Assessment of a Decision Support Tool in Participants With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Oregon Health and Science University

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PROTOCOL TITLE: Assessment of a Decision Support Tool in Participants with Type 1 
Diabetes  
  
STUDY SITE: 
Oregon Health Science University 
3181 SW Sam Jackson Park Rd 
Portland, OR 97639 
 
FUNDING: 
Helmsley Charitable Trust 
PRINCIPAL INVESTIGATORS: 
Jessica R. Castle MD; Peter Jacobs PhD  
 
CO-INVESTIGATORS:  
Joseph El Youssef MBBS 
Leah Wilson MD 
Melanie Jackson MD  
 
 
Background: 
 
Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia 
which can lead to severe acute and chronic complications. The burden and complexity of 
managing T1D results in the majority of people not reaching adequate glycemic control. Our 
team has developed a smartphone based application, DailyDose, that combines continuous 
glucose monitoring data and insulin data to provide decision support for subjects with type 1 
diabetes taking multiple daily injections (MDI).  
 
DailyDose provides on-demand, real-time dosing recommendations for insulin doses prior to 
meals and to correct hyperglycemia. DailyDose analyzes glucose patterns and provides weekly 
recommendations to the patient on insulin settings including carbohydrate ratios and correction 
factors. As needed, DailyDose will make weekly recommendations to change basal insulin.  Due 
to the ultra long-acting effects of Tresiba and Toujeo, DailyDose will only make 
recommendations to change these types of basal insulin every 2 weeks for safety. For subject 
safety, study investigators will set constraints on settings for short and long acting insulin during 
the onboarding process.  DailyDose will not be able to recommend insulin dose changes above or 
below the set safety thresholds. DailyDose also provides recommendations on carbohydrate 
intake for exercise and includes hypoglycemia and hyperglycemia alarms.  
 
Primary Objectives 
• To test the performance of the OHSU DailyDose MDI decision support tool as measured 
by percent of time with sensed glucose between 70-180 mg/dl as compared to CGM-
augmented MDI therapy. 
• To assess the usability of the OHSU DailyDose MDI decision support tool.   
 
Secondary Objectives 
• To test the performance of the OHSU DailyDose MDI decision support tool as measured 
by percent of time with sensed glucose less than 70 mg/dl as compared to CGM-
augmented MDI therapy. 

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• Assess cognitive, emotional and behavioral characteristics of the subjects and their 
response to DailyDose.  
 
Study Hypothesis: 
• The study hypothesis is that the OHSU DailyDose MDI decision support tool will 
increase time in range and decrease time in hypoglycemia as compared to the 14 day run-
in period using CGM-augmented MDI therapy.  
 
Primary Endpoint 
• Percent of time with sensed glucose between 70 – 180 mg/dl based on the Dexcom G6 
CGM data.  
 
Secondary Endpoints:  
• Mean sensed glucose based on the Dexcom G6 CGM data.  
• Percent of time with sensed glucose <70 mg/dl based on the Dexcom G6 CGM data.  
• 
Percent of time with sensed glucose <54 mg/dl based on the Dexcom G6 CGM data. 
• 
Percent of time with sensed glucose >180 mg/dl based on the Dexcom G6 CGM data. 
• 
Percent of time with sensed glucose >250 mg/dl based on the Dexcom G6 CGM data. 
• 
Coefficient of variation of sensor glucose based on the Dexcom G6 CGM data. 
• Evaluate cognitive, emotional and behavioral characteristics of the subjects and their 
response to DailyDose using validated surveys, including Clarke Hypoglycemia 
Awareness Scale, Hypoglycemia Fear Survey, Diabetes Distress Scale, Confidence in 
Diabetes Self-Care, Hypoglycemia Confidence Scale, Insulin Delivery Satisfaction 
Survey, Global Physical Activity Questionnaire and System Usability Scale.   
• Documentation and reporting of all adverse events including device/system-related 
events 
 
Study Type  
This is a single center, one treatment, pilot study designed to access the glucose control resulting 
from the use of the OHSU DailyDose MDI decision support tool.  
 
Study Population 
Study population will be adults with type 1 diabetes, ages 18 – 60 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. Twenty 
five subjects will be recruited to participate in studies.   
 
Power Analysis 
We estimate that 20 subjects provide 90% power to detect a paired difference in time in 
euglycemia of 10% or more on the absolute scale between the first and final 14 days of the study, 
assuming a standard deviation (SD) of 13% and a two-sided test with alpha = 0.05. The SD of 
13% is the upper limit of a 60% confidence interval for the SD of the difference between 
measurements taken 2-3 weeks apart in unpublished pilot data (n=24), using percent time in 
euglycemia during one week. It is also consistent with published findings [1, 2] if we assume a 

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correlation between paired measurements of 0.6 to 0.7. Sample size calculations were performed 
using Stata version 15. 
 
