Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Care Clinics
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Sponsor: Intermountain Health Care, Inc.

1 
 
TITLE:  
Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary 
Care Clinics  
 
SUMMARY: 
A parallel randomized, multi-site prospective trial was conducted at four Intermountain 
Healthcare Clinics using a new CGM device (Dexcom G6) compared to a standard of care finger 
stick glucometer (FSG) (Contour Next One). All participants received usual care in Primary Care 
clinics for six consecutive months while using these devices. Data were collected via electronic 
medical records, device outputs, exit surveys, and insurance company (SelectHealth) claims in 
accordance with Institutional Review Board approval. 
 
AUTHORS: 
Isaacson B, Kaufusi S, Sorensen J, Joy E, Jones C, Ingram V, Mark N, Phillips M, Briesacher M 
PROTOCOL ID #: 1050955 
IRB #: 1050955   
DOCUMENT DATE: November 08, 2018 
 
 
 
 
Intermountain Healthcare, Salt Lake City, Utah, United States 
May 21, 2020 
 
 

2 
STUDY INFORMATION 
Title 
Assessing the Feasibility of Continuous Glucose Monitoring in 
Reimagine Primary Care Clinics  
Short Title 
CGM - Reimagine Primary Care 
Protocol ID # 
1050955 
Protocol Issue Date 
08Nov2018 
IRB Approval Date 
19Nov2018 
Amendment Date(s) 
N/A 
Location of Research 
Intermountain Healthcare’s Reimagine Primary Care Clinics  
(Cottonwood Family Practice, Cottonwood Senior, Avenues Internal  
Medicine and Holladay Internal Medicine) 
Principal Investigator 
Liz Joy, MD, MPH  
Intermountain Healthcare  
Medical Director, Community Health, Nutrition Services, Health  
Promotion & Wellness 
Adjunct Professor, Family & Preventive Medicine  
University of Utah School of Medicine 
801-442-3721 (office) 
385-282-2700 (clinic) 801-541-
5592 (cell) liz.joy@imail.org 
Co-Principal Investigator, if 
applicable 
N/A 
Sub-Investigator 
Brad Isaacson, PhD, MBA, MSF 
Internal Collaborators 
Mark Briesacher, MD 
Mike Phillips, MD 
Raj Shrestha, MHCDS 
Anne Pendo, MD 
Seth Glickman, MD, MBA 
Rebekah Couper-Noles, RN 
Nick Duncan, MD 
Chad Spain, MD 
Megan Skibitsky, MD 
Karen Hill-Garrett, MD 
Nedda Hendler, MD 
Brett Porter, MD   
Megan Rowe, PA  
Ryan Wight, PA  
Christopher Jones, MD 
Stephanie Kaufusi, MS 
Jeff Sorensen, MStat 
Whitney Weaver, JD 
Karla Zimmermann, BA  
External Collaborators 
Savvysherpa (but no access to PHI) 
Sponsor 
Business Development  
Intermountain Healthcare 
36 South State Street, Suite 1600 
Salt Lake City, UT 84111 

3 
Contract Research 
Organization (CRO) (if 
applicable) 
N/A 
Study Team 
The study team is the internal collaborators noted above 
 
PROTOCOL SUMMARY 
Purpose of Study 
To assess the impact of continuous glucose monitoring versus standard 
of care (e.g. a finger-prick protocol using a glucometer) on clinical 
outcomes, healthcare utilization, and cost in patients with type I or II 
diabetes treated within the Reimagine Primary Care clinics.   
Design 
Parallel Randomized Controlled Trial 
Research Designation 
The team intends to consent patients, collect data, analyze and publish; 
this will likely be a research designation.  
Study Duration 
13 Months (November 1, 2018 – December 31, 2019)  
Number of Subjects 
We aim to recruit 125 patients, expecting 20% attrition rate by the 
sixthmonth follow-up, yielding about 100 patients for analysis (Section 
7.2 Sample Size and Power).  
Description of Subject 
Population 
Patients with diabetes treated within the Intermountain Healthcare 
Reimagine Primary Care program between 1 November 2018 through 31 
December 2019.  
Eligibility Criteria 
Inclusion Criteria: Patients with type 1 or type 2 diabetes, having a 
HbA1c ≥6.5%, currently using glucometers or are prescribed a glucose 
meter at their index encounter, treated within Intermountain Healthcare’s 
Reimagine Primary Care (RPC) program, and being seen by an RPC 
provider during the period of 1 November 2018 to 31 December 2019. 
Patients must have access to a smart phone to download applications, 
have Bluetooth capabilities for data sharing, log/view their continuous 
glucose monitor (CGM) data, and to take an exit survey. 
Exclusion Criteria: Patients who are pregnant, not classified as having 
diabetes based on A1c levels, presence of vascular disease, age >80 
years, diagnosis of dementia, and patients not currently using a glucose 
meter to monitor their sugar levels (and not being provided during the 
consulting visit).  
Screening and/or Recruitment 
Location 
Patients will be recruited while in the waiting room at the Reimagine 
Primary Care Clinics by a CITI/HIPAA trained coordinator or contacted 
by phone as per phone script instructs. These persons will maintain 
recruitment logs and load data in Tableau for real-time evaluation.  

