Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes
Phase: NA
Conditions: Type1diabetes
Sponsor: Tandem Diabetes Care, Inc.

 
 
Open, Single Arm, Prospective, Multicenter Study of an 
Investigational Extended Wear Insulin Infusion Set During 
Home Use in People with Type 1 Diabetes 
Protocol Identifying Number: 150-1261-00 
IDE Sponsor: Capillary Biomedical 
Version Number: v.5.0 
08 February 2024 
CONFIDENTIAL 
 
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CAPILLARY BIOMEDICAL 150-1261-00 CB1 PROTOCOL V5.0 
CONFIDENTIAL 
PAGE 2 OF 59 
Signature Page 
Open, Single Arm, Prospective, Multicenter Study of an 
Investigational Extended Wear Insulin Infusion Set During 
Home Use in People with Type 1 Diabetes 
Protocol Identifying Number: 150-1261-00 
IDE Sponsor: Capillary Biomedical 
Version Number: v.5.0 
 08 February 2024 
 
JCHR Protocol Director 
 
Name, degree 
John Lum, MS / Jaeb Center for Health Research 
Signature/Date 
 
 
Sponsor  
Capillary Biomedical 
Name, degree 
Alayne Lehman, RN, MS 
Signature/Date 
 
 
Clinical Lead Investigator 
 
Name, degree 
Rayhan Lal, M.D. / Stanford University 
Signature/Date 
 
 
Medical Monitor 
 
Name, degree 
Douglas B. Muchmore, M.D. / Capillary Biomedical 
Signature/Date 
 
 
John Lum
I agree to the terms defined by the 
placement of my signature in this document
2024-04-10 09:49-04:00
Alayne 
Lehman
Digitally signed by 
Alayne Lehman 
Date: 2024.04.11 
13:56:03 -07'00'
DOUGLAS 
MUCHMORE
Digitally signed by 
DOUGLAS 
MUCHMORE 
Date: 2024.04.14 
08:50:44 -07'00'
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KEY ROLES 
 
Protocol Chair/Director 
 
Name, degree 
Rayhan Lal, MD 
Institution Name 
Stanford University  
 
JCHR Coordinating Center Director 
 
Name, degree 
John Lum, MS 
Institution Name 
Jaeb Center for Health Research 
 
Medical Monitor 
 
Name, degree 
Douglas B. Muchmore, MD 
Institution Name 
Capillary Biomedical 
 
Sponsor 
 
Name, degree 
Alayne Lehman, RN, MS 
Title 
Director Clinical Affairs 
Institution Name 
Capillary Biomedical 
 
 
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VERSION HISTORY 
VERSION
NUMBER 
AUTHOR 
APPROVER 
EFFECTIVE 
DATE 
REVISION DESCRIPTION 
1.0 
John Lum
Alayne Lehman
20 Aug 2021
Original
2.0 
John Lum 
Alayne Lehman 
28 Oct 2021 
Major revisions include: 
 Addressed FDA questions during IDE 
review 
 Revised language in primary efficacy 
endpoint  
 Revised inclusion criteria  
 Revised sample size 
 Revised statistical methods 
 Added background information 
 Added infusion set removal guidelines
3.0 
Alayne Lehman 
Alayne Lehman 
09 Jan 2023 
Major revisions include: 
 Addressed FDA questions during IDE 
review 
 Revised language in 
secondary/exploratory endpoints  
 Revised exclusion criteria 
 Added background information 
 Revised hyperglycemia management and 
infusion set guidelines
4.0* 
John Lum 
Alayne Lehman 
05 Sep 2023 
 Added version history table 
 Removed requirement to provide digital 
photographs of infusion sets/sites  
 Updated schedule of study visits and 
procedures in Table 1 
 Added background information in 
Chapter 1 
 Updated hyperglycemia management and 
infusion set guidelines language in 
Section 1.4 
 Removed insulin reimbursement per IRB 
request in Section 7.1 
 Revised key secondary endpoints in 
Sections 1.3.3 and 8.4.4 
 Fixed clerical errors, typos, formatting 
throughout protocol
5.0 
Alayne Lehman, 
John Lum 
Alayne Lehman 
08 Feb 2024 
 Added Dexcom G7 CGM support to the 
protocol to allow participants to use 
either Dexcom G6 or Dexcom G7 in the 
study 
 Reworded “serum ketone” as “blood 
ketone” in eligibility criteria for 
consistency with “blood glucose” 
 Added clarification that insulin aspart 
and insulin lispro along with name brand 
Humalog and Novolog are permitted in 
this clinical trial. 
 Changed required time to be on baseline 
insulin from 3 months to 1 month 
 Clarified the screening assessment of 
Control-IQ adherence will be based on 
Subject’s personal t:connect data 
 Added wording to hyperglycemic/ketoic 
reportable event to include “the 
participant contacted the site and 
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VERSION
NUMBER 
AUTHOR 
APPROVER 
EFFECTIVE 
DATE 
REVISION DESCRIPTION 
received guidance on how to manage the 
acute hyperglycemia/ketosis event 
unrelated to the infusion set
 
   *Version in effect at study initiation
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TABLE OF CONTENTS 
CHAPTER 1: BACKGROUND INFORMATION ............................................................................................. 19 
1.1 Introduction ....................................................................................................................................... 19 
1.1.1 Statement of the Problem ............................................................................................................ 19 
1.1.2 Preclinical Testing of the Capillary Biomedical Infusion Cannula ............................................. 19 
1.1.3 Human Use of the Capillary Biomedical Infusion Cannula ........................................................ 20 
1.2 Objective and Rationale ..................................................................................................................... 21 
1.3 Endpoints ........................................................................................................................................... 21 
1.3.1 Primary Efficacy Endpoint .......................................................................................................... 21 
1.3.2 Safety Endpoints .......................................................................................................................... 21 
1.3.3 Key Secondary Endpoint ............................................................................................................. 21 
1.3.4 Other Secondary Endpoints ......................................................................................................... 22 
1.3.5 Exploratory Endpoint .................................................................................................................. 22 
1.4 Subject Hyperglycemia Management and Infusion Set Removal Guidelines ................................... 22 
1.5 Potential Risks and Benefits of the Investigational Device System .................................................. 23 
1.5.1 Known Potential Risks ................................................................................................................ 24 
1.5.1.1 Risk of Hypoglycemia ........................................................................................................ 24 
1.5.1.2 Risk of Hyperglycemia ....................................................................................................... 24 
1.5.1.3 Insulin Infusion Risks ......................................................................................................... 24 
1.5.1.4 Risks of Use of Insulin Pump with Automated Insulin Delivery ........................................ 24 
1.5.1.5 Fingerstick Risks ................................................................................................................. 24 
1.5.1.6 CGM Subcutaneous Catheter Risks .................................................................................... 25 
1.5.1.7 Risks Associated with Device Reuse .................................................................................. 25 
1.5.1.8 Rapid-Acting Insulin Analog Adverse Reactions ............................................................... 25 
1.5.1.9 Questionnaire-Associated Risks ......................................................................................... 25 
1.5.1.10 Other Risks ........................................................................................................................ 25 
1.5.2 Known Potential Benefits ............................................................................................................ 25 
1.5.3 Risk Assessment .......................................................................................................................... 26 
1.6 General Considerations...................................................................................................................... 26 
CHAPTER 2: STUDY ENROLLMENT AND SCREENING .............................................................................. 27 
2.1 Subject Recruitment and Enrollment ................................................................................................. 27 
2.1.1 Informed Consent and Authorization Procedures ....................................................................... 27 
2.2 Subject Inclusion Criteria .................................................................................................................. 27 
2.3 Subject Exclusion Criteria ................................................................................................................. 28 
2.4 Eligibility Assessment and Baseline Data Collection ....................................................................... 29 
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2.5 Historical Information ....................................................................................................................... 29 
2.6 Screening Testing and Procedures ..................................................................................................... 29 
2.7 Screen Failures .................................................................................................................................. 30 
CHAPTER 3: MAIN STUDY ......................................................................................................................... 31 
3.1 Study Infusion Set Initiation Visit ..................................................................................................... 31 
3.1.1 Baseline HbA1c Determination ................................................................................................... 31 
3.1.2 Study Infusion Set Training and Initiation .................................................................................. 31 
3.2 Hyperglycemia Management Guidelines .......................................................................................... 32 
3.3 Hypoglycemia Management .............................................................................................................. 32 
3.4 Daily Text .......................................................................................................................................... 32 
3.5 Follow-up Visit and Contact Schedule .............................................................................................. 32 
3.5.1 Procedures at Study Visits ........................................................................................................... 33 
3.5.1.1 Day 3 ................................................................................................................................... 33 
3.5.1.2 Week 2 ................................................................................................................................ 33 
3.5.1.3 Week 6 ................................................................................................................................ 33 
3.5.1.4 Final Visit............................................................................................................................ 33 
3.5.2 Study Completion ........................................................................................................................ 34 
3.5.3 Early Study Discontinuation ........................................................................................................ 34 
CHAPTER 4: STUDY DEVICES .................................................................................................................... 35 
4.1 Description of the Investigational Device: SteadiSet Infusion Set .................................................... 35 
4.2 Insulin Pump ...................................................................................................................................... 35 
4.3 Insulin Cartridges .............................................................................................................................. 35 
4.4 Ancillary Supplies ............................................................................................................................. 35 
4.5 Blood Glucose Meter ......................................................................................................................... 36 
4.6 Blood Ketone Meter .......................................................................................................................... 36 
4.7 Continuous Glucose Monitor ............................................................................................................. 36 
4.8 Subject Access to Study Devices at Study Closure ........................................................................... 36 
CHAPTER 5: TESTING PROCEDURES AND QUESTIONNAIRES ................................................................. 37 
5.1 Laboratory Testing ............................................................................................................................ 37 
5.1.1 HbA1c ......................................................................................................................................... 37 
5.1.2 Urine Pregnancy .......................................................................................................................... 37 
5.2 Questionnaires ................................................................................................................................... 37 
5.2.1 Screening Visit ............................................................................................................................ 37 
5.2.2 Week 2 Visit ................................................................................................................................ 37 
5.2.3 Final Visit .................................................................................................................................... 37 
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CHAPTER 6: UNANTICIPATED PROBLEM, ADVERSE EVENT, AND DEVICE ISSUE REPORTING ............ 38 
6.1 Unanticipated Problems ..................................................................................................................... 38 
6.2 Adverse Events .................................................................................................................................. 38 
6.2.1 Definitions ................................................................................................................................... 38 
6.2.2 Reportable Adverse Events ......................................................................................................... 39 
6.2.3 Hypoglycemic Events .................................................................................................................. 40 
6.2.4 Hyperglycemic/Ketotic Events .................................................................................................... 40 
6.2.5 Relationship of Adverse Event to Study Investigational Device ................................................. 41 
6.2.6 Severity (Intensity) of Adverse Events ........................................................................................ 41 
6.2.7 Expectedness ............................................................................................................................... 42 
6.2.8 Coding of Adverse Events ........................................................................................................... 42 
6.2.9 Outcome of Adverse Events ........................................................................................................ 42 
6.3 Reportable Device Issues ................................................................................................................... 43 
6.4 Timing of Event Reporting ................................................................................................................ 43 
6.5 Safety Oversight ................................................................................................................................ 44 
6.6 Stopping Criteria ............................................................................................................................... 44 
6.6.1 Subject Discontinuation of Study Device .................................................................................... 44 
6.6.2 Criteria for Suspending or Stopping Overall Study ..................................................................... 45 
CHAPTER 7: MISCELLANEOUS CONSIDERATIONS ................................................................................... 46 
7.1 Drugs Used as Part of the Protocol .................................................................................................... 46 
7.2 Collection of Medical Conditions and Medications .......................................................................... 46 
7.3 Prohibited Medications, Devices, Treatments, and Procedures ......................................................... 46 
7.4 Pregnancy Reporting ......................................................................................................................... 46 
7.5 Subject Compensation ....................................................................................................................... 46 
7.6 Subject Withdrawal ........................................................................................................................... 46 
7.7 Confidentiality ................................................................................................................................... 47 
CHAPTER 8: STATISTICAL CONSIDERATIONS .......................................................................................... 48 
8.1 Statistical and Analytical Plans ......................................................................................................... 48 
8.2 Statistical Hypotheses ........................................................................................................................ 48 
8.3 Power ................................................................................................................................................. 48 
8.4 Outcome Measures ............................................................................................................................ 48 
8.4.1 Clinical Events Committee .......................................................................................................... 48 
8.4.2 Primary Efficacy Endpoint .......................................................................................................... 48 
8.4.3 Safety Endpoints .......................................................................................................................... 49 
8.4.4 Key Secondary Endpoint ............................................................................................................. 49 
8.4.5 Other Secondary Endpoints ......................................................................................................... 49 
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8.4.6 Exploratory Endpoint .................................................................................................................. 49 
8.5 Analysis Datasets and Sensitivity Analyses ...................................................................................... 50 
8.6 Analysis of the Primary Efficacy Endpoint(s) ................................................................................... 50 
8.7 Analysis of the Secondary and Exploratory Endpoints ..................................................................... 50 
8.8 Safety Analyses ................................................................................................................................. 51 
8.9 Baseline Descriptive Statistics ........................................................................................................... 51 
8.10 Planned Interim Analyses ................................................................................................................ 51 
8.11 Multiple Comparison/Multiplicity ................................................................................................... 51 
CHAPTER 9: DATA COLLECTION AND MONITORING .............................................................................. 52 
9.1 Case Report Forms and Other Data Collection ................................................................................. 52 
9.2 Study Records Retention ................................................................................................................... 52 
9.3 Quality Assurance and Monitoring .................................................................................................... 52 
9.4 Protocol Deviations ........................................................................................................................... 53 
CHAPTER 10: ETHICS/PROTECTION OF HUMAN SUBJECTS .................................................................... 54 
10.1 Ethical Standard ............................................................................................................................... 54 
10.2 Institutional Review Boards ............................................................................................................ 54 
10.3 Informed Consent Process ............................................................................................................... 54 
10.3.1 Consent Procedures and Documentation ................................................................................... 54 
10.3.2 Subject and Data Confidentiality ............................................................................................... 54 
10.3.3 Subject Future Use of Stored Specimens and Data ................................................................... 55 
CHAPTER 11: REFERENCES ....................................................................................................................... 56 
APPENDIX A: RELEVANT LITERATURE ON INFUSION SETS .................................................................... 58 
A.1 Failure Modes and Failure Rates for Current Infusion Sets ............................................................. 58 
A.2 Effect of Wear Time on PK/PD and Test Meal Response ................................................................ 58 
A.3 Experience with Extended Wear (>3 days) ...................................................................................... 59 
 
 
 
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LIST OF ABBREVIATIONS 
ABBREVIATION 
DEFINITION 
ADE 
Adverse Device Effect  
AE 
Adverse Event 
AP 
Artificial Pancreas 
BG 
Blood Glucose 
BGM 
Blood Glucose Meter 
BMI 
Body Mass Index 
CA 
California 
CEC 
Clinical Events Committee 
CI 
Confidence Interval 
CFR 
Code of Federal Regulations 
CO2 
Carbon Dioxide 
CRF 
Case Report Form 
CGM 
Continuous Glucose Monitor 
CSII 
Continuous Subcutaneous Insulin Infusion 
CT 
Computed Tomography 
DCCT 
Diabetes Control and Complications Trial  
DKA 
Diabetic Ketoacidosis 
DOI 
Day of Insertion 
DPP-4 
Dipeptidyl peptidase-4 
e.g. 
exempli gratia (for example) 
eCRF 
electronic Case Report Form 
et al. 
et alia (and others) 
etc. 
et cetera (and so forth) 
FDA 
Food and Drug Administration 
FL 
Florida 
GEE 
Generalized Estimated Equations 
GLP-1 
Glucagon-like peptide-1 
HbA1c 
Glycated Hemoglobin 
i.e. 
id est (that is) 
ICF 
Informed Consent Form 
ICH 
International Conference of Harmonization 
IFU 
Instructions For Use  
ID 
Identification 
IIS 
Insulin Infusion Set 
Inc 
Incorporated 
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ABBREVIATION 
DEFINITION 
IRB 
Institutional Review Board 
JCHR 
Jaeb Center Health Research  
JDRF 
Juvenile Diabetes Research Foundation 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg/dL 
milligrams per deciliter 
Micro-CT 
micro computed tomography 
mmol/L 
millimoles per liter 
MRI 
Magnetic Resonance Imaging 
NGSP 
National Glycohemoglobin Standardization Program 
p 
probability 
PD  
Pharmacodynamic 
pH 
power of Hydrogen 
PI 
Principal Investigator 
PK 
Pharmacokinetic 
QA 
Quality Assurance 
QC 
Quality Control 
RBM 
Risk Based Monitoring 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SC 
Subcutaneous 
SD 
Standard deviation 
SGLT-2 
Sodium-glucose cotransporter-2 
SOP 
Standard Operating Procedures 
T1D 
Type 1 Diabetes 
UADE 
Unanticipated Adverse Device Effect 
WOCBP 
Women of Childbearing Potential  
 