Protocol Summary: 
Subjects will be on study for 10 weeks. Subjects will begin the study with a training visit on the 
Dexcom G6 CGM system and the InPen and Clipsulin smart insulin pens. Subjects will use these 
devices for the next 14 days at home. Subjects will return to OHSU at the end of the 14 days for 
a training on using the DailyDose system. Subjects will then return home to use the DailyDose 
system for 8 weeks. Sensor glucose, exercise, insulin and meal data will be collected during the 
DailyDose portion of the study in order to produce recommendations for insulin dosing. Subjects 
will wear the Dexcom G6 and an Apple Watch physical activity monitor for the entire study. 
Insulin data will be collected using the InPen for aspart insulin and Clipsulin for the long acting 
insulin. Subjects will complete a 30 minute aerobic exercise video at home once per week.  
Subjects will also be asked to complete two additional exercise sessions on their own at home, 
one aerobic session and the other whatever type of exercise they would normally do (aerobic, 
resistance etc.). Subjects will use the bolus calculator within the DailyDose app. Subjects will be 
instructed to test capillary blood glucose (CBG) after exercise, for symptoms of hypoglycemia or 
hypoglycemia alerts and again 15 minutes after rescue carbohydrate treatment until CBG >70 
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 
 
 
 
Subject Criteria 
Inclusion Criteria:  
1. Diagnosis of type 1 diabetes mellitus for at least 1 year.  
2. Male or female subjects 18 to 60 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. Use of multiple daily insulin injections (MDI) for at least 4 weeks at time of screening 
visit.    
5. A1C 7.0-10.0% at the time of screening. 
6. Willingness to follow all study procedures, including attending all clinic visits.  
7. Willingness to sign informed consent and HIPAA documents. 
 

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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. History of severe hypoglycemia during the past 6 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.  
6. Any active infection. 
7. Known or suspected abuse of alcohol, narcotics, or illicit drugs.  
8. Seizure disorder. 
9. Active foot ulceration. 
10. Peripheral arterial disease. 
11. Major surgical operation within 30 days prior to screening. 
12. Use of an investigational drug within 30 days prior to screening. 
13. Chronic usage of any immunosuppressive medication (such as cyclosporine, 
azathioprine, sirolimus, or tacrolimus). 
14. Allergy to aspart insulin. 
15. Current administration of oral or parenteral corticosteroids. 
16. 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).  
17. Current use of any medication intended to lower glucose other than insulin (ex. use of 
liraglutide). 
18. Vision impairment which in the opinion of the investigator would preclude the use of the 
smart phone application.  
19. A positive response to any of the questions from the Physical Activity Readiness 
Questionnaire (see Appendix A) 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).  
20. Any clinically significant disease or disorder which in the opinion of the Investigator 
may jeopardize the subject’s safety or compliance with the protocol.  

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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. The T1D Exchange will send out approved recruitment emails to Glu 
community users in the Portland/Vancouver area. Handouts may also be made available to 
faculty at Providence, Tuality, Kaiser and Legacy. Records from OHSU Schnitzer Diabetes 
Clinic subjects 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, 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 50 subjects may be screened in this study.  Goal enrollment is 25 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) 
All screening visits will take place at OHSU’s Oregon Clinical Translational Research Institute 
(OCTRI) outpatient clinic 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.  

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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).  An EKG will be completed.  
 
A study investigator will assess inclusion/exclusion criteria and review the subject’s medical 
record for clarification as needed.   A three-digit subject ID number will be assigned to the 
subject.  Subjects will complete several questionnaires, one on physical activity readiness and 
one on hypoglycemia unawareness. This visit will take approximately 1 ½ hours. 
 
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.  
 
Start of 14 day Run-in (Visit 2): 
This visit will take place within 12 weeks of the screening visit. This visit 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. This visit will take approximately 60 minutes, depending on subject 
experience. 
 
Subjects will receive training on how to use the Dexcom G6 CGM system including changing 
out the sensor every 10 days.  The wire glucose sensor is sterile and commercially available from 
DexcomTM and will be used for single use only as directed by the manufacturer.  Subjects will be 
trained to insert the sensor into the subcutaneous tissue of the abdomen after appropriate 
preparation of the abdominal skin as per the manufacturer’s directions.  Subjects will be trained 
how to pair the Dexcom G6 transmitter to the Dexcom G6 app on a provided study iPhone, start 
and stop a new sensor session, and how to enter calibrations. The Dexcom G6 does not require 
calibrations. As part of the training, the study staff will review with the participants that Dexcom 
G6 values can be inaccurate. In the event that the participant’s symptoms (such as symptoms of 
hypoglycemia or hyperglycemia) are discrepant with the G6 CGM reading, then the participants 
will be instructed to perform a CBG and use this CBG value to make treatment decisions and use 
the CBG value to calibrate the Dexcom G6 device.  Participants will be provided with a copy of 
the Dexcom G6 user guide.    
 
The CGM alerts will be set at 70 mg/dL and 250 mg/dL with user able to adjust. Subjects will be 
given a Contour Next meter for measuring their CBG and Precision Xtra meter for measuring 

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ketones.  Subjects will be instructed to test CBGs after exercise, for symptoms of hypoglycemia 
or hypoglycemia alerts and again 15 minutes after rescue carbohydrate treatment until CBG >70 
mg/dl. Subjects will be instructed to enter rescue carbohydrate treatment into the Dexcom G6 
mobile app before/during and after exercise. When the CGM ≥ 300 mg/dl for over 2 hours or > 
400 mg/dl, subjects will be instructed to check a capillary blood glucose and serum ketones. If 
ketones are 0.6-1.4 mM, subjects will be instructed to take a correction bolus.  If ketones are 1.5-
3 mM, subjects will call the study investigator right away for further instructions. If ketones are 
> 3mM, subjects will be instructed to go directly to the nearest emergency room and to contact 
the study investigator. 
 
