Study to Understand Gaining Access to Blood Glucose Records (SUGAR), A Randomized Controlled Trial of the Effect of the Livongo Health Diabetes Management Program vs. Standard Care on Glycemic Control
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: University of California, San Francisco

Study Protocol 
 
Title: Study to Understand Gaining Access to blood glucose Records (SUGAR), A Randomized Controlled 
Trial of the Eﬀect of the Livongo Health Diabetes Management Program vs. Standard Care on Glycemic 
Control 
 
Brief Title: Study to Understand Gaining Access to Blood Glucose Records (SUGAR) 
 
NCT02956642 
 
Protocol revision approved 5/12/2022 

Study Application (Version 1.19)
1.0
General Information
*Enter the full title of your study:
Eureka #001: Study to Understand Gaining Access to blood glucose Records (SUGAR), A 
Randomized Controlled Trial of the Effect of the Livongo Health Diabetes Management Program 
vs. Standard Care on Glycemic Control
 
 
*Enter the study alias:
Eureka #001: SUGAR
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add departments
2.1 and Specify Research Location:
Is 
Primary? Department Name
UCSF - 
 - M_MED-CORE-CARD
138310
UCSF - 
 - M_PEDS-ENDOCRINOLOGY
136219
 
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
 
Wong, Jenise MD, PhD
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Olgin, Jeffrey E MD, MD 
 Other Investigator
B) Research Support Staff
Maguire, Carol A 
N

 Study Coordinator
Peyser, Noah, PhD 
 UCSF Core Personnel
Rohdin-Bibby, Linnea 
 Study Coordinator
3.3 *Please add a Study Contact
 
Maguire, Carol A 
Olgin, Jeffrey E MD, MD 
Peyser, Noah, PhD 
Rohdin-Bibby, Linnea 
Wong, Jenise MD, PhD 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s)
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 
Initial Screening Questions
Updated June 2017
4.1  
: 
* PROJECT SUMMARY
 
(REQUIRED) Give a brief overview of this project (250 words or less). Tell us 
what this study is about, who is being studied, and what it aims to achieve. If you have an NIH 
  
Abstract, paste it here:  Click on the orange question mark to the right for more detailed instructions.
This is a randomized controlled trial (RCT) exploring the effect of using the Livongo Health 
Diabetes Management Program versus standard blood glucose (BG) monitoring on glycemic 
control, as measured by change in hemoglobin A1c (A1c), in adults with diabetes over the course 
of 6 months.  Secondary outcomes include frequency of BG monitoring, frequency of BG 
measurements outside of the target range, change in diabetes distress, and number of self-
reported emergency room visits or hospitalizations.
 
 
4.2  
: 
* HUD DEVICE (REQUIRED) Does this application involve a 
 (HUD):
Humanitarian Use Device
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
4.3  
: (Click the Help link for definitions and guidance): 
* TYPE OF RESEARCH
 
(REQUIRED)
Biomedical research 

Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is 
mainly social/behavioral but also involves specimen collection or blood draws to look at 
biological measures) 
4.4  
 
* SUBJECT CONTACT:
 
(REQUIRED) Does this study involve 
 contact or interactions with 
ANY
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  
Does your protocol involve any radiation exposure to patients/subjects 
* RADIATION EXPOSURE: 
 from 
 
for 
 purposes (e.g., x-rays, CT-scans, DEXA, CT-guided biopsy, 
EITHER
standard care
 
OR
research
radiation therapy, or nuclear medicine including PET, MUGA or bone scans): (REQUIRED)
  Yes  
  No
4.6  
 
* RISK LEVEL: 
 
(REQUIRED) What is your estimation of the risk level, including all screening 
procedures and study activities 
:
(Help Text updated 9/13)
Minimal risk 
Greater than minimal risk 
4.7  * REVIEW LEVEL: 
 
(REQUIRED) Requested review level (Click on the orange question mark to the 
right for definitions and guidance):
Full Committee 
Expedited 
Exempt 
4.8  
 
* EXPEDITED REVIEW CATEGORIES:
 
(REQUIRED)     If you think this study qualifies for expedited 
 
review, select the 
 that the research falls under: (check all that apply)
regulatory categories
Category 1: A very limited number of studies of approved drugs and devices
Category 2: Blood sampling
Category 3: Noninvasive specimen collection (e.g. buccal swabs, urine, hair and nail clippings, 
etc.)
Category 4: Noninvasive clinical procedures (e.g. physical sensors such as pulse oximeters, 
MRI, EKG, EEG, ultrasound, moderate exercise testing, etc.)
Category 5: Research involving materials (data, documents, records, or specimens) that were 
previously collected for either nonresearch or research purposes
Category 6: Use of recordings (voice, video, digital or image)
Category 7: Low risk behavioral research or research employing survey, interview, oral 
history, focus group, program evaluation, human factors evaluation, or quality assurance 
methodologies
4.11  
 
* CLINICAL TRIAL:
 
(REQUIRED)     Is this a clinical trial? According to The World Health Organization 
    
(WHO) and the International Committee of Medical Journal Editors (ICMJE) a 
is:
 
clinical trial
 
Any research study that prospectively assigns human participants or groups of humans to one 
or more health-related interventions to evaluate the effects on health outcomes.
      ICMJE requires 
 of a clinical trial in a public database (such as ClinicalTrials.gov) 
registration
    
prior to enrollment, for eventual publication of results in member biomedical journals.
Guidance: 
Public Law 110-85 requires that all investigators who perform an 
 must 
applicable clinical trial
        
ensure that the trial is registered on a government web site called 
.
ClinicalTrials.gov
 
The FDA 
   
requires registration for “applicable clinical trials,” defined as follows:

For any trials of drugs and biologics: controlled clinical investigations, other than Phase 1 
investigations, of a product subject to FDA regulation.
For trials of biomedical devices: controlled trials with health outcomes of devices subject to 
FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.
    For additional information on the 
 registration process at UCSF and the definition 
ClinicalTrials.gov
of a clinical trial for purposes of registration, visit the ClinicalTrials.gov section of the UCSF Clinical 
 
  
  
Research Resource HUB.
 Yes  
 No
Clinical Trial Registration
  "NCT" number for this trial:
NCT02956642
If you don't yet have the NCT#, type 'Pending.' 
4.12  
 
* CLINICAL TRIAL PHASE (REQUIRED) Check the applicable phase(s) 
:
(Help Text updated 9/13)
Phase I
Phase II
Phase III
Phase IV
4.13  
: 
* INVESTIGATOR-INITIATED
 
(REQUIRED) Is this an investigator-initiated study:
 Yes  
 No
4.14  SCIENTIFIC REVIEW: If this study has undergone scientific or scholarly review, please indicate 
which entity performed the review (check all that apply):
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final CHR 
approval for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
CTSI Consultation Services
Departmental scientific review
Other:
4.15  
 
* STEM CELLS: (REQUIRED) Does this study involve 
(including iPS cells and adult 
human stem cells 
stem cells), gametes or embryos:
No 
Yes, and requires CHR and GESCR review 
Yes, and requires GESCR review, but NOT CHR review 
4.16    
    
 
* FINANCIAL INTERESTS: (REQUIRED)
Do you or any other responsible personnel (or the spouse, 
registered domestic partner and/or dependent children thereof) have 
 related to 
financial interests
  
this study:  
  Yes  
  No
5.0
 Funding

5.1  
FEDERAL FUNDING: 
* 
(REQUIRED) Is this study currently supported in whole or in part by Federal 
funding, 
, OR has it received 
 Federal funding in the past:
even by a subcontract
ANY
  Yes  
  No
5.2  
Is this project linked in any way to the Department of Defense (DoD): 
* DoD INVOLVEMENT: 
(REQUIRED)
  Yes  
  No
5.3  
 
SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a 
 
Subcontract, please list only the Prime Sponsor:
External Sponsors:
 
 
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution:
Contract 
Type:
Project 
Number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 
Livongo Health Inc 
04 
UCSF 
Contract P0518133  
Sponsor Name:
Livongo Health Inc 
Sponsor Type:
04 
Sponsor Role:
Funding
CFDA Number:
 
Grant/Contract Number:
 
Awardee Institution::
UCSF 
Is Institution the Primary 
Grant Holder:
No 
if No, then who is the Primary 
Grantee?
 
