.  
• Related: The temporal sequence is relevant, or the event abates upon completion 
of the procedure/ use of devices, or the event cannot be reasonably explained by 
the participant’s condition or comorbidities. The event is related or most likely 
associated with the procedures or the devices. 
• Causal Relationship: The serious event is associated with the investigational 
device or with procedures beyond reasonable doubt. 
For the purposes of dichotomizing the causal relationship in safety summaries, events 
that are “Related”, “Possibly Related” or have a “Causal Relationship” will be considered 
related.  
6.3 SEVERITY 
The severity of the adverse event will be rated based upon the following grades: 

 
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• Mild: Usually transient, requires no special treatment, and does not interfere with 
the participant’s daily activities. 
• Moderate: Usually causes a low level of inconvenience, discomfort or concern to 
the participant and may interfere with daily activities but is usually ameliorated by 
simple therapeutic measures and participant is able to continue in study. 
• Severe: Interrupts a participant’s usual daily activities, causes severe discomfort, 
may cause discontinuation of study device, and generally requires systemic drug 
therapy or other treatment. 
6.4 OUTCOME 
The outcome of each reportable adverse event will be classified by the investigator as 
follows: 
• Recovered/Resolved: The participant recovered from the AE/SAE without 
sequelae. 
• Recovered/Resolved with Sequelae: The event persisted and had stabilized 
without further anticipated change in the event status. 
• Fatal: A fatal outcome is defined as the SAE that resulted in death. Only the event 
that was the cause of death should be reported as fatal. AEs/SAEs that were 
ongoing at the time of death; however, were not the cause of death, will be 
recorded as “resolved” at the time of death. 
• Not Recovered/Not Resolved (Ongoing): An ongoing AE/SAE is defined as the 
event was ongoing with an undetermined outcome. 
o An ongoing outcome will require follow-up by the site in order to determine 
the final outcome of the AE/SAE or until participant completes the study. 
o The outcome of an ongoing event at the time of death that was not the 
cause of death, will be updated and recorded as “resolved” with the date of 
death recorded as the stop date. 
• Unknown: An unknown outcome is defined as an inability to access the participant 
or the participant’s records to determine the outcome (for example, a participant 
that was lost to follow-up). 
If any  Unanticipated Adverse Device Effects (UADEs) are ongoing when a participant 
completes the study (or withdraws), the participant will continue to be followed until the 
event resolves or has no prospect of improvement or change, even after the participant 
has completed all applicable study visits/contacts, unless that participant has withdrawn 
their consent. For all other reportable adverse events, data collection will end at the time 
the participant completes the study.  
Note: Participants should continue to receive appropriate medical care for an adverse 
event after their participation in the study ends. 

 
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6.5 ANALYSIS OF ADVERSE EVENTS 
All adverse events reported over the course of the study will be summarized and 
tabulated by study phase (standard therapy through end of study), event category, 
seriousness, severity, and relationship to the study procedure and the devices. For the 
purposes of summarization, an event will be considered “Related” if the relationship was 
deemed as “Possibly Related”, “Related” or have a “Causal Relationship”. In cases where 
the same event is reported more than once per participant, the event will only be counted 
once in the incidence table(s). 
Adverse events leading to death or to discontinuation from the study will be listed 
separately. A listing of all adverse events will be provided. Adverse events reported for 
subjects excluded from mITT will be listed separately. 
6.6 EVALUATION OF DEVICE DEFICIENCIES 
Device deficiencies will be tabulated and listed in a manner similar to the methods 
described for adverse events. Any device deficiency with potential to cause a Serious 
Adverse Event, leading to an adverse event, or leading to study termination will be listed 
separately. 
7 
GENERAL STATISTICAL CONSIDERATIONS 
7.1 VISIT AND ANALYSIS WINDOWS 
CGM data will be included in the analysis through the specific visit as reported on the 
appropriate eCRF, and not necessarily through the optimal visit date. The nominal visit 
interval as reported on the appropriate eCRF will be used for analysis of HbA1c, PROs, 
and other outcomes recorded or collected during the office/telephone visits. Missing 13-
week HbA1c and PRO data can be included in the analysis as long as the data was 
collected within the specific analysis window (as further described in Section 7.6 of this 
document). 
7.2 ANALYSIS SETS 
The following analysis sets are planned for the study:   
7.2.1 ITT (Intention to Treat) Analysis Set 
The ITT analysis set includes all participants that are enrolled in the study. 
7.2.2 mITT (modified Intention to Treat) Analysis Set 
The modified Intention to Treat (mITT) analysis set is a subset of the ITT analysis set. 
The mITT analysis set will consist of all participants who have been randomized. The 
mITT analysis set will be used as the primary analysis for the primary, secondary and 
endpoints and for other clinical outcome data. 