Subjects will be provided with Novolog insulin cartridges for use in the InPen smart insulin pen. 
Subjects will be instructed to not use the InPen smartphone application for bolus calculation but 
to continue with their usual insulin care calculating insulin doses based on their usual insulin 
carbohydrate and correction factor ratios. If the subject was using a different type of insulin, the 
doses will be reviewed by a study investigator but will generally be kept the same given short-
acting insulin formulations such as Humalog, Admelog, and Apidra are equivalent to Novolog. 
Subjects will use the Clipsulin smart insulin pen with their normal long acting insulin. In the 
event that the long-acting insulin used by the subject will not work with the Clipsulin device, the 
subject will be provided with Basaglar, Lantus Solostar or Tresiba insulin pens and the study 
investigator will review insulin dose with the subject.  Subjects will be given an Apple Watch to 
wear that will be paired with the study iPhone. Subjects will be asked to announce exercise to the 
Apple Watch. Subjects will be instructed on the use of these devices.  
 
Subjects will complete 6 surveys, listed below. All surveys are located in Appendices D-J.  
• Confidence in Diabetes Self-Care Scale [3] 
• Diabetes Distress Scale [4] 
• Hypoglycemia Fear Survey [5] 
• Hypoglycemia Confidence Scale [6] 
• Insulin Delivery Satisfaction Survey [7] 
• Global Physical Activity Questionnaire 
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 delivered to the 
participant via a courier and study staff virtually connecting with participants for training on the 
devices, going over responses to questionnaires and study procedures while they are at home.    
 
The goal will be for this visit to run for 14 days with subjects immediately beginning the 8 week 
DailyDose visit after completion. To allow for scheduling issues, this visit can go over, but must 
be completed within 20 days. If the run-in visit is longer than 14 days, we will use the later 14 
days of data for analysis. If there is not 14 days of CGM data collected during the run-in period 
due to sensor issues etc, the run-in may be extended to a total of 24 days in order to capture 14 
days of data for analysis.  
 
Start of 8 week use of DailyDose (Visit 3): 
This visit will take place at the OHSU OCTRI outpatient clinic, the Biomedical Engineering 
Point of Care (BME POC) Laboratory or Harold Schnitzer Diabetes Health Center clinic. At this 

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visit, subjects will go through the onboarding process with the DailyDose app. This process will 
occur with the study investigator and involve:  
1. Training on using the Dexcom G6 CGM within the DailyDose app. 
2. Entering subject choices for meals, either entering carbohydrate amount or selecting 
preset meal size. 
3. Entering long and short acting insulin types along with dose, frequency and correction 
and insulin carbohydrate ratios. 
4. Setting up alerts for low and high blood glucose alerts.  
5. Training on the app including bolus calculator, alerts, accepting/declining 
recommendations, logging exercise, using the insights tab/settings/logbook. Training will 
include that the bolus calculator is a suggestion and that participants should use their 
judgement on what insulin dose to take as the bolus calculator is not aware of certain 
circumstances such as illness or alcohol use.   
6. The study investigator setting safety constraints for changing insulin dosing for both short 
and long acting insulin.  
The study investigator will use the glucose and insulin data from the 14 day run in period to 
determine the optimal settings for each participant at the start of the 8 week intervention period. 
 
Subjects will continue to use Novolog cartridges for use in the InPen smart pen and their own 
long-acting insulin (with the exception of those subjects that were given Basaglar, Lantus, or 
Tresiba as described above).  
DailyDose has glucose alerts for safety. The G6 CGM alerts in DailyDose will be set at 70 
mg/dL and 250 mg/dL with user able to adjust. There is a very low glucose alert (<55 mg/dL) 
that cannot be adjusted. Subjects will be able to set an alert time before bed if a night time low 
glucose is predicted by the system. There is also an alert when glucose is predicted to go low 
within 30 minutes. Subjects will continue to follow instructions to check ketones as during the 
run-in period.  Subjects will also be given recommendations with regards to adjusting insulin 
doses and ingestions of carbohydrates if applicable before and after exercise as outlined below.  
This visit will take approximately 3-4 hours, depending on subject experience. Subjects will go 
home and use the DailyDose system for the next 8 weeks.  
 
Study staff will follow-up with subject by phone within the first 4 days of using DailyDose, after 
7-11 days of using DailyDose, after 21-25 days, and after 41-45 days. Study staff may contact 
subjects via text message or phone call at other times at the investigator’s discretion. For an 
additional safety review, a study investigator will review the Dexcom G6 data for each subject 
every 7-10 days on study.  If the CGM < 70 mg/dl more than 10% of the time or < 54 mg/dl 
more than 4% of the time, the investigator will call the participant and review the subject’s 
insulin dosing and adjust accordingly and confirm the participant is comfortable with changes in 
insulin doses prior to making the adjustments. There will be a cloud-based portal where the study 
investigator can input new insulin settings for the user.  The user’s study phone would have to be 
connected to the internet to upload the new settings. The period of the day in which the changes 
to insulin dosing would be implemented potentially would not roll around for another 24 hours, 

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which would be sufficient time for the phone to connect to the internet.  If the physician is 
inputting changes to settings that would need to be implemented quickly (i.e. for an upcoming 
meal), study staff will text the patient to ensure that the phone is connected to the internet to 
receive the new settings. DailyDose shall alert investigators if the user’s recommended settings 
reach the maximum or minimum insulin limits. The investigator will update the minimum and 
maximum settings if appropriate on the portal on the next business day. Subjects will have the 
ability to accept or decline recommendations, change their insulin settings and to contact study 
staff. 
 
