Clinical trial NCT04378114
Conditions: Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus
Sponsor: Medtronic Diabetes
Start date: 2020-05-18; Completion date: 2020-07-17
Enrollment: 104 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.

Detailed description:
The study is a multi-center, prospective, study without controls. The purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.

Arms: arm 1: Subjects wear Guardian™ Sensor (3) over 7 days and undergo one frequent sample test (FST). C sensor algorithm applied retrospectively to raw sensor data. arm 2: Subjects wear Guardian™ Sensor (3) over 7 days and undergo one FST. Zeus sensor algorithm applied retrospectively to raw sensor data.
Interventions: intervention 1: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data. intervention 2: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data. intervention 3: Acetominophen
Intervention descriptions: intervention 1: Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when C sensor algorithm is used. intervention 2: Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when Zeus sensor algorithm is used. intervention 3: One time administration of acetaminophen.

Protocol documents:
Prot_000.pdf: 
 
 
Clinical Investigation Plan 
Title  
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in 
Adults 
NCT Number NCT04378114 
Document Description  Clinical Investigational Plan (Version A)  
Document Version Date 18-MAR-2020 
 


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SAP_001.pdf: 
 
 
Clinical Investigation Plan 
Title  
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in 
Adults 
NCT Number NCT04378114 
Document Description  Statistical Analysis Plan (Version 1.0) 
Document Version Date 13-JUL-2020 
 


CIP 333 Statistical Analysis Plan 
 
Form 
 
Revision 1.0 
Page 1 of 7 
 
 
This document is electronically controlled 
Medtronic Business Restricted 
056-F286, Statistical Analysis Plan Template 
Version B 
 
 
Statistical Analysis Plan 
Clinical Investigation Plan Title  Impact of Acetaminophen on Performance of 
Guardian™ Sensor (3) in Adults 
 
Clinical Investigation Plan Identifier 333 
Clinical Investigation Plan Version Version A 
Sponsor/Local Sponsor Medtronic MiniMed 
(“Medtronic”) 
18000 Devonshire St 
Northridge, CA 91325 
866.948.6633 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. 
Any distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it 
may not be further disclosed by them. 
 
 
 


CIP 333 Statistical Analysis Plan 
 
Form 
 
Revision 1.0 
Page 2 of 7 
 
 
This document is electronically controlled 
Medtronic Business Restricted 
056-F286, Statistical Analysis Plan Template 
Version B 
Table of Contents 
1. 
Version History ........................................................................................................................ 3 
2. 
List of Abbreviations and Definitions of Terms ............................................................................ 3 
3. 
Introduction............................................................................................................................. 3 
4. 
Study Objectives ...................................................................................................................... 4 
5. 
Investigation Plan .................................................................................................................... 4 
6. 
Determination of Sample Size ................................................................................................... 4 
7. 
Statistical Methods ................................................................................................................... 4 
7.1 
Study Subjects ........................................................................................................................... 4 
7.2 
General Methodology ............................................................................................................... 5 
7.3 
Center Pooling ........................................................................................................................... 5 
7.4 
Handling of Missing, Unused, and Spurious Data and Dropouts .............................................. 5 
7.5 
Adjustments for Multiple Comparisons .................................................................................... 5 
7.6 
Demographic and Other Baseline Characteristics .................................................................... 5 
7.7 
Treatment Characteristics ......................................................................................................... 5 
7.8 
Interim Analyses ........................................................................................................................ 5 
7.9 
Evaluation of Objectives ........................................................................................................... 6 
7.10 
Safety Evaluation....................................................................................................................... 6 
7.11 
Health Outcomes Analyses ....................................................................................................... 6 
7.12 
Changes to Planned Analysis..................................................................................................... 7 
8. 
Validation Requirements ........................................................................................................... 7 
9. 
References .............................................................................................................................. 7 
 
 


CIP 333 Statistical Analysis Plan 
Form 
Revision 1.0 
Page 3 of 7 
This document is electronically controlled 
Medtronic Business Restricted 
056-F286, Statistical Analysis Plan Template
Version B 
1.
Version History
Version 
Summary of Changes 
Author(s)/Title 
1.0 
13-JUL-2020
•
New Document
 