 
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7.2.3 PP (Per Protocol) Analysis Set 
The Per-Protocol (PP) analysis set is a subset of the mITT analysis set. Participants will 
be included in the PP analysis set if they have a minimum of 70% system use as 
measured by the study sensor (Control group) or Omnipod 5 (Intervention group) during 
the 13-week randomization period over a minimum duration of 10 weeks and have 
completed the study without major protocol deviations. The PP analysis set will be used 
as supportive analysis for the endpoints. 
To meet the minimum data requirement for inclusion in the PP analysis set, the subject 
must meet both of the following criteria: 
1. Minimum duration of randomized period of 10 weeks (70 days); see Section 
7.5.2 for calculation of non-CGM derived randomized period 
2. ≥70% of system use during the randomized period; this is calculated as 
o For subjects randomized to Omnipod 5: 
 
(
௡௨௠௕௘௥ ௢௙ ை௉5 ௥௘௖௢௥ௗ௦
288
) ÷ (݈݁݊݃ݐℎ ݋݂ ݊݋݊−𝐶ܩܯ ݎܽ݊݀݉݅ݖ݁݀ ݌݁ݎ݅݋݀ ݅݊ ݀ܽݕݏ) ≥0.7  
 
o For subjects randomized to Control: 
 
(
௡௨௠௕௘௥ ௢௙ ௅௜௕௥௘ ௥௘௖௢௥ௗ௦
96
) ÷ (݈݁݊݃ݐℎ ݋݂ ݊݋݊−𝐶ܩܯ ݎܽ݊݀݉݅ݖ݁݀ ݌݁ݎ݅݋݀ ݅݊ ݀ܽݕݏ) ≥0.7  
 
For Omnipod 5, all records inclusive of error codes are included.  
The following will be considered major protocol deviations: 
• Major inclusion/exclusion criterion deviation 
• Significant protocol non-compliance that may confound the study objective data 
(e.g., use of prohibited medications, not using control group (MDI therapy) for 
prolonged period)  
The list of participants excluded from the PP analysis set will be determined prior to 
analysis. If the PP analysis set does not differ from the mITT analysis set, separate 
analyses will not be presented. 
7.3 CONTROL OF SYSTEMATIC BIAS 
Several measures are incorporated into the study design to help minimize study bias as 
follows: 
1) This is a prospective, randomized, parallel-group multi-center study to help ensure 
that investigator or site or subject enrollment bias is minimized. Selection of 

 
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participants will be made from the Investigator’s usual subject load. Consecutively 
eligible subjects should be enrolled into the study. 
2) This document specifies appropriate statistical methodology to ensure that bias is 
minimized.  
3) The effectiveness measures will be based on the direct output from the device or 
are analyzed at a National Glycohemoglobin Standardization Program (NGSP) 
certified central laboratory, ensuring objective reporting.  
4) A Medical Monitor will adjudicate all SAEs and device-related adverse events to 
ensure consistency across all evets; the Medical Monitor’s assessment of adverse 
events will be used for regulatory reports, product labeling, and publications or 
presentation. 
7.4 CALCULATION OF ENDPOINT OUTCOMES 
7.4.1 Change from Baseline in HbA1c  
Change from baseline in HbA1c at 13 weeks will be compared between groups. The 
data will be collected at Visit 1 (Screening) and at Visit 9 (13 weeks), as well as Visit 15 
(Day 180 during the extension phase). Change from baseline in HbA1c is calculated as 
follows: 
𝐶ℎܽ݊݃݁ ݂ݎ݋݉ ܤܽݏ݈݁݅݊݁ ݅݊ ܪܾܣ1ܿ= ܪܾܣ1ܿ (݂݋݈݈݋ݓ−ݑ݌) − ܪܾܣ1ܿ (ܸ݅ݏ݅ݐ 1) 
7.4.2 Calculation of Percentage of Time 
Several effectiveness endpoints involve calculation of percentage of time in a specific 
glycemic range. These endpoints will be based on the direct output from a device, either 
the Continuous Glucose Monitoring (CGM) device (Abbott FreeStyle Libre 2 Glucose 
Sensor, “FreeStyle Libre 2”) or Omnipod 5. The percentage of time in a specified range 
(e.g., TIR) will be calculated per participant as follows: 
100 × # ݋݂ 𝐶ܩܯ ݎ݁ܽ݀݅݊݃ݏ ݅݊ ܽ ݏ݌݂݁ܿ݅݅݁݀ ݎܽ݊݃݁ 
# ݋݂ ݁ݒ݈ܽݑܾ݈ܽ݁ 𝐶ܩܯ ݎ݁ܽ݀݅݊݃ݏ
 
