Development of a Context-aware Glucose Prediction Algorithm in Patients With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Oregon Health and Science University

 
 
 
 
 
 
 
 
 
 
PROTOCOL TITLE: Development of a context-aware glucose prediction algorithm in 
patients with type 1 diabetes 
 
 
NCT04154904 
 
IRB# 20248 
 
Protocol and Consent and Authorization Version date: June 11, 2021 
 
PI: Jessica Castle MD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL TITLE: Development of a context-aware glucose prediction algorithm in 
patients with type 1 diabetes  
  
STUDY SITE: 
Oregon Health Science University 
3181 SW Sam Jackson Park Rd 
Portland, OR 97639 

 
 
 
 
 
 
FUNDING: 
NIH 
 
PRINCIPAL INVESTIGATORS: 
Jessica R. Castle MD; Peter Jacobs PhD  
 
CO-INVESTIGATORS:  
Joseph El Youssef MBBS 
Leah Wilson MD 
 
Background: 
T1D is characterized by the autoimmune destruction of β cells. These patients rely on the 
administration of insulin, putting them at significant risk of hypoglycemia and excessive 
hyperglycemia. Repeated exposures to hypoglycemia can result in hypoglycemia unawareness 
[1, 2]. These patients have a 20x increased likelihood of experiencing severe hypoglycemia 
compared with those patients without it [3]. Better approaches to helping people avoid 
hypoglycemia are critical to improve glycemic control and reduce complications. Continuous 
glucose monitoring (CGM) has been shown to help T1D patients improve time in range and 
avoid hypoglycemia [4, 5]. Automated Insulin Delivery (AID) systems have now become an 
important standard-of-care for people with T1D and have demonstrated a reduction, but not 
elimination, of hypoglycemia during long-term studies [6-10]. AID systems have not been shown 
to be effective at eliminating exercise-induced hypoglycemia, even when incorporating 
additional physical activity sensors such as heart rate and accelerometry sensors [11-16].  
 
One limitation of current AID systems is that they have no knowledge about the context or 
environment that a person is currently experiencing. Contextual patterns can potentially improve 
the performance of an AID by recognizing environments or patterns of living that are related to 
changes in glucose. The team at OHSU is developing a context-aware glucose prediction 
algorithm that will capture context data from the patient both indoors and outdoors. This context 
data will be provided to the algorithm to allow for detecting contextual patterns that might relate 
to hypo- or hyperglycemia. The goal of this study will be the creation of a data set that will 
include contextual patterns along with glucose, insulin and physiological data. Participants will 
complete meals and exercise at specific times.  The purpose of the prescribed meals and 
exercise sessions is to generate ground truth patterns that will be used in the design of the 
context-aware glucose prediction algorithm.  
 
Primary Objective 
 
To assess the accuracy of the context-aware glucose prediction by comparing glucose 
prediction values against the Dexcom G6 CGM values using mean absolute relative 
error (MARE)  
 
To assess the accuracy of the context-aware glucose prediction by comparing glucose 
prediction values against the Dexcom G6 CGM values using mean relative error (MRE). 
Study Hypothesis: 
 
The study hypothesis is that context pattern data will improve the accuracy of the 
prediction of hypoglycemia and hyperglycemia in the context-aware glucose prediction 
algorithm.  
 
Primary Endpoints:  
 
Comparison of the accuracy of hypoglycemia prediction comparing glucose prediction 
values against the Dexcom G6 CGM values using mean absolute relative error (MARE). 
 
Comparison of the accuracy of hypoglycemia prediction comparing glucose prediction 
values against the Dexcom G6 CGM values using mean relative error (MRE). 

 
 
 
 
 
 
Study Type  
This is a single center randomized prospective study measuring the accuracy of the 
context-aware glucose prediction against the Dexcom G6 CGM values.    
 
Study Population 
Study population will be adults with type 1 diabetes, ages 18 – 65 years of age.  Older subjects 
are excluded due to higher risk of unrecognized coronary artery disease.  Younger subjects are 
excluded as it is appropriate to assess safety and efficacy first in the adult population. Thirty 
subjects will be recruited to participate in studies.   
 
Protocol Summary: 
Subjects will be on study for 28 days.  Sensor glucose, activity, exercise, insulin, indoor and 
outdoor contextual patterns and meal data will be collected during this time. Subjects will wear 
the Dexcom G6 CGM system and a FitBit Ionic (or similar FitBit), Polar, Garmin or Apple Watch 
physical activity monitor for the entire 28 days. Physical activity monitors will send data to the 
iPancreas mobile app created by OHSU. iPancreas will be supplied to participants on a 
separate study-provided phone. Subjects will continue to use their own insulin pump. Subjects 
will be asked to also wear a MotioWear indoor/outdoor context-aware tracking tag and to install 
the MotioWear beacons within their home. Subjects will be randomized to complete either 
aerobic, high intensity interval training, or resistance exercise videos twice weekly at home 
during weeks 1 and 2 and once weekly during weeks 3 and 4. Subjects will also ingest a self-
selected meal prior to these prescribed exercise sessions. Subjects will consume a high 
carbohydrate dinner once each week on the same day, at approximately the same time (but not 
on the exercise days).  
 
Subjects will use the T1 DEXI mobile app created by OHSU to capture meal and exercise data 
along with photos of meals over the 28 day period. Subjects will take photos of their food the 
day of and the day after they complete the exercise video. While at home, subjects will check 
CBG before and after exercise, for symptoms of hypoglycemia, and for Dexcom G6 alarms for 
sensor <70 mg/dL and >250 mg/dL. See Figure 1 below for a diagram of the study flow. The 
study investigators retain the authority to modify any aspects of the protocol at his/her discretion 
if he/she believes the subject’s safety is a concern.    
 
Figure 1: Study Flow Design 
 
 
 
Background on MotioWear System 
Our group at OHSU has developed a unique context measurement system in collaboration with 
MotioSens (Portland OR) called MotioWear. MotioWear (Figure 2) is comprised of a wearable 
tag, beacons that are plugged in around a home, and a data hub that captures the movement 

 
 
 
 
 
and context data and transmits it back to a remote monitoring server. The wearable tag includes 
several sensors important for movement and context awareness: (1) a time of flight (TOF) radio 
transceiver that ranges with the beacon positioned around the home to track location and 
inferred activity of daily living, (2) a 9-axis inertial measurement including accelerometer, 
magnetometer, and gyroscope, (3) a Bluetooth low energy (BTLE) wireless transceiver for 
device interconnectivity, and (4) a global positioning system (GPS) sensor for outdoor tracking. 
We have developed sophisticated tracking and inference algorithms for indoor / outdoor tracking 
of a person wearing the tag and inferring context based on movement patterns [17-21]. 
Indoor context using MotioWear: MotioWear learns the specific regions of interest within a home 
through a simple calibration routine that takes about 15-20 minutes. During this home calibration 
routine, the person carries the MotioWear tag in their pocket while using the MotioWear smart-
phone app to identify regions of interest (e.g. bathroom, shower, toilet, kitchen, bed, refrigerator 
etc). The system matches the x,y,z locations detected by the MotioWear tag during the 
calibration routine with the ROIs indicated on the MotioWear smart-phone app. After the 
calibration routine is completed, the system can infer the person’s location within these regions 
of interest within the home and infer activities. 
Outdoor context using MotioWear: MotioWear uses GPS to get outdoor context. Latitude and 
longitude collected by the MotioWear tag are overlaid on Google Maps (Figure 2); geographic 
information systems techniques are used to relate location to regions of interest including 
restaurants, parks, gyms, hospitals, etc.  
While MotioWear is a sophisticated tool that we plan to use within this study to quantify context, 
a context-aware AID could potentially use contextual information gathered from a variety of 
other ubiquitous wearable and beacon-based technologies that are now becoming commercially 
available, including such in-home monitoring technologies developed by Google (Echo), Apple 
(iBeacon) and Amazon (Alexa). The purpose of our work with MotioWear is to demonstrate the 
benefit of context such that in the future, AID systems can make use of context regardless of 
how this context information is gathered; it is our intentent that CA-AID systems will be 
hardware agnostic, and not dependent on one platform such as MotioWear. 
 
Subject Criteria 
Inclusion Criteria:  
1. Diagnosis of type 1 diabetes mellitus for at least 1 year.  
2. Male or female subjects 18 to 65 years of age.  
3. Physically willing and able to perform 30 min of exercise (as determined by the 
investigator after reviewing the subject’s activity level).  
4. Current 
use of 
an 
insulin 
pump 
for at 
least 3 
months.  
5. Able 
and 
willing 
to count Figure 2: (a) MotioWear tag based indoor/outdoor tracking and context 
awareness system. (b) MotioLab software that can be used to do real-time 
tracking indoors and outdoors. (c) Beacons are placed around the home, creating 
a wireless mesh that the wearable communicates with. A smart-phone app 
identifies key regions of interest. 
(a) 
(b) 
(c) 

 
 
 
 
 
carbohydrates during study period as determined by the investigator after reviewing 
participant’s insulin pump download. 
6. A1C <10.5% at the time of screening. 
7. Has a smart phone.  
8. Willingness to follow all study procedures, including attending all clinic visits.  
9. Willingness to sign informed consent and HIPAA documents.  
 