2.
List of Abbreviations and Definitions of Terms
Abbreviation 
Definition 
HbA1c 
Glycosylated hemoglobin 
AE 
Adverse Event 
BG 
Blood Glucose 
BMI 
Body Mass Index 
CGM 
Continuous Glucose Monitoring 
CGMS 
Continuous Glucose Monitoring System 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan 
DKA 
Diabetic Ketoacidosis 
eCRF 
Electronic Case Report Form 
FST 
Frequent Sample Testing 
GST 
Glucose Sensor Transmitter 
MARD 
Mean Absolute Relative Difference 
RF 
Radio Frequency 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SG 
Sensor Glucose 
SMBG 
Self-Monitoring of Blood Glucose 
SQ 
Subcutaneous 
UADE 
Unanticipated Adverse Device Effect 
YSI™* 
Yellow Springs Instrument 
3.
Introduction
Current methods of continuous glucose monitoring (CGM) include the use of subcutaneous (SQ) glucose 
sensors worn by the user, which convert glucose from the subject’s interstitial fluid into an electronic 
signal, the strength of which is proportional to the amount of glucose present in the fluid. A CGM sensor 
is attached to a transmitter, which typically sends interstitial glucose information to a monitor (e.g., the 
Guardian™ Connect App) as radio frequency (RF) signals. The sensor is composed of a microelectrode 
with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. 


CIP 333 Statistical Analysis Plan 
 
Form 
 
Revision 1.0 
Page 4 of 7 
 
 
This document is electronically controlled 
Medtronic Business Restricted 
056-F286, Statistical Analysis Plan Template 
Version B 
Previous in vitro testing has demonstrated that the presence of acetaminophen can be associated with a 
minimal increase in the positive bias of the sensor glucose reading relative to the true glucose 
concentration in the test solution. Clinical studies will further characterize the in vivo impact of 
acetaminophen ingestion on sensor accuracy.  
Following completion of the study, raw sensor data collected by the Guardian™ Connect Transmitters 
will be processed using the C and Zeus algorithms. For the C algorithm, sensor glucose will be generated 
based on 2 calibrations per day. For the Zeus algorithm, sensor glucose will be generated based on 0 
calibration and 2 calibrations on Day 1.  
4. 
Study Objectives 
Error! Reference source not found.The primary objective of the study is to characterize the impact of 
acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) 
with the system in subjects 18-80 years of age.  
 
5. 
Investigation Plan 
The study is a multi-center, prospective, single-arm study without controls.  
See CIP Section 5 for additional details on Study Design. 
A total of up to 150 previously-diagnosed type 1 or type 2 diabetes subjects will be enrolled in order to 
have 75 subjects complete the study. Up to 9 investigational centers in the US will be used during the 
study. 
Subjects will wear two sensors (one sensor in the abdomen and one in the arm location) and undergo 6 
hours of FST on Day 4 (74-98 hours) or Day 5 (98-122 hours). No randomization or blinding will be used. 
6. 
Determination of Sample Size 
Given that this study is not statistically powered, no sample size calculation is performed. Due to 
potential attritions of sensor data, up to 150 subjects will be enrolled at up to 9 investigational centers 
in order to have 75 subjects who complete the study. 
7. 
Statistical Methods 
7.1 Study Subjects 
7.1.1 
Disposition of Subjects 
The number of subjects enrolled in the study will be presented by training period and study period.  The 
reasons for discontinuing prior to study completion will be summarized. 