The following CGM readings will be excluded from analysis, and therefore, from 
calculation of TIR endpoints: 
• No glucose value is provided in the device output, such as due to an error or device 
deficiency during which the device does not record glucose readings 
• CGM readings reported prior to start of the applicable period, or after the end of 
the applicable period (e.g., no readings prior to start of the randomized period will 
be included in the analysis of TIR during randomized period) 
7.4.3 Change from Baseline in Body Mass Index (BMI) 
Change from Baseline in BMI at 13 weeks will be compared between groups. Height is 
collected at Visit 1 (Screening); weight is collected at Visit 1 and at Visit 9 (13 weeks). 
Change in BMI is calculated as follows: 

 
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𝐶ℎܽ݊݃݁ ݂ݎ݋݉ ܤܽݏ݈݁݅݊݁ ݅݊ ܤܯܫ=  ܤܯܫ (13 ݓ݁݁݇ݏ) −ܤܯܫ (ܸ݅ݏ݅ݐ 1) 
where BMI at baseline (Visit 1) is calculated as: 
ܤܯܫ (ܸ݅ݏ݅ݐ 1) = ܹ݁݅݃ℎݐ ܽݐ ܸ݅ݏ݅ݐ 1 (݇݃)
(ܪ݁݅݃ℎݐ ܽݐ ܸ݅ݏ݅ݐ 1 (݉))2 
and BMI at 13 weeks (Visit 9) is calculated as: 
ܤܯܫ (13 ݓ݁݁݇ݏ) = ܹ݁݅݃ℎݐ ܽݐ 13 ݓ݁݁݇ݏ (݇݃)
(ܪ݁݅݃ℎݐ ܽݐ ܸ݅ݏ݅ݐ 1 (݉))2  
If a subject’s weight is reported in pounds, the following conversion will be performed: 
ܹ݁݅݃ℎݐ (݇݃) = ܹ݁݅݃ℎݐ (݈ܾݏ)
2.2
 
If a subject’s height is reported in inches, the following conversion will be performed: 
ܪ݁݅݃ℎݐ (݉) = ܪ݁݅݃ℎݐ (݅݊) ∗2.54
100
 
BMI for children (age <18 years) will be converted to z-score based on the SAS 
program provided by the U.S. Center for Disease Control and Prevention (CDC)6. 
7.4.4 Change from Baseline in Total Daily Insulin (TDI) 
Change from Baseline in TDI (units/kg) at the end of the 13-week randomized period 
will be compared between groups. The insulin requirements will be collected at Visit 2 
(Standard Therapy) and at Visit 9 (13 weeks randomized period), and change in TDI 
will be calculated as follows: 
ܶܦܫ (ܿℎܽ݊݃݁ ݂ݎ݋݉ ܤܽݏ݈݁݅݊݁, ݑ݊݅ݐݏ/݇݃) = ܶܦܫ (13 ݓ݁݁݇ݏ) −ܶܦܫ (ܸ݅ݏ݅ݐ 2)
ݏݑܾ݆݁ܿݐ′ݏ ݓ݁݅݃ℎݐ ܽݐ ܸ݅ݏ݅ݐ 1
 