4 
Brief Description of Study 
Procedures 
This is a parallel randomized controlled trial. Eligible patients who 
consent will be randomized to one of two groups: (1) the intervention 
group who will be given a Dexcom G6 for CGM, or (2) the control group 
who will follow their current standard finger-prick protocol via a provided  
Contour Next ONE glucometer. The CGM group must download the 
Dexcom G6 and Clarity mobile apps for data capture, whereas the 
standard of care group will use the Contour Next mobile app for their 
respective readings.  
The Dexcom G6 captures real-time, dynamic glucose data every five 
minutes. Devices used in this study are FDA approved and commercially 
available.  
Primary Endpoint 
Hemoglobin A1c (HbA1c) level 
Secondary Endpoints 
Glycemic variability per mean amplitude of glycemic excursion (MAGE), 
coefficient of variation of HbA1c, range of HbA1c, frequency of 
hypoglycemic events, healthcare utilization per count of  
inpatient/outpatient visits, cost of care, current HEDIS performance on 
diabetes and behavioral health measures, coding specificity for diabetes, 
emergency department visit per 1000 rate, overall and for patients with 
diabetes, and hospitalization per 1000 rate related to  
 
diabetes, and self-reported behavioral changes (e.g. feeling more 
empowered to self-manage care, engaged with changing healthcare 
behaviors, and patient perceptions of the technology). 
Analysis Population(s) 
Patients with diabetes treated at all Reimagine Primary Care facilities  
(Avenues Internal Medicine, Cottonwood Family Medicine, Cottonwood 
Senior Clinic, and Holladay Internal Medicine) from 1 November 2018 to 
31 December 2019 will be included in this study.  
Benefits 
Successful demonstration of CGM will allow patients to manage their 
condition, which may avoid the highs and lows of glucose monitoring and 
make patients feel better. This may reduce healthcare utilization and cost 
for the patients and the healthcare system as a whole. Furthermore, 
general knowledge on how to engage with patients in remote monitoring 
pilots will be better understood through this study.  
Risks 
This study includes recruiting patients and data will be collected. To 
minimize any breach in of private information the team will store  data 
within the enterprise data warehouse/medical record, REDCap, and on 
secured mobile applications from Contour Next and Dexcom. While all 
devices used are FDA approved, there could be challenges for new 
users when using the new Dexcom G6 
Authors 
Liz Joy, MD 
Mike Phillips, MD, MBA 
Brad Isaacson, PhD, MBA, MSF 
Anne Pendo, MD 
Christopher Jones, MD 
Stephanie Kaufusi, MS 
Jeff Sorensen, MStat 
Disclaimer: The information in this document is confidential and will not be disclosed to others without written 
authorization from Intermountain Healthcare. 
TABLE OF CONTENTS 