Exclusion Criteria:  
1. Female of childbearing potential who is pregnant or intending to become pregnant or 
breast-feeding, or is not using adequate contraceptive methods. Acceptable 
contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, 
an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the 
man uses a condom), or abstinence. 
2. Any cardiovascular disease, defined as a clinically significant EKG abnormality at the 
time of screening or any history of: stroke, heart failure, myocardial infarction, angina 
pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree 
heart block or any non-physiological arrhythmia judged by the investigator to be 
exclusionary. 
3. Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the 
OHSU laboratory). 
4. Liver failure, cirrhosis, or any other liver disease that compromises liver function as 
determined by the investigator.   
5. Hematocrit of less than 36% for men, less than 32% for women. 
6. History of severe hypoglycemia during the past 12 months prior to screening visit or 
hypoglycemia unawareness as judged by the investigator. Subjects will complete a 
hypoglycemia awareness questionnaire.  Subjects will be excluded for four or more R 
responses.  
7. Adrenal insufficiency. 
8. Any active infection. 
9. Known or suspected abuse of alcohol, narcotics, or illicit drugs.  
10. Seizure disorder. 
11. Active foot ulceration. 
12. Peripheral arterial disease. 
13. Major surgical operation within 30 days prior to screening. 
14. Use of an investigational drug within 30 days prior to screening. 
15. Chronic usage of any immunosuppressive medication (such as cyclosporine, 
azathioprine, sirolimus, or tacrolimus). 
16. Bleeding disorder or platelet count below 50,000. 
17. Current administration of oral or parenteral corticosteroids. 
18. Any life threatening disease, including malignant neoplasms and medical history of 
malignant neoplasms within the past 5 years prior to screening (except basal and 
squamous cell skin cancer).  
19. Beta blockers or non-dihydropyridine calcium channel blockers. 

 
 
 
 
 
20. Current use of any medication intended to lower glucose other than insulin (ex. use of 
liraglutide). 
21. A positive response to any of the questions from the Physical Activity Readiness 
Questionnaire with one exception: subject will not be excluded if he/she takes a single 
blood pressure medication that doesn’t impact heart rate and blood pressure is controlled 
on the medication (blood pressure is less than 140/90 mmHg).  
22. Any chest discomfort with physical activity, including pain or pressure, or other types of 
discomfort.  
23. Any clinically significant disease or disorder which in the opinion of the Investigator 
may jeopardize the subject’s safety or compliance with the protocol.  
 
Subject Recruiting: 
Subjects will be recruited from OHSU clinics, from flyers to be posted in approved places at 
OHSU or posted on the web to the clinical trials page for the OHSU Schnitzer Diabetes Clinic, to 
the Clinic’s facebook group, ads on facebook, electronic newletter or from the OHSU Subject 
Recruitment website. Handouts may also be made available to faculty at Providence, Tuality, 
Kaiser and Legacy to pass along to patients/participants who show interest in the study. 
Records from OHSU Schnitzer Diabetes Clinic patients may be screened to find potential 
subjects. Subjects will also be recruited from a list of subjects who participated in past OHSU 
studies who have agreed to be contacted regarding future studies involving Drs. Castle or El 
Youssef, from the OHSU diabetes research registry and/or www.clinicaltrials.gov. Non-English 
speaking subjects will not be recruited since this protocol would require the use of medical 
devices and mobile software that do not have non-english versions available.  
 
Up to 75 subjects may be screened in this study.  Goal enrollment is 30 subjects.   
 
Withdrawal Criteria 
The subject may withdraw at will at any time or at the discretion of the Investigator.  
 
A subject must be withdrawn if the following applies: 
1. Hypoglycemia during the treatment period posing a safety problem as judged by the 
investigator.  
2. Hyperglycemia during the treatment period posing a safety problem as judged by the 
investigator.  
3. Protocol deviation having influence on efficacy or safety data as judged by the 
Investigator.  
4. Substantial and repeated non-compliance with trial procedures.  
5. Pregnancy.  
6. Intention of becoming pregnant.  
 
Visit Procedures 
Staff will confirm participant and household do not have COVID-19 or symptoms of COVID-19 
prior to conducting any face-to-face visits.  In order to minimize face to face contact with 
participants per OHSU Covid-19 policy, there is the option to complete some visits virtually.  
 
Screening (Visit 1) 
Screening will take place within 12 weeks prior to Visit 2.  All screening visits will take place at 
OHSU’s Oregon Clinical Translational Research Institute (OCTRI) outpatient clinic, the 

 
 
 
 
 
Biomedical Engineering Point of Care (BME POC) Laboratory or at the Harold Schnitzer 
Diabetes Health Center. The subject will be sent the consent form prior to the screening by 
email so that they can have time to read it fully at their leisure and prepare any questions they 
might have. Upon arrival at the clinic and prior to any procedures, study staff will explain the 
study, give the subject ample time to ask questions and consider participation, and ensure that 
subject voices understanding of the informed consent and study requirements. To minimize the 
possibility of coercion and to ensure that subject is signing the appropriate version of consent, 
an informed consent checklist will be used by study staff. After the subject has signed the 
consent, a copy of the consent/authorization form will be given to the subject. The original will 
be kept for the source document.  
 
A capillary blood glucose (CBG) will be obtained and measured by a Contour Next glucose 
meter and recorded after consenting. Prior to measurement of any blood samples, the meter will 
undergo quality control testing with two different glucose levels, one high and one low, and both 
values must fall within the accepted range for a meter to be used.  
 
Study personnel will review medical history, and medications. Height, weight, pulse, and blood 
pressure will be obtained.  A study investigator will perform a physical examination, excluding 
breast and pelvic exams. Females of child-bearing potential will take a urine pregnancy test, 
which must be negative to participate.  A venous blood sample will be taken for the following 
tests: hemoglobin A1C, complete blood count, complete metabolic set (including creatinine, liver 
set, and electrolytes.  If subjects have had any of the aforementioned labs performed within the 
3 months prior to the screening visit and we can access the results, a venous blood sample will 
not be taken for that test. An EKG will be completed. A study investigator will assess 
inclusion/exclusion criteria and review the subject’s medical record for clarification as needed. 
The participant’s insulin pump will be downloaded to determine if they are counting 
carbohydrates for meals.  A three-digit subject ID number will be assigned to the subject.  One 
research staff member and a study investigator will on site for this visit.   
When the risk of Covid-19 is considered to be significant and OHSU is on modified operations, 
only one staff member will be in the room with the participant at a time and the only time staff 
will have to be within 6 feet of the participant is when the study investigator is completing the 
physical exam and when research staff is completing the EKG and drawing blood for screening 
labs.  
 
This visit will take approximately 1.5 hours.  
 
Study Start-up Visit (Visit 2): 
Subjects will be on study for 28 days.  Sensor glucose, activity, exercise, insulin, indoor and 
ouotdoor contextual patterns and meal data will be collected during this time. Subjects will wear 
the Dexcom G6 CGM system along with the Dexcom G6 smart phone application. Subjects will 
wear a FitBit Ionic (or similar FitBit), Polar, Garmin or Apple Watch physical activity monitor. 
Subjects will continue to use their own insulin pump. Subjects will be given a MotioWear 
indoor/outdoor context-aware tracking tag to wear and be shown how to install the MotioWear 
beacons within their home. Subjects may be asked to plug the MotioWear beacon into their 
router to improve data uploads. In this visit, they will be asked to complete a lifestyle 
questionnaire asking about their current exercise habits and blood glucose management. 
Subjects will be instructed on the use of the T1 DEXI mobile app created by OHSU to capture 
meal and exercise data along with photos of meals. Subjects will be instructed to take photos of 
their food the day of and the day after they complete the exercise video. Study staff may contact 
subjects by phone, text, or email for clarification if the meal photo is difficult to interpret. While at 
home, subjects will check CBG before and after exercise, for symptoms of hypoglycemia, and 

 
 
 
 
 
for Dexcom G6 alarms for sensor <70 mg/dL and >250 mg/dL. Subjects will be provided with a 
Contour Next blood glucose meter for testing capillary blood glucose.  
 
Subjects will be randomized to complete either aerobic, high intensity interval training, or 
resistance exercise videos twice weekly at home during weeks 1 and 2 and once weekly during 
weeks 3 and 4. Subjects will be instructed to complete the exercise for the video sessions in the 
same location in their home on the same day at approximately the same time. The exercise 
videos are approximately 30 minutes long. A list of exercises to be performed is provided in 
Appendix E. Subjects will also ingest a self-selected meal prior to these prescribed exercise 
sessions. Instructions for the exercise will be provided via video links. Subjects will be instructed 
to check a CBG before initiating exercise to ensure safety. Subjects will be instructed to consume 
a snack if glucose is <120 mg/dL and delay exercise until glucose is >80 mg/dL. Also, if glucose 
is >250 mg/dL, subjects will be instructed to calculate if a correction dose is needed and delay 
exercise until glucose is <250 mg/dL. Subjects will enter information about exercise into the T1 
DEXI app. Subjects will receive reminders via phone or text to complete their exercise and to 
monitor adherence to protocol. Participants may also receive reminders to enter activity 
information through the T1DEXI app. Subjects will also be instructed to check a CBG after 
exercise and consume a snack if needed. 
 
Subjects will consume a high carbohydrate dinner prepared by OHSU Bionutrition once each 
week on the same day at approximately the same time (but not on the exercise study video 
days). The meals can potentially be picked up all at once and frozen until use. 
 
Subjects will be able to contact study staff for any issues with the devices. Study staff will follow-
up with subjects every 7 days. Subjects may receive text messages from study staff with study 
reminders/instructions or clarification of meal photos. This visit should take approximately 1.5 
hours, depending on subject experience. Participants will be asked to download his/her pump 
weekly or biweekly during the 28 days on study. This will allow for frequent data capture in case 
of a battery change or loss of power to the pump which can erase insulin data.   
 
When the risk of Covid-19 is considered to be significant and OHSU is on modified operations: 
there is the option to complete this visit via Webex with the study devices/meals delivered to the 
participant via a courier and study staff virtually connecting with participants for training on the 
devices and study procedures while they are at home.   
 
The study staff and participants will be screened for COVID-19 symptoms within the prior 14 
days and day of the Start-up visit per “OHSU COVID-19 Clinical Research Risk Assessment 
Screening and Mitigation” protocol as follows: 
 
 
Fever or chills  
 
Cough 
 
Shortness of breath or difficulty breathing 
 
Fatigue  
 
Muscle or body aches  
 
Headache 
 
New loss of taste or smell 
 
Sore throat 

 
 
 
 
 
 
Congestion or runny nose 
 
Diarrhea 
The study staff member(s) will go into the participant’s home for installation of the tracking 
devices, maintaining appropriate social distancing. No more than two staff members will be 
assigned to installation. Due to the lengthy installation process, two staff members performing 
set up will help minimize time spent in the participant’s home (with 2 staff - approximately 2 
hours). The staff in the home will wear masks, eye shields and gloves during the installation.  All 
participants and family members present during the installation will wear masks.  
 