7.4.5 Additional CGM-Derived Endpoints 
Additional CGM-derived endpoints, such as coefficient of variation (CV), percentage of 
time >250 mg/dL, percentage of time <54 mg/dL, TIR during daytime and nighttime 
hours will be compared between groups at the end of the 13-week randomized period.  
CV is calculated per subject as follows, then summarized and compared between 
groups: 
𝐶ܸ(%) = ܵܦ ݋݂ ݈݃ݑܿ݋ݏ݁
݉݁ܽ݊ ݈݃ݑܿ݋ݏ݁ 
 
 
6  The SAS Program for CDC Growth Charts that Includes the Extended BMI Calculations. 
https://www.cdc.gov/nccdphp/dnpao/growthcharts/resources/sas.htm 

 
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7.4.6 Hypoglycemia and Hyperglycemia Events 
7.4.6.1 Down-Sampling 
The number of hypoglycemia and hyperglycemia events will be based on the data 
obtained from the glucose sensor. As the Libre device reports glycemic values 
every ~15 minutes, and the Omnipod 5 device reports glycemic values every ~5 
minutes, the glycemic readings obtained from Omnipod 5 will be “down-sampled” 
to match the frequency of readings from the Libre device. This “down-sampling” 
will only be applied for the calculation of the number of hyperglycemia and 
hypoglycemia events; all Omnipod 5 readings will be used in the assessment of 
other glycemic measures. 
The “down-sampling” of Omnipod 5 data will be performed as follows: 
1. The readings within the relevant analysis period (e.g., randomized period) are 
sorted by local time for each subject. 
2. The first reading for the subject will be included in analysis. 
3. The time of the second reading will be compared to the time of the first reading 
that was included in analysis. 
a. If the readings are <13 minutes apart, the second reading will not be 
included in analysis. 
b. If the readings are ≥13 minutes apart, the second reading will be 
included in analysis. 
4. The time of the third reading will be compared to the time of the most recent 
reading that was included in analysis. 
a. If the readings are <13 minutes apart, the third reading will not be 
included in analysis. 
b. If the readings are ≥13 minutes apart, the third reading will be included 
in analysis. 
 
This process will continue until all Omnipod 5 readings from the relevant analysis 
period have been assessed for inclusion in analysis. Allowing each subsequent 
Omnipod 5 reading to be no less than 13 minutes from the previous reading that 
is included in analysis will ensure the same frequency of reported values between 
the two devices. 
7.4.6.2 Number of Hypoglycemia Events 
This endpoint will be assessed separately using <70 mg/dL and <54 mg/dL as 
definitions of hypoglycemia for ≥ 15 minutes. Therefore, a hypoglycemia event will 
be recorded if two consecutive readings are in hypoglycemic range (either <70 
mg/dL or <54 mg/dL, depending on endpoint) with the difference between the two 
readings 13-17 minutes, inclusive. The subject will be eligible for a new event 
when no hypoglycemia readings have occurred for 41 minutes (equivalent to two 
consecutive readings above the hypoglycemia range).  

 
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7.4.6.3 Number of Hyperglycemia Events 
This endpoint is defined as glucose sensor values ≥300 mg/dL for ≥1 hour. 
Therefore, a hyperglycemia event will be recorded if four consecutive readings are 
in hyperglycemic range (≥300 mg/dL) with the difference between the first and the 
last reading 56-64 minutes, inclusive. The subject will be eligible for a new event 
when no hyperglycemia readings have occurred for 71 minutes (equivalent to four 
consecutive readings below the hyperglycemia range). 
7.5 LENGTH OF STUDY PERIODS 
For certain analysis, it may be needed to calculate the length of the study period. The 
length of study period is calculated as the difference between the start and the end of 
study period. CGM derived and Non-CGM derived endpoints will require different 
definitions for start and end of study periods based on the availability of data collected. 
Start and end of study periods period are defined below.  
7.5.1 CGM Endpoints 
CGM data are collected continuously throughout the study. 
The period for CGM data collection is defined as follows for the subjects in the 
Intervention group: 
Period 
Start Date/Time 
End Date Time 
13-week randomized 
period (Period 1) 
• 
Earlier of the first non-error CGM 
reading using Omnipod 5, or 
Date/Time participant entered 
automated mode at Visit 4. 
• 
Subjects continuing into 13-week 
extension. 
o 
Noon on the day of Visit 9 
• 
Subjects not continuing into 13-week 
extension. 
o 
Earlier of (1) the last non-error 
CGM reading using Omnipod 5, on 
or prior to the date the Controller 
was returned to the site, or (2) the 
last non-error CGM reading using 
Omnipod 5 on the date of study 
exit visit (Visit 9). 
13-week extension 
(Period 1) 
• 
One second after noon (12:00:01) 
on the day of Visit 9  
• 
Subjects continuing into  extension 
through commercialization 
o 
Noon on the day of Visit 15 
• 
Subjects not continuing into  extension 
through commercialization 
o 
Earlier of (1) the last non-error CGM 
reading using Omnipod 5, on or 
prior to the date the Controller was 
returned to the site, or (2) the last 
non-error CGM reading using 
Omnipod 5 on the date of study exit 
visit (Visit 15) 
Extension through 
commercialization 
(Period 2) 
• 
One second after noon (12:00:01) 
on the day of Visit 15 
• 
Earlier of (1) the last non-error CGM 
reading using Omnipod 5, on or prior to 
the date the Controller was returned to 
the site, or (2) the last non-error CGM 