 
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SITE PRINCIPAL INVESTIGATOR STATEMENT OF COMPLIANCE 
Protocol Title: Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear 
Insulin Infusion Set During Home Use in People with Type 1 Diabetes 
Protocol Version/Date: v5.0 / 08 February 2024 
I have read the protocol specified above. In my formal capacity as a Site Principal Investigator, my 
duties include ensuring the safety of the study subjects enrolled under my supervision and providing the 
Jaeb Center for Health Research, which serves as the Coordinating Center for the protocol, with complete 
and timely information, as outlined in the protocol. It is understood that all information pertaining to the 
study will be held strictly confidential and that this confidentiality requirement applies to all study staff 
at this site. 
This trial will be carried out in accordance with ICH E6 Good Clinical Practice (GCP) and as required 
by the following: United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
As the Principal Investigator, I will assure that no deviation from, or changes to the protocol will take 
place without prior agreement from the sponsor and documented approval from the Institutional Review 
Board (IRB), or other approved Ethics Committee, except where necessary to eliminate an immediate 
hazard(s) to the trial subjects. 
All key personnel (all individuals responsible for the design and conduct of this trial) have completed 
Human Subjects Protection Training and Good Clinical Practice Training. Further, I agree to ensure that 
all staff members involved in the conduct of this study are informed about their obligations in meeting the 
above commitments. 
Investigator’s Signature __________________________________ 
Date _____ / _____ / _____ 
 
dd 
mmm 
yyyy 
Investigator’s Name ____________________________________ 
Site Name/Number _____________________________________ 
 
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PROTOCOL SUMMARY 
 
Title 
Open, Single-Arm, Prospective, Multicenter Study of an Investigational Extended Wear 
Insulin Infusion Set During Home Use in People with Type 1 Diabetes 
Précis 
Prospective evaluation of the SteadiSet insulin infusion set with 12 wear periods of up to 
7 days each in adults with type 1 diabetes (T1D) using Tandem pump with t:slim X2 
Control-IQ 
Investigational Device 
SteadiSet 
Objectives 
Primary Objective: 
 The evaluation of SteadiSet device function as evidenced by the absence of device 
failure due to uncontrolled hyperglycemia with or without ketosis 
Secondary Objectives: 
 Characterization of safety endpoints, glycemic control and insulin dosing while using 
the SteadiSet device 
Study Design 
Prospective, Multi Center, Single Arm study 
Number of Sites 
Up to 20 sites in the United States 
Endpoint  
Primary Efficacy Endpoint: 
Percentage of successfully inserted SteadiSet infusion sets (i.e., not removed within 8 hours 
of insertion) that are not withdrawn from use prior to 7 days (168 hours) due to either  
(1), (2), or (3): 
1. 
Blood Glucose value ≥250 mg/dL with ketones >1.0 mmol/L, in the absence of 
illness or other physiological stress.  
2. 
Blood Glucose value ≥250 mg/dL for at least 60 minutes duration, 3 hours or more 
following a snack or meal event AND failure to respond to up to 2 adequate 
corrective boluses delivered by the pump with a fall of at least 50 mg/dL. 
3. 
Investigator advises the infusion set should be replaced to assure subject’s safety 
See Section 1.4 Subject Hyperglycemia Management and Infusion Set Removal Guidelines 
for additional details. 
A Clinical Events Committee (CEC) will adjudicate primary and secondary clinical endpoint 
events based on review of all available information that is relevant to determine whether 
protocol-defined endpoint events have occurred during the study. See Section 8.4.1 Clinical 
Events Committee for additional details. 
Safety Endpoints: 
The incidence, severity, and relationship to the investigational device of all reported adverse 
events (serious and non-serious including diabetic ketoacidosis (DKA) and severe 
hypoglycemia) from day of insertion through day of device removal for each wear period. 
Key Secondary Endpoint: 
Proportion (%) of SteadiSet infusion sets withdrawn from use at any time following insertion 
prior to 7 days (168 hours) as evidenced by one or more of the following device failure 
modes. NOTE: infusion set removals prior to 168 hours due to miscalculation of date and/or 
time, along with other removals that cannot be ascribed to the investigational device 
performance, are excluded from this proportion calculation.  
1. 
Infusion set failure as defined in the Primary Endpoint (including any such 
removals occurring during the first 8 hours following set insertion) 
2. 
Evidence of infusion set site infection defined as requiring treatment or at the 
investigator’s judgment  
3. 
Cannula dislodgement from subcutaneous (SC) space (with or without liquid 
leakage at the cannula insertion site) 
a. 
Leakage at the cannula insertion site may or may not be deemed by the 
investigator to constitute infusion set failure following consultation with 
the study subject 
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b. 
Accidental removal events (e.g., tubing caught on doorknob) are 
excluded from this proportion calculation 
4. 
Occurrence of a non-resolvable pump occlusion alarm 
5. 
Other device malfunction (e.g., inability to pierce skin, bending, or other 
malformation that might impact insulin infusion, securement failure)  
6. 
Presence of pain of sufficient severity to prompt early removal of infusion set 
7. 
Any other event that can be ascribed to the investigational device performance that 
results in failure of insulin delivery 
Other Secondary Endpoints: 
1. 
Standard glucose control metrics obtained from CGM, including hyper- and 
hypoglycemic episodes, time in range, mean 24-hour glucose, and other measures 
2. 
Total daily insulin dose, basal dose, bolus dose, and bolus basal ratio overall and 
 
by day of infusion set wear 
3. 
Subject tolerability levels for the infusion set insertion as assessed by a pain scale 
of 0 to 100 with zero being no pain and 100 being significant pain 
4. 
Hyperglycemia trends in days 1-3 versus after day 3  
5. 
Infusion set performance (including set failures as defined above and also glucose 
metrics, insulin doses, pump occlusion alarms and hyperglycemia trends) in 
subjects who use low doses (e.g., <25 units/day) of insulin and in subjects who 
experience frequent stops and start of pump use 
Exploratory Endpoint: 
1. 
HbA1c change from baseline to the end of study participation. 
Eligibility Criteria 
Inclusion Criteria: 
1. Age 18 to 80 years old inclusive 
2. Generally in good health, as determined by the investigator 
3. Living in the United States with no plans to move outside the United States during 
the study 
4. Diagnosis of T1D for at least 12 months 
5. Minimum of 6 months of insulin pump experience and at least 3 months of current 
experience with a Tandem pump 
6. Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 
1 month at the time of enrollment  
7. Minimum of 14 days of Control-IQ data immediately preceding screening that 
demonstrate pump use compliance, including at least 85% of time with Control-IQ 
technology active 
8. HbA1c <9.0% in the last 6 months.  
9. Willing to implement and adhere to pump alert/alarm settings on a study-provided 
pump as instructed during the study 
10. Willing to wear each investigational infusion set for up to 7 days during each of the 12 
consecutive wear periods in the study 
11. Willing to perform blood ketone and blood glucose (fingerstick) measurements as 
directed using provided ketone and blood glucose meters and strips 
12. Access to internet for required periodic uploads of study device data 
13. BMI in the range 18–35 kg/m2, both inclusive 
14. Currently using one of the following insulins with no expectation of a need to change 
insulin type during the study: 
a. Humalog™ (insulin lispro) 
b. NovoLog™ (insulin aspart) 
15. Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 
month at the time of enrollment 
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16. Willing to change insulin cartridge every 48-72 hours, as recommended by patient’s 
healthcare provider during the study 
17. Has routine access to a smart phone e.g., ability to receive text messages  
18. Has the ability to understand and comply with protocol procedures and to provide 
informed consent (i.e., English proficient in both verbal and written communication) 
 
Exclusion Criteria: 
1. Concurrent use of any non-insulin glucose-lowering agent, other than metformin 
(for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, 
sulfonylureas) 
2. Female subject is pregnant, planning to become pregnant, or not using adequate method 
of contraception 
3. Episodes of severe hypoglycemia in the last 6 months resulting in: 
a. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization) 
b. Loss of consciousness 
c. Seizures 
4. One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring 
hospitalization 
5. Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of 
carbohydrates per day, or intending to begin one during the study period  
6. Known cardiovascular disease considered to be clinically relevant by the investigator 
7. Known history of any of the following conditions: 
a. Cushing’s Disease 
b. Pancreatic islet cell tumor 
c. Insulinoma 
d. Lipodystrophy 
e. Extensive lipohypertrophy, as assessed by the investigator 
8. Currently undergoing treatment with: 
a. Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from 
screening), 
b. Thyroid hormones, unless use has been stable during the past 3 months 
9. Significant history of any of the following, that in the opinion of the investigator would 
compromise safety or successful study participation: 
a. Alcoholism 
b. Drug abuse 
10. Significant acute or chronic illness, that in the opinion of the investigator might 
interfere with safety or integrity of study results 
11. Current participation in another clinical drug or device study 
12. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) 
who is a study site personnel directly affiliated with this study or who is an employee of 
Capillary Biomedical 
Sample Size 
Up to 300 with the goal of completing approximately 120 Subjects for each insulin type 
(Humalog and Novolog) 
Treatment Groups 
All subjects use the SteadiSet insulin infusion set for 12 wear periods of up to 7 days each. 
Subject Duration 
Up to 14 weeks for each subject to complete the study 
Study Duration (planned) 
8 months from first enrollment until last subject visit 
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Protocol Overview/Synopsis 
Subjects with T1D and experience using a Tandem t:slim X2 pump with Control-IQ 
technology will be evaluated for study participation. Following screening, eligible subjects 
will enter the active phase of the study and receive the SteadiSet infusion set and a 
study-provided Control-IQ pump for use during the study. Subjects will wear the SteadiSet 
infusion set with the study pump for up to 7 days for each of 12 consecutive wear periods. 
Statistical Methods and 
Sample Size Documentation 
Kaplan-Meier estimates will be reported along with a curve used to estimate the proportion 
of infusion sets that meet the primary and secondary endpoint definitions. A point estimate 
and two-sided 95% confidence interval for the 7-day survival rate will be calculated with a 
bootstrap to account for the correlated data from having each subject wear multiple infusion 
sets. A corresponding p-value will be given for the null hypothesis that the true survival 
probability is 75%. 
If the true success probability is 83% and we conservatively estimate the within-subject 
correlation to be as high as 0.4, then a sample size of 120 patients per insulin type with 12 
infusion set wears per subject would give 87% power for a two-sided test at alpha = 0.05 to 
reject the null hypothesis that the success rate is 75%. Nine wears per subject, N=120 
subjects would give 86% power. 
 
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SCHEMATIC OF STUDY DESIGN 
 
Figure 1. Study Schematic. Note timing of study visits/calls at 2 weeks and 6 weeks will be with respect to initiation of Set #1 and likely will not correspond exactly 
with removal of Set #2 and Set #6, respectively. See Section 3.5 for additional visit and contact schedule details. 
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Table 1-1. Schedule of Study Visits and Procedures 
 
Screening/ 
Baseline 
Visit 
Day 0 - 
Initiation of 
Study Infusion 
Set 
3 Days 
2 Weeks 
6 Weeks 
Final Visit 
Unsched. 
Call/Visit 
Visit Window  
N/A 
≤14 days 
(-1 to +3 
days) 
(± 4 days) 
(± 7 days) 
(+ 7 days 
from final 
wear period) 
N/A 
Informed Consent (enrollment) 
X 
 
 
 
 
 
 
Eligibility Criteria  
X1 
 
 
 
 
 
Medical History including baseline 
medications 
X 
 
 
 
 
 
 
Survey Usability, Satisfaction & Preference2  
X 
 
X 
 
X 
 
Height and Weight to Calculate BMI 
X 
 
 
 
 
 
 
Pregnancy Test (Urine) for WOCBP3  
X 
 
 
 
 
 
Central Lab HbA1c 
 
X 
 
 
 
X 
 
Subject Training for SteadiSet 
 
X 
 
 
 
 
 
Upload Ketone and Glucose Meters 
 
 
 
X 
X 
X 
 
Insertion of 1st SteadiSet by Subject 
 
X 
 
 
 
 
 
Pain Assessment  
 
Infusion Set Insertion 
 
Dispense SteadiSets & other study supplies 
X 
 
 
 
 
 
Upload Insulin Pump Data 
X 
 
At time of each infusion set removal and study visit 
X 
Adverse Event Assessment  
 
X 
X 
X 
X 
X 
X 
Reportable Medication Changes 
 
 
X 
X 
X 
X 
X 
Collect all used & unused infusion sets 
 
 
 
 
 
X 
 
1Confirm eligibility if the screening and initiation visits are not completed on the same day. 
2There are 2 different SUS scales. The 1st assess the Subject’s opinion of their commercial infusion set and should be completed before insertion of the study device. The next two are 
surveys assess the Subject’s opinion of the study device after use. Site to send the appropriate link to Subject to complete each assessment. 
3Pregnancy test should be completed at Day 0 before insertion of investigational product. 
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Chapter 1: Background Information 
1 
1.1 Introduction 
2 
Type 1 diabetes (T1D) causes autoimmune pancreatic beta cell destruction and lifelong dependency on 
3 
exogenous insulin, typically delivered via either multiple daily injections or via an infusion set with a 
4 
subcutaneous catheter (continuous subcutaneous insulin infusion, or CSII). 
5 
1.1.1 Statement of the Problem 
6 
Insulin infusion sets fail early and fail often. Research from Stanford University found that most infusion 
7 
set failures are due to cannula kinking or a clogged insulin port3, Table 1-1. Additional literature on 
8 
infusion set failures, which is indicative of a high failure rate with currently available infusion sets, is 
9 
provided in Appendix A, Relevant Literature on Infusion Sets. 
10 
Table 1-1. Infusion Set Failure Rate by Duration of Use 
11 
DAY(S) OF USE 
FAILURE RATE 
Day 1 
> 15% 
Day 3 
> 25% 
Day 7 
> 65% 
 