Contract Type:
Contract 
Project Number:
P0518133 
UCSF RAS System Award 
Number ("A" + 6 digits):
 
Grant Number for Studies Not 
Funded thru UCSF:
 
Grant Title:
 
PI Name:
(If PI is not the same as 
identified on the study.)
 
Explain Any Significant 
Discrepancy:
 

If the funding is coming through UCSF and you don't know 
the A or P number,  you can search the eProposal side for 
the contract or grant (this does NOT replace adding the 
sponsor by name above 
 entering the A or P number):
AND
Project Status
Proposal Number
Project Title
Principal 
Investigator
No Projects are Linked to this IRB Study
Other Funding Sources and Unfunded Research - 
Gift, Program, or Internal Funding (check all that 
apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project
6.0
 Sites, Programs, Resources, and External IRB Review
6.1  
 
 (check all that apply):
UCSF AND AFFILIATED SITES
UCSF (including Laurel Heights and all the other sites outside the main hospitals)
Parnassus
Mission Bay
China Basin
Mount Zion
Helen Diller Family Comprehensive Cancer Center
Langley Porter Psychiatric Institute
San Francisco General Hospital (SFGH)
SF VA Medical Center (SF VAMC)
Blood Centers of the Pacific (BCP)
Blood Systems Research Institute (BSRI)
Fresno Community Medical Center
Gallo
Gladstone
Jewish Home
Institute on Aging (IOA)
SF Dept of Public Health (DPH)
6.2  
At what locations will study visits and activities occur:
LOCATIONS: 
This is a remote and mobile-based study. Due to the nature of this study, there is the potential 
that participants from all over the United States may be recruited.
6.3  
Will any study procedures or tests be conducted off-site by non-UCSF 
OFF-SITE PROCEDURES: 
personnel:
 Yes  
 No
Please identify which procedures may be done off-site:

Participants will either be directed to a nearby Quest Labs to get their hemoglobin A1c and lipid 
panel labs done, OR be sent a mail-in lab test kit (Home Access Health Corporations) for them to 
provide a blood sample at home. If participants choose to use the Home Access mail-in lab kit 
rather than visit a lab, their sample will be shipped (using the shipping materials provided) to the 
Home Access centralized lab for testing and determination of hemoglobin A1c and lipid panel 
levels.
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
6.5  * CTSI CRS SERVICES: (REQUIRED) Will this study be carried out at one of the UCSF Clinical Research 
 units or utilize 
:
Services (CRS)
CRS services
  Yes  
  No
6.6  * MULTI-CENTER TRIAL:
 
 (REQUIRED) Is this a multicenter research trial? By multi-center trial, we 
mean a study where the protocol is developed by an industry sponsor, consortium, a disease-group, 
etc., who then selects sites across the nation or in different countries to participate in the trial. The 
local sites do not have any control over the design of the protocol. 
  Yes  
  No
6.7  
Check all the other types of sites not affiliated with UCSF with which you are 
OTHER SITE TYPES: 
cooperating or collaborating on this project:   Do NOT check any boxes below if this is a 
multi-center clinical trial, UCSF is just one of the sites, and neither UCSF nor its 
affiliates are the coordinating center.
Other UC Campus
Other institution
Other community-based site
Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)
6.10  
Does this application include a request to rely on an a central IRB 
* 
: 
RELYING ON AN EXTERNAL IRB
(other than the NCI CIRB) or an external IRB (UC, commercial, or institutional): 
 
(REQUIRED)  
  Yes  
  No
7.0
 Research Plan and Procedures
7.1  This new consolidated section requests information about:
Hypothesis
Aims
Study Design

Background and Significance
Preliminary Studies
Procedures
Statistical Methods
References
Later sections include:
Drugs and Devices
Sample Size, Eligibility, and Subjects
Recruitment and Consent
Risks and Benefits
Data and Safety Monitoring Plan
Confidentiality, Privacy and Security
Financial Considerations
Qualifications of Personnel
Other Approval and Registrations
7.2  
Describe the hypothesis or what the study hopes to prove 
:
HYPOTHESIS: 
(Help Text updated 9/13)
We hypothesize that use of the Livongo Health system results in a greater improvement in hemoglobin 
A1c (A1c) compared to standard blood glucose (BG) monitoring, measured by the iHealth Bluetooth-
enabled glucose meter.
7.3  
List the specific aims:
AIMS: 
To determine the effect of use of the Livongo Health system versus standard BG monitoring in adults 
with type 2 diabetes on glycemic control as measured by A1c.  As a secondary outcome, we will 
determine the effect of use of the Livongo Health system on fasting lipid panels.
7.4  
Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
DESIGN: 
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.):  
The study is a two-arm randomized controlled trial (RCT). Participants will either be randomized to 
receive the Livongo Health system or the iHealth glucose meter for measuring their blood glucose.
7.5  
 Briefly provide the background and significance of this study (e.g. 
BACKGROUND AND SIGNIFICANCE:
 
why is this study needed) (space limit: one half page):
The goal of Livongo Health (
) is to help people with diabetes and other 
http://www.livongo.com/
chronic conditions better manage their health by using a combination of patented technology, smart 
analytics, and a coaching team. For the purposes of this study, Livongo will provide a comprehensive 
diabetes care solution that involves unlimited test strips, real-time glucose monitoring with real-time 
feedback and support of coaches. We will compare this comprehensive system with current standard 
blood glucose (BG) monitoring with the iHealth Bluetooth glucose meter and standard diabetes care.
 
The core components of Livongo Diabetes include (1) a cellular connected Livongo glucose meter that 
measures blood glucose and centrally stores the glucose data in a secure cloud, (2) an unlimited 
supply of glucose test strips mailed to a member’s home, and (3) access to a diabetes coaching team 
for questions, goal setting and support for extreme glucose excursions.
 
The Livongo glucose meter captures biometric data including blood glucose data, medication usage 
and other information.  The data is instantly analyzed in Livongo Health’s intelligent cloud.  Immediate 
personalized education and support is returned directly through the meter.  Livongo Health’s Certified 
Diabetes Educators (CDEs) are on-call to provide further support and education when requested by 
member or automatically when a member is in their high and low zones.  Using the clinically-proven 
AADE7 Self-Care Behaviors, a member’s coaching experience is customized based on the member’s 
health information and biometric data.
 

Many research studies have shown a positive impact of health coaching, lifestyle interventions, and structured 
blood glucose monitoring plans on diabetes outcomes. The comprehensive Livongo diabetes program is poised to 
meet the individual needs of its members with diabetes based on member-reported health information and 
biometric data.  Using data and technology to create a personalized approach, the coaching team receives 
immediate feedback on whether outreach efforts make a difference in member behavior and blood glucose 
control.    We hypothesize that this novel coaching feedback system will lead to improved blood glucose control 
compared to the current standard of diabetes care.
 
This pilot study will utilize the National Institutes of Health-funded Eureka mHealth Research Platform (CHR 
#16-19397), a platform that enables investigators to conduct mobile and wireless health research in a less costly, 
more streamlined manner, in order to recruit participants, collect and store study data, and manage study 
participants.  The research platform will accelerate our ability to access a large cohort of volunteers who have 
agreed to participate in research (over 40,000 participants worldwide), and provide a quick, affordable means for 
collecting their health data through mobile and wireless technologies.   Access to this unique, diverse, real-world 
study population will allow us to generalize our study results compared to those we might obtain working 
through a highly specialized diabetes center.
7.6  
Briefly summarize any preliminary studies relevant to your proposed 
PRELIMINARY STUDIES: 
research 
:
(space limit: one half page)
Review of data from 4,544 individuals with diabetes who were enrolled in the Livongo program from 
October 2014 through December 2015 shows that members used the Livongo glucose meter to 
measure their blood glucose levels an average of 2 times per day. Using an individual fixed-effects 
logit model to look at the relative change in the odds of having at least one daily high blood glucose 
reading (defined as BG >180 mg/dL) or one daily low blood glucose reading (defined as < 80 mg/dL) in 
subsequent months two through twelve compared with month one as the baseline, there was a 
statistically significant and sustained reduction in the likelihood of having a day with a blood glucose 
reading >180 mg/dL at all subsequent months compared to baseline.  There was a sustained reduction 
in the likelihood of having a day with a blood glucose reading < 80 mg/dL at all subsequent months 
compared to baseline.  For members enrolled in the Livongo Diabetes program, the likelihood of 
BG>180 or BG< 80 is decreased in Months 2-12 compared to Month 1 of the program.
 