 
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Period 
Start Date/Time 
End Date Time 
reading using Omnipod 5 on the date of 
study exit visit  
 
The period for CGM data collection is defined as follows for the subjects in the Control 
group: 
Period 
Start Date/Time 
End Date Time 
13-week 
randomized period 
(Period 1) 
• 
Noon on the day of Visit 4 
• Subjects continuing into 13-week 
extension. 
o 
The last CGM reading using 
Libre sensor prior to the start 
of the 13-week extension. 
• Subjects not continuing into 13-
week extension. 
o 
The last CGM reading using 
Libre sensor on the date of 
study exit visit (Visit 9) 
13-week extension 
(Period 1) 
• 
Earlier of (1) the first non-error CGM 
reading using Omnipod 5, or (2) 
Date/Time participant entered 
automated mode at Visit 10 
• 
Subjects continuing into extension 
through commercialization 
o 
Noon on the day of Visit 15 
• 
Subjects not continuing into 
extension through 
commercialization 
o 
Earlier of (1) the last non-error 
CGM reading using Omnipod 5, 
on or prior to the date the 
Controller was returned to the 
site, or (2) the last non-error 
CGM reading using Omnipod 5 
on the date of study exit visit 
(Visit 15) 
Extension through 
commercialization 
(Period 2) 
• 
One second after noon (12:00:01) on the 
day of Visit 15 
• 
Earlier of (1) the last non-error CGM 
reading using Omnipod 5, on or 
prior to the date the Controller was 
returned to the site, or (2) the last 
non-error CGM reading using 
Omnipod 5 on the date of study exit 
visit 
 
7.5.2 Non-CGM Endpoints 
Start and end of study periods for non-CGM endpoints (e.g., HbA1c, safety analyses) will 
be based on the protocol definitions for start of study periods regardless of randomization 
(or treated) arm. Start and end of study periods period are defined below. 
Period 
Start Date/Time 
End Date Time 
13-week randomized 
period (Period 1) 
• 
Date of Visit 3. 
• 
Date of Visit 9. 
13-week extension 
(Period 1) 
• 
1 day following Date of Visit 9. 
• 
Date of Visit 15. 

 
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Period 
Start Date/Time 
End Date Time 
Extension through 
commercialization 
• 
1 day following Date of Visit 15. 
• 
Date of Study Exit Visit 
 