Data Collection 
In this study, we will be collecting de-identified physiologic data from people with type 1 
diabetes.  The following data will be collected from participants in this study: 
 
Responses from the “Lifestyle Questionnaire” 
 Glucose sensor data (Dexcom G6) 
 Insulin data from the subject’s insulin pump.  
 Physical activity data will be collected with the OHSU iPancreas app on a study provided 
phone and recorded through a FitBit Ionic, Polar, Garmin or Apple Watch.  iPancreas 
will send physical activity data to the iPancreas server. This fitness data will include the 
following: 
o Heart rate 
o Step count 
o Metabolic expenditure 
o Sleep 
o Activity types (e.g. running, jogging, etc). 
 Self-report food and exercise data logged by the participant 
To collect the data, each participant in the study will use their own phone and a study provided 
phone to collect data.   
 A Dexcom commercial app will collect data from the Dexcom G6 glucose sensor on the 
subject’s phone or on a provided study phone.   
 The activity watch commercial app will collect sleep data from the watch on the provided 
study phone.  
 A custom app developed by OHSU called T1-Dexi will also be installed on the subject’s 
phone or on a provided study phone.  The T1-Dexi app has undergone a security review 
by OHSU IT and the results of this can be provided upon request.   
 A custom app developed by OHSU called iPancreas will be installed on a provided study 
phone. The iPancreas app has undergone a security review by OHSU IT and the results of 
this can be provided upon request.  
 
The T1-Dexi app will serve as the ‘data aggregator’ on the phone and will perform the following 
functions: 
 T1-Dexi app will collect self-report meals and exercise data from the participants both as 
text / categorical selections and also as food photographs collected from the camera on 
the phone. 
 Data is collected by the T1-Dexi app and this non-medical, deidentified data is pushed to 
the OHSU-version of the Amazon Web Services (AWS) Cloud instance. The following 
data is pushed to the Dexi AWS server: 

 
 
 
 
 
a. Photographs of the user’s food as taken on their smart phone camera 
b. Food types and amounts as acquired by the T1-Dexi app 
c. Exercise types and amounts as acquired by the T1-Dexi app 
d. Insulin pen data acquired through Apple Health Kit 
 Physical Activity Data is collected by the iPancreas app and this non-medical, 
deidentified data is pushed to the OHSU-version of the Amazon Web Services (AWS) 
Cloud instance. The following data is pushed to the iPancreas AWS server: 
a. Heart rate  
b. Accelerometry  
c. METs 
 The data stored within AWS is de-identified and does not contain any information from 
the 18 HIPAA designations of personally identifiable information.   
 
Day 28 Study Completion visit: 
At this visit, the devices will be turned in and the subject’s insulin pump will be downloaded. A 
study investigator will be available for consult if needed regarding insulin management. The 
Dexcom sensor will be removed from the subject. The sensor site will be inspected for signs of 
irritation or infection. In addition, the sensor will be inspected for the possibility of breakage or 
fracture. If there is any evidence of sensor breakage, it will be recorded. If an area of 
inflammation of 1 cm or greater exists around the point of insertion, a de-identified photograph 
will be taken of the area and the subject will return 1-3 days later for a follow-up visit. If the study 
coordinator notes any significant redness or swelling, the study investigator will be contacted. A 
capillary blood glucose value will be taken immediately prior to discharging the subject. Subjects 
will be given oral carbohydrate for values below 85 mg/dl, and will be instructed to give an 
injection of aspart insulin if deemed appropriate by the study investigator for values above 150 
mg/dl. This visit will take approximately 1 hour.  
 
There is the option to complete this visit by Webex. Participants will be given shipping boxes for 
sending all devices back.  Participants will be given a checklist of equipment to return with 
instructions on how to uninstall the tracking devices. Participants will connect with a study 
coordinator virtually to complete the visit.   
 
If a study visit is stopped prematurely the subject will be asked if they can repeat the study visit 
that was terminated early with additional compensation provided. Repeating the study visit will 
be optional. If the study period is paused for a period of time, such as if the patient begins taking 
a medication that impacts glucose like steroids, the participant may be asked if they can repeat 
that part of the study period with additional compensation provided.  
 
Cleaning and Disinfecting  
All devices will be cleaned and disinfected between subjects. The Dexcom G6 transmitters, 
MotioWear devices and physical activity monitor will be cleaned by study staff.   Technicians 
who are disinfecting units will wash hands thoroughly and wear gloves. All items will undergo 
intermediate-level disinfection using SANI-CLOTH AF3 Germicidal disposable wipes.  The 
disinfectant will be applied and allowed to air dry. After disinfection, when the units are 
completely dry, they will be placed in a sealed bag labeled with subject information.  
 
Statistical methods 
 
The hypothesis of this study is that we will be able to identify contextual patterns in the 
movement data that will relate to glycemic outcomes.  We will use machine learning techniques 

 
 
 
 
 
including k-means clustering and Gaussian mixture models to group contextual patterns and 
then relate these groups of patterns with glycemic outcomes including the following: 
 Time in hypoglyemia (<70 mg/dL) 
 Time in hyperglycemia (>180 mg/dL) 
 Time in a target range (70-180 mg/dL) 
 Mean glucose 
 Glucose variability (standard deviation and coefficient of variance).   
 
We will evaluate if the clusters of contextual patterns are related to differences in glycemic 
outcome measures using generalized estimating equations, which takes into account correlated 
data and repeated measures.  Data will be analyzed using an intention-to-treat analysis and 
missing sensed glucose values will be interpolated for up to 20 min segments.   
    
Confidentiality and Protection of Human Subjects 
RISKS and BENEFITS 
Risks: The risks of the protocol procedures are considered minor. Subjects will be managing 
their own blood glucose as they normally would.  
Risks from exercise include falls, sprains, bruises, very low risk of bone fractures and head 
trauma. The likelihood of significant harm is quite low.  
There is a small risk of sensor fracture, and in such a case, a piece of the sensor could be left in 
the tissue after sensor removal. For this reason, the study investigator will inspect each 
removed sensor for the possibility of breakage or fracture. Any evidence of sensor breakage will 
be recorded and reported to the sensor company. 
 
Benefits: The subject may not directly benefit from being in this study; however, their 
participation may help to advance automated insulin decision support software. 
 
COSTS:   
Subjects will receive $500 for completion of all study visits.  If subjects withdraw early from the 
study, compensation will be given as follows: $125 per 7 study days in the study. If the subject 
completes a partial week, the subject will also receive $125 for the partial week. There is no 
compensation for the screening visit. Additional reimbursement will be available for participants 
who complete protocol requirements to help compensate for their time. The payment amount 
will be specified in the informed consent form. 
 
Monitoring Entity: 
This investigation will be monitored by the principal investigators, Jessica Castle, MD and Peter 
Jacobs, PhD. Drs. Jacobs and Castle have no commercial interest in any of the companies 
which manufacture any of the devices used in this study.  
 
Data Collection: 
Subject privacy will be protected by using a three-digit identifying number to code study 
documents. Study staff will record data required by the protocol onto the Case Report Forms 
(CRF). Case report forms (CRF) for this study will be entered into REDCAP, a clinical research 
electronic data application designed to support traditional case report form data capture for 
research studies housed at Oregon Health Science University and administered by the Oregon 
Clinical and Translation Research Institute (OCTRI). Investigators and research coordinator will 
verify that the procedures are conducted according to the approved protocol. All paper source 
documents will be kept in a locked cabinet for a minimum of five years. Original, completed 

 
 
 
 
 
CRF’s will be kept with the PI in a designated repository. All data from CRF’s will subsequently 
be entered into the authorized electronic REDCAP database.  
 
Recording of Data: 
Investigators and staff will record data collected during the clinical trial on the CRF’s. Case 
report forms (CRF) for this study will be entered into REDCAP, a clinical research electronic 
data repository housed at Oregon Health Science University and administered by the Oregon 
Clinical and Translation Research Institute (OCTRI). The REDCAP CRFs will include: 
1. Screening form 
2. Startup visit 
3. Study Completion visit 
4. Adverse Event form 
5. Serious Adverse Event form 
6. Concomitant Medications 
7. Lifestyle questionnaires 
 
The Principal Investigators may authorize other personnel to make entries in the CRF.  
 
The de-identified data collected during this study will be used for analysis of the primary and 
secondary endpoints listed in this protocol. This data will also be stored in the OregonAPC 
repository according to IRB protocol 19858.  During screening, participants may sign the 
consent form to store their study data in the data repository.  The data to be collected includes: 
1) glucose sensor data, 2) blood glucose data, 3) insulin data, 4) physical activity data, and 5) 
food and exercise data. All data, except for blood glucose and insulin, is aggregated by the 
DEXI app. The blood glucose data is collected through downloading the Contour Next BG 
meters and exporting data as an excel file. The insulin data is collected by downloading the 
subject’s insulin pump. There are no biological specimens collected during this study. 
 
Monitoring Procedures: 
This protocol is written in accordance with the principles established by the 18th World Medical 
Assembly General Assembly (Helsinki, 1964) and amendments and clarifications adopted by 
the 29th (Tokyo, 1975), 35th (Venice, 1983), 41st (Hong Kong, 1989), 48th (Somerset West, 
South Africa, 1996), 52nd (Edinburgh, 2000), 53rd (Washington, 2002), 55th (Tokyo, 2004), 
59th (Seoul, 2008), and 64th (Brazil, 2013) General Assemblies. The investigator will ensure 
that the study described in this protocol is conducted in full conformance with those principles, 
the protocol, current FDA regulations, ICH Good Clinical Practices (GCP) guidelines, Good 
Laboratory Practices (GLP) guidelines, local ethical and regulatory requirements, including the 
Federal Food, Drug and Cosmetic Act, U.S. applicable Code of Federal Regulations (title 21), 
any IEC requirements relative to clinical studies.  
Should a conflict arise, the investigator will follow whichever law or guideline affords the 
greater protection to the individual subject. The investigator will also ensure thorough familiarity 
with the appropriate use and potential risks of use of the study device, as described in this 
protocol, prior to the initiation of the study. 
Unanticipated problems will be detected by reviewing descriptions of known or foreseeable 
adverse events and risks in the IRB-approved research protocol and the current IRB approved 
consent form, any underlying disease or conditions of the subject experiencing the adverse 

 
 
 
 
 
event, a careful assessment of whether the adverse event is related or possibly related to the 
subject’s participation in the study. 
 