In addition, econometric difference-in-difference modeling of lab data provided by a large self-
insured employer client suggests that Livongo members experience improvements not only in 
HbA1c but also in lipid levels.  Total cholesterol tests show the strongest effect. Pre-Livongo users 
and non-users have similar values but towards the end of the one-year intervention period, 
Livongo users have substantially lower values. The regression results show a 37.2% (p=0.04) 
reduction which translates into a 64.0-point reduction in cholesterol values.  Triglycerides also 
trended downwards by 8.3% (p=0.80) reduction in test values over one year. This translates to a 
10.0-point reduction in cholesterol values.
7.7  
Is this a treatment study, i.e. does this study intend to provide treatment 
* TREATMENT PROTOCOL: 
to individuals with a medical or psychological condition: (REQUIRED) 
  Yes  
  No
7.8  
Types of research activities that will be carried out. Check all that 
 COMMON RESEARCH ACTIVITIES: 
*
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Observation
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Administration of contrast agent
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-
guided biopsies, DEXA scans, MUGA or PET scan)
Biopsy conducted solely for research purposes
Use of placebo
Sham surgical procedure

Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs, 
etc.)
Fitness tests or other exertion activities
Use of mobile health apps or other apps
Social media-based research activities
None of the above
7.9  
PROCEDURES / METHODS: 
* 
(REQUIRED)
Describe the research methods and study activities taking place at 
each site (e.g. what will participants be asked to do and what will 
members of the study team do?). If there will be multiple 
participant groups or study sites, explain what will happen with 
each group or study sites.
 
If some of the activities would occur even if the person were not in 
the study, as in the case of treatment or tests performed for 
diagnostic purposes, clearly differentiate between those activities 
that will be done solely for research purposes and those that are 
happening as part of routine care.
 
Please call our office at 415-476-1814 and ask to speak to someone on the 
Expedited Review team if you need help differentiating between what parts 
are research and what parts aren't.
1.     Surveys and Measurements
All study participants may complete surveys via their personal iOS smartphone device on: 
study qualification (intake survey/eligibility screener discussed further in Section 10.3), diabetes 
status (initial diabetes survey), physical activity (iPAQ), quality of life (SF-12), vitals (attached), 
demographics (attached) hospitalizations and interaction with health care provider (attached), 
and diabetes distress (attached). Most survey data will be collected at 1, 3, and 6 months. 
There will also be Weekly Engagment surveys (attached) which will be two simple questions 
each week. At the end of the study, a Feedback survey (attached) will ask participants about 
their study experiences.  Surveys will each have a simple description to introduce participants 
to the survey they are being asked to take (document attached). These surveys will be 
administered through the Eureka  mHealth Research Platform, the study's main tool for data 
collection, data storage, and study management. Specific usability assessments that are native 
to the Livongo or iHealth platform may also be shown through the device to the participants in 
order to gather user feedback information.
After qualifying and providing consent to participate in the study, participants will be referred to 
a convenient lab for establishing hemoglobin A1c (A1c) levels and lipid panel levels. A1c labs 
will be collected at months 1 (baseline), 3, and 6 (closeout). For each A1c lab, 1mL of blood will 
be drawn. Lipid panels (total cholesterol, LDL, HDL, and triglycerides) will be collected at 
months 1 (baseline) and 6 (closeout). For each lipid panel lab, 1mL of blood will be drawn.
As an alternative to visiting a lab, participants will have the option of using a Home Access 
Health Co. Mail-in Laboratory Test Kit to collect a sample for establishing A1c and lipid pabel 
levels. Just as if they were to visit a local lab, these samples will be collected at months 1 
(baseline), 3, and 6 (closeout). At months 1 and 6, participants will use a professional use 
finger prick blood collection kit to collect 75 microliters of blood. The Mail-in Lab Test is coded 
for A1c and complete lipid panel testing. This professional use kit requires a requisition for the 
participant, which will be provided by Home Access physicians. At month 3, participants will 
use an FDA approved direct-to-consumer A1c kit to collect 35 microliters of blood for A1c levels 
only. No physician authorization is required for this kit. When time for each blood draw at 
months 1, 3, and 6, participants will be sent the appropriate kit that will include everything 

necessary for successful collection, packaging, and mailing of specimen, including a cover 
letter from the SUGAR Study Team (attached). All samples will be mailed to the Home Access 
Health laboratory for testing. 
Participants are strongly encouraged to be consistent with whichever method they choose. This 
means that if their first blood draw occurs at a Quest Labs, we would like them to complete 
their second and third blood draws at a Quest Labs as well. If they choose to use a home kit for 
their first blood draw, we would like them to use a home kit for their second and third blood 
draws if possible. 
If a participant wishes to obtain a copy of the lab results, they may email the study 
coordinator to request a copy at sugar@eurekaplatform.org. Their results will be 
sent through the study coordinator's UCSF email securely with "ePHI:" or "Secure:" 
in the subject field. We have indicated in the consent form how a participant may 
retrieve their lab results and have also included the statement that we do not 
provide a clinical interpretation of their data from the study or provide medical advice. Add
 
itionally, we have included language indicating participation in this study does not in any 
way substitute for professional medical advice, diagnosis, or treatment that their doctor or 
other healthcare provider may give them. If they think they may have a medical 
emergency, they are recommended to call their doctor or notify emergency services.
2.     Randomization
Once the baseline A1c value is obtained, the patient will be randomized (block randomization 
by diabetes type).
3.     Device Usage
After randomization, participants will receive either the Livongo Health system or the iHealth 
glucose meter by mail.
If a participant is randomized to the iHealth treatment group, participants 
will download the iHealth iOS application (iHealth Gluco-Smart) and receive 
an iHealth blood glucose meter in the mail. Participants will link the iHealth 
application with a mobile version of the Eureka mHealth Research Platform.
If a participant is randomized to the Livongo system treatment group, the 
participant will receive the Livongo blood glucose meter device in the mail, 
create a Livongo account, and link their Livongo account with the Eureka 
mHealth Research Platform.
Livongo- or iHealth-specific instructions will be provided with each meter and a study 
coordinator will be available to answer study participant questions about using the BG 
meters.  Participants may be referred to Livongo or iHealth customer service for technical 
support, if needed.
Participants will not be given specific instructions on how often to check their BG, or how often 
they should use the Livongo system or iHealth glucose meter as a part of this study.  This is 
done in order to determine the uptake of the intervention and resulting behavior without outside 
prompting.
Participants will either use the Livongo system or the iHealth glucose meter for 6 months from 
the time of enrollment in the study.
4.     Messaging/Reminders
Participants who have been mailed a BG meter but are not using the device after two weeks 
will be contacted by in-app push notifications, text messages, email or a phone call for device 
setup and/or assistance.
Particpants will also recieve reminders to complete study activities via in-app push notifications, 
text messages, email or a phone call.
Two weeks prior to the end of the study period, participants will be contacted by email and/or 
receive in-app push notifications to remind them to complete their A1c measurement and 
closeout surveys.
 