DailyDose will present up to 7 recommendations to the user every 7 days. The app will not 
provide recommendations if less than 4 out of 7 days of CGM data is available.  For safety, 
subjects will be instructed to only use the bolus calculator to calculate meal amounts and not for 
calculating insulin correction doses for 3 hours if they notice the InPen didn’t capture a dose or 
the dose didn’t appear in DailyDose app. Due to the ultra long-acting effects of Tresiba and 
Toujeo, DailyDose will only make recommendations to change these types of basal insulin every 
2 weeks for safety. Participants will be instructed to alert investigators if they receive “Insulin 
pen not sending data” alert on two subsequent days despite attempts to repair the Inpen device 
with the smartphone. 
 
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 study staff virtually connecting with 
participants for training. A study investigator will enter the minimum and maximum insulin 
settings for the study into the Physician Portal.  
 
At-home Exercise Sessions: 
During the 14 day run-in and 8 week DailyDose visits, subjects will be asked to complete at-
home aerobic exercise sessions using a 30 minute exercise video once per week. Subjects will be 
asked to complete an additional two exercise sessions each week, one aerobic session and the 
other with an activity of their choice. Subjects will be instructed to check a CBG after exercise 
(as soon as possible after exercise but no later than 15 minutes after the completion of exercise) 
to ensure safety.  
 
The DailyDose app will give instructions to the subject before and during exercise based on the 
published PEAK recommendations [8]. The PEAK guidelines include a set of standardized 
instructions for diabetes treatment based on the glucose level, insulin on board and type of 
exercise. Subjects will receive reminders via phone or text to complete their exercise and to 
monitor adherence to protocol.  
 
Study Completion visit: 
Subjects will return to OHSU after the completion of the 8 week DailyDose visit to end the 
study.  This visit will be conducted in the Harold Schnitzer Diabetes Health Center, the 
Biomedical Engineering Point of Care (BME POC) Laboratory or the OCTRI outpatient research 
unit.  At this visit, the iPhone, Clipsulin device, and Apple watch will be turned in. The study 
investigator will consult with the subject regarding appropriate insulin dosing for the remainder 
of the day. Subjects will complete 6 surveys, listed below.  

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• Confidence in Diabetes Self-Care Scale [3] 
• Diabetes Distress Scale [4] 
• Hypoglycemia Fear Survey [5] 
• Hypoglycemia Confidence Scale [6] 
• Insulin Delivery Satisfaction Survey [7] 
• the System Usability Scale [9] 
This visit will take approximately 60 minutes. 
 
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. 
Participants will connect with study staff virtually to complete the visit and go over responses to 
questionnaires.  
 
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. 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 200 
mg/dl.  
 
If the 8 week DailyDose study period is paused for a period of time, such as due to technical 
problems, the participant may be asked if they can repeat that part of the study period with 
additional compensation provided. Problems that would qualify for extending the study time are 
1) insufficient study supplies that require the participant to go off of DailyDose for a period of 
time (such as running out of CGM supplies), 2) issues with the smartphone such that DailyDose 
cannot be used/accessed (such as a due to a damaged phone), 3) issues with the CGM system or 
the capture of the CGM data by DailyDose such that DailyDose cannot generate 
recommendations due to insufficient CGM data, or 4) scheduling issues such that the participant 
is finished with the run-in period but their DailyDose start visit is delayed. Participants can 
complete up to 4 additional weeks to make up time the study was paused. The study team will 
track when participants extend their study time and the reason and this will be included in the 
annual report to the FDA. 
 
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: 
• Glucose sensor data (Dexcom G6) 
• Glucose meter data (Contour Next) 
• Ketone meter data (Precision Xtra)  
• Short-acting insulin data (InPen)  

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• Long-acting insulin (Clipsulin)  
• Self-report food and exercise data logged by the participant 
• Responses to surveys 
 
To collect the data, each participant in the study will be given an Apple iPhone.  The iPhone will 
have the following apps that will be used to collect data.   
• The Dexcom G6 app and the DailyDose app will collect data from the Dexcom G6 
glucose sensor.   
• A Companion InPen commercial app will collect data from the short-acting insulin 
InPen.   
• A Clipsulin commercial app will collect data from the Clipsulin long-acting insulin pen.   
• A custom app developed by OHSU called DailyDose will also be installed on the 
iPhone.  The DailyDose app has undergone a security review by OHSU IT and the results 
of this can be provided upon request.   
 