5 
1.0 INTRODUCTION ............................................................................................................................................7 
1.1 Background and Rationale ........................................................................................................................7 
1.2 Previous Work .............................................................................................................................................8 
2.0 STUDY OBJECTIVES/PURPOSE OF THE STUDY ................................................................................8 
3.0 STUDY DESIGN ...........................................................................................................................................10 
3.1 Study Duration ...........................................................................................................................................11 
3.2 Number of Subjects ..................................................................................................................................11 
3.3 Screening and Selection of Subjects .....................................................................................................12 
3.3.1 Inclusion Criteria ....................................................................................................................................12 
3.3.2 Exclusion Criteria ...................................................................................................................................12 
4.0 STUDY PROCEDURES ..............................................................................................................................12 
4.1 Informed Consent .....................................................................................................................................12 
4.2 Methods ......................................................................................................................................................13 
4.3 Risks ...........................................................................................................................................................13 
4.4 Benefits .......................................................................................................................................................14 
5.0 END OF STUDY CONSIDERATIONS ......................................................................................................14 
5.1 Study Completion ......................................................................................................................................14 
5.2 Voluntary Withdrawal of Consent ...........................................................................................................14 
5.3 Early Termination ......................................................................................................................................14 
5.4 Lost to Follow-Up Subjects ......................................................................................................................14 
5.5 Records Retention ....................................................................................................................................15 
6.0 MONITORING AND SAFETY REPORTING ...........................................................................................15 
6.1 Monitoring ..................................................................................................................................................15 
6.2 Safety Reporting .......................................................................................................................................15 
7.0 STATISTICAL ANALYSIS ...........................................................................................................................15 
7.1 Statistical Considerations ........................................................................................................................16 
7.2 Sample Size and Power ..........................................................................................................................16 
8.0 DISSEMINATION OF RESULTS ...............................................................................................................17 
8.1 Release of Information to Participants ..................................................................................................17 
8.2 Public Release of Information .................................................................................................................17 
8.3 Data-Sharing with Collaborators ............................................................................................................17 
8.4 Publications ................................................................................................................................................17 
9.0 FINANCIAL CONSIDERATIONS ...............................................................................................................18 
9.1 Funding Source .........................................................................................................................................18 
9.2 Compensation ...........................................................................................................................................18 
9.3 Disclosure of Conflicts of Information ....................................................................................................18 

6 
10.0 REFERENCES ...........................................................................................................................................19 
11.0 PROTOCOL SIGNATURE PAGE ...........................................................................................................19 
12.0 APPENDIX A ..............................................................................................................................................20 
 
 
 

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ABBREVIATIONS AND DEFINITIONS 
• 
ACO: Accountable Care Organization 
• 
CGM: Continuous Glucose Monitoring 
• 
Cv: Coefficient of Variation 
• 
GDM: Gestational Diabetes Mellitus 
• 
GLMM: Generalized Linear Mixed Models 
• 
HbA1c: Hemoglobin A1c 
• 
HTE: Heterogeneity of Treatment Effect 
• 
MAGE: Mean Amplitude of Glycemic Excursion 
• 
T2DM: Type II Diabetes Mellitus 
• 
SOC: Standard of Care 
1.0    INTRODUCTION 
1.1 
Background and Rationale 
Approximately 30 million Americans, or 9% of the population has diabetes, a condition in which a person does 
not make enough insulin, or the body cannot use its own to effectively manage blood glucose levels [1]. Improper 
diabetes management is associated with severe comorbidities which include: heart disease, stroke, kidney 
disease, ocular problems, dental disease, nerve damage, and vascularity issues. The epidemic continues to 
challenge systems like Intermountain Healthcare, an accountable care organization (ACO), since diabetes cost 
$327 billion per year (representing $1 in every $7 dollars spent) on healthcare in the United States [2]. 
Furthermore, people with diagnosed diabetes incur average medical expenditures of $16,752 per year, of which 
about $9,601 is directly attributed to diabetes [2]. New treatment options are needed to manage population 
health, especially with 84 million adults having been diagnosed with prediabetes diabetes [3]. 
In an effort to reduce the physical, economic and social burden of diabetes, several healthcare systems have 
evaluated the use of telehealth to monitor glucose levels. In a metanalysis by Lee et al., the authors 
demonstrated that telehealth interventions produced a small, but significant improvement in hemoglobin A1c 
(HbA1c) levels compared with usual care (mean difference: -0.55, 95% CI: -0.73 to − 0.36) [4]. The Ontario 
Health Technology Advisory Committee also showed that the blood glucose home telemonitoring technologies 
they used yielded a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used 
adjunctively to a broader telemedicine initiative for adults with type 2 diabetes [5].  