12 
This high failure rate prevents wider adoption of insulin pump therapy that could improve current patient 
13 
outcomes and expand pump access to more users. 
14 
Results from pre-clinical animal and bench studies of the Capillary Biomedical infusion set design 
15 
(see Section 1.1.2) have shown a lower rate of cannula kinking (2.1% vs 32.5% for straight Teflon 
16 
cannulas, p<0.001) and improved infusion set functionality for extended use periods beyond 72 hours 
17 
(In-Vivo Study of the Tissue Trauma Caused by a New, Kink-Resistant Insulin Infusion Set Compared 
18 
to a Commercial Control over Two Weeks of Wear Time [unpublished data, 2021]). 
19 
Currently, a change of insulin infusion sets is recommended every 72 hours for commercially available 
20 
Teflon insulin infusion sets and every 48 hours for steel cannulas.1,7 Based on clinical experience and 
21 
recently published data, there is evidence that cannula wear time might be extended in some patients 
22 
without worsening of glucose control. 1,3,8,9 Other patients report a worsening of glycemic control over 
23 
time, which prompts them to change the infusion set prior to the recommended 3-day period.1,3 An ideal 
24 
IIS would provide high reliability while leveraging the on/off insulin pharmacokinetics (PK) and 
25 
pharmacodynamics (PD) of modern rapid-acting insulin analogs over an extended period (>3 days). 
26 
An optimized IIS would also enhance the safety and performance of a closed-loop artificial pancreas 
27 
(AP) system,10 perhaps with CGM and insulin infusion combined in one device, capable of a 7+ day 
28 
wear-time.11-13 
29 
1.1.2 Preclinical Testing of the Capillary Biomedical Infusion Cannula 
30 
Between 2016 and 2018, Capillary Biomedical, Inc. (CapBio) and the Jefferson Artificial Pancreas 
31 
Center (JAPC, Thomas Jefferson University, Philadelphia, PA) performed preclinical studies in 18 swine 
32 
funded by JDRF. The JAPC research team iteratively tested multiple generations of cannulas developed 
33 
by CapBio to identify the optimum cannula design that eventually became the Achilles Infusion Set. 
34 
The Achilles prototype was well tolerated by all animals (n=3) with no signs of inflammation or infection. 
35 
The JAPC was able to show the improved CapBio cannula design successfully prevented kinking (0% 
36 
versus 57% kink rate in Silhouette commercial angled cannulas, p<0.001). As measured in micro-CT, 
37 
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the surface-area-to-volume ratio of a bolus of insulin/x-ray contrast agent was significantly greater than 
38 
that of a bolus delivered through a commercial catheter (+16.5%, p<0.05), suggesting better delivery of 
39 
insulin into the adjacent tissue and vasculature/lymphatics. The JAPC furthermore evaluated tissue 
40 
response to Achilles cannulas by means of histopathological staining. The inflammatory layer 
41 
(thrombus, inflammatory cells, collagen, debris, proteins, etc.) was consistently thinner around CapBio 
42 
cannulas compared with the commercial Silhouette over 8 days of wear time (p<0.001). The overall area 
43 
of inflamed tissue surrounding the CapBio cannula was significantly larger around Silhouette control 
44 
catheters compared to the Achilles cannula between 4 and 8 days of wear time (p=0.003). A publication 
45 
of a head-to-head comparison of the Achilles infusion set and a commercial infusion set with a 90° 
46 
cannula is currently in preparation. The methods have been published in 2019 together with results 
47 
showing significantly better tissue response when using angled cannulas.14 
48 
1.1.3 Human Use of the Capillary Biomedical Infusion Cannula 
49 
Feasibility Study 
50 
This was a prospective non-randomized home use feasibility study of the manually inserted Achilles 
51 
device (previous version of the SteadiSet) performance, usability, tolerability and safety in patients with 
52 
T1D. Twenty-one subjects were enrolled at St. Vincent’s Hospital, Melbourne, Australia, under principal 
53 
investigator Prof. David O’Neal. The study was composed of 3 periods with each period initiated at the 
54 
CRU and followed by a home-use phase of up to 7 days. A run-in period (Week 1) was followed by two 
55 
test periods (Week 2 and Week 3) in which subjects discontinued the use of their routine IIS and managed 
56 
their BG solely using the Achilles infusion set and their insulin pump. Week 2 and Week 3 were 
57 
considered complete when an Achilles infusion set failure occurred, or the subject wore the Achilles 
58 
for the total 7-day wear period. Twenty subjects completed the study and a total of 41 infusion sets were 
59 
inserted in Week 2 and Week 3. The overall 7-day survival rate for the infusion sets was 88% (36/41). 
60 
Proportional time spent with glucose <3.9 mmol/L did not increase while wearing the Achilles infusion 
61 
set. 
62 
A total of 23 adverse events were reported from 15 (75%) of subjects. The most common adverse events 
63 
included: hyperglycemia (35%) and infusion/insertion site reactions (35%). There were no serious or 
64 
unanticipated adverse events from this investigation. Overall, the Achilles infusion set was safe and well 
65 
tolerated for and extended wear time. Results published Kastner JR, Venkatesh N, Brown K, Muchmore 
66 
DB, Ekinci E, Fourlanos S, Joseph JI, Shafeeq M, Shi L, Strange P, Strasma PJ, O'Neal DN. Feasibility 
67 
study of a prototype extended-wear insulin infusion set in adults with type 1 diabetes. Diabetes Obes 
68 
Metab. 2022 Jun;24(6):1143-1149. doi: 10.1111/dom.14685. Epub 2022 Mar 18. PMID: 35257468. 
69 
PK/PD Study 150-1022-00 
70 
This was a prospective, single center, randomized sequence, 2-way crossover study to assess the Achilles 
71 
device’s performance, survivability, consistency, efficacy, and safety over an extended wear time of up 
72 
to 7 days. Pharmacokinetic (PK) and pharmacodynamic (PD) profiles of a bolus of rapid-acting insulin 
73 
were measured on 4 separate days of IIS wear time during 2 separate wear periods. Following a wash-out 
74 
period, subjects crossed over into the investigational or control group, respectively. Seven subjects 
75 
enrolled and six subjects completed the study at the Advanced Metabolic Care + Research (AMCR) 
76 
endocrinology center in Escondido, CA, USA under principal investigator Dr. Timothy Bailey. No 
77 
serious or unanticipated adverse events were reported from this investigation. The study was terminated 
78 
early by the sponsor after randomization of 7 subjects, and the final study report is complete. The 
79 
pharmacokinetic results of the study confirm and extend previous studies that have shown that insulin 
80 
exposure is accelerated as wear time increases over 7 days of infusion set use. Further, the results of this 
81 
small study are supportive of the conclusion that the Achilles IIS reliably delivers insulin and facilitates 
82 
maintenance of satisfactory glucose control over 7 days. Given the progressive acceleration of insulin 
83 
exposure over the 7-day wear period, it may be that the deployment of an automated insulin delivery 
84 
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system may help to automatically match insulin delivery to insulin requirements across infusion set wear 
85 
time. Results published in a brief report: Kastner JR et.al Progressive acceleration of insulin exposure 
86 
over 7 days of infusion set wear. Diabetes Technol Ther. 2202 Dec 20.doi:10.89/dia 2022.0323. 
87 
Pilot Study 150-1139-00 
88 
This study was designed as a controlled, random-sequence, single-center study of device performance, 
89 
tolerability, and safety of the SteadiSet infusion set compared to a commercially available Teflon control 
90 
device during four home use periods of up to 14 days each (AABB vs. BBAA). The primary endpoint of 
91 
this study was the duration (days) of successful insulin delivery through the SteadiSet before removal due 
92 
to normal use, or an infusion set failure. 
93 
Thirteen subjects were enrolled with 12 subjects completing the study at the Medical University of Graz, 
94 
Austria under principal investigator Dr. Julia Mader. There were no unexpected or serious adverse events. 
95 
Results published: Kastner, Jasmine R., PhD. et. al. Current insulin infusion set failure criteria may be too 
96 
stringent for real-life settings and may skew infusion set failure outcomes in extended-wear infusion set 
97 
studies. Diabetes, Obesity and Metabolism 08 December 2022, https://doi.org/10.1111/dom.14935. 
98 
1.2 Objective and Rationale 
99 
The objective of this prospective, multi center, single-arm study is to assess the efficacy, safety, and 
100 
tolerability of using the SteadiSet infusion set for insulin delivery when each set is used continuously for 
101 
up to 7 days in adults with T1D, to provide data for regulatory submission. 
102 
The rationale for the study is based on the aforementioned literature that has documented that high failure 
103 
rate with currently available infusion sets and the promising preliminary data indicating that the SteadiSet 
104 
infusion set may fail less frequently and function longer. 
105 
1.3 Endpoints 
106 
1.3.1 Primary Efficacy Endpoint 
107 
Percentage of successfully inserted SteadiSet infusion sets (i.e., not removed within 8 hours of insertion) 
108 
that are not withdrawn from use prior to 7 days (168 hours) due to either (1), (2), or (3): 
109 
1. Blood Glucose value ≥250 mg/dL with ketones >1.0 mmol/L, in the absence of illness or other 
110 
physiological stress.  
111 
2. Blood Glucose value ≥250 mg/dL for at least 60 minutes duration, 3 hours or more following a 
112 
snack or meal event AND failure to respond to up to 2 adequate corrective boluses delivered by 
113 
the pump with a fall of at least 50 mg/dL. 
114 
3. Investigator advises the infusion set should be replaced to assure subject’s safety 
115 
1.3.2 Safety Endpoints 
116 
The incidence, severity, and relationship to the investigational device of all reported adverse events 
117 
(serious and non-serious including DKA and severe hypoglycemia) from day of insertion through day 
118 
of device removal for each wear period. 
119 
1.3.3 Key Secondary Endpoint 
120 
Proportion (%) of SteadiSet infusion sets withdrawn from use at any time following insertion prior to 7 
121 
days (168 hours) as evidenced by one or more of the following device failure modes. NOTE: infusion set 
122 
removals prior to 168 hours due to miscalculation of date and/or time, along with other removals that 
123 
cannot be ascribed to the investigational device performance, are excluded from this proportion 
124 
calculation.  
125 
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1. Infusion set failure as defined in the Primary Endpoint (including any such removals occurring 
126 
during the first 8 hours following set insertion) 
127 
2. Evidence of infusion set site infection defined as requiring treatment or at the investigator’s 
128 
judgment 
129 
3. Cannula dislodgement from subcutaneous (SC) space (with or without liquid leakage at the 
130 
cannula insertion site) 
131 
a. Leakage at the cannula insertion site may or may not be deemed by the investigator to 
132 
constitute infusion set failure following consultation with the study subject 
133 
b. Accidental removal events (e.g., tubing caught on doorknob) are excluded from this 
134 
proportion calculation 
135 
4. Occurrence of a non-resolvable pump occlusion alarm 
136 
5. Other device malfunction (e.g., inability to pierce skin, bending, or other malformation that might 
137 
impact insulin infusion, securement failure) 
138 
6. Presence of pain of sufficient severity to prompt early removal of infusion set 
139 
7. Any other event that can be ascribed to the investigational device performance that results in 
140 
failure of insulin delivery 
141 
1.3.4 Other Secondary Endpoints 
142 
1. Standard glucose control metrics obtained from CGM, including hyper- and hypoglycemic 
143 
episodes, time in range, mean 24-hour glucose, and other measures 
144 
2. Total daily insulin dose, basal dose, bolus dose, and bolus basal ratio, overall, and by day of 
145 
infusion set wear 
146 
3. Subject tolerability levels for the infusion set insertion as assessed by a pain scale of 0 to 100 
147 
with zero being no pain and 100 being significant pain 
148 
4. Hyperglycemia trends in days 1-3 versus after day 3 
149 
5. Infusion set performance (including set failures as defined above and also glucose metrics, 
150 
insulin doses, pump occlusion alarms and hyperglycemia trends) in subjects who use low doses 
151 
(e.g., <25 units/day) of insulin and in subjects who experience frequent stops and start of pump 
152 
use 
153 
1.3.5 Exploratory Endpoint 
154 
1. HbA1c change from baseline to the end of study participation.  
155 
1.4 Subject Hyperglycemia Management and Infusion Set Removal 
156 
Guidelines 
157 
1. If, in the absence of illness or other physiological stress, blood glucose is ≥250 mg/dL and 
158 
ketones are >1.0 mmol/L, then infusion set failure is established.* 
159 
o Ketones are to be measured any time the blood glucose value is ≥250 mg/dL 
160 
o If ketones are elevated the subject should test ketones hourly until ketones fall below 
161 
0.6 mmol/L. 
162 
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2. If the CGM glucose value is ≥250 mg/dL for 60 minutes or longer, 3 hours or more following a 
163 
snack or meal event AND ketones measure ≤1.0 mmol/L then attempts to correct the 
164 
hyperglycemia are to occur as follows: 
165 
o Confirm the blood glucose value is >250 mg/dL with a fingerstick BG value. 
166 
o If this fingerstick BG value is <250 mg/dL the subject will be instructed to continue 
167 
to follow CGM readings. 
168 
 
If confirmatory fingerstick BG value is ≥250 mg/dL then an initial manual correction bolus 
169 
delivered by the pump is to be given using the fingerstick BG value.  
170 
 
60 minutes from the initial correction bolus (not the time of an auto bolus) will start the 
171 
hourly testing schedule for fingerstick BGs and ketones. If the repeat ketone level after the 
172 
initial correction bolus is ≤1.0 mmol/L, and the glucose has not fallen by 50 mg/dL then a 
173 
second correction bolus should be administered using the same procedures described above. 
174 
(The manual correction bolus dose given from the Bolus Calculator the subject administers 
175 
will take into consideration the estimated residual Insulin on Board) 
176 
o If a repeat fingerstick BG value shows failure to respond to the second correction 
177 
bolus within an additional hour with a fall of 50 mg/dL from the fingerstick BG prior 
178 
to initial correction bolus and there has been no intervening snack or meal event, 
179 
then the infusion set failure is established.* 
180 
o If the fingerstick BG has responded to the second correction bolus with a fall of at 
181 
least 50 mg/dL from the fingerstick BG prior to the initial correction bolous AND the 
182 
fingerstick BG is still ≥250 mg/dL then fingerstick BGs and ketone levels should be 
183 
rechecked hourly until the fingerstick BG level falls below 250 mg/dL.  
184 
o If fingerstick BG does not fall below 250 mg/dL within six (6) hours from initial 
185 
hyperglycemic event (i.e., 9 hours after a meal event) infusion set failure is 
186 
established*.  
187 
o If the ketone level measures >1.0 mmol/L at any of these hourly rechecks, then the 
188 
infusion set is deemed to have failed.* 
189 
*If the above scenarios occur prior to 174 hours of infusion set wear, the subject is required to 
190 
contact the study site to confirm set failure prior to removing the infusion set and provide 
191 
information to the study site regarding circumstances around the event.  
192 
If study personnel are not available the subject should remove and replace the infusion set. If this 
193 
happens, the subject will need to contact the study site at their earliest convenience to provide the 
194 
study personnel with detailed information regarding the events surrounding the infusion set 
195 
removal.  
196 
When the study site personnel have been contacted (either during the infusion set change 
197 
procedure or afterwards), they will conduct a structured interview and document the relevant 
198 
information in the eCRF. 
199 
If infusion is still functioning satisfactorily after 174 hours, then subject may take up to 18 additional 
200 
hours to replace the set. In no case should the set be worn beyond 192 hours of use.  
201 
1.5 Potential Risks and Benefits of the Investigational Device System 
202 
Risks and benefits are detailed below. Loss of confidentiality is a potential risk; however, data are 
203 
handled securely to minimize this risk. Hypoglycemia and hyperglycemia are always a risk in subjects 
204 
with type 1 diabetes and insulin treatment, and subjects will be monitored for this. 
205 
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The SteadiSet device has been analyzed for possible hazards using the methods in ISO 14971:2012 
206 
Medical Devices, Application of Risk Management to Medical Devices. Capillary Biomedical Inc. 
207 
considers SteadiSet to be adequately safe to justify its use in clinical trials based on the benefits compared 
208 
to overall risk. 
209 
1.5.1 Known Potential Risks 
210 
1.5.1.1 Risk of Hypoglycemia 
211 
As with any person having type 1 diabetes and using insulin, there is always a risk of hypoglycemia. 
212 
The frequency of hypoglycemia should be no more than it would be as part of daily living. Symptoms 
213 
of hypoglycemia can include sweating, jitteriness, and not feeling well. Severe hypoglycemia is possible 
214 
with loss of consciousness or seizures. Recurrent hypoglycemia may reduce hypoglycemia awareness. 
215 
A CGM functioning poorly and significantly over-reading glucose values could lead to inappropriate 
216 
insulin delivery. 
217 
1.5.1.2 Risk of Hyperglycemia 
218 
Hyperglycemia and ketonemia could occur if insulin delivery is attenuated or suspended for an extended 
219 
period or if the pump or infusion set is not working properly. A poorly functioning CGM significantly 
220 
under-reading blood glucose values could lead to inappropriate suspension of insulin delivery. 
221 
1.5.1.3 Insulin Infusion Risks 
222 
The study infusion set is inserted under the skin. Infection can occur very infrequently, but, if an infection 
223 
was to occur, oral and/or topical antibiotics can be used to treat the infection. 
224 
Examples of possible infusion site reactions include: localized pain, bleeding, bruising, induration, 
225 
infection, itching/pruritus, purulence, reddening (erythema), swelling, and other non-specified irritation. 
226 
Infusion set failure may occur, leading to hyperglycemia or ketosis. The risk for infusion set failure may 
227 
be increased in this study because sets are worn for an extended period. Examples of insulin infusion 
228 
failure modes include: clogs, accidental removal, insulin leak from site, insulin leak from set or tubing, 
229 
adhesive failure, cannula insertion failure (not all holes below epidermis), incomplete tubing prime, 
230 
incomplete cannula prime, air bubbles in tubing, inadequate insulin pump/cartridge/infusion set 
231 
connection, and cannula inserted too deep. 
232 
1.5.1.4 Risks of Use of Insulin Pump with Automated Insulin Delivery 
233 
CGM sensor readings higher or lower than the actual blood glucose level increases the risk for 
234 
hypoglycemia and hyperglycemia with use of automated insulin delivery systems. 
235 
Algorithm or other device malfunctions could produce a suspension of insulin delivery or over-delivery of 
236 
insulin which increases risk for hyperglycemia and hypoglycemia. 
237 
1.5.1.5 Fingerstick Risks 
238 
About 1 drop of blood will be removed by fingerstick for measuring HbA1c or doing other tests. Pain is 
239 
common at the time of lancing. In about 1 in 10 cases, a small amount of bleeding under the skin will 
240 
produce a bruise; a small scar may persist for several weeks. The risk of local infection is less than 1 in 
241 
1000. This should not be a significant contributor to risks in this study as finger sticks are part of the usual 
242 
care for people with diabetes. 
243 
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1.5.1.6 CGM Subcutaneous Catheter Risks 
244 
Use of CGM has a low risk for developing a local skin infection at the site of the sensor needle 
245 
placement. There may be bleeding where the catheter is put in and bleeding under the skin causes a 
246 
bruise (1 in 10 risk). 
247 
On rare occasions, the sensor may break and leave a small portion of the sensor under the skin that may 
248 
cause redness, swelling or pain at the insertion site. 
249 
1.5.1.7 Risks Associated with Device Reuse 
250 
In this study, device components (CGM, BG meter, or ketone meter) will not be reused between different 
251 
subjects. 
252 
1.5.1.8 Rapid-Acting Insulin Analog Adverse Reactions 
253 
Study subjects must be current users of rapid-acting insulin analogs at the time of enrollment (i.e., 
254 
completion of consent documentation). Therefore, the risk of adverse reactions to commercially available 
255 
rapid-acting insulin used during the study should be very low, but development of the following 
256 
conditions is possible: anaphylaxis, antibody production, hypokalemia, lipodystrophy, peripheral edema, 
257 
renal or hepatic impairment, and weight gain. 
258 
1.5.1.9 Questionnaire-Associated Risks 
259 
As part of the study, subjects will complete questionnaires which include questions about their private 
260 
attitudes, feelings and behavior related to the investigational equipment as well as managing diabetes. It is 
261 
possible that some people may find these questionnaires to be mildly upsetting. Similar questionnaires 
262 
have been used in previous research and these types of reactions have been uncommon. 
263 
1.5.1.10 Other Risks 
264 
Some subjects may develop skin irritation or allergic reactions to the adhesives used to secure the CGM, 
265 
or to secure the insulin infusion sets for the continuous subcutaneous insulin infusion.  
266 
Data uploaded from the subject’s pump, CGM and study blood glucose and ketone meter will be collected 
267 
for the study as measures of diabetes self-management behaviors. Some people may be uncomfortable 
268 
with the researchers' having such detailed information about their daily diabetes habits. 
269 
There may be other risks that are unknown at this time and new risks that may be identified during the 
270 
study. 
271 
The infusion set has not been tested with radiation therapy or an MRI procedure. The infusion set should 
272 
be removed before radiation therapy or an MRI procedure.  
273 
1.5.2 Known Potential Benefits 
274 
Study participation may not provide any immediate benefit to study subjects. However, results of this 
275 
research may result in the following potential benefits to the study subjects or to future patients with 
276 
diabetes: 
277 
 