The DailyDose app will serve as the ‘data aggregator’ on the phone and will perform the 
following functions: 
• DailyDose app will collect self-report meal and exercise data from the participants.  
• DailyDose app will aggregate all of the data collected from the glucose sensor, insulin 
pens and self-logged food and exercise data to be stored as de-identified data within the 
iCloud storage area of the phone.  The data stored within iCloud is de-identified and does 
not contain any information from the 18 HIPAA designations of personally identifiable 
information.  ITG has granted an Exception approval for using and storing data on the 
iCloud.  Data stored on the iCloud will be deleted once the study is complete.   
 
We will install the OHSU Intelligent Hub on the iPhones.  Upon enrollment, subjects will be 
assigned with a three-digit code that will be used instead of their name, medical record number 
or other personally identifying information. The key associating the code and the subjects 
personal identifying information will be restricted to the PI and study staff. The key will be 
encrypted and kept secure on a restricted OHSU network drive in a limited access folder as 
stated below. The iPhones will be registered to the study participants’ unique study ID number 
and all of the data stored on the iPhone will be associated with this ID.  
 
Subject privacy will be protected by using a three-digit identifying number to code paper study 
documents. Study staff will record data required by the protocol onto the Case Report Forms 
(CRF) during study visits. The CRFs and all surveys will be collected on paper. All DailyDose 
and survey data will be coded and uploaded after collection by study staff to an Oregon Clinical 
and Translation Research Institute (OCTRI) REDCap Cloud server. Investigators and research 
coordinators 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. The 
CRFs will include: 
1. Screening form 
2. 7 Surveys  
3. 14 day Run-in Visit 

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4. 8 week DailyDose Visit 
5. Study Completion Visit 
6. Physician CGM Review Form 
7. Phone/Email Update Form 
8. Adverse Event form 
9. Serious Adverse Event form 
10. Concomitant Medications 
 
The Principal Investigators may authorize other personnel to make entries in the CRF.  
The coded data will be stored in the OregonAPC repository according to IRB protocol 19858.  
The key to the code for this study will not be stored in the repository and only named study 
members on this project will have access to the key for this study. Researchers who request data 
from the repository will not receive any identifiers aside from date and we do not anticipate that 
the date will allow those researchers to re-identify the data. However, some of the researchers 
named on this project may use the data from the repository which would mean that the repository 
data will still be potentially identifiable to those who have access to the key as part of this 
project. During screening, all participants will sign the consent form to store their study data in 
the data repository.   
 
Cleaning and Disinfecting  
All devices will be cleaned and disinfected between subjects. Dexcom G6 transmitters will only 
be used for a single participant. The Apple iPhone, Clipsulin device and Apple Watch 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 Oxivir Tb 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 
 
CGM data from 14 day run-in period will be compared to the last 14 days while using 
DailyDose. Endpoints will be calculated as a summary measure per subject per time period. 
These include:  
• Percent of time with glucose in the ranges 
o 70-180 mg/dL (primary outcome) 
o <70 mg/dL 
o <54 mg/dL  
o >180 mg/dL  
o >250 mg/dL 
• Mean and CV of sensor glucose (secondary outcomes) 
We anticipate that the primary outcome (percent of time in range 70-180 mg/dL) will be 
approximately normally distributed. We will review the appropriateness of this assumption using 
both goodness-of-fit tests and diagnostic plots, such as quantile-normal plots. If the normality 
assumption holds, possibly with a transformation of the outcome, we will test the difference 
between the initial and final 14 days using a paired t-test. In the case of mild departures from 

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normality or unequal variances at the two time points, we will re-analyze the primary outcome as 
the difference between the two time periods using bootstrapped standard errors, which avoid 
distributional assumptions. We will use two-sided tests at the 0.05 level of significance. 
 
Secondary outcomes (with the exception of mean and CV of sensor glucose, for which we will 
use the same approach as for the primary outcome) are likely to have skewed distributions and 
will be presented as median (quartiles) and tested with two-sided non-parametricWilcoxon 
signed-rank tests at the 0.05 level. Because these are secondary outcomes and not independent of 
each other, we do not plan to adjust p-values for multiple comparisons. 
Missing data: Participants contributing at least 72 hours in the baseline and final periods will be 
included. Missing sensed glucose values will be interpolated for up to 30 min segments. Longer 
periods of missing data will be omitted if they represent <3% of observation time (which will be 
truncated if a participant leaves the study early). If the missing data are >3% of observation time, 
we will use available CBG values to interpolate or impute using measurements from similar time 
periods on other observation days. In the case that >2 subjects fail to complete the study, we will 
analyze the primary outcome under multiple imputation using baseline values.  
Confidentiality and Protection of Human Subjects 
RISKS and BENEFITS 
Risks: The risks of the protocol procedures are considered minor. There is a risk of 
hyperglycemia and hypoglycemia, but users are unlikely to experience severe low or high blood 
sugar because there are low and high glucose alerts available with the DailyDose app.  Exercise 
may increase the risk of hypoglycemia.  
Risks from exercise include falls, sprains, bruises, very low risk of bone fractures and head 
trauma. The likelihood of significant harm is quite low.  
Rarely, there can be allergic responses to insulin such as skin redness, hives, itching of the skin, 
swelling of the mouth, or breathing difficulties. These reactions are considered very unlikely. 
 
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 FDA and 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 $700 for completion of all study visits.  If subjects withdraw early from the 
study, compensation will be given as follows: $100 for the 14 day run in period and $75 per 
week for the 8 week DailyDose period. There is no compensation for the screening visit.  
If a participant completes additional time on study to make up for time the study was paused due 
to technical issues, participants will receive an additional $75 per week. 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. 
 