8 
Intermountain Healthcare has piloted continuous glucose monitoring (CGM) and continues to expand its digital 
health services. However, to date, these 
services have not been used in 
Reimagine  
Primary  
Care 
 Clinics  
(Cottonwood Senior, Cottonwood Family  
Medicine, Avenues Internal Medicine, 
Holladay Internal Medicine) to treat atrisk 
patients. These patients have, on 
average,  
four  
comorbidities  and 
represent a challenging cohort to treat. 
Furthermore, data from the first eight 
months of operations in the Reimagine 
Primary Care Clinics have reported 1723 
diagnoses of diabetes and 560 cases of 
pre-diabetes (Figure 1). Understanding if 
these patients will use remote CGM 
technology,  
learning  
how  
real-
time knowledge influences their behavior, 
and assessing the impact on cost, care 
and utilization, is critical prior to 
expanding the number of Reimagine 
Primary Care sites within Intermountain Healthcare.  
1.2 
Previous Work 
Intermountain Healthcare has participated in two previous CGM studies with Drs. Christopher Jones and Liz Joy 
(IRB #: 1050741 and 1050410). Each are described in detail below:  
• 
IRB #1050741 – This recently completed quality improvement study successfully recruited n=20 patients 
with Type 2 Diabetes Mellitus (T2DM) to evaluate an integrated, CGM-based lifestyle modification 
program for glucose management in patients >65 years of age. The team is currently evaluating the data, 
but results will highlight the importance of education, self-discovery, and the way that we engage with our 
patients.  
• 
IRB #1050410 – Each year there are approximately 3000 gestational diabetes mellitus (GDM) 
pregnancies in the United States— contributing to an additional $10,200 per affected pregnancy in cost. 
Most concerning is that women who have had GDM are 7x more likely to develop type 2 diabetes than 
women who did not have GDM during their pregnancy, and at least 40% of women with GDM will develop 
this disease. Therefore, the goal of our second CGM pilot was to: (1) accurately predict which women 
are at risk, (2) optimize recruitment and enrollment, (3) provide behavioral support to promote adherence 
to interventions, and (4) collect actionable data.  
In this study, n=403 women were consented (n=189 at Intermountain Medical Center and n=214 at LDS 
Hospital). Dr. Joy and her staff discovered through qualitative feedback that women will wear a CGM 
device, are excited to see their data, and did not expect compensation for participation. Data is still being 
analyzed by Savvysherpa to assess patient outcomes.  
2.0    STUDY OBJECTIVES/PURPOSE OF THE STUDY 
The purpose of this study is to assess the effect of using CGM versus a standard of care (e.g. traditional 
fingerprick protocol) in an at-risk, diabetic patient population. The impact will be measured in terms of clinical 
outcomes (e.g., HbA1c level, glycemic variability), health care utilization (inpatient/outpatient visits), self-reported 
patient perceptions, and costs. We expect that CGM will empower patients to better manage their diabetes—
ultimately, improving their health and reducing the burden of disease.  
Figure 1 