Development of an extended wear insulin infusion set 
278 
 
Reduction in the number of required infusion set insertions and number of infusion sites 
279 
 
Reduction in infusion site (skin/tissue) reactions 
280 
 
Improved glucose control (e.g., more stable insulin kinetics) 
281 
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 
Improved Continuous Subcutaneous Insulin Infusion (CSII) and insulin pump therapy options 
282 
 
Reduced environmental waste 
283 
1.5.3 Risk Assessment 
284 
It is the assessment of the investigators that this protocol falls under DHHS 45 CFR 46.406 and 21 CFR 
285 
50.53 as a clinical investigation involving greater than minimal risk and no prospect of direct benefit to 
286 
individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition. 
287 
1.6 General Considerations 
288 
The study is being conducted in compliance with the policies described in the study policies document, 
289 
with the ethical principles that have their origin in the Declaration of Helsinki, with the protocol described 
290 
herein, and with the standards of Good Clinical Practice (GCP). 
291 
The protocol is considered a significant risk device study since the study infusion set is experimental. 
292 
Therefore, an investigational device exemption (IDE) from the U.S. Food and Drug Administration 
293 
(FDA) is required to conduct the study.
294 
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Chapter 2: Study Enrollment and Screening 
295 
2.1 Subject Recruitment and Enrollment 
296 
Enrollment will proceed with the goal of 240 subjects (120 each on insulins lispro and aspart) completing 
297 
the main study phase involving use of the study infusion set. A maximum of 300 individuals may be 
298 
consented for screening to achieve this goal. Subjects who complete at least six wear periods will be 
299 
considered as completers. Subjects who have signed consent and started the screening process may be 
300 
permitted to continue into the trial, if eligible, even if the goal of 240 completers has been reached.  
301 
Study subjects will be recruited from up to 20 clinical centers in the United States. All eligible subjects 
302 
will be included without regard to gender, race, or ethnicity. Each site may contribute a maximum of 
303 
25 subjects toward the target of 240 who complete the main study phase. If the enrollment of one insulin 
304 
type reaches its enrollment goal, that insulin cohort may be closed and only subjects using the insulin in 
305 
the other insulin cohort would then be eligible for study enrollment. 
306 
2.1.1 Informed Consent and Authorization Procedures 
307 
Potential eligibility may be assessed as part of a routine-care examination or via interaction with the 
308 
potential subject following a direct inquiry (e.g., resulting from IRB-approved recruiting materials) or a 
309 
referral from another source. Before completing any procedures or collecting any data that are not part of 
310 
usual care, electronic informed consent will be obtained. 
311 
The potential study subject will be provided with the Informed Consent Form to read and will be given 
312 
the opportunity to ask questions either in-person, via phone/videoconference, or by mail or email. If the 
313 
potential subject is interested in the study, the investigator will schedule a virtual or in-person visit to 
314 
discuss the study, and if the potential subject agrees to participate, that individual will electronically sign 
315 
the Informed Consent Form through the JCHR study website, and the enrolling investigator will also 
316 
electronically sign the document. A copy of the electronically signed consent form can be printed by the 
317 
subject and another copy will be printed by the site to add to the subject’s study record. 
318 
As part of the informed consent process, the subject will be asked to sign an authorization for release of 
319 
personal information. This may be done electronically with the consent, or on paper if the site requires 
320 
their own process. The investigator, or his or her designee, will review the study-specific information that 
321 
will be collected and to whom that information will be disclosed. After speaking with the subject, 
322 
questions will be answered about the details regarding authorization. 
323 
A subject is considered enrolled when the informed consent form has been electronically signed by 
324 
all parties and HIPAA authorization has been provided. No study procedures may be performed 
325 
before the completion of the informed consent documentation.  
326 
2.2 Subject Inclusion Criteria 
327 
Individuals must meet the following inclusion criteria to be eligible to participate in the study. 
328 
1. Age 18 to 80 years old inclusive 
329 
2. Generally, in good health, as determined by the investigator 
330 
3. Living in the United States with no plans to move outside the United States during the study 
331 
4. Diagnosis of T1D for at least 12 months 
332 
5. Minimum of 6 months of insulin pump experience and at least 3 months of current experience 
333 
with a Tandem pump 
334 
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6. Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at 
335 
the time of enrollment 
336 
7. Minimum of 14 days of Control-IQ data immediately preceding screening that demonstrate pump 
337 
use compliance, including at least 85% of time with Control-IQ technology active  
338 
8. HbA1c <9.0% in the last 6 months 
339 
9. Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as 
340 
instructed during the study 
341 
10. Willing to wear each investigational infusion set for up to 7 days during each of the 12 
342 
consecutive wear periods in the study 
343 
11. Willing to perform  blood ketone and blood glucose (fingerstick) measurements as directed using 
344 
provided ketone and blood glucose meters and strips 
345 
12. Access to internet for required periodic uploads of study device data 
346 
13. BMI in the range 18–35 kg/m2, both inclusive 
347 
14. Currently using one of the following insulins with no expectation of a need to change insulin type 
348 
during the study: 
349 
a. Humalog™ (insulin lispro) 
350 
b. NovoLog™ (insulin aspart) 
351 
15. Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the 
352 
time of enrollment  
353 
16. Willing to change insulin cartridge every 48-72 hours, as recommended by patient’s healthcare 
354 
provider during the study 
355 
17. Has routine access to a smart phone e.g., ability to receive text messages  
356 
18. Has the ability to understand and comply with protocol procedures and to provide informed 
357 
consent (i.e., English proficient in both verbal and written communication) 
358 
2.3 Subject Exclusion Criteria 
359 
Individuals meeting any of the following exclusion criteria at baseline will be excluded from study 
360 
participation. 
361 
1. Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, 
362 
GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) 
363 
2. Female subject is pregnant, planning to become pregnant, or not using adequate method of 
364 
contraception  
365 
3. Episodes of severe hypoglycemia in the last 6 months resulting in: 
366 
a. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization) 
367 
b. Loss of consciousness 
368 
c. Seizures 
369 
4. One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring 
370 
hospitalization 
371 
5. Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, 
372 
or intending to begin one during the study period 
373 
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6. Known cardiovascular disease considered to be clinically relevant by the investigator 
374 
7. Known history of any of the following conditions: 
375 
a. Cushing’s Disease 
376 
b. Pancreatic islet cell tumor 
377 
c. Insulinoma 
378 
d. Lipodystrophy 
379 
e. Extensive lipohypertrophy, as assessed by the investigator 
380 
8. Currently undergoing treatment with: 
381 
a. Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from 
382 
screening), 
383 
b. Thyroid hormones, unless use has been stable during the past 3 months 
384 
9. Significant history of any of the following, that in the opinion of the investigator would 
385 
compromise safety or successful study participation: 
386 
a. Alcoholism 
387 
b. Drug abuse 
388 
10. Significant acute or chronic illness, that in the opinion of the investigator might interfere with 
389 
safety or integrity of study results 
390 
11. Current participation in another clinical drug or device study 
391 
12. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a 
392 
study site personnel directly affiliated with this study or who is an employee of Capillary 
393 
Biomedical 
394 
2.4 Eligibility Assessment and Baseline Data Collection 
395 
Potential subjects will be evaluated for study eligibility through the elicitation of a medical history and 
396 
local laboratory testing as needed in the judgment of the investigator (as part of usual care). 
397 
The screening visit and subsequent scheduled study visits may be conducted virtually via videoconference 
398 
at the discretion of the study investigator, for example due to institutional restrictions or the subject or 
399 
investigator’s preference for a remote visit. Study staff will discuss the feasibility of conducting virtual 
400 
visits with each subject and provide support as needed to ensure adequate access. The initial screening 
401 
visit must be completed within 30 days of subject enrollment (i.e., completion of consent documentation). 
402 
2.5 Historical Information  
403 
A history will be elicited from the subject and extracted from available medical records with respect to 
404 
the subject’s diabetes history, current diabetes management, other past and current medical problems, 
405 
past and current medications, and drug allergies. 
406 
When evaluating subjects not already being treated at the enrolling clinic, information will be solicited 
407 
from the subject’s primary diabetes provider, for example, via a phone call or videoconference between 
408 
the enrolling investigator and the current provider. 
409 
2.6 Screening Testing and Procedures 
410 
At the Screening Visit the following procedures will be performed/information will be elicited: 
411 
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 
Assessment of eligibility 
412 
 
Demographics (date of birth, gender, race, and ethnicity) 
413 
 
Contact information (retained at the site and provided to Coordinating Center to allow 
414 
automated text or email messages during study) 
415 
 
Medical history as described above in Section 2.4 
416 
 
Substance use history (drinking, smoking, and drug habits) 
417 
 
Current medications 
418 
 
Measurement of height/weight 
419 
 
If the visit is conducted virtually, a verbal report of the subject’s weight and verbal 
420 
report of height will be acceptable. 
421 
 
Urine pregnancy test for all women who have reached menarche and are premenopausal 
422 
and are not surgically sterile. 
423 
 
If the visit is conducted virtually, a negative urine pregnancy test result from a test kit 
424 
sent to the subject may be confirmed via teleconference. 
425 
 
Determination of adherence to Control-IQ use in the 14 days prior to screening based on 
426 
data from the subject’s  personal t:connect account.  
427 
 
Subjects must have had Control-IQ technology active at least 85% of the time during 
428 
the 14 days before screening to be eligible to continue in the study. 
429 
 
Verification HbA1c is <9.0% in the last 6 months.  
430 
 
Completion of the Usability, Satisfaction & Preference Survey (study web site link sent to 
431 
subject) to evaluate subject’s experience with the insertion and daily wear of their current 
432 
infusion set before exposure to the study infusion set. 
433 
 
Subject demonstrates proficiency in following study procedures. 
434 
Screening procedures will last approximately 2 hours. 
435 
2.7 Screen Failures 
436 
Individuals who do not initially meet study eligibility requirements, such as required Control-IQ 
437 
adherence or estimated HbA1c value, may be rescreened once while study enrollment is still open. 
438 
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Chapter 3: Main Study 
439 
3.1 Study Infusion Set Initiation Visit 
440 
This visit may be concurrent with the Screening Visit or may be completed within 14 days of completion 
441 
of the Screening visit. Study site will verify subjects received all study supplies. 
442 
Study supplies, including study Control-IQ insulin pump, SteadiSet infusion sets, BG and ketone meters, 
443 
and ancillary supplies, will be provided to the subject either in-person at the clinic or via delivery by other 
444 
means (personal delivery, overnight shipment, etc). 
445 
Before dispensing, BG and ketone meters will be QC tested with control solution to verify readings are 
446 
within the target range per manufacturer labeling. 
447 
Study subjects will be provided with a Tandem t:slimX2 with Control-IQ insulin pump to use in the study 
448 
instead of their personal insulin pump. The study pump will be programmed by the Study Site with 
449 
criteria outlined in Section 3.2 as well as subject's personnel profile settings. Subjects will continue to use 
450 
their personal Dexcom G6 or G7 CGM system. Subjects may switch between G6 and G7 sensors during 
451 
the course of the study and will be instructed to only do so at the time of insertion of a new study infusion 
452 
set.  
453 
The Tandem t:connect mobile app will not work with the study insulin pumps. Subjects will upload study 
454 
insulin pump data via USB cable. Subjects may use available manufacturer-provided software and 
455 
features of their personal CGM related to mobile data access or remote monitoring. 
456 
3.1.1 Baseline HbA1c Determination 
457 
A capillary blood sample will be obtained for baseline HbA1c determination. For remote subject’s capillary 
458 
collection, supplies will be provided to the subject within 3 days of the Study Infusion Set Initiation Visit. 
459 
Collection of HbA1c may occur either in-person at the clinic, or via delivery by other means (personal 
460 
delivery, overnight shipment, etc.). 
461 
3.1.2 Study Infusion Set Training and Initiation 
462 
Subjects will be trained (in-person or via videoconference) on how to insert the SteadiSet infusion set. 
463 
The initial insertion will be observed either in person or on video during a virtual visit.  
464 
Subjects who are unable to insert the SteadiSet within 3 attempts will be dropped from study 
465 
participation.  
466 
Points of training will include the following: 
467 
 
Subjects will be advised to avoid inserting the SteadiSet device in places that may cause 
468 
pressure—e.g., under a belt or snug waist band.  
469 
 
Subjects will be advised to closely monitor their CGM for the first 8 hours following the insertion 
470 
of each SteadiSet. If CGM is uncorrectable per the hyperglycemic management guidelines, the 
471 
subject will be instructed to call the study center for guidance. 
472 
 
Subjects will be given guidelines with detailed procedures on what to do if prolonged elevated 
473 
CGM glucose or other signs that infusion set failure might have occurred (Section 3.2). 
474 
 
Subjects will be instructed to contact the study site before removing an infusion set that has been 
475 
worn for less than 7 full days.  
476 
 
Subjects will be instructed to retain all parts of the used infusion set and label and return to the 
477 
clinic. 
478 
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 
Subjects will be instructed to insert a new sequential infusion set following removal of each prior 
479 
set until 12 infusion sets have been used. Sets that fail in the first 8 hours of use will be replaced 
480 
and will not count toward the target of 12 infusion sets worn. 
481 
 
Subjects will be instructed to change the insulin cartridge every 48-72 hours, as recommended by 
482 
their healthcare provider. 
483 
 
Subjects will be instructed to change their insulin cartridge and infusion set independent of each 
484 
other and follow instructions in the Participant Guidebook and IFU. Subjects will be instructed to 
485 
contact study site if there is concern about infusion set failure. 
486 
 
Subjects will be required to upload insulin pump data (which includes both insulin dosing and 
487 
CGM data). This will be performed remotely for virtual visits or in clinic for face-to-face visits. 
488 
Ketone and BG meters will be uploaded during face-to-face visits.  
489 
 