7.6 HANDLING OF MISSING DATA 
7.6.1. Missing Data Handling for HbA1c/PRO 
It is likely that at least some participants do not contribute data for the primary endpoint 
(change in HbA1c) or patient-reported outcome endpoints (e.g., due to early withdrawal). 
For the main analysis of change in HbA1c/PRO, missing values for the participants in the 
mITT analysis set will be imputed as follows:  
• If a participant withdrew from the study early and provided HbA1c/PRO value 
collected within 13±2 weeks from start of the 13-week randomized period, the last 
known HbA1c/PRO values will be imputed for change in HbA1c/PRO data 
endpoint.  
• If a participant is confirmed to have withdrawn early from the study due to 
unsatisfactory treatment or potential loss of efficacy outside of the 13±2 weeks 
window, the change in HbA1c/PRO data endpoint will be assumed to be zero (e.g., 
no change). 
• If a participant does not provide a value for change in HbA1c/PRO for other reason 
(e.g., lost sample, participant lost to follow-up), the change in HbA1c/PRO data 
endpoint will be imputed using multiple imputation.  
Missing data will be handled using multiple imputation assuming missing at random 
(MAR). The imputation model will include change from baseline for the PRO score or 
HbA1c value at 13 weeks, treatment group, baseline value, age, sex, and duration of 
diagnosis. Multiple imputation will involve the following steps: 
1. Generate 100 imputed data sets.  
2. Fit the mixed effects linear regression model on each imputed dataset. Calculate 
the point estimate and standard error of the treatment group difference for each 
imputed dataset. 
3. Pool the estimates across imputations to get an overall point estimate and 
confidence interval for the treatment group difference. 
7.6.2. Missing Data Handling for CGM-derived Endpoints 
Due to the nature of the data and study design, it is anticipated that all randomized 
participants will contribute at least some sensor data post-randomization. Hence, it is 
possible that there will be no need for imputation of missing values for these endpoints. 

 
Omnipod 5 RADIANT Study 
Statistical Analysis Plan 
 
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Rev 2.0 
 
All randomized participant s (i.e., mITT analysis set) will provide an endpoint value for all 
secondary sensor-derived endpoints as follows:  
• If a randomized participant provides at least seven days’ worth of sensor readings 
(2,016 readings for Omnipod 5 system; and 672 readings for Libre sensor for 
Control subjects) during both the standard therapy and 13-week randomized 
period, all the available sensor readings will be collapsed (averaged) for a per-
participant value for a specific CGM-derived endpoint. 
 
• If a randomized participant does not provide at least seven days’ worth of sensor 
readings (2,016 readings for Omnipod 5 system; and 672 readings for Libre sensor 
for Control subjects) during both the standard therapy and 13-week randomized 
period, the sensor readings for that participant will be excluded from analysis, and 
instead, a per-participant value for a specific CGM-derived endpoint will be 
handled as described in Section 5.1.2. 
Gaps in sensor data, such as due to loss of signal, will not be imputed. Sensor values 
missing for other reasons will not be imputed. No additional imputations for missing data 
are planned for the endpoints involving sensor data.  
No imputation for missing data is planned for the analysis of extension period endpoints 
or summaries. 
7.7 PATIENT-REPORTED OUTCOMES 
The following questionnaires will be used to evaluate general and disease and disease-
specific quality of life, and device usability.  
Type 1-Diabetes Distress Scale (T1-DDS) 
The T1-DDS is a 28-item self-report instrument. Each item is rated on a 6-point scale 
from (1) “not a problem” to (6) “a very serious problem.” The scale yields an overall 
distress score based on average responses along the 1-6 scale for all 28 items (range = 
1-6). The scale also yields a score for each of seven subscales based on the average 
response on all of the items in that subscale (range = 1-6) 7. 
T1-DDS is collected from adult subjects (aged 18-70 years) at Baseline (Visit 3) as well 
as at the end of 13 weeks (Visit 9), end of the extension period 1 (Visit 15), and end of 
extension period 2. 
Hypoglycemia Confidence Scale (HCS) 
 
 
7 L. Fisher, W. H. Polonsky, D. M. Hessler, U. Masharani, I. Blumer, A. L. Peters, L. A. Strycker and V. 
Bowyer, "Understanding the sources of diabetes distress in adults with type 1 diabetes," J Diabetes 
Complications, vol. 29, no. 4, pp. 572-7, 2015. 