Participation in this research study will not affect individual participants' standard clinical care for 
Note: 
diabetes. Participants will remain under the care of their current health care provider and will be able to 
continute receiving all usual care from that provider. The health care provider will continue to provide 
recommendations for the number of times the participant shoudl check their blood glucose. Although 
the participant wil be asked to use a different glucose meter for this study, the number of times they 

use it will still be determined by their health care provider. The same information that they received 
from their existing glucose meter will be available from the study glucose meter. During the study, they 
will be provided with glucose meter strips at no charge, to ensure that an insufficient number of strips 
will not interfere with their standard of care.
7.11  
List all questionnaires, surveys, interview, or focus group guides that will be used for 
INSTRUMENTS: 
this study:
If the instruments are not complete or not available because they 
will be developed as part of this study, describe the basic content or 
include an outline and submit the final versions to the IRB with a 
modification for approval prior to use.
Survey instruments:
Intake Survey + General Diabetes Status
Basic Demographics
Social Demographics
Internet Use
Diabetes Distress
Physical Activity (IPAQ)
Quality of Life (SF-12)
Hospital Visit and Health Care Provider
Diabetes Empowerment
Attach any unpublished instruments in the 'Other Study Documents' 
section of the Initial Review Submission Packet form after 
completing the study application. Published instruments should 
NOT be attached.
7.12  
Are you drawing any blood or collecting other biosamples (e.g. tissue, 
* BIOSPECIMEN COLLECTION: 
buccal swabs, urine, saliva, hair, etc.): (REQUIRED)
 Yes  
 No
Could this study generate genetic data that may be broadly shared (e.g., submitted to 
* 
NIH in compliance with Genomic Data Sharing (GDS)/Genome-Wide Association 
 requirements): 
Studies (GWAS)
(REQUIRED)
  Yes  
  No
Based on current research trends, we strongly recommend 
 
including the genomic data sharing language in the consent form to 
allow future sharing, even if you don't anticipate it now. It's easier 
than trying to reconsent all the specimen donors!
7.13  
(check all that apply): 
TYPE OF SPECIMENS 
* 
(REQUIRED) 
Blood
Tissue (describe below):
Existing/archival materials (name source below): --
Other (describe below):
7.14  
(check all that apply): 
SPECIMENS ARE: 
* 
(REQUIRED)

Leftover specimens from a clinical diagnostic or therapeutic procedure
Specimens collected for research purposes only (including extra samples taken during a 
clinical procedure)
Other
7.15  
Specimens will ultimately be stored (check all that apply): 
 DESTINATION: 
*
(REQUIRED) 
Outside Entity:
Cooperative group bank
NIH
Other university
Industry sponsor
Other
UCSF:
UCSF repository/bank being established under this protocol
Existing UCSF specimen repository/bank with CHR approval
Other location at UCSF (please describe)
Provide the name of the bank and iRIS approval number (if not being 
banked at UCSF under this protocol). If you checked 'Other,' please provide 
the location or lab:
The blood samples we draw (through Quest Labs or Home Access mail-in kit) will be used for 
analysis of the participant's blood sugar levels. The study does not intend to store or bank any of 
the samples after analysis. The participants will be sent their requisition in a secure email or 
through a secure download link to bring with them to the lab if they miss their selected date.
7.18  
 
: Will any specimens or portions of specimens be retained after the study is 
* FUTURE SPECIMEN USE
over for possible use in future research studies: (REQUIRED) 
  Yes  
  No
7.20  
Will clinical follow-up data be linked to specimens (i.e., will medical 
CLINICAL FOLLOW-UP DATA: 
* 
record information continue to be abstracted after the specimen is collected): (REQUIRED) 
  Yes  
  No
Provide duration of follow-up or 'indefinitely':
7.25  
Briefly summarize the methods and types of analyses that will be 
STATISTICAL METHODS: 
performed:
Descriptive statistics (t-tests for continuous variables and chi-squared tests for dichotomous 
variables) will be used to compare demographic, clinical, and socioeconomic variables.  The 
primary outcome measure is change in A1c. Data will be analyzed as a comparison between 
experimental and control groups. Data may also be stratified by duration of diabetes and baseline 
HbA1c (< 7.0% vs 7.0).  Methods for analyzing longitudinal data (mixed-effects linear regression 
models or generalized estimating equations) will be used to look for the effect of using Livongo on 
change in A1c, adjusting for possible confounding variables.  Similar models will be used to 
examine secondary outcomes.

7.26  
(a separate bibliography can be attached 
REFERENCES: List only the 5-10 most relevant references 
for reference purposes if this study involves novel approaches, agents, or an emerging technology 
that the IRB may not be familiar with):
1.        Thom DH, Willard-Grace R, Hessler D, et al. The impact of health coaching on medication 
adherence in patients with poorly controlled diabetes, hypertension, and/or hyperlipidemia: a 
randomized controlled trial. J Am Board Fam Med 2015;28(1):38–45.
2.        Cinar AB, Oktay I, Schou L. “Smile healthy to your diabetes”: health coaching-based 
intervention for oral health and diabetes management. Clin Oral Investig 2014;18(7):1793–801.
3.        Huang X-L, Pan J-H, Chen D, Chen J, Chen F, Hu T-T. Efficacy of lifestyle interventions in 
patients with type 2 diabetes: A systematic review and meta-analysis. European Journal of 
Internal Medicine 2016;27(C):37–47.
4.        Hesselink A. Effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes.
5.        The Look AHEAD Research Group. Eight-year weight losses with an intensive lifestyle 
intervention: The look AHEAD study. Obesity 2014;22(1):5–13.
6.        Allemann S, Houriet C, Diem P, Stettler C. Self-monitoring of blood glucose in non-insulin 
treated patients with type 2 diabetes: a systematic review and meta-analysis. Curr Med Res 
Opin 2009;25(12):2903–13.
7.        Schnell O, Alawi H, Battelino T, et al. Addressing Schemes of Self-Monitoring of Blood Glucose 
in Type 2 Diabetes: A European Perspective and Expert Recommendation. Diabetes 
Technology & Therapeutics 2011;13(9):959–65.
8.        Self-Monitoring of Blood Glucose in Type 2 Diabetes: Recent Studies. 2013;:1–11.
9.        Robertson E. Barriers and Behaviors in Blood Glucose Monitoring. 2008;:1–3.
10.      AADE7TM Self-Care Behaviors. The Diabetes Educator 2008;34(3):445–9.
11.      Kollmann A, Riedl M, Kastner P, Schreier G, Ludvik B. Feasibility of a Mobile Phone–Based 
Data Service for Functional Insulin Treatment of Type 1 Diabetes Mellitus Patients. Journal of 
Medical Internet Research 2007;9(5):e36.
12.      Lanzola G, Capozzi D, D'Annunzio G, Ferrari P, Bellazzi R, Larizza C. Going Mobile with a 
Multiaccess Service for the Management of Diabetic Patients. J Diabetes Sci Technol 2007;1
(5):730–7.
13.       Toscos TR, Ponder SW, Anderson BJ, et al. Integrating an Automated Diabetes Management 
System into the family management of children with type 1 diabetes: results from a 12-month 
randomized controlled technology trial. Diabetes Care 2012;35(3):498–502.
8.0
 Drugs and Devices
8.1  
Are you 
 any drugs and/or biologics that are either 
* DRUGS AND/OR BIOLOGICS: 
STUDYING
approved or unapproved: (REQUIRED)
  Yes  
  No
 
Note: This question is frequently answered incorrectly. If any drugs 
or biologics, approved or unapproved, are being administered under 
this protocol, you should check 'Yes' unless you are 
 sure 
absolutely
that NONE of the drugs are part of the research protocol. Tip: Ask 
the PI or the sponsor if you are not sure how to answer this 
question.