Subjects who have only virtual visits will be provided with three ketone and BG meters each, and 
490 
will be instructed to mail the meters to the study site at week 2, week 6 and final visits. 
491 
3.2 Hyperglycemia Management Guidelines 
492 
The study pump’s Control-IQ High Alert, which cannot be disabled, will alert the subject when there is 
493 
a CGM reading >200 mg/dL and no prediction the CGM will decrease in the next 30 minutes. 
494 
The study pump’s optional CGM High Alert will be configured by study staff with a threshold of 
495 
250 mg/dL and a Repeat setting of 60 minutes, so the alert recurs every 60 minutes as long as the 
496 
hyperglycemia persists. High BG reminder should be set to OFF. 
497 
The pump will have the “out of range” alert set for 20 minutes (shortest possible setting) to reduce risk of 
498 
missing data. The pump “low insulin alert” will be set at ≥ 20 units to reduce risk of running the pump on 
499 
an empty cartridge. It is recommended to set the Auto Off Alert to OFF. Site Reminder alert may be set to 
500 
ON to remind subjects to change their cartridge but not their infusion set.  
501 
Subjects will be instructed not to modify the alert settings configured by study staff that are described 
502 
above. 
503 
Subjects will receive training on how to address Occlusion alarm #1 (resolvable alarm) and Occlusion 
504 
alarm #2 (non-resolvable alarm) requires infusion set change. 
505 
Study subjects will be provided a written Hyperglycemia Management Guidelines that will specify the 
506 
steps to take in case of prolonged hyperglycemia, testing of blood glucose, ketones, and correction 
507 
boluses. 
508 
3.3 Hypoglycemia Management 
509 
Hypoglycemia will be managed by the Study subjects as they would as part of their usual diabetes 
510 
management. Hypoglycemia alarms may be set at the discretion of the study subject. 
511 
3.4 Daily Text 
512 
Subjects will receive a daily reminder text indicating the target date and time of infusion set removal. 
513 
The daily text will provide a link to a questionnaire for the subject to complete with each infusion set 
514 
insertion and removal providing specifics about all infusion set changes.  
515 
3.5 Follow-up Visit and Contact Schedule 
516 
Subjects will have the following scheduled follow-up visits and phone contacts as follows: 
517 
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Table 3-1 Follow-up Visit and Contact Schedule 
518 
TIMING 
CONTACT TYPE 
TARGET/ 
ALLOWABLE WINDOW 
(AROUND TARGET DAY/WEEK) 
3 Days 
Phone 
-1 to +3 days 
2 Weeks 
Clinic/Virtual  
± 4 days 
6 Weeks 
Clinic/Virtual 
± 7 days 
Final Visit (completion of 
12th wear period or 
termination) 
Clinic/Virtual  
+ 7 days 
 
519 
The Final Visit will occur after the subject has completed the 12th set wear period. The maximum time 
520 
point will be approximately 12 weeks but generally will be less. The visit should occur within 7 days 
521 
following the 12th wear period or the last study infusion set worn. 
522 
Additional contacts will occur when a subject experiences an infusion set failure prior to 7 days of use or 
523 
when a subject has concerns about hyperglycemia or any other aspect of the study. Additional visits can 
524 
occur as needed. 
525 
3.5.1 Procedures at Study Visits 
526 
3.5.1.1  Day 3 
527 
 
Assessment of compliance with guidelines for SteadiSet device use  
528 
 
Assessment of adverse events, adverse device effects, and device issues 
529 
 
Review key aspects of study protocol regarding infusion set failure 
530 
3.5.1.2  Week 2  
531 
Procedures are identical to those above for the 3-Day visit with the addition of: 
532 
 
Completion of the Usability, Satisfaction & Preference Survey (study web site link sent to 
533 
subject) to evaluate subject’s experience with the insertion and daily wear of the SteadiSet 
534 
infusion set. 
535 
 
Upload Ketone and BG meters 
536 
3.5.1.3  Week 6  
537 
Procedures are identical to those above for the 3-Day visit, with the addition of: 
538 
 
Upload Ketone and BG meters 
539 
3.5.1.4  Final Visit 
540 
The following will occur. 
541 
 
Upload Ketone and BG meters 
542 
 
Assessment of adverse events, adverse device effects, and device issues 
543 
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 
Completion of the Usability, Satisfaction & Preference Survey (study web site link sent to 
544 
subject) to evaluate subject’s experience with the insertion and daily wear of the SteadiSet 
545 
infusion set. 
546 
 
A capillary blood sample will be obtained for end-of-study HbA1c determination. Capillary 
547 
collection supplies will be provided to the subject as described above, before the Final Visit so 
548 
that sample collection can occur during the Final Visit. 
549 
 
Collection of all used and unused (as applicable) SteadiSet devices, ancillary supplies and study 
550 
pump. 
551 
3.5.2 Study Completion 
552 
Subjects will have completed all study protocol requirements at the end of the 12th wear period (Wear 
553 
Period 12) regardless of actual total days of SteadiSet infusion set wear. Subject will return to using their 
554 
personal pump and routine insulin infusion sets at the completion of their participation in the study. 
555 
3.5.3 Early Study Discontinuation 
556 
Subjects who discontinue the study prior to the 12th infusion set wear period either by choice or by 
557 
investigator decision, will be asked to complete the end of study visit as outlined in Final Visit Section 
558 
3.5.1.4. 
559 
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Chapter 4: Study Devices 
560 
4.1 Description of the Investigational Device: SteadiSet Infusion Set 
561 
The Capillary Biomedical, Inc. (CapBio) SteadiSet Infusion Set (SteadiSet device) is a sterile single use 
562 
device for continuous subcutaneous insulin infusion (CSII). SteadiSet Infusion Sets are designed to be 
563 
used with commercially available infusion pumps by direct connection; this will limit pump use to only 
564 
Tandem t:slim X2 insulin pumps. The investigational SteadiSet Infusion Set contains a coil reinforced 
565 
soft polymer indwelling cannula with one distal and three proximal holes. This cannula is deployed into 
566 
subcutaneous tissue via an integrated single use insertion device (inserter). Figure 2 The SteadiSet 
567 
consists of an (A) insertion mechanism, hub holding the cannula in place, and (B) pump-specific tubing 
568 
set. For this study only the longest tubing (43 inch) will be used. The SteadiSet Infusion Set, with 
569 
cannula, insertion mechanism, and tubing, is individually packaged and sterilized in a vacuum formed cup 
570 
with a Tyvek™ lid. 
571 
 
572 
Figure 2. Components of the SteadiSet Infusion Set 
573 
 
574 
A. Cartridge connector 
575 
B. Set connector 
576 
C. Inserter 
577 
D. Set with cannula (inside inserter) 
578 
E. Paper liner 
579 
F. Disconnect cover 
580 
G. Set  
581 
For this clinical trial subjects will be exposed to the device for 12 consecutive wear periods of up to 
582 
7 days each. Devices will be returned to the study site at the end of study participation, defined as after 
583 
12 wear periods or end of their study participation regardless of the number of wear periods. 
584 
4.2 Insulin Pump 
585 
Subjects will be provided with a Tandem t:slim X2 pump with Control-IQ technology and insulin 
586 
cartridges that will be the same as the commercially-available device. These pumps will be returned at 
587 
conclusion of study participation. 
588 
4.3 Insulin Cartridges  
589 
Insulin cartridges will be provided to subjects. 
590 
4.4 Ancillary Supplies 
591 
Subjects will be provided with ancillary supplies as requested to be used at their discretion for skin prep 
592 
and tapes to assist in securing infusion sets. Under taping is prohibited in this study. In addition, subjects 
593 
may request lancets and alcohol wipes.   
 
 
 
594 
G 
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4.5 Blood Glucose Meter 
595 
A study BG meter will be provided to subjects with test strips. 
596 
4.6 Blood Ketone Meter 
597 
A study Blood Ketone meter will be provided to subjects with test strips. 
598 
4.7 Continuous Glucose Monitor 
599 
Subjects will use their personal Dexcom G6 or G7 CGM and personal supplies for measuring glucose and 
600 
communicating with the Tandem pump. 
601 
4.8 Subject Access to Study Devices at Study Closure 
602 
Subjects will return the study pump and all used and unused study infusion sets. Subjects may keep the 
603 
ancillary supplies, BG and ketone meters once confirmation all data has been uploaded into study 
604 
database. 
605 
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Chapter 5: Testing Procedures and Questionnaires 
606 
5.1 Laboratory Testing 
607 
5.1.1 HbA1c 
608 
Performed at the Day 0 Visit and Final Visit. 
609 
Blood samples will be sent to the central laboratory for sample analysis using an NGSP approved method. 
610 
5.1.2 Urine Pregnancy 
611 
Urine pregnancy testing will be performed locally at clinical sites for females of child-bearing potential at 
612 
the Screening visit and anytime pregnancy is suspected or performed at home with a urine pregnancy kit 
613 
sent to the subject if visits are virtual. Pregnancy test results will be reported to the study center per the 
614 
clinical site’s standard procedures. 
615 
5.2 Questionnaires 
616 
5.2.1 Screening Visit 
617 
Study personnel will ask subjects to complete a Usability, Satisfaction & Preference Survey with 
618 
multiple-choice questions and optional comment areas about their experience with their current insulin 
619 
infusion set during their Screening Visit. The survey takes approximately 5 to 10 minutes to complete.  
620 
5.2.2 Week 2 Visit 
621 
Study personnel will ask subjects to complete a Usability, Satisfaction & Preference Survey with 
622 
multiple-choice questions and optional comment areas about their experience with the SteadiSet infusion 
623 
set following their first two Wear Periods. The survey should take approximately 5 to 10 minutes to 
624 
complete. 
625 
5.2.3 Final Visit 
626 
Study personnel will ask subjects to complete a Usability, Satisfaction & Preference Survey with 
627 
multiple-choice questions and optional comment areas about their experience with the SteadiSet infusion 
628 
set following their final Wear Period. The survey should take approximately 5 to 10 minutes to complete. 
629 
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Chapter 6: Unanticipated Problem, Adverse Event, and 
630 
Device Issue Reporting 
631 
6.1 Unanticipated Problems 
632 
Site investigators will promptly report to the Coordinating Center on an eCRF all unanticipated problems 
633 
meeting the criteria below. Sites overseen by the JCHR IRB must report Unanticipated Problems to the 
634 
IRB within seven (7) calendar days of recognition. Sites using other IRBs will follow their reporting 
635 
guidelines. All Serious and Unanticipated Adverse Events must be reported to the Coordinating Center 
636 
within 24 hours of learning of the events. For this protocol, an unanticipated problem is an incident, 
637 
experience, or outcome that meets all of the following criteria: 
638 
 
Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are 
639 
described in the protocol related documents, such as the IRB-approved research protocol and 
640 
informed consent document; and (b) the characteristics of the subject population being studied 
641 
 
Related or possibly related to participation in the research (possibly related means there is a 
642 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
643 
procedures involved in the research) 
644 
 
Suggests that the research places subjects or others at a greater risk of harm than was previously 
645 
known or recognized (including physical, psychological, economic, or social harm) 
646 
The Coordinating Center will also report to the IRB all unanticipated problems not directly involving a 
647 
specific site such as such as unanticipated problems that occur study-wide or at another participating 
648 
entity such as a pharmacy or laboratory. These instances must be reported to the JCHR IRB within seven 
649 
(7) calendar days of recognition. The Director of the Human Research Protection Program (HRPP) will 
650 
report to the appropriate regulatory authorities if the IRB determines that the event indeed meets the 
651 
criteria of an Unanticipated Problem requiring additional reporting to fulfill the reporting obligations of 
652 
the HRPP. 
653 
6.2 Adverse Events 
654 
6.2.1 Definitions 
655 
Adverse Event (AE): Any untoward medical occurrence (including laboratory findings) associated with 
656 
study procedures, the use of a device, biologic, or drug in humans, including any comparator used, 
657 
whether or not the event is considered related (i.e., irrespective of the relationship between the adverse 
658 
event and the device(s) under investigation). 
659 
Serious Adverse Event (SAE): Any untoward medical occurrence that results in any of the following 
660 
outcomes: 
661 
 
Death. 
662 
 
A life-threatening adverse event (a non-life-threatening event which, had it been more severe, 
663 
might have become life-threatening, is not necessarily considered a serious adverse event). 
664 
 
Inpatient hospitalization or prolongation of existing hospitalization. 
665 
 
A persistent or significant disability/incapacity or substantial disruption of the ability to 
666 
conduct normal life functions. 
667 
 
A congenital anomaly or birth defect. 
668 
An important medical event that may not result in death, be life-threatening, or require hospitalization 
669 
may be considered serious when, based upon appropriate medical judgment, may jeopardize the patient or 
670 
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subject and may require medical and/or surgical intervention to prevent one of the outcomes listed in this 
671 
definition. Note: If either the Sponsor or investigator believes the event is serious, the event must be 
672 
considered serious and evaluated by the Sponsor for expedited reporting. See 21 CFR 812.3(s) for more 
673 
information. 
674 
Unanticipated Adverse Device Effect (UADE): Any serious adverse effect on health or safety or any 
675 
life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or 
676 
death was not previously identified in nature, severity, or degree of incidence in the investigational plan 
677 
or application (including a supplementary plan or application), or any other unanticipated serious problem 
678 
associated with a device that relates to the rights, safety, or welfare of subjects (21 CFR 812.3(s)). 
679 
Adverse Device Effect (ADE): Any untoward medical occurrence in a study subject which the device 
680 
may have caused or to which the device may have contributed. This definition includes adverse events 
681 
resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or 
682 
operation, or any malfunction of the investigational medical device; any event resulting from use error or 
683 
from intentional misuse of the investigational medical device. (Note that an Adverse Event Form is to be 
684 
completed in addition to a Device Deficiency or Issue Form, unless excluded from reporting as defined in 
685 
Section 6.2). 
686 
Device Complaints and Malfunctions: A device complication or complaint is something that happens to 
687 
a device or related to device performance, whereas an adverse event happens to a subject. A device 
688 
complaint may occur independently from an AE, or along with an AE. An AE may occur without a 
689 
device complaint or there may be an AE related to a device complaint. A device malfunction is any 
690 
failure of a device to meet its performance specifications or otherwise perform as intended. Performance 
691 
specifications include all claims made in the labeling for the device. The intended performance of a 
692 
device refers to the intended use for which the device is labeled or marketed. (21 CFR 803.3). Note: for 
693 
reporting purposes, sites will not be asked to distinguish between device complaints and malfunctions. 
694 
Use Error: User action or lack of user action while using the medical device (3.34) that leads to a different 
695 
result than that intended by the manufacturer or expected by the user. Includes the inability of the user to 
696 
complete a task. Use errors can result from a mismatch between the characteristics of the user, user 
697 
interface, task or use environment. Users might be aware or unaware that a use error has occurred. An 
698 
unexpected physiological response of the patient is not by itself considered a use error. A malfunction of a 
699 
medical device that causes an unexpected result is not considered a use error. (ISO 14155:2020) 
700 
6.2.2 Reportable Adverse Events 
701 
For this protocol, a reportable adverse event includes any untoward medical occurrence that meets one of 
702 
the following criteria: 
703 
1. A SAE 
704 
2. An ADE as defined in Section 6.2.1, unless excluded from reporting in Section 6.3 
705 
3. An AE as defined in Section 6.2.1 occurring in association with a study procedure 
706 
4. An AE as defined in Section 6.2.1 not related to a device issue which leads to temporary or 
707 
permanent discontinuation of a study device 
708 
5. An AE as defined in Section 6.2.1 that affects the subject’s ability to complete any study 
709 
procedures 
710 
6. An AE as defined in Section 6.2.1 for which a visit is made to a hospital emergency department  
711 
7. Hypoglycemia meeting the reporting criteria defined in Section 6.2.3 
712 
8. Diabetic ketoacidosis (DKA) as defined below; or in the absence of DKA, hyperglycemia or 
713 
ketosis event meeting the reporting criteria in Section 6.2.4 
714 
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Hypoglycemia and hyperglycemia not meeting the criteria below will not be recorded as adverse events 
715 
unless associated with an Adverse Device Effect or discontinuation of the study device. Skin reactions 
716 
from sensor placement are only reportable if severe and/or required treatment. 
717 
All reportable AEs—whether volunteered by the subject, discovered by study personnel during 
718 
questioning, or detected through physical examination, laboratory test, or other means—will be reported 
719 
on an AE form online. Each AE form is reviewed by the Medical Monitor to assess safety and to verify 
720 
the coding and the reporting that is required. 
721 
6.2.3 Hypoglycemic Events 
722 
Hypoglycemia not associated with an Adverse Device Effect is only reportable as an adverse event when 
723 
one of the following criteria is met: 
724 
A hypoglycemic event occurred meeting the following definition of severe hypoglycemia: 
725 
 