9 
In this study, patients with type I and II diabetes will record their blood glucose levels since the output of the 
Dexcom G6 and the Contour Next ONE measure interstitial glucose. However, as noted in the 3.0 Study Design, 
although the American Diabetes Association has provided a conversion table in which blood glucose = 28.7 X 
A1C – 46.7 [6], the current standard of care is to have patients directly measure their blood glucose in the clinic 
rather than approximating. Thus, patients enrolled in this study will track their glucose with the general hypothesis 
being that those who more consistently monitor their blood glucose levels (and avoid the high peak to valley 
changes), will have a lower HbA1c at the end of the study. This will be tested by having HbA1c levels measured 
at two distinct time points: (1) at the time of enrollment, and (2) at the end of the pilot (six months). HbA1c levels 
may also be checked at the study midpoint (three months) if determined to be current standard of care by the 
provider and this data will also be considered. The aims below are written for HbA1c to confirm to the current 
standard of care.  
Aim 1: Assess impact of CGM on glycosylated hemoglobin levels  
Specific Aim 1a (primary analysis): Measure the effect of CGM vs. standard finger-prick protocol on HbA1c 
• 
Hypothesis for Aim 1a: The patient-level six-month reduction in HbA1c will be greater among those 
randomized to CGM than that among those randomized to standard finger-prick protocol. 
• 
Process for Aim 1a: We will compare the distributions of the patient-level, six-month change in HbA1c 
between randomized groups using the two-sided Wilcoxon rank-sum test. 
Specific Aim 1b: Measure the longitudinal change in mean amplitude of glycemic excursion (MAGE) in CGM 
• 
Hypothesis for Aim 1b: The patient-level daily MAGE will decrease over six months of CGM.  
• 
Process for Aim 1b: MAGE is a metric of glycemic variability that can be measured from CGM, but not 
from infrequent (daily) monitoring. Thus, among CGM patients only, we will measure the six-month 
longitudinal change in 24-hr average MAGE. Upon computing each CGM patient’s daily MAGE, we will 
use patient-level hierarchical modeling (generalized linear mixed models) to estimate the overall 
sixmonth longitudinal trend in MAGE. 
Specific Aim 1c: Measure longitudinal change in daily coefficient of variation (Cv) of blood glucose in CGM 
• 
Hypothesis for Aim 1c: The patient-level daily Cv of blood glucose will decrease over six months of 
CGM.  
• 
Process for Aim 1c: Like that of MAGE, Cv of blood glucose is a metric of glycemic variability that 
requires near continuous monitoring. Thus, among CGM patients only, we will measure the six-month 
longitudinal change in daily Cv of blood glucose using the standard equation: Cv = σ/μ. Once we have 
computed each CGM patient’s daily Cv of blood glucose, we will use patient-level hierarchical modeling 
(generalized linear mixed models) to estimate the overall six-month longitudinal trend in Cv of blood 
glucose. Additionally, we will report the patient- and group-level distributions in daily blood glucose 
extrema (i.e., minimum and maximum).  
Specific Aim 1d: Measure longitudinal change in overall blood glucose range and “time in range” (𝑚𝑎𝑥‒𝑚𝑖𝑛) in 
CGM 
• 
Hypothesis for Aim 1d: The patient-level daily blood glucose range will decrease and time in range 
(which is defined by glucose levels from 70 to 180) will increase over six months of CGM usage. 
• 
Process for Aim 1d: Again, like MAGE and Cv, the blood glucose range is a metric of glycemic variability 
that is most meaningful with near continuous monitoring. So, among CGM patients only, we will measure 
the blood glucose range for the ith day as 𝑅𝑎𝑛𝑔𝑒𝑖 = 𝑚𝑎𝑥𝐻𝑏𝐴1𝑐 ‒𝑚𝑖𝑛𝐻𝑏𝐴1𝑐, and then use patient-level 
hierarchical modeling (e.g., generalized linear mixed models) to estimate the overall six-month 
longitudinal trend in HbA1c range. 
Specific Aim 1e: Measure the effect of CGM vs. the standard finger-prick protocol on frequency of hypoglycemic 
events 

10 
• 
Hypothesis for Aim 1e: The patient-level six-month reduction in frequency of hypoglycemic events will 
be greater among those randomized to CGM than that among those randomized to control. 
• 
Process for Aim 1e: Measure the patient-level change in rate of hypoglycemic events as the patientlevel 
slope of the six-month linear change in the so-called “intensity” (λ) of the estimated nonhomogeneous 
Poisson point process. Once we’ve computed each patient’s six-month linear change in λ, we will 
compare the distributions between randomized groups. Note that the motivation for measuring change 
in frequency as the slope of λ estimated from a non-homogeneous Poisson process is that it allows us 
to compare changes in frequency of hypoglycemic events between groups with different modes of 
monitoring (continuous vs daily).  
Aim 2: Assess impact of CGM on healthcare utilization and cost 
Specific Aim 2a: Measure the effect of CGM vs. standard finger-prick protocol on healthcare utilization 
• 
Hypothesis for Aim 2a: The count of primary care, specialist, and emergency department visits or 
hospital stays over six months will be fewer among those randomized to CGM than that among those 
randomized to standard finger-prick protocol. 
• 
Process for Aim 2a: For each patient, count their visits to a primary care provider or specialist or 
emergency department/hospital admission. Next, compare the distributions of visit counts between 
randomized groups using a Poisson test, aggregated as well as stratified by visit type.  Other metrics for 
evaluating utilization may include: current HEDIS performance on diabetes and behavioral health 
measures, coding specificity for diabetes, emergency department visit per 1000 rate, overall and for 
patients with diabetes, and hospitalization per 1000 rate related to diabetes. 
Specific Aim 2b: Measure the effect of CGM vs standard finger-prick protocol on cost 
• 
Hypothesis for Aim 2b: The total variable cost associated with healthcare services/visits over six months 
will be fewer among those randomized to CGM than that among those randomized to standard fingerprick 
protocol. 
• 
Process for Aim 2b: For each patient, measure total variable cost of associated healthcare services and 
visits. Then compare the distribution of costs between randomized groups using the Wilcoxon rank-sum 
test, a non-parametric analogue of Student’s t-test. 
Aim 3: Qualitatively understand patient perspective of CGM 
Specific Aim 3a: Record patients’ self-reported willingness to participate in a CGM pilot 
• 
Hypothesis for Aim 3a: Greater than 80% of patients who will have been approached to participate in 
this study will consent to participation.   
Process for Aim 3a: The team will record the number of patients approached, consented and those 
that participate in this study. Metrics will be helpful for estimating future recruitment in other Reimagine 
Primary Care studies.  
Specific Aim 3b: Understand patient satisfaction with CGM 
• 
Hypothesis for Aim 3b: Patient’s will be satisfied with CGM device. 
• 
Process for Aim 3b: Develop and deploy exit surveys targeting patients randomized to CGM to assess 
satisfaction with the CGM device and related digital health monitoring services.  
Specific Aim 3c: Understand how CGM changed patient behavior • 
Hypothesis for Aim 3c: Patients will have felt empowered by CGM. 
• 
Process for Aim 3c: Within the survey developed/deployed per Aim 3b, include 5-point Likert-based 
questions soliciting patient opinions and perspectives. Summarize those perspectives so that research 
investigators and operational leaders can use this information to change clinical operations (as needed).  
  