8.3  
: Are you 
 any medical devices, in vitro diagnostics, or assays that are 
* MEDICAL DEVICES
STUDYING
 
either approved or unapproved:(REQUIRED)
 Yes  
 No
8.4     
 Are you requesting a Non-Significant Risk (NSR) determination for an investigational device: 
* NSR:
        
(REQUIRED)
 
Note: an 
 is different from an Investigational Device Exemption 
NSR determination
(IDE). Check the Help link for more guidance on what types of devices can qualify for an NSR 
  
determination.  
  Yes  
  No
8.5  
List the medical devices or in vitro diagnostics to be studied or used. In the device 
LIST THE DEVICES: 
details screen you will be asked questions such as:   
Whether the device is FDA approved or investigational
Medicare device category
If the device will be provided at no cost
If an IDE is necessary, the IDE number, and who holds the IDE
Risk category of the device
FDA status of the device
    Please see the 
 for more details about the use of devices in research, including 
UCSF IRB website
the Investigator Checklist for Significant Risk, Non-Significant Risk, and/or IDE Exempt Device Studies
        
 
 If the sponsor’s protocol does not list the IDE number, you must 
Verification of IDE numbers:
submit documentation from the sponsor or FDA identifying the IDE number for this study. Attach this 
        
documentation in the Other Study Documents section of the Initial Review Submission Packet.
 
  
If you have any correspondence from the FDA or sponsor regarding this device, 
     
  
please attach it to the application.
 
View 
Details
Device Name
Is the Device 
FDA Approved
Is this a new 
device or a new 
use of an already 
approved device
IDE Number
iHealth Wireless Smart 
Gluco-Monitoring System 
Yes 
No 
 
Manufacturer/Supplier of 
Device
iHealth Labs 
Medicare Category
A
B
Where will the Devices Be 
Stored
 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Is the Device FDA Approved
Yes 
Is this a new device or a new 
use of an already approved 
device
No  
Is an IDE necessary
No  
IDE Number
 
Who holds the IDE
N/A  
IDE details
 

In the opinion of the sponsor, 
select the level of risk 
associated with this device
No Significant Risk  
Livongo In Touch Blood 
Glucose Monitoring System 
Yes 
No 
 
Manufacturer/Supplier of 
Device
Livongo 
Medicare Category
A
B
Where will the Devices Be 
Stored
 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Is the Device FDA Approved
Yes 
Is this a new device or a new 
use of an already approved 
device
No  
Is an IDE necessary
No  
IDE Number
 
Who holds the IDE
N/A  
IDE details
 
In the opinion of the sponsor, 
select the level of risk 
associated with this device
No Significant Risk  
8.6  
Is this an expanded access or compassionate use protocol, meaning the primary purpose is to 
* 
diagnose, monitor or treat a patient's condition, rather than the collection of safety and efficacy data 
of the experimental agent: (REQUIRED) 
  Yes  
  No
9.0
 Sample Size and Eligibility Criteria
9.1  
 
How many people will you enroll:
ENROLLMENT TARGET: 
300
 If there are multiple participant groups, indicate how many people will be 
in each group:
Livongo Health system (experimental group) - 150
iHealth glucose meter (control/standard group) - 150
9.3  
Explain how and why the number of people was chosen. For multi-site 
SAMPLE SIZE JUSTIFICATION: 
studies, this is referring to the number that will be enrolled across all sites:
Sample size:
Null Hypothesis: There is no association between use of Livongo and change in A1c.
Alternative Hypothesis: (two-sided): The use of Livongo is associated with change 
in A1c.

Effect size (t-test) = 0.5%
Evidence:
A1c decreased from 7.9% to 7.5% in 3 month study of mobile phone-based 
data service (Kollman, et al., 2007, J Med Internet Res, 9:e36)  
A1c decreased from 8.4% to 7.85% (adults) and 8.52 to 8.06% (children) 
in 6 month study using a multi-access diabetes management service 
(Lanzola, et al., 2007, J Diabetes Sci Technol, 1:730-7)
Difference in change in A1c -0.35 (intervention) vs +0.15 (control) after 12 
months of using an automated diabetes management system (wireless 
glucose transfer) (Toscos, et al., 2012, Diabetes Care, 35:498-502)
Standard deviation = 1% (based on the above publications)
Standardized effect size = E/S = 0.5
Using a two-sided t-test of 0.05 and power of 80%, n=63 
 per group
participants
We anticipate that we will be able to recruit 300 participants (150 in each arm).  Using the above 
parameters, the study would have 80% power to detect a minimum effect size of 0.33% (and 
90% power to detect a minimum effect size of 0.38%).  
 
9.4  
Eligible age ranges: 
* 
 AGE RANGE: 
PARTICIPANT
(REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+
9.5  
 Data will be collected from or about the following types of people (check all 
STUDY POPULATIONS:
* 
 
that apply): (REQUIRED)
Inpatients
Outpatients
Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above
9.6  
Check the populations that may be enrolled: 
SPECIAL SUBJECT GROUPS: 
* 
(REQUIRED)
Children / Minors
Subjects unable to consent for themselves
Subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
If not already addressed in the Background and Significance questions in 
the Research Plan section or elsewhere, explain why it is appropriate to 
include the types of subjects checked above in this particular study:

1.  
2.  
There is a chance that a person who is economically or educationally disadvantaged may have the 
opportunity to join the study as long as they fulfill all of the inclusion criteria and do not meet any 
of the exclusion criteria. It is important to allow these participants to join the SUGAR Study 
because this population, much like others who may participate in the study, may also:
Utilizes smartphone and mobile phone technology in daily life, and
Suffers from diabetes and can benefit from additional diabetes management.
Describe the additional safeguards that have been included in the study to 
protect the rights and welfare of these subjects and minimize coercion or 
undue influence:
Here are some examples:
evaluating capacity to consent for individuals who may be decisionally 
impaired (specify how)
calibrating payment amounts to be non-coercive for the financially 
disadvantaged
conducting more in-depth evaluations of subjects’ understanding of 
the study and the voluntary nature of participation
involving advocates in the consent process
More information and other safeguards are described here: Vulnerable 
 and 
.
Subject Populations
Recruiting Staff and Students
As mentioned in this application, all participants will receive equal treatment, resources 
(depending on their treatment group), and all active and compliant participants will receive 
equal payment (see Section 13) during their participation. Additionally, all participants are able to 
read the consent form before joining the study and are always given the option to opt-out of the 
study after enrolling. During the enrollment and recruitment phase, participants will sign up for 
the study on their own volition and will not be forced or coerced to participate. All study activities 
are completely voluntary.
9.7  
 Briefly describe the population(s) that will be involved in this study. Include 
INCLUSION CRITERIA: 
anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers, providers, 
administrators, students, parents, family members, etc.):
People with type 2 DM on any type of medication
Self-reported A1c level >= 7%
Adults, age ≥18 years
Not using continuous glucose monitoring or an insulin pump
iOS Smartphone with access to data and/or Wi-Fi
9.8  
 List any exclusion criteria (e.g. reasons why someone would not be included in 
EXCLUSION CRITERIA:
the study):
Using continuous glucose monitoring during the study period
People with type 1 DM
Self-reported A1c level < 7%
Using an insulin pump during the study period
Unable or unwilling to switch BG meters to the study meter
Hospitalization for DKA or hypoglycemia in the past 1 month prior to enrollment
Pregnant patients, or intention to become pregnant during the study period
Participants who are currently using, or have every used, the Livongo Health Program
9.9    
Do any study activities take place on patient 
* RESEARCH CONDUCTED ON PATIENT CARE WARDS: 
  
care units at UCSF medical facilities: (REQUIRED)  

  Yes  
  No
10.0
 Recruitment and Consent
10.1  
 
What kinds of methods will be used to identify potential participants for 
* RECRUITMENT METHODS: 
recruitment (check all that apply): (REQUIRED)
Medical records review
Recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials 
you will provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social 
media, presentation of the study at community events/media, etc.)
Online recruiting tool such as TrialSpark
CTSI Recruitment Services unit
Other method (describe below)
Attach your recruitment materials (e.g., flyers, ads, recruitment 
letter templates, email text, etc.) in the Other Study Documents 
section of the Initial Review Submission Packet Form.
10.3  
How, when, and by whom will eligibility for recruitment be 
DETERMINATION OF ELIGIBILITY: 
determined:
Initial eligibility will be determined through a mobile application version of the Eureka mHealth 
Research Platform.
 