The event required assistance of another person due to altered consciousness, and required 
726 
another person to actively administer carbohydrate, glucagon, or other resuscitative actions. 
727 
This means that the subject was impaired cognitively to the point that he/she was unable to 
728 
treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, 
729 
and/or combative, or experienced seizure or loss of consciousness. These episodes may 
730 
be associated with sufficient neuroglycopenia to induce seizure or loss of consciousness. 
731 
If glucose measurements are not available during such an event, neurological recovery 
732 
attributable to the restoration of glucose to normal is considered sufficient evidence that the 
733 
event was induced by a low glucose concentration. 
734 
 
Evaluation or treatment was obtained at a health care provider facility for an acute event 
735 
involving hypoglycemia, or the subject contacted the site and received guidance following 
736 
the occurrence of an acute event involving hypoglycemia. 
737 
When a severe hypoglycemia event occurs (as defined above), a Hypoglycemia Form should be 
738 
completed in addition to the Adverse Event Form. Severe hypoglycemia events should be considered to 
739 
be serious adverse events with respect to reporting requirements. When a severe hypoglycemia event 
740 
occurs during use of a study device, it generally will be considered unrelated to the device if the device 
741 
functioned as intended and there does not appear to be a flaw in how the device is intended to function. 
742 
6.2.4 Hyperglycemic/Ketotic Events 
743 
Hyperglycemia with or without ketosis that is associated with an infusion set failure will be reported on a 
744 
protocol-specific CRF and not reported separately as an AE unless criteria for an SAE are met. 
745 
Hyperglycemia not associated with an infusion set failure or other Adverse Device Effect is only 
746 
reportable as an adverse event when one of the following criteria is met:  
747 
 
The event involved DKA, as defined by the Diabetes Control and Complications Trial 
748 
(DCCT) and described below 
749 
 
Evaluation or treatment was obtained at a health care provider facility for an acute event 
750 
involving hyperglycemia or ketosis, or the participant contacted the site and received 
751 
guidance on how to manage the acute hyperglycemia/ketosis event unrelated to the infusion 
752 
set 
753 
 
Blood ketone level >1.5 mmol/L 
754 
Hyperglycemic events are classified as DKA if the following are present: 
755 
 
Symptoms such as polyuria, polydipsia, nausea, or vomiting; 
756 
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 
Serum ketones >1.5 mmol/L or large/moderate urine ketones; 
757 
 
Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate (or CO2) <15; and 
758 
 
Treatment provided in a health care facility. 
759 
When a hyperglycemia/ketotic event qualifies as a SAE as defined in Section 6.2.1, a 
760 
Hyperglycemia/DKA Form should be completed in addition to the Adverse Event Form. Events meeting 
761 
DKA criteria should be considered as serious adverse events with respect to reporting requirements. 
762 
Hyperglycemia events not meeting criteria for DKA generally will not be considered as serious adverse 
763 
events unless one of the SAE criteria in Section 6.2.1 is met. 
764 
When a hyperglycemia/DKA event occurs during use of a study device, it generally will be considered 
765 
unrelated to the device if the device functioned as intended and there does not appear to be a flaw in how 
766 
the device is intended to function. 
767 
6.2.5 Relationship of Adverse Event to Study Investigational Device 
768 
The study investigator will assess the relationship of any adverse event to be related or unrelated by 
769 
determining if there is a reasonable possibility that the adverse event may have been caused by the study 
770 
device. The Medical Monitor also will make this assessment, which may or may not agree with that of the 
771 
study investigator.  
772 
To ensure consistency of adverse event causality assessments, investigators should apply the following 
773 
general guideline when determining whether an adverse event is related: 
774 
Unrelated: The AE is clearly not related to a study drug/device and a likely alternative etiology 
775 
exists such as an underlying disease, environmental or toxic factors or other therapy. 
776 
Unlikely Related: The AE does not follow a reasonable temporal sequence during or after use of 
777 
study drug/device and a more likely alternative etiology exists such as an underlying disease, 
778 
environmental or toxic factors, or other therapy. 
779 
Possibly Related: The AE occurred in a reasonable time during or after use of study drug/device; 
780 
but could be related to another factor such as an underlying disease, environmental or toxic factors, 
781 
or other therapy; and there is a possible, though weak, scientific basis for establishing a causal 
782 
association between the AE and the study drug/device. 
783 
Probably Related: The AE occurred in a reasonable time during or after use of study drug/device; 
784 
is unlikely to be related to another factor such as an underlying disease, environmental or toxic 
785 
factors, or other therapy; and there is a plausible, though not strong, scientific basis for 
786 
establishing a causal association between the AE and the study drug/device. 
787 
Definitely Related: The AE occurred in a reasonable time during or after use of study 
788 
drug/device; cannot be explained by another factor such as an underlying disease, environmental 
789 
or toxic factors, or therapy; and there is a strong scientific basis for establishing a causal 
790 
association between the AE and the study drug/device. 
791 
Where these relatedness categories are used, events determined to be Possibly Related, Probably Related, 
792 
or Definitely Related will be considered to meet the reasonable possibility causality standard for 
793 
relatedness and necessitate reporting as required (see 21 CFR 812.3(s) for more information). 
794 
6.2.6 Severity (Intensity) of Adverse Events 
795 
The severity (intensity) of an adverse event will be rated on a three-point scale: (1) mild, (2) moderate, 
796 
or (3) severe. A severity assessment is a clinical determination of the intensity of an event. Thus, a severe 
797 
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adverse event is not necessarily serious. For example, itching for several days may be rated as severe, but 
798 
may not be clinically serious. 
799 
MILD: Usually transient, requires no special treatment, and does not interfere with the subject’s 
800 
daily activities. 
801 
MODERATE: Usually causes a low level of inconvenience, discomfort or concern to the subject 
802 
and may interfere with daily activities but is usually ameliorated by simple therapeutic measures 
803 
and subject is able to continue in study. 
804 
SEVERE: Interrupts a subject’s usual daily activities, causes severe discomfort, may cause 
805 
discontinuation of study device, and generally requires systemic drug therapy or other treatment. 
806 
6.2.7 Expectedness 
807 
For a serious adverse event that is considered possibly related to study device, the Medical Monitor will 
808 
classify the event as unexpected if the nature, severity, or frequency of the event is not consistent with 
809 
the risk information previously described in the protocol or the Clinical Investigator Brochure. 
810 
6.2.8 Coding of Adverse Events 
811 
Adverse events will be coded using the MedDRA dictionary. To facilitate coding, the site will enter a 
812 
preliminary MedDRA code which the Medical Monitor may accept or change (the Medical Monitor’s 
813 
MedDRA coding will be used for all reporting). The Medical Monitor will review the investigator’s 
814 
assessment of causality and may agree or disagree. Both the investigator’s and Medical Monitor’s 
815 
assessments will be recorded. The Medical Monitor will have the final say in determining the causality as 
816 
well as whether an event is classified as a serious adverse event and/or an unanticipated adverse device 
817 
effect. 
818 
6.2.9 Outcome of Adverse Events 
819 
The outcome of each reportable adverse event will be classified by the investigator as follows: 
820 
RECOVERED/RESOLVED (COMPLETE RECOVERY) – The subject recovered from the 
821 
AE/SAE without sequelae. Record the AE/SAE stop date. 
822 
RECOVERED/RESOLVED WITH SEQUELAE – AE/SAE where the subject recuperated but 
823 
retained pathological conditions resulting from the prior disease or injury. Record the 
824 
AE/SAE stop date. 
825 
FATAL – A fatal outcome is defined as the SAE that resulted in death. Only the event that was 
826 
the cause of death should be reported as fatal. AEs/SAEs that were ongoing at the time of death; 
827 
however, were not the cause of death, will be recorded as “resolved” at the time of death. 
828 
ONGOING (NOT RECOVERED/NOT RESOLVED) – An ongoing AE/SAE is defined as an 
829 
ongoing event with an undetermined outcome. 
830 
 
An ongoing outcome will require follow-up by the site in order to determine the final 
831 
outcome of the AE/SAE. 
832 
 
The outcome of an ongoing event at the time of death that was not the cause of death, will be 
833 
updated and recorded as “resolved” with the date of death recorded as the stop date. 
834 
ONGOING (MEDICALLY STABLE) – AE/SAE is ongoing, but medically stable. For example, 
835 
a chronic condition where no further change is expected. 
836 
If any reported adverse events are ongoing when a subject completes the study (or withdraws), adverse 
837 
events classified as UADEs or related SAEs will be followed until they are either resolved, or have no 
838 
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prospect of improvement or change, even after the subject has completed all applicable study 
839 
visits/contacts. For all other adverse events, data collection will end at the time the subject completes the 
840 
study. Note: Subjects should continue to receive appropriate medical care for an adverse event after their 
841 
participation in the study ends. 
842 
If a Subject is lost to follow up and Subject outcome cannot be determined, outcome classification will be 
843 
the last known outcome. 
844 
6.3 Reportable Device Issues 
845 
Infusion set failures will be reported on a protocol-specific CRF and not reported separately as a 
846 
Device Issue. 
847 
All UADEs and ADEs as defined in Section 6.2.1 will be reported on both a device issue form and AE 
848 
form, except for skin reactions from CGM sensor placement or pump infusion set placement that do not 
849 
require pharmacologic treatment. 
850 
Device complaints and device malfunctions will be reported except in the following circumstances. 
851 
These occurrences are expected and will not be reported on a Device Issue Form assuming criteria for a 
852 
UADE or ADE have not been met: 
853 
 
Battery lifespan deficiency due to inadequate charging or extensive wireless communication 
854 
 
Intermittent device component disconnections/communication failures not requiring system 
855 
replacement or workaround/resolution not specified in user guide/manual. 
856 
 
Device issues clearly addressed in the user guide manual that do not require additional 
857 
troubleshooting 
858 
6.4 Timing of Event Reporting 
859 
SAEs possibly related to a study device or study participation and UADEs must be reported by the 
860 
investigator to the Coordinating Center within twenty-four (24) hours of the site becoming aware of the 
861 
event. This can occur via phone or email, or by completion of the online serious adverse event form and 
862 
device issue form if applicable. If the form is not initially completed, it should be competed as soon as 
863 
possible after there is sufficient information to evaluate the event. All other reportable ADEs and other 
864 
reportable AEs should be submitted by completion on the online form within seven (7) days of the site 
865 
becoming aware of the event. 
866 
The Coordinating Center will notify all participating investigators of any adverse event that is serious, 
867 
related, and unexpected. Notification will be made within ten (10) working days after the Coordinating 
868 
Center becomes aware of the event. 
869 
Each principal investigator is responsible for reporting serious study-related adverse events and abiding 
870 
by any other reporting requirements specific to his/her Institutional Review Board or Ethics Committee. 
871 
Where the JCHR IRB is the overseeing IRB, sites must report all serious, related adverse events within 
872 
seven calendar days. 
873 
Upon receipt of a qualifying event, the Sponsor will investigate the event to determine if a UADE has 
874 
occurred, and if indicated, report the results of the investigation to all overseeing IRBs, and the FDA 
875 
within ten (10) working days of the Sponsor becoming aware of the UADE per 21CFR 812.46(b) (2). The 
876 
Sponsor in conjunction with the Medical Monitor must determine if the UADE presents an unreasonable 
877 
risk to subjects. If so, the Sponsor must ensure that all investigations, or parts of investigations presenting 
878 
that risk, are terminated as soon as possible but no later than five (5) working days after the Sponsor 
879 
makes this determination and no later than fifteen (15) working days after first receipt notice of the 
880 
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UADE. The investigator(s) may then be required to provide approval or acknowledgment of receipt of 
881 
that notification and must submit to their overseeing IRB as required. 
882 
The investigators are also required to report, without unjustified delay, all device deficiencies that could 
883 
have led to a UADE, including device deficiencies, irrespective of whether an adverse event occurred. 
884 
6.5 Safety Oversight 
885 
The study Medical Monitor will review all adverse events and adverse device events that are reported 
886 
during the study. SAEs typically will be reviewed within twenty-four (24) hours of reporting. Other AEs 
887 
typically will be reviewed on a weekly basis. Additionally, the Medical Monitor will review compiled 
888 
safety data at periodic intervals. 
889 
The Clinical Study Director will be informed of all cases of severe hypoglycemia and DKA and the 
890 
Medical Monitor’s assessment of relationship to the study device; and informed of all reported device 
891 
issues. 
892 
6.6 Stopping Criteria 
893 
6.6.1 Subject Discontinuation of Study Device 
894 
In the case of an unanticipated system malfunction resulting in a severe hypoglycemia or DKA event (or a 
895 
malfunction that could have led to severe hypoglycemia or DKA), use of the SteadiSet will be suspended 
896 
while the problem is diagnosed. The UADE will be reported to the IRB, Medical Monitor and FDA. After 
897 
assessment of the problem and any correction, use of the SteadiSet will not be restarted until approval is 
898 
received from the IRB, Medical Monitor, and FDA. 
899 
In the absence of a device malfunction, use of the SteadiSet by a subject will be discontinued if any of the 
900 
following occur: 
901 
 
The investigator believes it is unsafe for the subject to continue on the intervention. This 
902 
could be due to the development of a new medical condition or worsening of an existing 
903 
condition; or subject behavior contrary to the indications for use of the device that imposes 
904 
on the subject’s safety 
905 
 