CIP 333 Statistical Analysis Plan 
 
Form 
 
Revision 1.0 
Page 5 of 7 
 
 
This document is electronically controlled 
Medtronic Business Restricted 
056-F286, Statistical Analysis Plan Template 
Version B 
7.1.2 
Clinical Investigation Plan (CIP) Deviations 
All CIP deviations will be presented in the listings. 
7.1.3 
Analysis Sets 
The primary study population consists of all enrolled subjects who have at least one paired sensor and 
YSI™* measurement. In addition, subjects who are not qualified (e.g., fail to meet the fasting 
requirement or are impacted by unexpected conditions during FST) will be determined and excluded 
from the analysis.  
All enrolled subjects will be included in the safety analysis population. 
7.2 General Methodology 
All data collected from the time of screening until the end of the study will be collected either on eCRFs 
or electronically by downloading the various devices. Data and analysis will be summarized in a Clinical 
Study Report. 
7.3 Center Pooling 
Data will be pooled for analysis. 
7.4 Handling of Missing, Unused, and Spurious Data and 
Dropouts 
In determining the phase of adverse events and protocol deviations or in calculating the duration of 
diabetes, the first day of the month will be used for event dates with known year and month but 
unknown day, unless specified otherwise in the description; similarly, the first day of the year will be 
used for event dates with known year but unknown month and day, unless specified otherwise.  
All available data will be included in the data listings and tabulations. No additional imputation will be 
applied for the missing data. 
7.5 Adjustments for Multiple Comparisons 
No adjustments will be made.    
7.6 Demographic and Other Baseline Characteristics 
Subject characteristics, including age, gender, race, ethnicity, medical diagnosis, height, weight, and BMI 
will be summarized by descriptive statistics (mean, standard deviation, minimum, median, and 
maximum) for continuous variables and by counts and percentages for categorical variables. 
7.7 Treatment Characteristics  
Baseline and 1-hour post-ingestion serum acetaminophen concentration will be summarized. 
7.8 Interim Analyses  
No interim analysis will be conducted. 


CIP 333 Statistical Analysis Plan 
 
Form 
 
Revision 1.0 
Page 6 of 7 
 
 
This document is electronically controlled 
Medtronic Business Restricted 
056-F286, Statistical Analysis Plan Template 
Version B 
7.9 Evaluation of Objectives 
7.9.1 Primary Endpoints 
Bias between the Guardian™ Sensor (3) values and YSI™* plasma glucose values during the 1 hour 
before and 5 hours after ingestion of acetaminophen will be described by each hour. Summary statistics 
will include its mean, standard deviation, median, 95% confidence interval (CI), minimum, and 
maximum. 
7.9.2 Secondary Endpoints  
Mean absolute relative difference (MARD) between the Guardian™ Sensor (3) values and YSI™* plasma 
glucose values during the 1 hour before and 5 hours after ingestion of acetaminophen will be described 
by each hour. Summary statistics will include its mean, standard deviation, median, 95% CI, minimum, 
and maximum. 
20% mean agreement rate (±20 mg/dL (1.1 mmol/L) when reference YSI™* plasma glucose value less 
than or equal to (≤) 80 mg/dL (4.4 mmol/L) between the Guardian™ Sensor (3) values and YSI™* plasma 
glucose values during the 1 hour before and 5 hours after ingestion of acetaminophen will be described 
by each hour. Summary statistics will include its mean, standard deviation, median, 95% CI, minimum, 
and maximum. 
7.10 Safety Evaluation  
7.10.1 
Adverse Events (AE) 
Descriptive summary will be used to characterize all adverse events (AE): 
• 
Serious Adverse Events (SAEs) 
• 
Adverse Device Effects  
• 
Procedure Related AEs 
• 
Serious Adverse Device Effect (SADEs) 
• 
Unanticipated Adverse Device Effects (UADEs)  
• 
Severe hypoglycemia 
• 
Diabetic Ketoacidosis (DKA) 
• 
Deaths 
7.10.2 
Device Deficiencies 
Descriptive summary will be used to characterize device deficiencies: 
• 
All Investigational Center/subject reports of sensor damage, breakage or fracture 
will be included 
7.11 Health Outcomes Analyses  
Not Applicable 


CIP 333 Statistical Analysis Plan 
 
Form 
 
Revision 1.0 
Page 7 of 7 
 
 
This document is electronically controlled 
Medtronic Business Restricted 
056-F286, Statistical Analysis Plan Template 
Version B 
7.12 Changes to Planned Analysis  
Not Applicable 
8. 
Validation Requirements 
Level I or Level II validation are required for analysis output. Level I requires that the peer reviewer 
independently programs output and then compares the output with that generated by the original 
Statistical Programmer. Level II requires that the peer reviewer reviews the code; where appropriate, 
performs manual calculations or simple programming checks to verify the output. 
9. 
References  
American Diabetes Association. Hyperglycemic Crises in Diabetes. Diabetes Care. 2004; 27(1): S94-S102. 
 
American Diabetes Association Workgroup on Hypoglycemia, Defining and Reporting Hypoglycemia in 
Diabetes, Diabetes Care. 28:1245-1249, 2005