Triggers for reporting unanticipated problems are seizure, hospitalization, death or any other 
occurrence considered serious by the PI. If ongoing monitoring of the closed-loop studies 
reveals studies repeatedly being terminated because of unresponsive hyperglycemia or 
repeated serious hypoglycemia (resulting in altered mental status, loss of consciousness, or 
seizure) believed not amenable to revisions in control system parameter tuning, then the study 
will be discontinued immediately. If studies in two subjects are stopped for severe hypoglycemia 
or severe hyperglycemia, then the entire study will be halted. In addition, if there is any 
unexpected event such as death or patient hospitalization, the studies will be stopped until the 
root cause is evaluated. 
 
Any adverse event (AE) and/or unanticipated problem (UP) will be reported to the investigator 
monitor immediately by one of the investigators. Hypo- and hyperglycemia will not be 
considered AEs unless subject has positive ketones or displays symptoms of hypoglycemia 
such as: loss of consciousness, slurred speech, hospitalization or EMS services called.  One of 
the investigators will always be on-call during the closed-loop studies and will write up a 
description of the adverse event/unanticipated problem. All reportable new information (RNI) will 
be reported to the IRB within five calendar days after the PI learns of the event. RNI is any 
information that might meet the regulatory definition of an unanticipated problem involving risks 
to subjects or others or serious or continuing noncompliance that might impact the criteria for 
IRB approval. The report will be submitted to the IRB by the principal investigator or study 
coordinator. A summary of all UP's and adverse events, including those that do not meet the 
requirement for RNI, will be submitted with the continuing review.  
 
 
Confidentiality Procedures: 
To protect confidentiality, standard institutional practices will be followed as described in the 
OHSU Information Security and Research Data Resource Guide 
(http://ozone.ohsu.edu/cc/sec/isg/res_sec.pdf) to maintain the confidentiality and security of 
data collected in this study. Study staff will be trained regarding these procedures. See IRB 
protocol 19858 for a complete description of the confidentiality and security of the study data 
collected during this study to be stored in the OregonAPC repository. Paper files will be stored 
in locked filing cabinets in restricted access offices at OHSU. After the study, source documents 
will be maintained at the participating clinical center (or offsite record storage facilities) 2 years 
after a marketing application is approved for our group's decision support device or 
discontinuance of pursuit of marketing approval.   
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
Appendix A: Physical Activity Readiness Questionnaire 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Appendix B: Devices 
FitBit  
 
 
 
 
 
   Garmin Watch 
 
 
Polar Watch  
 
 
 
 
Apple Watch 
 
 
 
 
Dexcom G6 Continuous Glucose Monitoring System which includes Sensor and Sensor 
Transmitter 
 
      
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Smart phone with T1 DEXI app 
 
 
Contour Next Blood Glucose Meter 
 
 
 
 
  
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Appendix C: Hypoglycemia Awareness questionnaire:This survey item will be used to 
categorize awareness or having reduced awareness of hypoglycemia. 
 
 
1. Check the category that best describes you: (check one only) 
 
 I always have symptoms when my blood sugar is low (A) 
 I sometimes have symptoms when my blood sugar is low (R) 
 I no longer have symptoms when my blood sugar is low (R) 
 
 
2. Have you lost some of the symptoms that used to occur when your blood sugar was low? 
 
 Yes (R) 
 No (A) 
 
 
3. In the past 6 months how often have you had moderate hypoglycemia episodes? (Episodes 
where you might feel confused, disoriented, or lethargic and were unable to treat yourself). 
 
 Never (A) 
 Once or twice (R) 
 Every other month (R) 
 Once a month (R) 
 More than once a month (R) 
 
 
4. In the past year, how often have you had severe hypoglycemia episodes? (Episodes where 
you were unconscious or had a seizure and needed glucagon or intravenous glucose?) 
 
 Never (A) 
 1 time (R) 
 2 times (R) 
 3 times (R) 
 4 times (R) 
 5 times (R) 
 6 times (R) 
 7 times (R) 
 8 times (R) 
 9 times (R) 
 10 times (R) 
 11 times (R) 

 
 
 
 
 
 12 or more times (R) 
 
5. How often in the last month have you had readings < 70 mg/dl with symptoms?  
 
 
 Never 
 1 to 3 times 
 1 time/week 
 2 to 3 times/week 
 4 to 5 times/week 
 Almost daily 
 
6. How often in the last month have you had readings < 70 mgdl, without symptoms? R: 5<6, A: 
6<5; 
 
 Never 
 1 to 3 times 
 1 time/week 
 2 to 3 times/week 
 4 to 5 times/week 
 Almost daily 
 
 
7. How low does your blood sugar need to go before you feel symptoms? 
 
 60-69 mg/dl (A) 
 50-59 mg/dl (A) 
 40-49 mg/dl (R)  
 < 40 mg/dl (R) 
 
 
8. To what extent can you tell by your symptoms that your blood sugar is low? 
 
 Never (R) 
 Rarely (R) 
 Sometimes (R) 
 Often (A) 
 
 
 
 
 
 
 

 
 
 
 
 
Appendix D: Exercise Video Outlines  
 
 
Aerobic Exercise Video Outline 
Segment 
Segment Time 
Activities  
Warm-Up Intro 
(2 min) 
0:00 – 2:00 
0:00: Welcome! Marching Reach Up 
0:30: Side to Side Kick Back Pull Back 
0:45: Side to Side Kick Back Butt Kick 
1:00:  Side to Side Kick Back Butt Kick Reach 
out 
1:15: Grapevine 
1:30: Grapevine with Arm Circles 
Active Exercise 
(30 min) 
Each activity is performed 
for 30 seconds 
1. Modified Jump rope 
2. Jumping jacks 
3. Side to Side Knee Raise (alternate left/right 
crunch) 
4. Side Steps (active recovery) 
5. Modified Jump rope 
6. Jumping Jacks 
7. Side to Side Knee Raise (alternate left/right 
crunch) 
8. Side Steps (active recovery) 
9. Arms Alternating A, T and Y with Heal 
Tap 
10. Left Jab Bounce (left foot forward)  
11.  Side Steps (active recovery) 
12. Arms Alternating A, T and Y with Heal 
Tap  
13. Right Jab Bounce (right foot forward)  
14. Side Steps (active recovery) 
15. Right Leg Lunge Alternate Forward Back 
16. Left Leg Lunge Alternate Forward Back 
17. Jog in Place Hands Raised 
18. Side Steps (active recovery) 
19. Right Leg Lunge Alternate Forward Back 
20. Left Leg Lunge Alternate Forward Back 
21. Jog in Place Hands Raised 
22. Side Steps (active recovery) 
23. Squat to Upper Cut (right foot forward) 
24. Right Jab Bounce (right foot forward)  
25. Side Steps (active recovery) 
26. Squat to Upper Cut (left foot forward) 

 
 
 
 
 
27. Left Jab Bounce (left foot forward)  
28. Side Steps (active recovery) 
29. Horse Stance Overhead Reach Side Bend/ 
Standing Alternating Side Bend  
30. Side Jump with Squat Alternating Left 
Right 
31. Right Lateral lunge with Right Knee Drive 
Pull Up 
32. Left Lateral Lunge with Left Knee Drive 
Pull Up 
33. Side steps (active recovery) 
34. Horse Stance Overhead Reach Side Bend/ 
Standing Alternating Side Bend  
35. Side Jump with Squat Alternating Left 
Right  
36. Right Lateral lunge with Right Knee Drive 
Pull Up 
37. Left Lateral Lunge with Left Knee Drive 
Pull Up 
38. Side steps (active recovery) 
 
 
 
Intermittent High-Intensity Interval Exercise Video Outline 
 
Segment 
Segment Time 
Activities  
Warm-Up Intro (2 min) 
0:00 – 2:00 
0:00: Welcome!  
0:15: Jog with Front Japs 
0:30: Hip Circles Feet Apart 
0:45: Side to Side Reach Out 
1:00:  Alternating Direction Arm Circles Feet 
Apart 
1:15: Side steps (active recovery) 
1:45: Intro for exercise 
Active Exercise (30 min) Each activity is performed 
for 40 seconds, followed 
by a 70 second cool down 
1. High Knee Sprint with Heel Tap – 40 
seconds high intensity 
2. Side steps (active recovery)-10 seconds   
3. Side Steps with Arm Pull Back-1 minute  
4. Alternating Knee Lunges (knee touching 
ground) then Jump Up Arms Raised then 
Squat-high intensity-40 seconds 
5. Side steps (active recovery)-10 seconds   
6. Side Steps with Arm Pull Back-1 minute  

 
 
 
 