3.0    STUDY DESIGN 
This is a pilot, parallel randomized controlled trial of CGM versus a standard finger-prick protocol among patients 
with type I and II diabetes treated at Intermountain Healthcare’s Reimagine Primary Care Clinics. Patients will 

11 
be eligible if their most recent HbA1c level is ≥6.5% and they are either currently using a glucose meter or are 
prescribed a glucose meter at their index encounter. Upon consent, which will occur within in a private office/room 
within the Reimagine Care Clinic, patients will be randomized into one of two groups:  
• 
Intervention group: CGM using a Dexcom G6 to measure glycosylated hemoglobin levels every five 
minutes. Patients will be asked to download the Dexcom G6 and Clarity applications (to have access to 
their real-time data) and be given a link to complete an exit survey in REDCap near the end of their study 
participation. Data will be sent via Bluetooth and then exported by the Intermountain research team into 
a Tableau (or similar) dashboard for data analysis/comparison (Appendix A) 
• 
Control group: A standard finger-prick protocol that will require patients to continue with their daily 
fingerprick regimen established by their physician. This group will be given a Contour Next One meter to 
ensure that each patient is receiving the same level of accuracy by the same device. A review by 
Ekhlaspour et al of 17 glucose meters demonstrated wide variability, with only two devices achieving the 
2013 ISO standard (with the most accurate being the Contour Next) [7]. Patients in the control group will 
be asked to download the Contour Next application which will send data via Bluetooth similar to above. 
Data will be aggregated, and protected health information removed prior to analysis (by Intermountain 
Healthcare and Savvysherpa). At the end of the study, patients will be asked to complete a short survey 
in REDCap about their willingness to participate in future studies (Appendix A).  
Randomization will be assigned a priori using a random number generator from Microsoft Excel. Sub-Investigator 
will then transcribe these numbers and order them individually in concealed envelops and present them to the 
Research Coordinators to ensure the CRC is blinded. At time of consent the Research Coordinator will hand the 
patient the earliest numbered envelope to randomize. . Patients in both randomized groups will be given the 
devices and one month supplies to ensure compliance with the protocol. The Study Coordinator and patient will 
exchange contact information so that the CRC may resupply the patient with necessary equipment at the end of 
their month supply. The CRC may meet the patient at their Reimagine Care Clinic or off site for patient 
convenience. All patients are expected to participate for six months, which is near the minimum duration sufficient 
to measure clinically meaningful changes in hemoglobin A1c related to gradual behavioral changes (e.g., diet, 
exercise, insulin administration). Further, each patient will complete 2 mandatory blood draws and one elective 
blood draw at their designated Reimagine Care Clinic to evaluate HbA1c level changes over the course of the 
study.  Baseline HbA1c must be completed on day of enrollment (± 2 days) which Intermountain Heathcare may 
choose to cover if not paid for by patient’s SOC. An elective blood draw will be considered for data if completed 
at 3 months (±1 week) and a third required blood draw upon study completion (±2 weeks) which the study may 
also choose to cover if not SOC. 2 weeks from 180 enrollment) which the study may pay for if not covered by 
patient’s SOC. We postulate that those that have a more consistent interstitial glucose profile (which avoid the 
high peak to valley swings), will have a more pronounced difference in pre and post HbA1c levels. Specific Aim 
#1 above will help our team understand the relationship between interstitial glucose and HbA1c, along with other 
outcomes of interest which include weight loss, alterations in diet, change in physical activity, etc. 
3.1 
Study Duration 
This study will be conducted from 1 November 2018 through 31 December 2019 (13 months). This will allow 
sufficient time for study preparation (November 2018; 1 month), enrollment (approximately 3 months, starting 
December 1, 2018), follow-up (approximately 6 months from the time the last patient is consented), analysis 
(August 2019 – September 2019; 2 months), delivery of a final report to the Intermountain Healthcare Executive 
Leadership Team and co-authoring a manuscript for submission in a high-impact, peer-reviewed journal (October 
2019 – December 2019; 2 months).  
3.2 
Number of Subjects 
We aim to recruit 125 patients, expecting 20% attrition by the six-month follow-up, yielding about 100 patients 
for analysis (see 7.2 Sample Size and Power). 