 
Omnipod 5 RADIANT Study 
Statistical Analysis Plan 
 
Page 40 of 43 
Rev 2.0 
 
The HCS is a nine-item self-report scale that examines the degree to which people with 
diabetes feel able, secure, and comfortable regarding their ability to stay safe from 
hypoglycemic-related problems. Each item is rated on a 4-point scale from (1) “not 
confident at all” to (4) “very confident”. The total score is calculated as the sum of each 
item divided by the number of items completed 8. 
HCS is collected from subjects aged 12-70 years, and from caregivers of children aged 
4 to <18 years at Baseline (Visit 3) as well as at the end of 13 weeks (Visit 9), end of the 
extension period 1 (Visit 15), and end of extension period 2.  
Pittsburgh Sleep Quality Index (PSQI) 
The PSQI is used to measure the quality and patterns of sleep, by measuring seven 
domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, 
sleep disturbances, use of sleep medication, and daytime dysfunction over the last 
month. Responses are converted to a 0 to 3 scale, with higher scores indicating more 
negative quality of sleep. A global sum of >5 indicates a “poor” sleeper. The PSQI global 
score is calculated as the sum of the seven component scores 9 .  
PSQI is collected from subjects aged 12-70 years, and from caregivers of children aged 
4 to <18 years at Baseline (Visit 3) as well as at the end of 13 weeks (Visit 9) and at the 
end of the extension period 1 (Visit 15).  
EQ-5D-3L 
The EQ-5D-3L is a short, generic, validated quality-of-life instrument used to measure 
health outcomes. It consists of five dimensions (questions) regarding mobility, self-care, 
usual activities, pain/discomfort and anxiety/depression, and one visual analog scale to 
measure the subject’s self-rated health. Each of the five dimensions is divided into three 
levels of perceived problems: Level 1 indicating no problem, Level 2 indicating some 
problems, and Level 3 indicating extreme problems. Responses to five dimensions can 
be converted into a single summary index score 10. Both, subject-completed version and 
proxy version, will be used in this study. 
EQ-5D-3L, either subject-completed or proxy version, is collected from subjects aged 16-
70 years, and from caregivers of children aged 4 to <18 years at Baseline (Visit 3) as well 
as at the end of 13 weeks (Visit 9) and at the end of the extension period 1 (Visit 15).  
 
 
8 W. H. Polonsky, L. Fisher, D. Hessler and S. V. Edelman, "Investigating Hypoglycemic Confidence in 
Type 1 and Type 2 Diabete," Diabetes Technol The, vol. 19, no. 1, pp. 1-6, 2017. 
9 D. Buysse, C. Reynolds, T. Monk, S. Berman and D. Kupfer, "The Pittsburgh Sleep Quality Index: a 
new instrument for psychiatric practice and research," Psychiatry Res, vol. 28, no. 2, pp. 193-213, 1989. 
10 R. Rabin and F. D. Charro, "EQ-SD: a measure of health status from the EuroQol Group," Annals of 
Medicine, vol. 33, no. 5, pp. 337-343, 2001. 

 
Omnipod 5 RADIANT Study 
Statistical Analysis Plan 
 
Page 41 of 43 
Rev 2.0 
 
The EQ VAS records the subject’s self-rated health on a 0 to 100 scale. Missing values 
in the EQ VAS should be coded as “999” and ambiguous values (e.g., the line crosses 
the scale twice) should be treated as missing values. 
Diabetes Quality of Life-brief (DQOL-brief) 
The DQOL-brief is a 15-item instrument that provides a total quality-of-life score11. Each 
item is rated on a 5-point scale from (1) “Very Dissatisfied” or “All the Time” to (5) “Very 
Satisfied” or “Never.” Respondents must answer at least ten (two thirds) questions to be 
included in the analysis. The DQOL total score is calculated by summing the scores for 
all items and dividing by the numbers of responses answered. Higher scores indicate a 
more positive quality of life.  
DQOL-brief is collected from adult subjects (aged 18-70 years) at Baseline (Visit 3) as 
well as at the end of 13 weeks (Visit 9), end of the extension period 1 (Visit 15), and end 
of the extension period 2. 
Clarke Hypoglycemia Awareness 
Clarke Questionnaire is an eight-item questionnaire to assess reduced awareness of 
hypoglycemia12. Responses to each item are scored as “A” or “R” (or “U” which is equal 
to four “R” responses). Total of four or more “R” responses are considered to indicate 
reduced awareness. Generally, no missing data imputation will be performed, but it is 
possible in certain cases to determine whether or not a participant has reduced 
awareness, even in the presence of missing responses (e.g., participant is missing a 
single response, but if the participant only has two “R” responses for the remaining 
seven items, it can be concluded that the participant does not have reduced awareness 
since adding another “R” response would result in fewer than four “R”s). 
Clarke Questionnaire is collected from subjects aged 12-70 years, and from caregivers 
of children aged 4 to <12 years at Baseline (Visit 3) as well as at the end of 13 weeks 
(Visit 9) and end of the extension period 1 (Visit 15).  
System Usability Scale (SUS) 
The SUS is a 10-item questionnaire constructed on a 5-point Likert scale, with 
responses ranging from (1) “Strongly disagree” to (5) “Strongly agree”13. It is not 
recommended that the individual items be scored, but rather a single composite 
 