 
7. High Plank Alternating Knee Reach –  40 
seconds high intensity 
8. Side steps (active recovery)-10 seconds   
9. Side Steps with Arm Pull Back-1 minute  
10. Advanced Plank (Bear Crawl) Alternating 
Forward Backward– 40 seconds high 
intensity 
11. Side steps (active recovery)-10 seconds   
12. Side Steps with Arm Pull Back-1 minute  
13. Diagonal Plank Alternating Reach Out 
Opposite Arm Leg Back to Middle-40 
seconds high intensity 
14. Side steps (active recovery)-10 seconds   
15. Side Steps with Arm Pull Back-1 minute  
16. Skate-Hop Alternating Sides with Arm 
Lunge Forward Opposite Knee Kick Back-
40 seconds high intensity 
17. Side steps (active recovery)-10 seconds   
18. Side Steps with Arm Pull Back-1 minute  
19. Single Leg Crouch Down then Same Knee 
Forward-5 Left then 5 Right-Repeat-40 sec 
high intensity   
20. Side steps (active recovery)-10 seconds   
21. Side Steps with Arm Pull Back-1 minute  
22. Burpee (Bent Waist Rapid Jog Arm 
Punches Down then Plank then Jump Up)– 
40 seconds high intensity 
23. Side steps (active recovery)-10 seconds   
24. Side Steps with Arm Pull Back-1 minute  
25. Lay on Back-Feet Up Knees Locked-Reach 
Forward to Toes-40 seconds high intensity 
26. Side steps (active recovery)-10 seconds   
27. Side Steps with Arm Pull Back-1 minute  
28.  Upper Body Swimmer (High Plank 
Alterating Arm Circle Forward)-40 seconds 
high intensity 
 
 
 
Resistance Exercise Video Outline  
Segment 
Segment Time 
Activities  
Warm-Up Intro (2 min 20 
sec) 
0:00 – 2:20 
0:00: Alternating Heel Kick Forward Arm 
Swing 

 
 
 
 
 
0:15: Arms on Hips Alternating Straight Leg 
Extend with Bend at Waist 
0:30:  Arms on Hips Alternating Straight Leg 
Extend with Bend at Waist Add Arm Sweep 
0:45: Alternating Leg Lunge Knee 90 Degrees 
Arm Sweep Up 
1:10: Crunch (Arms Behind Head Alternating 
Knee Touch to Elbow) 
1:30: Scarecrow (Knees Slightly Bent Torso 
Forward Arms Down then Up) 
2:00: Alternating Side Lunge Arms Up/Down 
2:20: Toe Touches with Spread Arms/Legs 
Active Exercise (28 min) Each activity is performed 
at a controlled pace in 
good form. Aiming for 
about 2 seconds to pull 
the weight the entire 
range, holding for 1 
second, then controlling 
the return of the 
movement in about 
another 1 seconds. 
Set 1: (approximately 8 min) Upper Body 
Resistance band bicep curl 3 x 8 
Resistance band side lateral shoulder raise 3 
x 8 
Resistance band bent over row 3 x 8 
Resistance band bent over row arm forward 
then back 3 x 8 
 
Set 2: (approximately 10 min) Lower Body 
Resistance band squat 3 x 8 
Resistance band deadlift 3 x 8 
Resistance band reverse lunge 3 x 8 
Resistance band glut crunch with hip raise 3 x 
8 
 
Set 3: (approximately 10 min) Total Body and 
Abs 
Resistance band side lunge to diagonal lateral 
raise 3 x 8/side 
Resistance band (standing) squat with arm 
raise 3 x 8/side 
Resistance band (on back) alternating 
opposite arm and leg extend straight 3 x 8  
Resistance band (on back) alternating 
opposite arm and leg extend bent 3 x 8  
Resistance band (standing) alternating 
right/left crunch 3 x 8 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
References 
 
[1] 
P. E. Cryer, "Diverse causes of hypoglycemia-associated autonomic failure in diabetes," 
(in eng), N Engl J Med, vol. 350, no. 22, pp. 2272-9, May 27 2004. 
[2] 
P. E. Cryer, "Mechanisms of hypoglycemia-associated autonomic failure in diabetes," N 
Engl J Med, vol. 369, no. 4, pp. 362-72, Jul 25 2013. 
[3] 
U. Pedersen-Bjergaard et al., "Severe hypoglycaemia in 1076 adult patients with type 1 
diabetes: influence of risk markers and selection," (in eng), Diabetes Metab Res Rev, vol. 
20, no. 6, pp. 479-86, Nov-Dec 2004. 
[4] 
M. R. Rickels et al., "Continuous Glucose Monitoring for Hypoglycemia Avoidance and 
Glucose Counterregulation in Long-Standing Type 1 Diabetes," (in eng), J Clin 
Endocrinol Metab, vol. 103, no. 1, pp. 105-114, Jan 1 2018. 
[5] 
R. W. Beck et al., "Effect of Continuous Glucose Monitoring on Glycemic Control in 
Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized 
Clinical Trial," (in eng), Jama, vol. 317, no. 4, pp. 371-378, Jan 24 2017. 
[6] 
J. R. Castle et al., "Novel use of glucagon in a closed-loop system for prevention of 
hypoglycemia in type 1 diabetes," Diabetes Care, vol. 33, no. 6, pp. 1282-7, Jun 2010. 
[7] 
A. Haidar, L. Legault, V. Messier, T. M. Mitre, C. Leroux, and R. Rabasa-Lhoret, 
"Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and 
conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: 
an open-label randomised controlled crossover trial," Lancet Diabetes Endocrinol, vol. 3, 
no. 1, pp. 17-26, Jan 2015. 
[8] 
R. Hovorka et al., "Overnight closed-loop insulin delivery in young people with type 1 
diabetes: a free-living, randomized clinical trial," (in eng), Diabetes Care, vol. 37, no. 5, 
pp. 1204-11, 2014. 
[9] 
R. Nimri et al., "MD-Logic overnight control for 6 weeks of home use in patients with 
type 1 diabetes: randomized crossover trial," (in eng), Diabetes Care, vol. 37, no. 11, pp. 
3025-32, Nov 2014. 
[10] 
H. Thabit et al., "Home use of closed-loop insulin delivery for overnight glucose control 
in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study," (in 
eng), Lancet Diabetes Endocrinol, vol. 2, no. 9, pp. 701-9, Sep 2014. 
[11] 
M. D. Breton et al., "Closed-Loop Control During Intense Prolonged Outdoor Exercise in 
Adolescents With Type 1 Diabetes: The Artificial Pancreas Ski Study," (in eng), 
Diabetes Care, vol. 40, no. 12, pp. 1644-1650, Dec 2017. 
[12] 
J. Castle et al., "Randomized outpatient trial of single and dual-hormone closed-loop 
systems that adapt to exercise using wearable sensors," Diabetes Care, vol. in press, 
2018. 
[13] 
M. D. DeBoer, D. R. Chernavvsky, K. Topchyan, B. P. Kovatchev, G. L. Francis, and M. 
D. Breton, "Heart rate informed artificial pancreas system enhances glycemic control 
during exercise in adolescents with T1D," (in eng), Pediatr Diabetes, vol. 18, no. 7, pp. 
540-546, Nov 2017. 
[14] 
P. G. Jacobs et al., "Randomized trial of a dual-hormone artificial pancreas with dosing 
adjustment during exercise compared with no adjustment and sensor-augmented pump 
therapy," (in eng), Diabetes Obes Metab, vol. 18, no. 11, pp. 1110-1119, Nov 2016. 

 
 
 
 
 
[15] 
N. Resalat, J. El Youssef, R. Reddy, and P. G. Jacobs, "Design of a dual-hormone model 
predictive control for artificial pancreas with exercise model," (in eng), Conf Proc IEEE 
Eng Med Biol Soc, vol. 2016, pp. 2270-2273, Aug 2016. 
[16] 
N. Resalat, J. E. Youssef, R. Reddy, and P. G. Jacobs, "Evaluation of model complexity 
in model predictive control within an exercise-enabled artificial pancreas," IFAC-
PapersOnLine, vol. 50, no. 1, pp. 7756-7761, 2017/07/01/ 2017. 
[17] 
P. G. Jacobs, A. S. Paul, and E. A. Wan, "EmbedRF position tracking and mobility 
assessment system: a low-power and low-cost system for passive assessment of patient 
health in a home health-care setting," in 24th International Technical Meeting of the 
Satellite Division of the Institute of Navigation 2011, ION GNSS 2011, Portland OR, 
2011, pp. 1499-1506. 
[18] 
A. S. Paul et al., "MobileRF: A Robust Device-Free Tracking System Based On a Hybrid 
Neural Network HMM Classifier," (in eng), Proc ACM Int Conf Ubiquitous Comput, vol. 
2014, pp. 159-170, 2014. 
[19] 
A. S. Paul, E. A. Wan, and P. G. Jacobs, "Sigma-point Kalman smooting for indoor 
tracking and auto-calibration using time-of-flight ranging," in Proceedings of the 24th 
International Technical Meeting of the Institute of Navigation (ION GNSS 2011), 
Portland OR, 2011, pp. 3461-3469. 
[20] 
M. C. Shastry et al., "Context-aware fall detection using inertial sensors and time-of-
flight transceivers," (in eng), Conf Proc IEEE Eng Med Biol Soc, vol. 2016, pp. 570-573, 
Aug 2016. 
[21] 
E. A. Wan, A. S. Paul, and P. G. Jacobs, "Tag-free RSSI based indoor localization," in 
Proceedings of the 2012 International Technical Meeting of the Institute of Navigation, 
Newport Beach, CA, 2011, pp. 940-944. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
CLINICAL RESEARCH CONSENT AND AUTHORIZATION 
SUMMARY OF KEY INFORMATION ABOUT THIS STUDY 
 
TITLE: Development of a context-aware glucose prediction algorithm in patients with 
type 1 diabetes 
 
PRINCIPAL INVESTIGATOR: Jessica Castle MD 
 
(503) 494-7072 
 
You are being asked to join a research study. This consent form contains important 
information to help you decide if you want to join the study or not.  
 
PURPOSE: 
The purpose of the study is for the creation of a dataset that will be used for the development 
of a glucose prediction system for the management of diabetes. This dataset will include 
glucose sensor values, fingerstick glucose values, insulin data, food and rescue carbohydrate 
consumption, as well as information on the type, intensity and duration of exercise. It will also 
include context data, which is collected from a sensor tag on the user’s body and sensors 
distributed in their living space. This data recognizes environments and patterns of living that 
are related to changes in glucose.  
 