Once a participant expresses interest in participating in the SUGAR Study, they will receive a 
study-specific link to download the Eureka mHealth Research Platform application, from the Apple 
App Store, onto their personal iOS device. After downloading the application and creating an 
account with the mobile version of the Eureka mHealth Research Platform (refer to CHR #16-
19397 for more details on registration process), the participant will answer an intake survey that 
will be used to assess initial eligibility. The answers to this screener will be stored in an 
anonymous and de-identified fashion. If the participant meets the eligibility criteria, they will be 
then be presented with the SUGAR Informed Consent (which contains a link to the Eureka 
mHealth Platform Privacy Policy) via the Eureka mHealth Research Platform application. After the 
consenting process, the anonymous eligibility data may be matched up to the consented 
participant.
 
Eligibility may also be determined in accordance to the pre-set criteria after a participant 
completes the initial diabetes status intake survey.
10.4  
Who initiates contact (check all that apply): 
INITIATION OF CONTACT: 
* 
(REQUIRED)
Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
Other (explain below)
10.5  
 (check all that apply): 
HOW IS CONTACT INITIATED:
* 
(REQUIRED)
In person
Phone
Letter / email

Website or app
Other (explain below)
Provide the URL for any website in Recruitment Plan section, or 
attach a mock-up of the website or the app screens in the Other 
Study Documents section of the Initial Review Submission Packet 
Form.
10.6  
Based on the checkboxes you chose above, please provide a narrative 
RECRUITMENT PLAN: 
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?
If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family 
members, providers, etc.), provide details about the recruitment plans for each group. 
(Recommended length - 100-250 words)
Participants may be recruited into the mobile-based study through a few methods:
Targeted ads displayed through social media (Facebook, Twitter, etc)
Targeted ads displayed on diabetes awareness or education websites (American Diabetes 
Association, Diabetes Society, etc)
Participants will initiate interaction with the mobile study on their own accord and volition.
10.7  
How will permission to participate (i.e., informed consent) be obtained from 
CONSENT METHODS: 
* 
each potential participant. If there will be multiple groups and different plans for consenting each, 
  
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
 
Participants will (check all that apply): (REQUIRED)
Sign a consent form at the end of the consent discussion (signed consent)
Provide online 'eConsent' using DocuSign or another E-Signature system
Click through a link in a survey or email after reading about the study and then complete the 
study online (electronic consent)
Be told about the study and be given a handout/information sheet and be asked if they agree 
to participate (verbal consent)
Complete the study activities and turn in materials, as in the case of a completed survey that 
is placed in a drop box or mailed to the study team (implied consent)
Not be able to provide consent and will have a family member consent for them, as in the 
case of a critically ill or unconscious patient (surrogate consent)
Not be able to provide consent (emergency waiver of consent - allowed for minimal risk 
research or greater than minimal risk research with an approved community consultation plan)
Not know about the study, as in the case of chart reviews or observations of public behavior 
(waiver of consent)
Other method (describe below)
10.8  
Describe the process for obtaining informed consent, including details such as 
CONSENT PROCESS: 
* 
who will have the consent discussion and when participants will be asked to sign the consent form in 
relation to finding out about the study: (REQUIRED)        
 
We encourage researchers to review our 
   
.
guidance on obtaining and documenting informed consent
If there are multiple groups being consented differently, provide details about the consent 
process for each group.
If you are relying on 
, provide details about how that will happen.
verbal or implied consent
For studies using online recruitment and consent or consent via mail, provide details here.
Informed consent will be obtained electronically through the mobile-based study workflow. In order to 
ensure that participants are thoroughly informed, we will implement the following series of screens:
 

1. An eligibility screen with the inclusion and/or exclusion criteria; participants can only proceed if they 
are deemed eligible.
2. A summary screen with the most important aspects from the complete informed consent form (ICF).
3. The complete SUGAR ICF; participants are only eligible to consent after they scroll through the 
entire document (buttton won't activate otherwise).
4. At any point in the SUGAR study, participants can contact a SUGAR study coordinator or team 
member to address any questions.
10.10  
Does this study rely on some deception or misinformation about what the 
* DECEPTION: 
researchers are observing to get valid data? (REQUIRED)
  Yes  
  No
10.13  
What is the estimated time commitment for participants (per visit and in total):
TIME: 
Total duration of participation in the study is 6 months from date of submitting their baseline 
hemoglobin A1c lab.  We estimate the following time commitments:
- Consent process: 5 minutes
- Baseline surveys: 12 minutes
- HbA1c and Lipid Panel test: At local lab: 5-10 minutes (plus travel time to the lab) x 3 (baseline, 
month 3, and 6 months/closeout). Using Home Kit: 15 - 20 minutes (no travel time to lab) x 3 (baseline, 
month 3, and 6 months/closeout)
- Use of the Livongo system vs control meter: 5-15 minutes per day
- Follow-up surveys: 15 minutes x 2 (3 months and 6 months)
 
 
IMPORTANT TIP: Ensure this information is consistent with the 
information provided in the consent form.
10.16  
Describe other alternatives to study participation, if any, that are available 
OTHER ALTERNATIVES: 
to prospective subjects:
Participants can choose to not participate or withdraw at any point in the study. 
 
11.0
 Risks and Benefits
11.1  
Check if your study involves any of these specific research-related risks 
RESEARCH-RELATED RISKS: 
to participants that may need to be disclosed in the consent form:
Physical discomforts or pain
Risks to employment, or social or legal standing
Possible personal discomfort due to sensitive topics (stress, embarassment, trauma)
Risk that the study team may observe possible evidence of child abuse, elder abuse, or a 
threat to self or others that they are required to report
For any boxes checked above, describe how you will minimize these risks 
* 
and discomforts, e.g., adding or increasing the frequency 
of monitoring, additional screening to identify and exclude people with 
diminished kidney or liver function, or modification of procedures such as 
changing imaging studies to avoid giving contrast agent to people who are 
more likely to suffer side effects from it, etc.: (REQUIRED)
Included here is a discussion of the possible risks and discomforts associated with participation in 
the SUGAR Study.  With regard to personal discomfort, the study will ask participants to answer 
survey questions, some of which may ask about the participant's behaviors, medical conditions, 
or lifestyle that may be uncomfortable to a patient. 

 
With regard to physical discomfort and pain, the study asks participants to take daily glucose 
meter readings, which includes a finger prick, in addition to hemoglobin A1c and lipid panel 
measurements, which involves a puncture in order to collect the blood sample.
 
Overall, the aforementioned could cause discomfort to participants, but these study activities 
pose relatively minimal risk.  The study team ensures each participant is aware of the possible 
risks before agreeing to take part in the SUGAR Study.
11.2  
Describe any anticipated risks and discomforts not listed above:
RISKS: 
Participants may experience discomfort from the blood draws, or during blood sample collection 
using a home kit, required for the study. There may also be financial risks such as wanting 
increased access to the healthcare system or incurring extra data charges due to increased 
interaction with the smartphone and increased cellular data usage.
 
Taking part in the SUGAR study requires us to email each participant their own blood draw order 
document to present to the lab technician. This email will be unencrypted. The emailed blood 
draw order, or requisition, contains the participant's name, date of birth, and the lab tests 
ordered for the study. The email will be sent without the "Secure:" function to reduce the burden 
on participants of creating a secure account with Cisco Web Services. This risk is clearly outlined 
in the consent form to ensure all participants are aware of the risk of receiving an unsecured 
email. If the participant does not wish to receive an unsecured email with PHI of name and birth 
date, then the participant may opt to not participate or withdraw from the study. We have spoken 
to the UCSF Privacy Office and they have approved of this process and of our consent language.
 
Additionally, as with any form of online activity, there may be a small risk of loss of privacy. For 
more information regarding this risk, please refer to UCSF IRB-approved study, Eureka mHealth 
Research Platform (#16-19397) as well as the Eureka Privacy Policy and Data Security Measures 
document (uploaded to "Other Study Documents" of this application).
 