12 
3.3 
Screening and Selection of Subjects 
Subjects will be screened and recruited by Research Coordinators with CITI/HIPAA training. These coordinators 
will be trained in advance by Drs. Christopher Jones and Liz Joy, on how to instruct patients of proper usage of 
their device, how to effectively interact with subjects, the questions that may be posed, how patients should 
interpret feedback from the devices/cellphones, etc. Dr. Jones will also consult with the providers so that they 
understand the questions that may be asked by the patients and how to provide best care practices.  
If a patient agrees to participate, a consent form will be electronically signed using REDCap. Participants will 
receive a paper copy of the consent containing all relevant and study pertaining information including important 
contact information. The subject will then be randomized into a study group and given the appropriate device by 
a Research Coordinator. Each patient will download the mobile apps relevant to their group, so their data can 
be tracked and transmitted by the study team.  
• 
Group #1 will download the Dexcom G6 and Clarity apps 
• 
Group #2 will download the Contour Next ONE Diabetes application.  
• 
Both groups will also use REDCap to complete the end of study survey (Appendix A).  
All devices will be registered prior to study startup and will be matched to a deidentified subject identifier (e.g. 
Subject_001). The coordinators will answer any study related questions that the patients may have before and 
during the study along with the Reimagine Primary Care clinicians who have agreed to participate as 
collaborators during the patient’s regular appointments. Before patient’s leave the clinic, (or ±2 days) a blood 
draw will be conducted at the Reimagine site by a certified phlebotomist or approved healthcare provider to 
collect initial HbA1c level.  
3.3.1 
Inclusion Criteria  
• 
Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5% 
• 
Patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be 
prescribed one by their healthcare provider)  
• 
Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood Family Medicine, 
Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal Medicine).  
• 
Patients  18-80 years of age 
3.3.2 
Exclusion Criteria 
• 
Patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor 
by their physician) 
• 
Patients that are not treated within the four Reimagine Primary Care clinics 
• 
Patients less than 18 years of age, and 81 years of age and older 
• 
Patients with a diagnosis of dementia 
• 
If the patient is currently using a Continuous Glucose Monitor 
• 
Patients with previous hospitalization for hypoglycemia within the last 18 months 
• 
No access to a mobile phone to download the Dexcom or Contour Next applications 
• 
Patients who are pregnant or planning to become pregnant over the course of their six-month 
participation 
4.0 STUDY PROCEDURES 
4.1 
Informed Consent 
Patients that meet eligibility criteria and agree to participate will be considered for the study. These patients 
will be identified in advance through Tableau/PowerChart or on the day of the appointment in the clinic. 
Patients may be approached with a brochure and ICF in the lobby prior to their appointment but will not be 
consented until their clinic visit is completed as to not disrupt clinic flow. If approved by the patient’s provider, 
they may also be contacted by phone from a Research Coordinator (using IRB approved phone script) to 
schedule a time to meet at their RPC Clinic for recruiting.  A consent that is approved by the Intermountain 