The subject requests that the treatment be stopped 
906 
 
Subject pregnancy 
907 
 
Two distinct episodes of DKA as defined in Section 6.2.4 
908 
 
Two distinct severe hypoglycemia events as defined in Section 6.2.3 
909 
 
One episode of DKA as defined in Section 6.2.4 and one severe hypoglycemia event as 
910 
defined in Section 6.2.3 
911 
Each DKA or severe hypoglycemia event will be reviewed by the Medical Monitor with respect to 
912 
determination of cause and whether the occurrence of the event can be attributed to use of the SteadiSet.  
913 
An additional requirement for continued SteadiSet use following a single DKA or severe hypoglycemia 
914 
event will be that the site investigator believes the event is unlikely to recur and that it is safe for the 
915 
subject to continue to use the system. Additionally, if the Medical Monitor determines the occurrence of 
916 
the event indicates that it is not safe for the Subject to continue to use the SteadiSet, use will be 
917 
discontinued. 
918 
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6.6.2 Criteria for Suspending or Stopping Overall Study 
919 
In addition to the suspension of device use due to a UADE as described in Section 6.6.1, study activities 
920 
could be similarly suspended if the manufacturer of any constituent study device requires stoppage of 
921 
device use for safety reasons (e.g., product recall). The affected study activities may resume if the 
922 
underlying problem can be corrected by a protocol or system modification that will not invalidate the 
923 
results obtained prior to suspension. 
924 
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Chapter 7: Miscellaneous Considerations 
925 
7.1 Drugs Used as Part of the Protocol 
926 
Subjects will use their personal insulin, either insulin lispro (Humalog) or insulin aspart (NovoLog), 
927 
throughout their study participation.  
928 
In the event a subject’s insulin changes from Humalog to NovoLog, or vice versa, it will be noted in the 
929 
case report form and analysed accordingly. 
930 
7.2 Collection of Medical Conditions and Medications 
931 
Pre-Existing Condition: Any medical condition that is either present at screening, a chronic disease, or a 
932 
prior condition that could impact the Subject’s health during the course of the study (e.g., prior 
933 
myocardial infarction or stroke). 
934 
Medical Conditions during the study: In addition to conditions meeting the reporting requirements for an 
935 
adverse event or device issue as described above, the following medical conditions should also be 
936 
reported: (1) new diagnosis of a chronic disease (i.e., not present at the time of enrollment), and (2) any 
937 
medical condition that could affect the subject’s ability to carry out any aspect of the protocol or could 
938 
affect an outcome assessment. New conditions or worsening of a previous medical condition should be 
939 
reported as adverse events. 
940 
Medications: All medications for the treatment of pre-existing conditions at screening and/or adverse 
941 
events, or other medications that could impact blood glucose, should be recorded. 
942 
7.3 Prohibited Medications, Devices, Treatments, and Procedures 
943 
Treatment with any insulin other than insulin lispro and insulin aspart and treatment with any non-insulin 
944 
glucose lowering agent besides metformin is not permitted. 
945 
The insulin pump and CGM device must be removed before magnetic resonance imaging (MRI), 
946 
computed tomography (CT) or diathermy treatment. Subjects may continue in the trial after temporarily 
947 
discontinuing use if requiring one of the above. 
948 
Subjects will be discontinued from the study if systemic corticosteroids are used for more than 7- 
949 
sequential days. 
950 
Under taping of the infusion set is prohibited. Over taping is acceptable per Subject’s preference. 
951 
7.4 Pregnancy Reporting 
952 
If pregnancy occurs, the subject will be discontinued from the study. The occurrence of pregnancy will be 
953 
reported to the Coordinating Center within seven days and to the JCHR IRB on the Unanticipated 
954 
Problem form within seven (7) calendar days. 
955 
7.5 Subject Compensation 
956 
Subject compensation will be specified in the informed consent form. 
957 
7.6 Subject Withdrawal 
958 
Participation in the study is voluntary, and a subject may withdraw at any time. For subjects who 
959 
withdraw, their data will be used up until the time of withdrawal. 
960 
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7.7 Confidentiality 
961 
For security and confidentiality purposes, subjects will be assigned an identifier that will be used instead 
962 
of their name. Protected health information gathered for this study will be shared with the coordinating 
963 
center, the Jaeb Center for Health Research in Tampa, FL. De-identified subject information may also be 
964 
provided to research sites involved in the study. 
965 
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PAGE 48 OF 59 
Chapter 8: Statistical Considerations 
966 
8.1 Statistical and Analytical Plans 
967 
The approach to sample size and statistical analyses is summarized below.  
968 
8.2 Statistical Hypotheses 
969 
A 95% confidence interval (95% CI) for the 7-day survival rate (i.e., primary efficacy endpoint as defined 
970 
in Section 8.4.2 below) will be calculated.  
971 
The null/alternative hypotheses are: 
972 
a. Null Hypothesis: The success rate is 75%. 
973 
b. Alternative Hypothesis: The success rate is different from 75% (two-sided). 
974 
8.3 Power 
975 
Assuming (1) n=120 subjects completing the study for each insulin type, (2) a null hypothesis stating that 
976 
the success rate is 75%, (3) a true success rate of 83%, (4) 12 wear periods per subject (5) within-subject 
977 
correlation of at most 0.4, and (6) two-sided type 1 error rate of 5% we will have statistical power of 87%. 
978 
Note that with only 9 wear periods per subject we would still have 86% power.  
979 
8.4 Outcome Measures 
980 
8.4.1 Clinical Events Committee 
981 
Clinical Primary and Secondary Endpoint events will be adjudicated by the Clinical Events Committee 
982 
(CEC). The CEC will be made up of the Medical Monitor, Lead Investigator and one independent 
983 
diabetes expert.  
984 
The CEC will adjudicate endpoint events based on review of all available information that is relevant to 
985 
determining whether protocol-defined clinical endpoint events have occurred during the study as outlined 
986 
in the CEC Charter. Operational details will be defined in a separate Clinical Events Committee SOP 
987 
document. 
988 
8.4.2 Primary Efficacy Endpoint 
989 
Percentage of successfully-inserted SteadiSet infusion sets (i.e., not removed within 8 hours of insertion) 
990 
that are not withdrawn from use prior to 7 days (168 hours) due to either (1), (2), or (3): 
991 
1. Blood Glucose value ≥250 mg/dL with ketones >1.0 mmol/L, in the absence of illness or other 
992 
physiological stress.  
993 
2. Blood Glucose value ≥250 mg/dL for at least 60 minutes duration, 3 hours or more following 
994 
a snack or meal event AND failure to respond to up to 2 adequate corrective boluses delivered by 
995 
the pump with a fall of at least 50 mg/dL. In the absence of BGM testing immediately prior to or 
996 
following a corrective bolus then CGM values will be used for the primary endpoint analyses. 
997 
3. Investigator advises the infusion set should be replaced to assure subject’s safety. 
998 
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8.4.3 Safety Endpoints 
999 
The incidence, severity, and relationship to the investigational device of all reported adverse events 
1000 
(serious and non-serious including DKA and severe hypoglycemia) from day of insertion through day of 
1001 
device removal for each wear period. 
1002 
8.4.4 Key Secondary Endpoint 
1003 
Proportion (%) of SteadiSet infusion sets withdrawn from use at any time following insertion prior to 7 
1004 
days (168 hours) as evidenced by one or more of the following device failure modes. NOTE: infusion set 
1005 
removals prior to 168 hours due to miscalculation of date and/or time, along with other removals that 
1006 
cannot be ascribed to the investigational device performance, are excluded from this proportion 
1007 
calculation. 
1008 
1. Infusion set failure as defined in the Primary Endpoint (including any such removals occurring 
1009 
during the first 8 hours following set insertion) 
1010 
2. Evidence of infusion set site infection defined as requiring treatment or at the investigator’s 
1011 
judgment  
1012 
3. Cannula dislodgement from subcutaneous (SC) space (with or without liquid leakage at the 
1013 
cannula insertion site) 
1014 
a. Leakage at the cannula insertion site may or may not be deemed by the investigator to 
1015 
constitute infusion set failure following consultation with the study subject 
1016 
b. Accidental removal events (e.g., tubing caught on doorknob) are excluded from this 
1017 
proportion calculation 
1018 
4. Occurrence of a non-resolvable pump occlusion alarm,  
1019 
5. Other device malfunction (e.g., inability to pierce skin, bending, or other malformation that might 
1020 
impact insulin infusion, securement failure) 
1021 
6. Presence of pain of sufficient severity to prompt early removal of infusion set 
1022 
7. Any other event that can be ascribed to the investigational device performance that results in 
1023 
failure of insulin delivery 
1024 
8.4.5 Other Secondary Endpoints 
1025 
1. Standard glucose control measures obtained from CGM, including observed hyper- and 
1026 
hypoglycemic episodes, time in range, mean 24-hour glucose, and other measures 
1027 
2. Total daily insulin dose, basal dose, bolus dose, and bolus basal ratio, overall, and by day of 
1028 
infusion set wear. 
1029 
3. Subject tolerability levels for the infusion set insertion as assessed by a pain scale of 0 to 100 with 
1030 
zero being no pain and 100 being significant pain 
1031 
4. Hyperglycemia trends in days 1-3 versus after day 3 
1032 
5. Infusion set performance (including set failures as defined above and also glucose metrics, insulin 
1033 
doses, pump occlusion alarms and hyperglycemia trends) in subjects who use low doses (e.g., 
1034 
<25 units/day) of insulin and in subjects who experience frequent stops and start of pump use 
1035 
8.4.6 Exploratory Endpoint 
1036 
1. HbA1c change from baseline to the end of study participation. 
1037 
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8.5 Analysis Datasets and Sensitivity Analyses 
1038 
1. Only wears of the investigational infusion set will be included in the analysis (i.e., any wear of a 
1039 
personal infusion set will be excluded) 
1040 
2. All subjects with at least one wear of the investigational infusion set and all such wears will be 
1041 
included in the primary and secondary efficacy analyses. Subjects who complete at least six wear 
1042 
periods will be considered as “completers.”  
1043 
3. Since this is not a randomized trial, the intention-to-treat principle does not apply. 
1044 
4. All reported adverse events will be included in the safety analyses. 
1045 
8.6 Analysis of the Primary Efficacy Endpoint(s) 
1046 
Analysis will be done separately for each insulin type (Humalog and Novolog). 
1047 
Kaplan-Meier estimates will be reported along with a curve used to estimate the proportion of infusion 
1048 
sets that last at least 7 days. Any infusion sets that are removed prior to day 7 without meeting the stated 
1049 
failure criteria will be treated as a censored observation. 
1050 
A two-sided 95% confidence interval (95% CI) for the 7-day survival rate will be calculated with a 
1051 
bootstrap to account for the correlated data from having each subject wear multiple infusion sets. A 
1052 
corresponding p-value will be given for the null hypothesis that the true survival probability is 75%. 
1053 
8.7 Analysis of the Secondary and Exploratory Endpoints 
1054 
If results from the primary analysis are comparable for Humalog and Novolog, then the data will be 
1055 
pooled for secondary analyses. Otherwise, separate analyses will be done by insulin type. Percentage of 
1056 
SteadiSet infusion sets not withdrawn from use prior to 7 days (168 hours) as evidenced by the absence of 
1057 
device failure, and as defined above, will be analyzed using the same statistical methods as described 
1058 
above for the primary efficacy endpoint. 
1059 
A paired t-test will be used to compare the central lab HbA1c values measured at the final study visit 
1060 
versus the Day 0 value. A two-sided 95% CI will be given for the mean difference. Only subjects with a 
1061 
central lab value at both times will be included in this analysis. Similar pre- post comparisons will be 
1062 
done with selected CGM metrics. These will include data from the final 14 days of the study compared 
1063 
with the baseline CGM data. 
1064 
Survey and pain assessment results will be tabulated. 
1065 
The other continuous and binary outcomes will be summarized as appropriate to their distributions (i.e., 
1066 
mean (SD), median (IQR), or n (%)). Plots and 95% CI will be calculated for selected outcomes. 
1067 
CGM metrics will be calculated over the entire study period (24-hour, daytime, and nighttime) and by 
1068 
study week (24 hour only). 
1069 
Hyperglycemia Trend in Days 1-3 versus after Day 3 
1070 
The trend in hyperglycemia in days 1-3 versus after day 3 will be assessed with the CGM metrics % time 
1071 
above 180 mg/dL, % time above 250 mg/dL, and mean glucose. Summary statistics appropriate to their 
1072 
distributions, boxplots will be used to compare data in days 1-3 versus after day 3. Formal comparisons 
1073 
will be done using paired t-tests (or non-parametric analogs if the data are not approximately normally 
1074 
distributed) to account for the correlated data from the same subject. 
1075 
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8.8 Safety Analyses 
1076 
All enrolled subjects will be included in these analyses and all their safety events up to the end of study 
1077 
will be listed. In particular, any AEs involving hyperglycemia/ketosis will include an assessment whether 
1078 
or not it corresponded to an infusion set failure. 
1079 
The circumstances of all reportable adverse events as defined in the protocol above will be summarized. 
1080 
8.9 Baseline Descriptive Statistics 
1081 
Baseline demographic and clinical characteristics of the cohort of all enrolled subjects with at least one 
1082 
wear will be summarized in a table using summary statistics appropriate to the distribution of each 
1083 
variable. Will include: 
1084 
 