DURATION: 
Your participation in the study will consist of 3 visits over approximately 8 weeks. Most visits 
will last 1.5-2 hours.  
 
PROCEDURES:  
If you decide to take part in this study, you will have a number of tests and procedures.  
 After you qualify, you will begin the study with Visit 2, the start-up visit for the 28 day 
study.  You will be asked to fill out a lifestyle questionnaire asking about your current 
exercise routine and blood glucose management. You will be given the Dexcom G6 
CGM, a physical activity watch connected to a study phone, and a tracking tag to wear 
and a tracking beacon to install in your home for use during the next 28 days. You will 
install theG6 app on your personal phone.  
 You will be shown how to use a smart phone app on your phone to enter all of your 
meal and exercise data along with meal photos.  
 You will be asked to complete a 30-minute exercise video once or twice a week with a 
meal prior to exercise. 
 You will be asked to pick up and then consume a prepared meal once each week on the 
same day at a set time at home.  

 
 
 
 
 
 At the end of the 28 days, you will come in for a one-hour study completion visit 
where we will download your insulin pump.  
RISKS: There are risks involved in participating in the study, some of which may be very 
serious. These may include, but are not limited to, more common risks such as high blood 
glucose, low blood glucose to less common risks such as falls/injuries while exercising, or 
allergic reaction from the insulin. 
 
BENEFITS: You will not directly benefit from taking part in this research. This research may 
benefit future people with type 1 diabetes by helping to develop better management tools for 
diabetes.  
 
ALTERNATIVES: You may choose not to participate in this study or participate in another 
study if one is available. 
 
This is a voluntary research study.  You do not have to join the study.  Even if you decide to 
join now, you can change your mind later.  Please ask the Investigator if you have any 
questions about the study or about this consent form. 
 
END OF CONSENT SUMMARY 
 
 
 

 
 
 
 
 
 
 
 
IRB#: 20248 
 
 
MED. REC. NO. 
_____ 
NAME 
_____ 
BIRTHDATE _____ 
 
 
Clinical Research Consent and Authorization Form 
 
TITLE: Development of a context-aware glucose prediction algorithm in patients with type 
1 diabetes 
 
 
PRINCIPAL INVESTIGATOR: 
Jessica Castle MD  (503) 494-7072 
 
 
WHO IS PAYING FOR THE STUDY?:  National Institute of Health (NIH) 
 
WHO IS PROVIDING SUPPORT FOR THE STUDY?:   Dexcom 
 
OHSU is being compensated by the funder to conduct this study.  This is to pay for tests 
performed only for study purposes, and for the time involved on the part of the investigator(s) 
and study staff.  You may freely discuss this with your physician and the investigator if you have 
concerns. Your study doctor and the research staff have no financial involvement with the funder 
and are not being paid directly by the funder for conducting this study.  However, they may have 
travel expenses covered by the funder to attend study training meetings. 
 
DO ANY OF THE RESEARCHERS HAVE A CONFLICT OF INTEREST WITH THIS STUDY?   
OHSU and Drs. Jacob and Wan (co-investigators) and Jonathon Folsom have a financial interest 
in MotioSens, a company that is involved in this study. The nature of this financial interest and 
the design of the study have been reviewed by two committees at OHSU. They have put in place 
a plan to help ensure that this research study is not affected by the financial interest. If you would 
like more information, please contact the OHSU Research Integrity Office at (503) 494-7887. 
 
WHY IS THIS STUDY BEING DONE?: 
You have been invited to be in this research study because you have type 1 diabetes. The purpose 
of this study is to create a dataset that will be used in developing a glucose prediction model for 
an automated insulin delivery system. We will collect glucose sensor values, fingerstick glucose 
values, insulin data from your insulin pump, food and rescue carbohydrate data, and exercise 
data. We will also collect context data through sensors worn on your body and distributed in 
your home. Context means “what you are doing at a given time and where you are doing it”. This 
data will help us recognize repeatable patterns in your life. An example of this might be 
consistent low blood sugars while you at the gym on Mondays and Wednesdays from 6-8am. 
With the data, we can determine how those patterns affected your glucose. We believe that an 
automated insulin delivery system can use context data to recognize environments and living 
patterns that negatively affect your glucose. With the data collected by this study, we hope to 

 
 
 
 
 
design a system that can help predict low or high blood sugars based on known behavior 
patterns, adjust insulin accordingly and improve the time glucose is in the target range.   
 
This study requires 3 visits to the clinic and will take approximately 8 weeks to complete. 
 
The data we collect during your study will be kept in a data bank, also called a repository.  This 
data will be stored indefinitely and may be used and disclosed in the future for research. 
 
 
WHAT EXAMS, TESTS AND PROCEDURES ARE INVOLVED IN THIS STUDY?   
Visit 1 is a screening visit. If you qualify, you will participate in the study for 28 days. During the study, you 
will manage your blood sugar as you normally would using your own insulin pump with the addition of 
using the Dexcom G6 sensor and the Dexcom G6 app. You will also wear a physical activity watch and a 
tracking tag on your body, as well as placing tracking beacons in your home. The physical activity watch 
data will be collected on the iPancreas app. We will provide a phone with this app on it. You will use a 
mobile app, DEXI, to track your physical activity and meal data while at home, including taking pictures of 
your food on certain days. You will install the DEXI study app and the Dexcom G6 app on your phone. 
You will also be given a study-provided phone that will collect your heart rate data from your physical 
activity monitor. You will complete an exercise video twice a week during weeks one and two and once a 
week during weeks 3 and 4 at home after eating a meal of your choice. For the exercise, you will have an 
equal chance of being assigned to aerobic (cardio), anaerobic (strength), or high intensity interval exercise 
video sessions. You will also pick up and consume a dinner prepared by OHSU Bionutrition once a week 
on the same day at a set time at home.  See Figure 1 below for a diagram of the study flow. Data collected 
from/about you in this study will be used to develop a glucose prediction model for an automated insulin 
delivery system.  
 
Figure 1: Study Flow Design 
 
 
You will be using the Dexcom G6 CGM system including a sensor and transmitter. The Dexcom 
G6 CGM system is an FDA approved device. We expect to study up to 30 subjects in this study 
at OHSU.    
 
Clinic Visit #1: Screening Visit:   
The screening visit will be completed at the OHSU Oregon Clinical and Translational Research 
Institute Clinic (OCTRI), the Biomedical Engineering Point of Care (BME POC) Laboratory or at 
the OHSU Harold Schnitzer Diabetes Health Center.  After this consent form is signed, you will have 
blood drawn for tests. The blood test is to monitor diabetes control, liver and kidney function, 
electrolytes, and blood count. About one tablespoon of blood is needed for these tests.  If you have 
had any of these tests completed in the last 3 months and we can access the results, we will not draw 
blood for that test. If the blood tests show that you have medical problems such as kidney disease, 
liver disease or anemia, it will not be possible to include you in the study.   
 

 
 
 
 
 
You will also be asked questions about your medical history, and a brief physical exam will be 
performed. Your vitals will be taken (height, weight, pulse, blood pressure) along with a capillary 
blood glucose reading. If you are a woman who can become pregnant, you will need to take a 
urine pregnancy test. This test must be negative for you to participate in the study. You will also 
have an EKG done. As part of the screening procedures for this study, the investigator will review 
your medical records for information related to your eligibility in the study. For example, they may 
review your recent lab results and visit notes from your endocrinologist. We will download your 
insulin pump in order to determine how often you are counting carbohydrates for meals.   
 
You will be asked to fill out 2 questionnaires.  These questionnaires will be used by the 
investigators to accurately ascertain your: 
 Physical activity readiness 
 Hypoglycemia awareness 
 
When the risk of Covid-19 is considered to be significant and OHSU is at reduced operations, 
only one staff member will be in the room with you at a time wearing a mask and maintaining 
social distancing and the only time staff will have to be within 6 feet is when the study 
investigator is completing the physical exam and when research staff is completing the EKG and 
drawing blood for screening labs. We will give you a mask to wear during the visit.   
This visit will take about one and a half hours. 
 
Clinic Visit #2: Start-up Visit for 28 day study 
This visit will be completed at the OHSU Oregon Clinical and Translational Research Institute Clinic 
(OCTRI), the Biomedical Engineering Point of Care (BME POC) Laboratory or at the OHSU 
Harold Schnitzer Diabetes Health Center. This visit will last approximately 1.5 hours, depending on 
user experience.  
 
You will continue to use your own insulin pump and manage your glucose as you normally would 
for the 28 days. You will be asked to answer questionnaires from the “Lifestyle Questionnaire,” that 
ask about your exercise routine and your blood sugar control.You will insert a Dexcom G6 CGM 
according to the manufacturer’s directions and connect to the Dexcom G6 app, setting the alerts at 70 
and 250 mg/dl and changing out every 10 days. You will be given a physical activity watch 
connected to the iPancreas app on a study-provided phone. You will be given a tracking tag to wear 
and shown how to install tracking beacons in your home. You may be asked to plug the MotioWear 
beacon into your router to improve data uploads You will also be instructed on a mobile app, T1 
DEXI.  You will enter your physical activity and meal data into this app, including taking photos 
of all of your food on the day of and the day after exercise. You will install the study app, the 
commercial app for the activity watch, the app for the activity watch and the Dexcom G6 app on 
your personal phone. (If your phone is not compatible with the study apps, the provided study 
phone may be used.) 
 
You will be asked to complete two at-home exercise sessions using a 30 minute exercise video 
during weeks 1 and 2 and one session during weeks 3 and 4 after a meal of your choice. You will 
be assigned to either aerobic (cardio), anaerobic (strength), or high intensity interval exercise 
video sessions. You will be instructed to consume a snack if your glucose is <120 mg/dL and 
delay exercise until your glucose is >80 mg/dL. Also if your glucose is >250 mg/dL, you will be 
instructed to calculate if a correction dose is needed and delay exercise until glucose is <250 
mg/dL.  You will be given a Contour Next blood glucose meter and strips. You will be instructed 
to check your glucose after exercise and to consume a snack if needed.  
 