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Monitoring Procedures 
This investigation will be monitored by Jessica Castle, MD. Dr. Castle has no commercial 
interest in any of the companies which manufacture any of the devices used in this study.  
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, including study, disease or device-related 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 or if root 
cause or associations is with study devices. 
 
Triggers for reporting unanticipated problems are seizure, hospitalization, death or any other 
occurrence considered serious by the PI. If ongoing monitoring of the studies reveals studies 
repeatedly being terminated because of unresponsive hyperglycemia or repeated serious 
hypoglycemia (resulting in altered mental status, loss of consciousness, or seizure), 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. Severe 
hypoglycemia is defined as an event requiring the assistance of another person to administer 
carbohydrate, glucagon or resuscitative actions. Severe hyperglycemia is defined as capillary 
blood glucose that exceeds 300 mg/dl with serum ketones 3.0 mM or higher. 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. 
 
At all study visits, study staff will determine if any device, disease or study-related adverse 
events (AEs) have occurred. Any adverse event (AE) and/or unanticipated problem (UP) will be 
reported to the investigator monitor immediately by one of the investigators. All study, disease or 
device-related AEs or UPs will be monitored until adequately resolved or stable.  
Information regarding all AEs that occur during the study will be entered into appropriate CRFs. 
Such information will include, at a minimum: 
• Date of event 

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• Severity 
• Outcome 
• Resolution of event 
 
Unanticipated Adverse Device Effect (UADE) 
An unanticipated adverse device effect (UADE) is not expected to occur. An UADE is defined as 
any serious adverse effect on health or safety or any life-threatening problem or death caused by 
– or associated with – the device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (including documents such as 
the protocol, the informed consent document, other study-related documents), or any other 
unanticipated serious problem associated with the device that relates to the rights, safety, or welfare 
of participants.   
During the review of a reported SAE, if the Investigator determines the severity or extent of the 
event was not cited in this protocol or associated protocol materials, and the event was classified 
as, ‘possibly related’ to the device, the event will be documented as an UADE. If the event is 
classified as an UADE, the Investigator must notify the IRB and FDA within ten (10) working 
days of the original SAE notification. 
If determined that the UADE presents an unreasonable risk to participants, the investigators will 
terminate all investigations or parts of investigations presenting that risk as soon as possible, but 
not later than 5 working days after such determination is made and not later than 15 working days 
after first notice of the original SAE. A terminated study will not be resumed without IRB and 
FDA approval. 
Medical Device Reporting (MDR) Events 
A device issue, whether related to a complaint or not, is an allegation from the participant or study 
personnel regarding an indication of the failure of a device to meet user expectations for quality or 
performance specifications. Device issues will be recorded onto appropriate CRFs by site 
personnel. For purposes of this protocol, the CGM, Inpen, and Clipsulin devices are currently 
marketed. Therefore, the investigator will follow the required reporting regulations if an MDR 
reportable event occurs, according to standard operating procedures and FDA guidelines. (US 
MDR Reporting; Code of Federal Regulations Title 21 Part 803) 
MDR reportable events are events that manufacturers become aware of that reasonably suggest 
one of their marketed devices may have caused or contributed to a death or serious injury, or has 
malfunctioned and the malfunction of the device would likely cause or contribute to a death or 
serious injury if the malfunction were to recur (21 CFR 803.3). 
Disease related events 
Hypo- and hyperglycemia will not be considered AEs unless subject has positive ketones of 1.2 
mM or displays symptoms of hypoglycemia such as: loss of consciousness, slurred speech, 
hospitalization or EMS services called.  One of the investigators 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. 

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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. The FDA will be notified of any 
unanticipated adverse event related to the use of the study device. Notification will be made 
within 10 days after the Principal Investigator becomes aware of the event. Any SAE, including 
death, due to any cause (related or unrelated to devices), that may occur during a clinical study 
will be reported immediately (within 1 working day of learning of the event). 
 
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.  
Data for this project will be stored in OCTRI's installation of REDCap, a highly secure and robust 
web-based research data collection and management system. Features of REDCap that protect 
participants' privacy and data security include: 
• Physical Security: OCTRI's REDCap software is housed on servers located in ITG's 
Advanced Computing Center providing locked physical security. 
• Electronic Security: The REDCap servers are housed behind both the OHSU firewall and 
a second ACC firewall.  All transmissions of data from the application are encrypted over 
HTTPS with the industry standard TLS 1.1 protocol (AES 256-bit encryption).  
• Controlled User Access: REDCap is employs a robust multi-level security system that 
enables researchers to easily implement "minimum necessary" data access for their 
research staff, including specification of data fields that are identifiers. This feature 
includes “single click” ability to provide completely deidentified (removing all identified 
data fields and shifting dates) for analysis or other purposes.  User activities are logged to 
enable auditing of all data access.   Access is integrated with OHSU's network such that 
users who are also OHSU employees are authenticated against their OHSU network 
credentials.   
• Data Integrity: REDCap is jointly managed in accordance with OHSU Information 
Security Directives by ACC staff and members of OCTRI's Biomedical Informatics 
Program, ensuring fidelity of database configuration and back-ups.  User activities are 
logged to enable auditing of all data changes. 
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.   
 