 
11 Thomas E. Burroughs, Radhika Desikan, Brian M. Waterman, Debra Gilin, Janet McGill; Development 
and Validation of the Diabetes Quality of Life Brief Clinical Inventory. Diabetes Spectr 1 January 2004; 17 
(1): 41–49. https://doi.org/10.2337/diaspect.17.1.41 
12 Clarke WL, Cox DJ, Gonder-Frederick LA, Julian D, Schlundt D, Polonsky W. Reduced awareness of 
hypoglycemia in adults with IDDM. A prospective study of hypoglycemic frequency and associated 
symptoms. Diabetes Care. 1995 Apr;18(4):517-22. doi: 10.2337/diacare.18.4.517. PMID: 7497862. 
13 Brooke, John (1996). "SUS: a "quick and dirty" usability scale". In P. W. Jordan; B. Thomas; B. A. 
Weerdmeester; A. L. McClelland (eds.). Usability Evaluation in Industry. London: Taylor and Francis. 

 
Omnipod 5 RADIANT Study 
Statistical Analysis Plan 
 
Page 42 of 43 
Rev 2.0 
 
measure of the overall usability of the system should be reported. The SUS score 
ranges from 0 to 100, and is calculated as follows: 
1. For items 1, 3, 5, 7, and 9, subtract 1 from the reported score 
2. For items 2, 4, 6, 8, and 10, the contribution equals 5 minus the reported score 
3. Sum the contributions (each will range from 0 to 4), multiply by 2.5 
SUS is collected from subjects aged 12-70 years, and from caregivers of children aged 
4 to <12 years at Baseline (Visit 3) as well as Visit 8 and Visit 14.  
Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) 
The INSPIRE for adults is a 22-item validated questionnaire to evaluate the impact of 
automated insulin dosing (AID) systems on the psychosocial functioning and quality of 
life (QoL) of individuals with Type 1 diabetes14. Each item is rated on a six-point scale, 
from strongly disagree (score=0) or not applicable, to strongly agree (score=4). Mean 
score is calculated based on answered responses, then multiplied by 25. The final 
score will range from 0 to 100, with higher scores indicating more positive appraisal of 
the AID.  
INSPIRE is collected from subjects aged 8-70 years, and from caregivers of children 
aged 4 to <18 years at Baseline (Visit 3) as well as Visit 8 and Visit 14.  
Patient Health Questionnaire-2 (PHQ-2) 
The Patient Health Questionnaire-2 (PHQ-2) is a self-administered questionnaire about 
the frequency of depressed mood and anhedonia over the past two weeks. The PHQ-2 
score is obtained by adding the score for each question (total points), with a score 
ranging from 0 to 615. Its purpose is not to establish final diagnosis or to monitor 
depression severity, but rather to screen for depression.  The authors identify a cut-off 
score of 3 as the optimal cut point for screening purposes. 
PHQ-2 is collected from subjects aged 12-70 years at Baseline (Visit 3) as well as at the 
end of 13 weeks (Visit 9) and end of the extension period 1 (Visit 15).  
7.8 OTHER DATA SUMMARIES 
The distribution of each baseline characteristic or demographic parameter of interest 
(such as age, sex, medical history, etc.) will be presented. Data on all enrolled subjects 
and subjects included in mITT analysis set will be presented. Continuous variables will 
be summarized using count, mean, median, standard deviation, and range. Categorical 
variables will be summarized using counts and percentages. 
 
 
14 https://www.researchintorecovery.com/measures/inspire/ 
15 Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: Validity of a Two-Item 
Depression Screener. Medical Care. 2003;41:1284-92. 

 
Omnipod 5 RADIANT Study 
Statistical Analysis Plan 
 
Page 43 of 43 
Rev 2.0 
 
7.9 STATISTICAL SOFTWARE 
The statistical software package SAS® 9.4 or later will be used for all the data 
derivations, summarization, data listings and statistical analyses. Additional statistical 
software may be used for graphics or validation purposes as appropriate. 

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