 
11.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to 
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the 
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the 
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation
All data from this study will be stored on the Eureka mHealth Research Platform. Please see their 
Privacy Policy and Data Security Measures for details on how the platform protects privacy and 
ensures data security. The SUGAR informed consent form (ICF) will make sure that the 
participants are aware that the study will not be responsible for medical or data charges outside 
of what is specified in the study.
11.5  
BENEFITS: 
* 
(REQUIRED) Note: These are the benefits that the IRB will consider during their review. 
They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at 
large (check all that apply):
Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility, 
etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or 

alleviation of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
11.6  
Explain why the risks to subjects are reasonable in relation to anticipated 
RISK TO BENEFIT RATIO: 
benefits, if any, to the participant or society:
The prevalences of mobile health devices and smartphone usage are increasing in our society 
today.  We hope that the research data from this study using these platforms can one day help 
society towards better understanding, predicting, prevention, and monitoring of diabetes.
11.7  
Do you have a Data and Safety Monitoring Plan (DSMP) for this 
DATA AND SAFETY MONITORING: 
* 
study (
): (Click the Help link for guidance 
A DSMP is 
 for Greater than Minimal Risk research
required
 
on risk determination) (REQUIRED)
  Yes  
  No
This is not required for minimal risk research but the UCSF IRB strongly recommends 
one to ensure the data collected are adequate to meet the research aims:
12.0
 Confidentiality, Privacy, and Data Security
12.1  
Indicate how subject privacy will be protected:
PROTECTING PRIVACY: 
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be 
called, can messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added 
to their medical records or shared with others without the subject’s permission
Other methods (describe below)
Describe the other methods for protecting privacy:
The SUGAR Study will rely on the Eureka mHealth Research Platform Confidentiality, Privacy, and 
Data Security measures outlined in their CHR application (#16-19397).
 
This application also includes a copy of the Eureka mHealth Research Platform Privacy Policy and 
Data Security Measures document which explains, in depth, the ways in which Eureka will protect 
the privacy and data for the SUGAR Study. Additionally, any personnel involved in this project will 
have completed UCSF HIPAA Training and will store collected data according to standards. All of 
the electronic records will be stored under password protection and on a secure network.
12.2  
Do any of the instruments ask about illegal or stigmatized behavior:
SENSITIVE DATA: 
  Yes  
  No
12.3  
Could a breach of privacy or 
CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: 
confidentiality  result in any significant consequences to participants, such as criminal or civil 
liability, loss of state or federal benefits, or be damaging to the participant's financial standing, 
employability, or reputation:
 Yes  
 No
Describe the potential consequences:
Health-related data that the participant provides to the SUGAR Study may be sensitive (e.g., 
obesity or very high blood pressure), and could be embarrassing to participants or lead to 
insurance coverage problems if there was a breach of privacy of confidentiality.

Embarrassment
Criminal or civil liability
Loss of state or federal benefits
Damaging to the participant's financial standing, employability, or reputation
Potential risks to insurability (health, disability, or life insurance)
12.4  
Explain any extra steps that will be taken to assure 
EXTRA CONFIDENTIALITY MEASURES: 
confidentiality and protect identifiable information from improper use and disclosure, if any:
The Eureka mHealth Research Platform that hosts our mobile study takes confidentiality and 
privacy very seriously. Please see the Eureka IRB application and the Eureka Privacy Policy and 
Data Security Measures for details.
12.5  
Do you anticipate that this study may collect information that State or Federal 
 REPORTABILITY: 
*
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or 
others: (REQUIRED)
  Yes  
  No
12.6  
Will this study obain a Certificate of Confidentiality:
CERTIFICATE OF CONFIDENTIALITY: 
  Yes  
  No
12.7  
Will there be any sharing of 
 research test results 
SHARING OF RESEARCH RESULTS: 
EXPERIMENTAL
with subjects or their care providers:
 Yes  
 No
Note: This is unusual and not recommended, particularly in cases 
where the tests are carried out in a non-CLIA certified laboratory, 
the results are of unproven clinical significance, or where there are 
not known preventative strategies and/or treatments. If these are 
the most likely scenarios for your study, you should check 'No.'  
 
If you have an incidental finding of clear clinical significance, call 
the HRPP QIU at 415-476-1814 for a consult. 
Explain under what circumstances research results may be shared:
Participants will go to a nearby Quest Labs, which is an established commercial diagnostic 
laboratory company or they will use a Home Access mail-in lab kit, a professional use and FDA 
approved at-home laboratory testing kit, to obtain a baseline and closeout hemoglobin A1c test. 
We plan to share these results with participants as a courtesy for their participation.
12.8  
Will any personal identifiers be collected: 
IDENTIFIERS: 
* 
(REQUIRED) 
 Yes  
 No
Check all the identifiers that may be included:
Names
Dates
Postal addresses
Phone numbers

Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
Could study records include 
 photos or images (even 'unidentifiable' 
* 
ANY
ones): (REQUIRED)
  Yes  
  No
12.9  
 
Will identifiable information be shared with outside groups:
DATA DISCLOSURE: 
 Yes  
 No
IMPORTANT: The IRB now recommends that all consent forms 
include a provision for sharing of de-identified/coded data to permit 
re-use of data for secondary research purposes.
Provide the details of whom the data will be shared with and what types of 
information and identifiers will be shared:
Data recorded from blood glucose monitoring devices in this study will be shared with the 
sponsor, Livongo Health. 
For study management purposes, personal identifiers will  be shared with the sponsor, Livongo 
Health.  These identifiers include:
                      -Your name
                      -Your shipping address
                      -Your phone number
                      -Your email address
Livongo Health will access secure and encrypted data, and will only use your information for 
study-related purposes.
The consent form includes the above language to inform particpants of sharing of 
indentifiable information to the sponsor. 
For study purposes, personal identifiers will also be shared with Quest Labs or with 
Home Access Health Corporations. This is necessary to have lab requisitions faxed 
to the lab location, and to allow us to requisition out the professional use finger 
stick test kit to participants. These identifiers include:
Your name
Your shipping address
Your phone number
Your email address
Quest Labs and Home Access Health Co. will access secure and encrypted data 
and will only use your information for study-related purposes.

The consent form includes the above language to inform particpants of sharing of indentifiable 
information to Quest Labs and Home Acccess Health Co. 
 
Participants will be asked to download the iHealth Gluco-Smart app and create an account. 
The Gluco-Smart app is necessary to connect their iHealth device. We will not be sharing 
participants' data or identifiers with the iHealth Lab, Inc company. However, any personal 
identifiers the participants choose to input in the app will be managed by iHealth Lab, Inc 
such as their name and email address. Participants can choose to not provide information that 
identifies themselves.
 
The consent form includes the above language to inform particpants of sharing of indentifiable 
information to the iHealth Lab, Inc.
12.11  
(check all that apply): 
* DATA COLLECTION AND STORAGE: 
(REQUIRED)
Collection methods:
Paper-based (surveys, logs, diaries, etc.)
Electronic case report forms (CRFs), such as OnCore or another clinical trial management 
portal
Web-based online surveys or computer-assisted interview tool
Mobile applications (mobile or tablet-based)
Wearable devices
Audio/video recordings
Other:
Specify what other methods will you use to collect data: 
* 
(REQUIRED)
Bluetooth-enabled mobile health devices
What online survey tool will you use: 
* 
(REQUIRED)
Qualtrics (Recommended)
RedCAP (Recommended)
Survey Monkey (NOT recommended and may require UCSF ITS Security review)
Other
What's the name of the survey tool and who is it owned by
* 
: (REQUIRED)
Surveyor, managed by Eureka mHealth Research Platform
* For each app and device, please provide: (REQUIRED)
the name of the mobile application or wearable device
name  of the manufacturer / application owner
the FDA status (required for mobile health applications and mobile 
health devices)
Livongo Health System, Livongo, FDA Status: legally marketed device
iHealth Wireless Smart Gluco-Monitoring System, iHealth Labs, FDA Status: legally marketed 
device
Data will be collected/stored in systems owned by (check all that apply): 
* 
(REQUIRED)
UCSF
SF VAMC
Amazon (Amazon Cloud)
Other academic institution