 

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Appendix A: Physical Activity Readiness Questionnaire 
 
 
 

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Appendix B: Devices 
 
Apple Watch 
 
 
Dexcom G6 Continuous Glucose Monitoring System which includes Sensor and Sensor 
Transmitter 
 
       
 
 
iPhone Smart phone  
 
 
 
 
 

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Contour Next Blood Glucose Meter 
 
 
 
 
  
 
   
 
InPen Smart Insulin Pen 
 
 
 
Clipsulin Smart Insulin Pen 
 
 
 
 
 
 
 

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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) 

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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) 

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Appendix D: Confidence in Diabetes Self-Care Scale  
 
 
I believe I can…       
Strongly 
disagree 
Disagree Neither 
agree nor 
disagree 
Agree 
Strongly 
agree 
Plan my meals and snacks according to 
dietary guidelines. 
1 
2 
3 
4 
5 
check my blood glucose at least two 
times a day. 
1 
2 
3 
4 
5 
Perform the prescribed number of daily 
insulin injections. 
1 
2 
3 
4 
5 
Adjust my insulin for exercise, 
traveling, or celebrations. 
1 
2 
3 
4 
5 
Adjust my insulin when I am sick. 
1 
2 
3 
4 
5 
Detect high levels of blood glucose in 
time to correct. 
1 
2 
3 
4 
5 
Detect low levels of blood gluose in 
time to correct. 
1 
2 
3 
4 
5 
Treat a high blood glucose correctly. 
1 
2 
3 
4 
5 
Treat a low blood glucose correctly.  
1 
2 
3 
4 
5 
Keep daily records of my blood glucose. 
1 
2 
3 
4 
5 
Decide when it’s necessary to contact 
my doctor or diabetes educator. 
1 
2 
3 
4 
5 
Ask my doctor questions about my 
treatment plan. 
1 
2 
3 
4 
5 
Keep my blood glucose in the normal 
range when under stress. 
1 
2 
3 
4 
5 
Check my feet for sores or blisters every 
day. 
1 
2 
3 
4 
5 
Ask my friends or relatives for help 
with my diabetes. 
1 
2 
3 
4 
5 
Inform colleagues/others of my 
diabetes, if needed. 
1 
2 
3 
4 
5 
Keep my medical appointments. 
1 
2 
3 
4 
5 
Exercise two to three times weekly. 
1 
2 
3 
4 
5 
Figure out what foods to eat when 
dining out. 
1 
2 
3 
4 
5 
Read and hear about diabetes 
complications without getting 
discourgaged.  
1 
2 
3 
4 
5 
 

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Appendix E: Diabetes Distress Scale  
 
Directions: Living with diabetes can sometimes be tough. There may be many problems and 
hassles concerning diabetes and they can vary greatly in severity. Problems may range from 
minor hassles to major life difficulties.  Listed below are 17 potential problem areas that people 
with diabetes experience. Consider the degree to which each of the 17 items may have distressed 
or bothered you DURING THE PAST MONTH and circle the appropriate number. 
 
Please note that we are asking you to indicate the degree to which each item may be bothering 
you in your life, NOT whether the item is merely true for you.  If you feel that a particular item 
is not a bother or a problem for you, you would circle “1”.  If it is very bothersome to you, you 
might circle a “6”.  
 
I am…… 
Not a 
problem 
A slight 
problem 
A 
moderate 
problem 
Somewhat 
serious 
problem 
A 
serious 
problem 
A very 
serious 
problem 
1. Feeling that diabetes is taking 
up too much of my mental and 
physical energy every day. 
1 
2 
3 
4 
5 
6 
2. Feeling that my doctor doesn’t 
know enough about diabetes and 
diabetes care. 
1 
2 
3 
4 
5 
6 
3. Feeling angry, scared and/or 
depressed when I think about 
living with diabetes. 
1 
2 
3 
4 
5 
6 
4. Feeling that my doctor doesn’t 
give me clear enough directions 
on how to manage my diabetes. 
1 
2 
3 
4 
5 
6 
5. Feeling that I am not testing 
my blood sugars frequently 
enough. 
1 
2 
3 
4 
5 
6 
6. Feeling that I am often failing 
with my diabetes regimen. 
1 
2 
3 
4 
5 
6 
7. Feeling that friends or family 
are not supportive enough of my 
self care efforts (e.g. planning 
activities that conflict with my 
schedule, encouraging me to eat 
the “wrong foods”). 
1 
2 
3 
4 
5 
6 

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8. Feeling that diabetes controls 
my life. 
1 
2 
3 
4 
5 
6 
9. Feeling that my doctor doesn’t 
take my concerns seriously 
enough. 
1 
2 
3 
4 
5 
6 
10. Not feeling confident in my 
day-to-day ability to manage 
diabetes. 
1 
2 
3 
4 
5 
6 
11. Feeling that I will end up with 
serious long-term complications, 
no matter what I do. 
1 
2 
3 
4 
5 
6 
12. Feeling that I am not sticking 
closely enough to a good meal 
plan. 
1 
2 
3 
4 
5 
6 
13. Feeling that friends or family 
don’t appreciate how difficult 
living with diabetes can be. 
1 
2 
3 
4 
5 
6 
14. Feeling overwhelmed by the 
demands of living with diabetes. 
1 
2 
3 
4 
5 
6 
15. Feeling that I don’t have a 
doctor who I can see regularly 
about my diabetes. 
1 
2 
3 
4 
5 
6 
16. Not feeling motivated to keep 
up my diabetes self-management. 
1 
2 
3 
4 
5 
6 
17. Feeling that friends or family 
don’t give me the emotional 
support that I would like. 
1 
2 
3 
4 
5 
6 
 
 
 
 
 
 
 
 
 
 

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Appendix F: Hypoglycemia Fear Survey  
Participants will be instructed to circle one of the numbers to the right that best describes the last 
8 weeks.  
 