Age 
1085 
 
Gender 
1086 
 
Race/ethnicity 
1087 
 
Diabetes duration 
1088 
 
HbA1c 
1089 
 
BMI 
1090 
 
CGM metrics (including estimated HbA1c) 
1091 
 
Insulin type 
1092 
 
Infusion set type 
1093 
8.10 Planned Interim Analyses 
1094 
No formal interim efficacy analyses are planned for this study. 
1095 
8.11 Multiple Comparison/Multiplicity 
1096 
Since this is an exploratory and a single arm trial, there will be no formal adjustment for multiple 
1097 
comparisons. 
1098 
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Chapter 9: Data Collection and Monitoring 
1099 
9.1 Case Report Forms and Other Data Collection 
1100 
The main study data are collected on electronic case report forms (eCRFs). When data are directly 
1101 
collected in electronic case report forms, this will be considered the source data. For any data points for 
1102 
which the eCRF is not considered source (e.g., lab results that are transcribed from a printed report into 
1103 
the eCRF), the original source documentation must be maintained in the subject’s study chart or medical 
1104 
record. This source must be readily verifiable against the values entered into eCRF. Even where all study 
1105 
data are directly entered into the eCRFs at office visits, evidence of interaction with a live subject must be 
1106 
recorded (e.g., office note, visit record, etc.). 
1107 
Electronic device data files are obtained from the study software and individual hardware components. 
1108 
These electronic device files are considered the primary source documentation. 
1109 
9.2 Study Records Retention 
1110 
Each participating site will maintain appropriate medical and research records for this trial, in compliance 
1111 
with ICH E6 and regulatory and institutional requirements for the protection of confidentiality of subjects. 
1112 
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
1113 
application in an ICH region and until there are no pending or contemplated marketing applications in an 
1114 
ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical development 
1115 
of the investigational product. These documents should be retained for a longer period, however, if 
1116 
required by local regulations. No records will be destroyed without the written consent of the sponsor, if 
1117 
applicable. It is the responsibility of the sponsor to inform the investigator when these documents no 
1118 
longer need to be retained. 
1119 
9.3 Quality Assurance and Monitoring 
1120 
Designated personnel from the Coordinating Center will be responsible for maintaining quality assurance 
1121 
(QA) and quality control (QC) systems to ensure that the clinical portion of the trial is conducted and data 
1122 
are generated, documented and reported in compliance with the protocol, Good Clinical Practice (GCP) 
1123 
and the applicable regulatory requirements, as well as to ensure that the rights and wellbeing of trial 
1124 
subjects are protected and that the reported trial data are accurate, complete, and verifiable. Adverse 
1125 
events will be prioritized for monitoring. 
1126 
A risk-based monitoring (RBM) plan will be developed and revised as needed during the study, consistent 
1127 
with the FDA “Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to 
1128 
Monitoring” (August 2013). Study conduct and monitoring will conform with 21 Code of Federal 
1129 
Regulations (CFR) 812. This plan describes in detail who will conduct the monitoring, at what frequency 
1130 
monitoring will be done, at what level of detail monitoring will be performed, and the distribution of 
1131 
monitoring reports. 
1132 
The data of most importance for monitoring at the site are subject eligibility and adverse events, primary 
1133 
and secondary endpoints. Therefore, the RBM plan will focus on these areas. As much as possible, remote 
1134 
monitoring will be performed in real-time with on-site monitoring performed to evaluate the verity and 
1135 
completeness of the key site data. Elements of the RBM may include: 
1136 
Qualification assessment, training, and certification for sites and site personnel 
1137 
Oversight of Institutional Review Board (IRB) coverage and informed consent procedures 
1138 
Central (remote) data monitoring: validation of data entry, data edits/audit trail, protocol review of 
1139 
entered data and edits, statistical monitoring, study closeout 
1140 
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On-site monitoring (site visits): source data verification, site visit report 
1141 
Agent/Device accountability 
1142 
Communications with site staff 
1143 
Patient retention and visit completion 
1144 
Quality control reports 
1145 
Management of noncompliance 
1146 
Documenting monitoring activities 
1147 
Adverse event reporting and monitoring 
1148 
Coordinating Center representatives or their designees may visit the study facilities at any time in order 
1149 
to maintain current and personal knowledge of the study through review of the records, comparison with 
1150 
source documents, observation and discussion of the conduct and progress of the study. The study site 
1151 
will provide direct access to all trial related sites, source data/documents, and reports for the purpose of 
1152 
monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
1153 
9.4 Protocol Deviations 
1154 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or procedure 
1155 
requirements. The noncompliance may be either on the part of the subject, the investigator, or the study 
1156 
site staff. A significant (or major) deviation is any deviation that departs from the established materials in 
1157 
such a way that it poses an increase in the risk to subjects, adversely affects the welfare, rights, or safety 
1158 
of the research subjects, or negatively influences the scientific study integrity. As a result of a significant 
1159 
deviation, a corrective and preventive action plan shall be developed by the site and implemented 
1160 
promptly. 
1161 
The site PI/study staff is responsible for knowing and adhering to their IRB requirements. Further details 
1162 
about the handling of protocol deviations will be included in the monitoring plan. 
1163 
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PAGE 54 OF 59 
Chapter 10: Ethics/Protection of Human Subjects 
1164 
10.1 Ethical Standard 
1165 
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
1166 
Protection of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 
1167 
and/or the ICH E6. 
1168 
10.2 Institutional Review Boards 
1169 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be submitted 
1170 
to the IRB for review and approval. Approval of both the protocol and the consent form must be obtained 
1171 
before any subject is enrolled. Any amendment to the protocol will require review and approval by the 
1172 
IRB before the changes are implemented to the study. All changes to the consent form will be IRB 
1173 
approved; a determination will be made regarding whether previously consented subjects need to be re-
1174 
consented. 
1175 
10.3 Informed Consent Process 
1176 
10.3.1 Consent Procedures and Documentation 
1177 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
1178 
and continues throughout the individual’s study participation. Extensive discussion of risks and possible 
1179 
benefits of participation will be provided to the subjects and their families. Consent forms will be IRB-
1180 
approved and present to the subject in their native language. Subjects will be asked to read and review the 
1181 
document. The investigator will explain the research study to the subject and answer any questions that 
1182 
may arise. All subjects will receive a verbal explanation in terms suited to their comprehension of the 
1183 
purposes, procedures, and potential risks of the study and of their rights as research subjects. Subjects will 
1184 
have the opportunity to carefully review the written consent form and ask questions prior to signing. 
1185 
The subjects should have the opportunity to discuss the study with their surrogates or think about it prior 
1186 
to agreeing to participate. The subject will sign the informed consent document prior to any procedures 
1187 
being done specifically for the study. The subjects may withdraw consent at any time throughout the 
1188 
course of the trial. A copy of the informed consent document will be given to the subjects for their 
1189 
records. The rights and welfare of the subjects will be protected by emphasizing to them that the quality 
1190 
of their medical care will not be adversely affected if they decline to participate in this study. 
1191 
10.3.2 Subject and Data Confidentiality 
1192 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and the 
1193 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and 
1194 
genetic tests in addition to the clinical information relating to subjects. Therefore, the study protocol, 
1195 
documentation, data, and all other information generated will be held in strict confidence. No information 
1196 
concerning the study, or the data will be released to any unauthorized third party without prior written 
1197 
approval of the sponsor. 
1198 
The study monitor, other authorized representatives of the sponsor, representatives of the IRB, regulatory 
1199 
agencies or company supplying study product may inspect all documents and records required to be 
1200 
maintained by the investigator, including but not limited to, medical records (office, clinic, or hospital) 
1201 
and pharmacy records for the subjects in this study. The clinical study site will permit access to such 
1202 
records. 
1203 
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The study subject’s contact information will be securely stored at each clinical site for internal use during 
1204 
the study. At the end of the study, all records will continue to be kept in a secure location for as long a 
1205 
period as dictated by the reviewing IRB, institutional policies, or sponsor requirements. 
1206 
Study subject research data, which is for purposes of statistical analysis and scientific reporting, will be 
1207 
transmitted to and stored at the Jaeb Coordinating Center. This will not include the subject’s contact or 
1208 
identifying information, unless otherwise specified in the informed consent form. Rather, individual 
1209 
subjects and their research data will be identified by a unique study identification number. The study data 
1210 
entry and study management systems used by clinical sites and by Jaeb Coordinating Center research staff 
1211 
will be secured and password protected. At the end of the study, all study databases will be de-identified 
1212 
and archived at the Jaeb Coordinating Center. 
1213 
10.3.3 Subject Future Use of Stored Specimens and Data 
1214 
Data collected for this study will be analyzed and stored at Jaeb. After the study is completed, the de-
1215 
identified, archived data will be transmitted to and stored at Capillary Biomedical, under the supervision 
1216 
of the Program Manager for use by other researchers including those outside of the study. Permission to 
1217 
transmit data to Jaeb and Capillary Biomedical will be included in the informed consent. 
1218 
Blood and urine samples will only serve the purpose of identifying whether the subject can be included 
1219 
in the study. Biological samples will be destroyed/discarded after laboratory analysis.  
1220 
When the study is completed, access to study data and/or samples will be provided through 
1221 
Capillary Biomedical. 
1222 
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Chapter 11: References 
1223 
1. Schmid, V., Hohberg, C., Borchert, M., Forst, T. & Pfützner, A. Pilot Study for Assessment 
1224 
of Optimal Frequency for Changing Catheters in Insulin Pump Therapy—Trouble Starts on 
1225 
Day 3. J. Diabetes Sci. Technol. 4, 976–982 (2010). 
1226 
2. Swan, K. L. et al. Effect of Age of Infusion Site and Type of Rapid-Acting Analog on 
1227 
Pharmacodynamic Parameters of Insulin Boluses in Youth With Type 1 Diabetes Receiving 
1228 
Insulin Pump Therapy. Diabetes Care 32, 240–244 (2009). 
1229 
3. Patel, P. J. et al. Randomized trial of infusion set function: steel versus teflon. Diabetes 
1230 
Technol. Ther. 16, 15–19 (2014). 
1231 
4. Renard, E., Guerci, B., Leguerrier, A.-M., Boizel, R., & Accu-Chek FlexLink Study Group. 
1232 
Lower rate of initial failures and reduced occurrence of adverse events with a new catheter 
1233 
model for continuous subcutaneous insulin infusion: prospective, two-period, observational, 
1234 
multicenter study. Diabetes Technol. Ther. 12, 769–773 (2010). 
1235 
5. Clausen, T. S., Kaastrup, P. & Stallknecht, B. Effect of insulin catheter wear-time on 
1236 
subcutaneous adipose tissue blood flow and insulin absorption in humans. Diabetes Technol. 
1237 
Ther. 11, 575–580 (2009). 
1238 
6. Heinemann, L. Variability of insulin absorption and insulin action. Diabetes Technol. Ther. 
1239 
4, 673–682 (2002). 
1240 
7. Pfützner, A. et al. Using Insulin Infusion Sets in CSII for Longer Than the Recommended 
1241 
Usage Time Leads to a High Risk for Adverse Events: Results From a Prospective 
1242 
Randomized Crossover Study. J. Diabetes Sci. Technol. (2015) 
1243 
doi:10.1177/1932296815604438. 
1244 
8. Waldenmaier, D. et al. A prospective study of insulin infusion set use for up to 7 days: early 
1245 
replacement reasons and impact on glycemic control. Diabetes Technol. Ther. (2020) 
1246 
doi:10.1089/dia.2019.0445. 
1247 
9. Lal, R. A. et al. Longevity of the novel ConvaTec infusion set with Lantern technology. 
1248 
Diabetes Obes. Metab. (2021) doi:10.1111/dom.14395. 
1249 
10. Renard, E. Insulin delivery route for the artificial pancreas: subcutaneous, intraperitoneal, or 
1250 
intravenous? Pros and cons. J. Diabetes Sci. Technol. 2, 735–738 (2008). 
1251 
11. Hajnsek, M. et al. The single-port concept: combining optical glucose measurement with 
1252 
insulin infusion. Acta Diabetol. 51, 883–886 (2014). 
1253 
12. Rumpler, M. et al. First application of a transcutaneous optical single-port glucose 
1254 
monitoring device in patients with type 1 diabetes mellitus. Biosens. Bioelectron. (2016) 
1255 
doi:10.1016/j.bios.2016.08.039. 
1256 
13. Tschaikner, M. et al. Novel Single-Site Device for Conjoined Glucose Sensing and Insulin 
1257 
Infusion: Performance Evaluation in Diabetes Patients During Home-Use. IEEE Trans. 
1258 
Biomed. Eng. 67, 323–332 (2020). 
1259 
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14. Eisler, G. et al. In vivo investigation of the tissue response to commercial Teflon insulin 
1260 
infusion sets in large swine for 14 days: the effect of angle of insertion on tissue histology 
1261 
and insulin spread within the subcutaneous tissue. BMJ Open Diabetes Res. Amp Care 7, 
1262 
e000881 (2019). 
1263 
15. Liebner, T. et al. Insulinpumpenkatheter – Komplikationen im Kindes- und Jugendalter. 
1264 
Diabetol. Stoffwechs. 5, P151 (2010). 
1265 
16. Pfützner, A. et al. Using Insulin Infusion Sets in CSII for Longer Than the Recommended 
1266 
Usage Time Leads to a High Risk for Adverse Events: Results From a Prospective 
1267 
Randomized Crossover Study. J. Diabetes Sci. Technol. 9, 1292–8 (2015). 
1268 
17. Renard, E., Guerci, B., Leguerrier, A.-M. & Boizel, R. Lower rate of initial failures and 
1269 
reduced occurrence of adverse events with a new catheter model for continuous subcutaneous 
1270 
insulin infusion: prospective, two-period, observational, multicenter study. Diabetes Technol. 
1271 
Ther. 12, 769–773 (2010). 
1272 
18. van Bon, A. C., Bode, B. W., Sert-Langeron, C., DeVries, J. H. & Charpentier, G. Insulin 
1273 
Glulisine Compared to Insulin Aspart and to Insulin Lispro Administered by Continuous 
1274 
Subcutaneous Insulin Infusion in Patients with Type 1 Diabetes: A Randomized Controlled 
1275 
Trial. Diabetes Technol. Ther. 13, 607–614 (2011). 
1276 
19. Clausen, T. S., Kaastrup, P. & Stallknecht, B. Effect of insulin catheter wear-time on 
1277 
subcutaneous adipose tissue blood flow and insulin absorption in humans. Diabetes Technol. 
1278 
Ther. 11, 575–580 (2009). 
1279 
20. Swan, K. L. et al. Effect of Age of Infusion Site and Type of Rapid-Acting Analog on 
1280 
Pharmacodynamic Parameters of Insulin Boluses in Youth With Type 1 Diabetes Receiving 
1281 
Insulin Pump Therapy. Diabetes Care 32, 240–244 (2009). 
1282 
21. Vaughn, D. E. & Muchmore, D. B. Use of recombinant human hyaluronidase to accelerate 
1283 
rapid insulin analogue absorption: experience with subcutaneous injection and continuous 
1284 
infusion. Endocr. Pract. Off. J. Am. Coll. Endocrinol. Am. Assoc. Clin. Endocrinol. 17, 914–
1285 
21. 
1286 
22. Luijf, Y. M. et al. Patch pump versus conventional pump: postprandial glycemic excursions 
1287 
and the influence of wear time. Diabetes Technol. Ther. 15, 575–9 (2013). 
1288 
23. Simic, A. et al. Survival assessment of the extended-wear insulin infusion set featuring 
1289 
lantern technology in adults with type 1 diabetes by the glucose clamp technique. Diabetes 
1290 
Obes. Metab. 23, 1402–1408 (2021). 
1291 
24. Patel, P. J. et al. Randomized Trial of Infusion Set Function: Steel Versus Teflon. Diabetes 
1292 
Technol. Ther. 16, 1–5 (2013). 
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Appendix A: Relevant Literature on Infusion Sets 
1294 
A.1 Failure Modes and Failure Rates for Current Infusion Sets 
1295 
The nationwide pediatric surveillance of insulin infusion sets in Germany and Austria reported that 192 
1296 
(29%) patients had no infusion set issues at all. However, the other 475 (71%) patients reported 1,404 
1297 
events. The most often reported device adverse event was cannula obstruction (32.9%). A total of 14.2% 
1298 
of the patients reported that they had blood in the insulin infusion cannula; 11.1% had skin with redness 
1299 
and 10.1% reported cannula kinking. 36.2% of the reported complications occurred by day 1 of infusion 
1300 
set usage and 82.4% by the end of day 2.15 
1301 
Pfützner et al. performed a prospective randomized controlled crossover clinical trial to investigate the 
1302 
tolerability of 2-day use of commercial insulin infusion sets in comparison to 4-day use in a real-world 
1303 
setting. Twenty-four patients with T1D managed with an insulin pump were studied during two 3-month 
1304 
periods. The number of cannula-related adverse events was 290 with 2-day use versus 495 with 4-day use 
1305 
(P < .05). The overall number of treatment related events was 750 with 2-day use versus 934 with 4-day 
1306 
use (P < .001). There was no difference in glycemic control between the treatment arms. Treatment 
1307 
satisfaction was higher with 2-day use (very high/high satisfaction: 90.4% versus 4 day-use: 77.3%, P < 
1308 
.05). The authors concluded that using an infusion set for a longer than 2-3 days resulted in a clinically 
1309 
relevant increase in treatment-related tolerability problems.16 
1310 
Renard et al. performed a prospective, two-period, observational, multicenter study in 45 T1D 
1311 
outpatients. During the initial 1-month period the patients used a Teflon cannula (98% of cases) 
1312 
and crossed over to an investigational insulin infusion set (Accu-Chek FlexLink, Disetronic Medical 
1313 
Systems AG) for a 3-month period. Forty-five initial infusion failures occurred in 14 patients among 
1314 
507 commercial Teflon cannula insertions (8.9% of cases), whereas 15 failures were seen in nine 
1315 
patients during 488 investigational cannula insertions (3.1% of cases) (P<0.001). The overall rate of late 
1316 
cumulative events was 113 of 507 (22%) with the commercial infusion set versus 66 of 488 (14%) using 
1317 
the investigational infusion set (P<0.001). The occurrence of pain, skin reaction, or redness at the infusion 
1318 
site was lower using the investigational insulin infusion cannula.17 
1319 
Van Bon et al. conducted a multi-center trial of 256 patients on three insulins. Approximately 30% of 
1320 
patients experienced at least 1 perceived set failure during the 13-week study period with each insulin. 
1321 
More than 60% of patients experienced unexpected hyperglycemia during the 13-week study period. 
1322 
These results are similar to experts’ experience managing T1D using an insulin pump and currently 
1323 
available infusion sets. Improving the reliability, enhancing the comfort and extending the duration of 
1324 
infusion set use each would be important contributions to continuous subcutaneous insulin infusion 
1325 
therapy.18 
1326 
In a pilot study in 22 patients by Lal et al. conducted at Stanford University, the most common reason for 
1327 
infusion set removal was adhesive failure (50%), followed by hyperglycemia unresponsive to a correction 
1328 
bolus (33%), hyperglycemia with elevated ketones (8%), and infection of the insertion site (8%).9 
1329 
A.2 Effect of Wear Time on PK/PD and Test Meal Response 
1330 
Clausen et al. observed progressive acceleration of PK exposure over 4 days of wear time19, and 
1331 
confirmatory evidence was provided by Swan et al.20, who demonstrated progressive acceleration of 
1332 
PD over 3 days of catheter wear time. This was further confirmed by Vaughn and Muchmore.21 
1333 
Luijf et al. tested glucose response to a test challenge and showed substantial declines in glucose response 
1334 
between day 1 and day 3 of catheter wear.22 This improved glucose response was seen for both patch 
1335 
(tubeless) and conventional insulin pump systems, which was presumably a result of improved early 
1336 
insulin exposure that occurs over the first 3 or so days of catheter wear time.  
1337 
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Simic et al. performed a clamp study with 16 subjects assessing a new extended-wear infusion set with an 
1338 
anti-inflammatory coating and Lantern technology (ConvaTec) and found that while insulin absorption 
1339 
decreased over wear time, it was also significantly faster 4 and 7 days after insertion. None of the patients 
1340 
experienced severe hypoglycemia over a period of 7 days. The authors claim that increased rate of 
1341 
absorption my facilitate better postprandial control.23 
1342 
A.3 Experience with Extended Wear (>3 days) 
1343 
Patel et al. performed a randomized crossover clinical trial to compare the performance of Teflon versus 
1344 
stainless steel insulin infusion sets in ambulatory humans for up to 1 week. The subjects used a Quick-Set 
1345 
or a Sure-T CSII cannula until the infusion set failed or was worn for 1 week. After 7 days, both types of 
1346 
infusion sets had a 64% failure rate. Eighty-seven percent of the steel sets and 77% of the Teflon sets 
1347 
were functioning after 3 days (this number includes the 15% that failed on the first day because of 
1348 
kinking), after 5 days 68% of the steel and 59% of the Teflon sets were functioning, after 6 days 53% of 
1349 
the steel and 46% of the Teflon sets were functioning, and at the end of 7 days 32% of the steel and 32% 
1350 
of the Teflon sets were functioning. Overall, 30% failed because of hyperglycemia and a failed correction 
1351 
dose, 13% were removed for pain, 10% were pulled out by accident, 10% had erythema and/or induration 
1352 
of >10 mm, 5% fell out because of loss of adhesion, and 4% were removed for infection. The main 
1353 
predictor of length of wear was the individual subject. There was no increase in hyperglycemia or daily 
1354 
insulin requirements when an infusion set was successfully used for 7 days.24 
1355 
Waldenmaier et al. tested extended wear (≥7 days) of commercial steel and Teflon insulin infusion sets in 
1356 
40 adult subjects on insulin pump therapy. 66% of 160 inserted infusion sets were used for 7 days with no 
1357 
obvious difference between steel and Teflon infusion sets (mean wear time was 6.2 days). The main 
1358 
reasons for early infusion set replacements were occlusions (19%), adhesive issues (4%), and accidental 
1359 
removal (4%). Comparing glycemic control during day 1-3 and 1-7, there was no difference in mean BG 
1360 
and insulin dose. The authors concluded that infusion set replacement intervals may be individualized 
1361 
beyond the currently labeled maximum use duration.8 
1362 
Lal et al. assessed longevity of the previously mentioned ConvaTec infusion set in a pilot study including 
1363 
22 subjects. 45% of the novel infusion sets lasted 10 days, with a median wear time of 9.1 days. While the 
1364 
mean BG concentration increased significantly over time, the total daily insulin dose did not change 
1365 
throughout 10 days of set wear.9 
1366 
Recently, Medtronic reported an overall wear period success rate of 74.8% at 7 days using an extended 
1367 
wear infusion set (Buckingham et al., poster, American Diabetes Association annual meeting, 2021), 
1368 
leading to device approval by the FDA (510k). There has been no marketing experience reported for 
1369 
this device. 
1370 
Summarizing these various studies of cannula wear time, it appears that currently marketed infusion sets 
1371 
have limited life span, and room for improvement is present. 
1372 
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