3rd party vendor (business entity)
Other (explain below)
Do you have a contract or Data Use Agreement with a 3rd party for 
* 
research data collection, storage, access, and ownership: (REQUIRED)
 Yes  
 No
12.12  
Indicate how data are kept secure and protected from improper use and 
DATA SECURITY: 
disclosure (check all that apply):   NOTE: Whenever possible, do not store subject identifiers on 
laptops, PDAs, or other portable devices. If you collect subject identifiers on portable devices, 
you MUST encrypt the devices.
Data are stored securely in My Research
Data are coded; data key is destroyed at end of study
Data are coded; data key is kept separately and securely
Data are kept in a locked file cabinet
Data are kept in a locked office or suite
Electronic data are protected with a password
Data are stored on a secure network
Data are collected/stored using REDCap or REDCap Survey
Data are securely stored in OnCore
12.13  
  
Confirm below that you will keep data confidential: 
* DATA SECURITY: 
(REQUIRED)  I will keep 
any data sets that include identifiers secure and protected from improper use and disclosure by 
using methods such as:
Physical Security – Keeping data in locked file cabinets, locked offices, locked suites, and 
physically securing computers and servers.
Electronic Security – Following UCSF minimum security standards for electronic information 
, which includes (but is not limited to): not storing identifiers on portable devices 
resources
like laptops or flash drives if they are unencrypted, encrypting portable devices, and storing 
data in password-protected files and on secure networks.
 
Yes 
12.15  
Study data will be:
HIPAA APPLICABILITY: 
 
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service 
(THREDS) at SFGH
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
13.0
 Financial Considerations
13.1  
Will subjects be paid for participation, reimbursed for time or expenses, or receive any 
* PAYMENT: 
other kind of compensation: (REQUIRED)

 Yes  
 No
13.2  
Subjects payment or compensation method (check all that apply):
PAYMENT METHODS: 
Payments will be (check all that apply):
Cash
Check
Gift card
Debit card
UCSF Research Subject Payment Card
Reimbursement for parking and other expenses
Other:
13.3  
Describe the schedule and amounts of payments, including the total subjects 
PAYMENT SCHEDULE: 
can receive for completing the study: 
If there are multiple visits over time, explain how payments will be prorated for partial 
completion
If deviating from recommendations in Subject Payment Guidelines, include specific 
justification below
As a token of our appreciation, participants will be given a $25 gift card (up to $75) for each completed lab test at 
baseline, month 3, and closeout. In addition, participants can keep the glucose monitoring device assigned to 
them after the study ends (up to $190 value).
13.4  
Will subjects or their insurance be charged for any study activities:
COSTS TO SUBJECTS: 
 Yes  
 No
Describe the costs that may be incurred by subjects or 3rd party payers as 
a result of participation:
Explain why it is appropriate to charge those costs to the subjects
ompare subjects’ costs to the charges 
If this is a therapeutic study, c
that would typically be associated with receiving care off-study (e.g. is 
it more expensive to participate in this study than to receive care off-
study?)
While the study itself will not charge subjects with any fees for their participation, participants 
may incur additional data charges from their mobile phone provider while using their smartphone 
to complete study activities. We do not foresee these additional charges to be very substantial, 
but understand that this could be a challenge for some participants.
 
As an alternative, if a participant does not wish to incur data charges or use their data, they may 
use the Wi-Fi setting on their smartphone.
14.0
 Qualifications of Key Study Personnel
14.1          
 
  NOTE: This information is required and your application will be 
considered incomplete without it. If this study involves invasive or risky 
procedures, or procedures requiring special training or certification, please 
identify who will be conducting these procedures and provide details 

about their qualifications and training. Also identify each person who will be 
involved in the consent process. Click the orange question mark for more 
    
   
information and examples.
Under qualifications, please include:
Academic Title
Institutional Affiliation (UCSF, SFGH, VAMC, etc.)
Department
Certifications
        
  
  
 
November, 2015 - NEW Definition of Key Study Personnel and 
    
CITI Training Requirements:
  
  
include the Principal Investigator, other 
UCSF Key Study Personnel 
investigators and research personnel who are directly involved in conducting 
research with study participants or who are directly involved in using study 
participants’ identifiable private information during the course of the research. 
Key Personnel also include faculty mentors/advisors who provide direct 
oversight to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI 
        
on the IRB application.
 
The IRB requires that all Key Study Personnel 
complete Human Subjects Protection Training through 
 
CITI prior to approval of 
a new study, or a modification in which KSP are being added. More information 
  
  
on the CITI training requirement can be found on our website.  
      
KSP Name
Description of Study 
Responsibilities - Briefly 
describe what will each 
person be doing on the study. 
If there are procedures 
requiring special expertise or 
certification, identify who will 
be carrying these out. Also 
identify who will be obtaining 
informed consent.
Qualifications, Licensure, and 
Training
Wong, Jenise MD, PhD
Study design and 
oversight, designing 
study protocols and 
procedures, data 
analysis, manuscript 
preparation, 
dissemination of research 
findings.
Jenise Wong, MD, PhD, is 
an Assistant Adjunct 
Professor of Pediatrics, 
Division of 
Endocrinology. She has 
clinical research 
experience in diabetes 
technology and has 
completed requirements 
for Masters in Clinical 
Research (MAS) at UCSF.
Dr. Olgin, Jeffrey E MD, MD
Other investigator and 
faculty advisor - will help 
with study design, 
interpretation of results, 
and editing the 
manuscript.
Professor of Medicine, 
Chief of Cardiology, holds 
MD. Dr. Jeffrey Olgin has 
formal training 
experience in clinical 
research. He is 
experienced in patient-
oriented research and in 
supervising trainees in 
the same.
Maguire, Carol A
Eureka Project Director - 
authorized to consent, 
enroll patients into study, 
Carol Maguire manages 
clinical research in the 
UCSF's Division of 
Cardiology. She will 
oversee the CHR 

manage study documents
/databases, etc.
application submission 
and ongoing regulation 
only.
Rohdin-Bibby, Linnea
Eureka Project 
Coordinator - authorized 
to consent, enroll, and 
manage patient 
participation in the study.
Linnea Rohdin-Bibby is 
currently a clinical 
research coordinator and 
experienced in 
consenting patients. She 
has been adequately 
trained to assist patients 
in clinic on joining the 
study.
Peyser, Noah, PhD
UCSF CORE Personnel 
and Data Manager - 
authorized to analyze 
data and generate 
reports on Health eHeart 
and Eureka Platform data.
Noah Peyser is the 
Scientific Program 
Manager for the Health 
eHeart/ Eureka Platform. 
He has experience in 
clinical research and is 
currently working in 
reporting and delivering 
data for Health eHeart 
and Eureka studies.
15.0
 Other Approvals and Registrations
15.4  
Indicate if this study involves other regulated materials and requires approval 
OTHER APPROVALS: 
and/or authorization from the following regulatory committees:
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Controlled Substances
16.0
 End of Study Application
16.1  End of Study Application Form        
 
  To continue working on the Study 
: Click on the section you need to edit in the left-hand menu. Remember to save 
Application
        
through the entire Study Application after making changes.
 
If you are done working on 
        
:
the Study Application
 
Before proceeding, please go back to Section 
Important: 
4.0 Initial Screening Questions and Save and Continue through the form to make sure all the 
relevant sections and questions have been included. If you've changed any answers since 
you started, the branching may have changed. Your application will be incomplete and it will 
        
have to be returned for corrections. 
 
Once you are sure the form is complete, click 
Save and Continue. If this is a new study, you will automatically enter the Initial Review 
Submission Packet form, where you can attach consent forms or other study documents. 
        
Review the 
 for a list of required attachments.
Initial Review Submission Checklist
 
  
       
Answer all questions and attach all required documents to speed up your approval.
 
       
  
              
 
 
 
 
 

The UCSF IRB wants your feedback about this new form. Please click 
the link to take a 
 about the new application form.
brief survey