 
 
 
 
 
 

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Appendix G: Hypoglycemia Confidence Scale  
 
 
Not 
confident 
at all 
A little 
confident 
Moderately 
confident 
Very 
confident 
How confident are you that you can stay safe 
from serious problems with hypoglycemia 
when you are exercising? 
1 
2 
3 
4 
How confident are you that you can stay safe 
from serious problems with hypoglycemia 
when you are sleeping? 
1 
2 
3 
4 
How confident are you that you can stay safe 
from serious problems with hypoglycemia 
when you are driving? 
1 
2 
3 
4 
How confident are you that you can stay safe 
from serious problems with hypoglycemia 
when you are in social situations? 
1 
2 
3 
4 
How confident are you that you can stay safe 
from serious problems with hypoglycemia 
when you are alone? 
1 
2 
3 
4 
In general, how confident are you that you 
can: avoid serious problems due to 
hypoglycemia? 
1 
2 
3 
4 
In general, how confident are you that you 
can: catch and respond to hypoglycemia 
before your blood sugars get too low? 
1 
2 
3 
4 
In general, how confident are you that you 
can: continue to do the things you really want 
to do in your life, despite the risks of 
hypoglycemia? 
1 
2 
3 
4 
What is your best guess about how confident 
your spouse or partner feels about your 
ability to avoid serious problems due to 
hypoglycemia? 
1 
2 
3 
4 
 
 
 
 
 
 
 
 
 
 

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Appendix H: Insulin Delivery Satisfaction Survey  
 
My insulin delivery system… 
Strongly 
disagree 
Disagree Neither 
agree nor 
disagree 
Agree 
Strongly 
agree 
Helps me to feel more in control of my 
diabetes. 
1 
2 
3 
4 
5 
Works well when I need it. 
1 
2 
3 
4 
5 
Doesn’t really benefit me much.  
1 
2 
3 
4 
5 
Helps me feel more positive about the 
future.  
1 
2 
3 
4 
5 
Helps me keep my blood glucose levels 
stable.  
1 
2 
3 
4 
5 
Helps me to have good blood glucose 
control. 
1 
2 
3 
4 
5 
Is too complicated. 
1 
2 
3 
4 
5 
Is too much of a hassle to use.  
1 
2 
3 
4 
5 
Has too many pieces and parts to 
manage. 
1 
2 
3 
4 
5 
Takes too much time to use.  
1 
2 
3 
4 
5 
Is too expensive.  
1 
2 
3 
4 
5 
Is often embarrassing to use when I am 
in public.  
1 
2 
3 
4 
5 
Makes it difficult to be as spontaneous 
as I’d like to be.  
1 
2 
3 
4 
5 
Is inconvenient to use when I am away 
from home.  
1 
2 
3 
4 
5 
Is a hassle to carry around.  
1 
2 
3 
4 
5 
Helps me to avoid missing or forgetting 
doses.  
1 
2 
3 
4 
5 
Helps me to be more spontaneous in my 
life.  
1 
2 
3 
4 
5 
Helps me feel less restricted by 
diabetes.  
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 

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Appendix I: System Usability Scale  
 
 
Strongly 
disagree 
Disagree Neither 
agree nor 
disagree 
Agree 
Strongly 
agree 
I think I would like to use this product 
frequently. 
1 
2 
3 
4 
5 
I found the product unnecessarily 
complex.  
1 
2 
3 
4 
5 
I thought the product was easy to use.  
1 
2 
3 
4 
5 
I think I would need the support of a 
technical person to be able to use this 
product.  
1 
2 
3 
4 
5 
I found the various functions in the 
product were well integrated.  
1 
2 
3 
4 
5 
I thought there was too much 
inconsistency in this product.  
1 
2 
3 
4 
5 
I imagine that most people would learn 
to use this product very quickly.  
1 
2 
3 
4 
5 
I found the product very awkward to 
use.  
1 
2 
3 
4 
5 
I felt very confident using the product.  
1 
2 
3 
4 
5 
I needed to learn a lot of things before I 
could get going with this product.  
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix J: Global Physical Activity Questionnaire 
 

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References 
 
 
 
[1] 
G. Aleppo et al., "REPLACE-BG: A Randomized Trial Comparing Continuous Glucose 
Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-
Controlled Type 1 Diabetes," Diabetes Care, vol. 40, no. 4, pp. 538-545, Apr 2017, 
doi: 10.2337/dc16-2482. 
[2] 
R. W. Beck et al., "Effect of Continuous Glucose Monitoring on Glycemic Control in 
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