 
 
 
 
 
You will be asked to pick up and consume a high carbohydrate dinner prepared by OHSU 
Bionutrition once each week at home on the same day at the same approximate time of day (but 
not on the exercise days). The meals can be picked up all at once and frozen until use. You will 
be asked to download your pump weekly or biweekly during the 28 days on study. This will 
allow for frequent data capture in case of a battery change or loss of power to the pump which 
can erase insulin data.   
 
When the risk of Covid-19 is considered to be significant and OHSU is at reduced operations, 
the start-up visit can be completed by video with the study devices and meals being delivered to 
you by a courier. You will need to install a software program called Webex on your personal device 
for the video visit. Webex is a secure virtual software platform approved for use with OHSU patients. 
Study staff are available to assist with the install. To make installation quicker, no more than two 
research staff members may need to go into your home for installation of the tracking devices 
while maintaining appropriate social distancing. The staff members will wear masks, face shields 
and gloves during the installation. All participants and family members present during the 
installation will wear masks. Members of your household and our study staff will be screened for 
COVID-19 symptoms within the prior 14 days and day of the installation. 
 
If you experience difficulties with the devices, study staff will be available for assistance by phone or 
email. Study staff will follow-up with you every 7 days. You may be contacted at additional 
times by phone, email or text by study staff.  For example, staff may contact you to clarify the 
content of your food photos or to remind you to complete your exercise or pick up your meal.  
 
Clinic Visit #3: Study Completion Visit 
At this visit, study staff will remove the Dexcom sensor and you will turn in all devices.  Study 
staff will download your insulin pump. A study investigator will be available for consult if needed 
regarding insulin management. The sensor will be taken out earlier if the sensor is not working 
correctly or the investigator decides it should be removed.  It will also be taken out if you ask for it to 
be removed. We will inspect the skin where the sensor was placed and will take a photo of the area if 
it is red or swollen. Your face will not be included in the photograph. There is little risk of 
identification unless you have an identifying tattoo or mark on your stomach. If the study coordinator 
notes any significant redness or swelling, the study investigator will be contacted. If you have a red 
area around the place where the sensor was, the study investigator may ask you to return to the clinic 
to make sure you do not have an infection. This visit will take approximately 1 hour.  
 
There is the option to complete this visit by video using Webex. You will be given shipping 
boxes for sending all devices back at the end of the study.  You will be given a checklist of 
equipment to return with instructions on how to uninstall the tracking devices. You will connect 
with a study coordinator virtually to complete the visit.   
 
If the study period is paused for a period of time, such as if you begin taking a medication that 
impacts glucose like steroids, you may be asked if you can repeat that part of the study period 
with additional compensation provided. 
 
During the screening visit, you will have blood drawn for tests. Your blood will be destroyed after 
the OHSU lab finishes running the tests listed in table below. The following data will be 
collected during this study and stored in a repository: 1) Dexcom G6 sensor data, 2) blood 
glucose data from a study Contour Next BG meter, 3) insulin data from your pump, 4) physical 
activity data, 5) food and exercise data that you entered into the DailyDose app, and 6) context 
data from the tag worn on your body and the beacon from your home. In the future, this data may 

 
 
 
 
 
be used for other research studies at OHSU.  The data will be labeled as described in the WHO 
WILL SEE MY PERSONAL INFORMATION? section. 
 
If you have any questions regarding this study now or in the future, contact the principal 
investigators Jessica Castle, MD at (503) 494-7072 or Peter Jacobs PhD at (503) 494-3870 or 
you can contact the study coordinator Debbie Branigan at 503-418-9070. 
 
 
Clinic Visit Schedule  
Visit Number 
1 
3 
4 
Procedures 
Sign consent, obtain 
medical history and 
vitals 
 
28 day study start-up 
visit 
Study completion 
visit 
Lab Tests 
Blood Panel*, EKG, 
pregnancy test (if 
applicable) 
Pregnancy test (if 
applicable) 
 
Physical Exam 
History and Physical 
Exam 
 
Exam of skin 
Time 
1 ½ hours 
1 ½ hours 
60 minutes 
*The Blood Panel includes HgbA1C, liver tests (ALT, AST, albumin), kidney tests (creatinine), 
and electrolytes (Na, K, Ca) and a complete blood count to rule out anemia.  
 
WILL I RECEIVE RESULTS FROM THE TESTING IN THIS STUDY? 
Some of the information collected and created in this study may be placed in your OHSU 
medical record.  While the research is in progress, you may or may not have access to this 
information. After the study is complete, you will be able to access any study information that 
was added to your OHSU medical record.  If you have questions about what study information 
you will be able to access, and when, ask the investigator. 
 
We will run routine labs at your screening visit to monitor diabetes control, liver and kidney 
function, electrolytes, and blood count to determine if you are eligible for the study. We do not plan 
to share your test results with you or your primary care provider.  However, if we discover 
information that is important for your health care, either in this study or in the future, we will 
contact you and ask if you want to know the results.  If you choose to receive the results, you 
may need to have the test repeated in a non-research laboratory.  You may learn information 
about your health that is upsetting or that impacts your health. You will be able to ask the 
investigator about any of the study results.   
 
 
WHAT RISKS CAN I EXPECT FROM TAKING PART IN THIS STUDY?:  
Risk of Low and High Blood Sugar 
Exercise can cause the blood sugar to drop. Symptoms of low blood sugar can include sweating, 
weakness, shaking and not feeling well.  The Dexcom app will have high and low glucose alerts 
that you can adjust. There is a very low glucose alert that cannot be adjusted. Symptoms of high 
blood sugar includes increased thirst, tiredness, blurred vision and irritability. It is unlikely that 
you will experience severe low or high blood sugar because of the use of the Dexcom G6 sensor 
with alarms set.  
 
Blood Draw Risks 

 
 
 
 
 
We will draw blood from your arm at the screening visit.  You may feel some pain when your 
blood is drawn.  There is a small chance the needle will cause bleeding, a bruise, an infection, or 
fainting. 
 
Exercise 
You will be completing exercise.  You may feel tired and may have low or high blood sugar.  
Rarely, exercise may cause a heart attack, irregular heart rate or death.  You will an EKG 
performed at screening.   
 
Dexcom Sensor 
The Dexcom sensor may produce pain when it is inserted into the skin, similar to a pump site 
insertion or insulin injection. Rarely, a skin infection can occur at the site of insertion of the 
sensor.  Itchiness, redness, bleeding and bruising at the insertion site may occur. An allergy to 
the tape that holds the sensor to the skin is possible.  The risk of skin problems could be greater 
if you use a sensor for longer than it is supposed to be used.  There is a chance that the sensor or 
needle may break under your skin.  This is not expected to occur, but if it does, you should speak 
with your study doctor about what to do. 
 
Finger Stick Blood Glucose Measurements 
During the study blood glucose measurements need to be made with a finger stick.  The finger 
stick may cause pain or bruising. 
 
Pregnancy Risks for Women 
If you are nursing an infant or you are pregnant now, you cannot be in the study.  This study may 
involve risks to an embryo, fetus, or nursing infant that are currently unknown.  If you are 
sexually active and could become pregnant, you and your male partner(s) must use birth control 
that works well or you must not have sex. The investigator will talk to you about the types of 
birth control that are acceptable.  You will have to do this the whole time you are in this study. If 
you become pregnant during the research study, please tell the investigator and your doctor 
immediately. 
 
Lifestyle Questionnaire 
There is a slight risk of a breach of confidentiality with your questionnaire responses. However, 
the plan listed in the section “WHO WILL SEE MY PERSONAL INFORMATION?” makes it 
unlikely that the breach would occur. 
 
Other Side Effects 
One risk to taking part in this study is that the study may not be effective in helping to treat your 
disease. This means you may spend time in the study that may not provide you with any health-
related benefits. You may have some side effects we do not expect. 
 
Risks from Storage of Data in Repository 
There is a slight risk of a breach of confidentiality from keeping your data in a repository.  
However, the plan listed in the section “WHO WILL SEE MY PERSONAL INFORMATION?” 
makes it unlikely that a breach would occur.  
 
Risks from Using Provided Study Phone 
You will be provided with a phone with security controls in place. These controls include 
password access so only you can access the phone. However, if you lose the phone - or it is 
stolen - data could be accessed by other individuals not authorized by you to view your 

 
 
 
 
 
information. In using the study phone, you accept the risk, however slight, that your information 
could be compromised. 
 
WHAT ARE MY CHOICES IF I DECIDE NOT TO TAKE PART IN THIS STUDY?  
You may choose not to be in this study.  If you do not take part in this study, the alternative is to 
continue your current diabetes treatment and care. You could chose to use the Dexcom G6 CGM 
system for management of your diabetes without being in the study. We encourage you to 
discuss your options with your study doctor, your general primary care physician, or another 
health care professional.   
 
WHO WILL SEE MY PERSONAL INFORMATION? 
We will take steps to keep your personal information confidential, but we cannot guarantee total 
privacy. To protect your privacy, you will be assigned a 3-digit number to identify your study 
data. The key associating the 3-digit number and your personal identifying information will be 
restricted to the study staff.  It will also be encrypted and kept secure on a restricted OHSU drive 
in a limited access folder. The study phone you will use will be registered to this 3-digit number.  
All of the data stored on the phone will be associated with this ID.  The data that will be stored 
includes: 
 Exercise, sleep and activity data from the exercise Watch  
 glucose sensor data from the Dexcom G6 CGM 
 insulin from your insulin pump 
 the food and exercise data you log in the study app (this app has undergone a security 
review by the OHSU Information Technology department)  
 the context data collected from the wearable tags and beacon in your home 
We will create and collect health information about you as described in the WHY IS THIS 
STUDY BEING DONE? and the WHAT EXAMS, TESTS AND PROCEDURES ARE 
INVOLVED IN THIS STUDY? sections of this form.  Health information is private and is 
protected under federal law and Oregon law.  By agreeing to be in this study, you are giving 
permission (also called authorization) for us to use and disclose your health information as 
described in this form. 
 
The investigators, study staff, and others at OHSU may use the information we collect and create 
about you in order to conduct and oversee this research study and store in a repository.  
 
We may release this information to others outside of OHSU who are involved in conducting or 
overseeing research, including: 
 
 The funder of this study, National Institute of Health (NIH), and Dexcom Inc., and the 
funder’s representatives  
 The Food and Drug Administration 
 The Office for Human Research Protections, a federal agency that oversees research 
involving humans 
 
Those listed above may also be permitted to review and copy your records, including your 
medical records. 
 
Your name, date of birth and social security number may be provided to the study funder (or an 
organization acting on their behalf) so the funder can meet Medicare reporting requirements 

 
 
 
 
 
 
Data from this study may be shared with other investigators for future research studies.  All 
identifying information about you aside from some dates will be removed from the data before it 
is released to any other investigators.  
 
To protect your privacy, you will be assigned a 3-digit number to identify your study data. There 
will be a key linking your 3 digit subject ID to your personal health information. The study 
phone you will use will be registered to this 3-digit number.  All of the data stored on the phone 
will be associated with this ID.  The key is encrypted with a password and stored in a secure 
OHSU cloud database. The lead coordinator, Deborah Branigan, and research coordinators listed 
on this IRB protocol will have access to this encrypted key but outside researchers will not.  
 
By participating in this study, you are giving permission for your data to be stored indefinitely in 
a repository in order to be used in future research studies. Generally, a research repository 
collects, stores and distributes data for use in future research projects. Storing and gathering lots 
of data together can help to conduct future research and avoid re-collecting data over and over 
again. The purpose of this data repository will be to combine all of the study data from the 
OregonAPC group into one set for future engineering development of diabetes technologies. 
The data stored on the phone is uploaded into a secure OHSU approved cloud database 
repository along with your blood glucose data from the meter and pump. Data access will be 
reviewed and tracked to ensure that data is only released to authorized individuals. The data will 
remain in the cloud database until the PI for the repository, Dr. Jessica Castle, decides to 
discontinue the repository. The termination will include the destruction of the data in a secure 
way. If you withdraw your consent from this project, your data will be destroyed.   
 
We will not release information about you to others not listed above, unless required or permitted 
by law.  We will not use your name or your identity for publication or publicity purposes, unless 
we have your special permission. 
 
When we send specimens or information outside of OHSU, they may no longer be protected 
under federal or Oregon law. In this case, your specimens or information could be used or re-
released without your permission. 
 
We may continue to use and disclose your information as described above indefinitely. 
 
Some of the information collected and created in this study may be placed in your OHSU 
medical record.  While the research is in progress, you may or may not have access to this 
information. After the study is complete, you will be able to access any study information that 
was added to your OHSU medical record.  If you have questions about what study information 
you will be able to access, and when, ask the investigator. 
 
WILL ANY OF MY INFORMATION OR SAMPLES FROM THIS STUDY BE USED FOR 
ANY COMMERCIAL PROFIT?  
Any data obtained from you in this research may be used for commercial purposes, such as 
making a discovery that could, in the future, be patented or licensed to a company, which could 
result in a possible financial benefit to that company, OHSU, and its researchers.  There are no 
plans to pay you if this happens.  You will not have any property rights or ownership or financial 
interest in or arising from products or data that may result from your participation in this study.  

 
 
 
 
 
Further, you will have no responsibility or liability for any use that may be made of your samples 
or information. 
 
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?   
There will be no cost to you or your insurance company to participate in this study. 
 
You will receive $500 for completion of all study visits.  If you withdraw early from the study, 
compensation will be $125 per 7 days on study. There is no compensation for the screening visit. 
If you complete a partial week, you will also receive $125 for the partial week. We will request 
your social security number in order to process any payments for participation.  
 
You will receive additional compensation for completion of study procedures at home. You will 
get $2 when you complete and enter a required exercise or meal session on the correct time/date. 
You can receive a maximum of $6/week in incentives. We will text you once a week to notify 
you of your progress. 
 
You may receive payment via a debit card.  There may be fees (for example, if the card is 
inactive for more than six months), which will be deducted from the balance on your card. 
Details on how to use the card and any fees are included in the separate card member agreement 
and FAQ sheet given to you with the debit card. 
 
Payment received as compensation for participation in research is considered taxable income for 
a research subject. If payments are more than $600 in any one calendar year, OHSU is required 
to report this information to the Internal Revenue Service (IRS).  Research subject payments 
exceeding $600 during any calendar year will result in a 1099 (Miscellaneous Income) form 
being issued to the research subject and a copy will be sent to the IRS.  
 
WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS STUDY?:   
If you believe you have been injured or harmed as a result of participating in this research and 
require treatment, contact Dr. Jessica Castle by phone at (503) 494-7072 or page her at (503) 
494-8311 or Peter Jacobs by phone at (503) 494-3870. 
If you are injured or harmed by the study device or study procedures, you will be treated.  OHSU 
and the funders do not offer any financial compensation or payment for the cost of treatment if 
you are injured or harmed as a result of participating in this research.  Therefore, any medical 
treatment you need may be billed to you or your insurance.  However, you are not prevented 
from seeking to collect compensation for injury related to negligence on the part of those 
involved in the research.  Oregon law (Oregon Tort Claims Act (ORS 30.260 through 30.300)) 
may limit the dollar amount that you may recover from OHSU or its caregivers and researchers 
for a claim relating to care or research at OHSU, and the time you have to bring a claim. 
 
If you have questions on this subject, please call the OHSU Research Integrity Office at (503) 
494-7887. 
 
WHERE CAN I GET MORE INFORMATION? 
If you have any questions, concerns, or complaints regarding this study now or in the future, 
contact Jessica Castle at (503) 494-7072, Peter Jacobs at (503) 494-3870 or Deborah Branigan at 
(503) 418-9070.  
 

 
 
 
 
 
This research has been approved and is overseen by an Institutional Review Board (“IRB”), a 
committee that protects the rights and welfare of research participants. You may talk to the IRB 
at (503) 494-7887 or irb@ohsu.edu if: 
• 
Your questions, concerns, or complaints are not being answered by the research team. 
• 
You want to talk to someone besides the research team. 
• 
You have questions about your rights as a research participant. 
• 
You want to get more information or provide input about this research. 
 
You may also submit a report to the OHSU Integrity Hotline online at 
https://secure.ethicspoint.com/domain/media/en/gui/18915/index.html or by calling toll-free 
(877) 733-8313 (anonymous and available 24 hours a day, 7 days a week).   
 
WHAT ARE MY RESPONSIBILITIES IN THIS STUDY? 
There are important instructions for you to follow during the study. We will ask you to use the 
DEXI app for entering your meal, rescue carbohydrate, exercise data and food photos.  We will 
also ask you to wear your physical activity monitor to collect data using the iPancreas app. We 
will ask you to respond to the glucose sensor alarms and insert a new G6 sensor every 10 days.  
We will ask you to wear a tracking tag and place beacons for tracking in your home. We will ask 
you to exercise two times per week 90 minutes after a meal and to pick up and eat a prepared 
meal once a week at home during the 28 days.   
 
DO I HAVE TO TAKE PART IN THIS STUDY? 
Your participation in this study is voluntary.  You do not have to join this or any research study.  
You do not have to allow the use and disclosure of your health information in the study, but if 
you do not, you cannot be in the study.   
 
Your health care provider may be one of the investigators of this research study and, as an 
investigator, is interested in both your clinical welfare and in the conduct of this study.  Before 
entering this study or at any time during the research, you may ask for a second opinion about 
your care from another doctor who is in no way involved in this project.  You do not have to be 
in any research study offered by your physician.   
 
The participation of OHSU students or employees in OHSU research is completely voluntary 
and you are free to choose not to serve as a research participant in this protocol for any reason.  
If you do elect to participate in this study, you may withdraw from the study at any time without 
affecting your relationship with OHSU, the investigator, the investigator’s department, or your 
grade in any course.   
 
IF I DECIDE TO TAKE PART IN THIS STUDY, CAN I STOP LATER? 
If you do join the study and later change your mind, you have the right to quit at any time.  This 
includes the right to withdraw your authorization to use and disclose your health information. If 
you choose not to join any or all parts of this study, or if you withdraw early from any or all parts 
of the study, there will be no penalty or loss of benefits to which you are otherwise entitled, 
including being able to receive health care services or insurance coverage for services.  Talk to 
the investigator if you want to withdraw from the study.  
 
If you no longer want your health information to be used and disclosed as described in this form, 
you must send a written request or email stating that you are revoking your authorization to: 
 
Jessica Castle, MD 

 
 
 
 
 
Oregon Health and Science University 
3181 SW Sam Jackson Park Rd. 
MC: OP 05-DC 
Portland, Oregon 97239 
castleje@ohsu.edu 
 
Your request will be effective as of the date we receive it.  However, health information 
collected before your request is received may continue to be used and disclosed to the extent that 
we have already acted based on your authorization.   
 
If you choose to withdraw from the study, you will be asked to bring in all of the study devices 
and have the Dexcom sensor removed.   
 
If in the future you decide you no longer want to participate in this research, we will destroy all 
your information.  However, if your samples are already being used in an ongoing research 
project and if their withdrawal jeopardizes the success of the entire project, we may ask to 
continue to use them until the project is completed. 
 
You may be removed from the study if the investigator stops the study, you become pregnant, 
you develop serious side effects, or you do not follow study instructions. 
 
We will give you any new information during the course of this research study that might change 
the way you feel about being in the study. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. law. This web site will not include information that can identify you. At most, the web 
site will include a summary of the results. You can search this web site at any time. 
 
 
 
SIGNATURES:  
State:  Your signature below indicates that you have read this entire form and that you agree to 
be in this study.   
 
We will give you a copy of this signed form. 
 
 
 
Participant Printed Name 
 
Participant Signature 
 
Date 
Person Obtaining Consent Printed 
Name 
 
Person Obtaining Consent Signature 
 
Date