13 
Healthcare Institutional Review Board (IRB) will be obtained prior to study inclusion, signed electronically in 
REDCap by the subject or his/her legally authorized representative, in accordance with applicable regulations.   
The informed consent process will occur at a Reimagine Primary Care facility. Research Coordinators, the 
Principal Investigator, Co-Investigators, or an appropriately delegated member of the study team may administer 
the informed consent process.   
Patients will be given as much time as they need to consider participation, ask questions, and obtain satisfactory 
answers to their questions. If a patient cannot consent due to time restraints or other conflicting obligations it will 
be allowable for the patient to return to the Reimagine Care Clinic to meet with the Research Coordinator to 
finish consenting at a later time. Patients who agree to participate, will receive a unique study identifier. Lastly, 
since patients are signing electronically, they will be provided a handout that matches their exact consent form 
to take home which will have information on who to call with questions, comments or concerns.  
4.2 
Methods 
Patients will be screened for eligibility per Inclusion and Exclusion criteria (See Sections 3.3.1 and 3.3.2 
respectively) and consented as described in Section 4.1.  
The following information will be obtained from each subject’s medical records, and/or during procedures, 
treatments, study-specific visits, and/or follow-up visits that are generally part of their usual or specialized care: 
• 
Patient’s ID number (EMPI) 
• 
General demographic information (age, gender, height, weight, race, ethnicity) 
• 
Patient’s contact information (email, home address, and phone) 
• 
Health history (personal health history, previous laboratory and glucose test results, medications, 
healthcare utilization and cost data)  
• 
Current medications/medication history 
• 
Glucose levels and historical A1c reports 
Group #2 data will be transmitted from the Contour Next One device to the Contour mobile app via Bluetooth. 
Should this process fail, a contingency plan has been devised for patients to manually record their readings in 
an online REDCap form or provide their readings to their Research Coordinator who will properly store the data. 
Patients in the intervention group will have their data automatically uploaded via the Dexcom G6 app where it 
will then be obtained by Intermountain Healthcare researchers. No protected health information will be shared 
with those outside of this research study unless approved by the IRB. Coordinators will check in with the patients 
on a monthly basis (or more frequently for non-compliance) to ensure proper data entry and to answer any 
questions (if necessary). 
4.3 
Risks 
This study is low risk. The study uses FDA approved devices that are commercially-available to track glucose 
monitoring. The Intervention Group should experience less pain than the standard of care since they will not 
have daily finger pricks, and The Control Group is the current standard of care. As with all studies that involve 
data, there is always a risk that this could be shared, however, study-related information will be stored within 
Intermountain’s system and applications that have been reviewed and approved by cybersecurity. Further, by 
using study ID number (e.g. Subject_001) rather than referring to PHI, we will minimize the risk of incidental 
disclosure.  
The Dexcom G6 is a pressure sensitive acrylic adhesive coated on top of a polyester spunlace fabric. The plastic 
housing is attached to the patch by direct pressure and heat. There is no latex or bovine components in the 
adhesive however, if the patient has a severe acrylic or polyester allergy it is possible they may experience skin 
irritation or topical allergic reactions at the site of which sensor was applied. 

14 
4.4 
Benefits 
Patients enrolled in this study may benefit by utilizing a new FDA-approved device which will provide real-time 
data on their blood glucose levels (Intervention Group). CGM may empower patients to better manage their 
diabetes, potentially resulting in better stabilized blood glucose levels, reduced patient costs and burden of care, 
as well as potentially reducing the hazard of development of diabetic complications. Additionally, data collected 
in this study might be used to improve clinical/operational decisions, potentially yielding a more efficient and 
cost-effective care process model for high-risk patients. 
5.0   END OF STUDY CONSIDERATIONS  
5.1 
Study Completion 
A participating subject will be considered to have completed the study if and only if: 
• 
He/she completed the treatment/intervention course described in this protocol 
• 
He/she has complied with all the procedures and completed the two required blood draws within the 
allowable window  
• 
He/she finished the exit survey 
5.2 
Voluntary Withdrawal of Consent 
Subjects shall have the ability to withdraw consent for study participation and/or the use of their clinical 
information at any time and for any reason, without penalty or loss of benefit to which the subject is otherwise 
entitled, by contacting the Principal Investigator or a designated member of his research team, preferably in 
writing and addressed to the Principal Investigator at the address indicated on the cover page of this protocol. 
In the case a subject enrolled in this study decides to withdraw from the research, or an Investigator decides to 
terminate a subject’s participation, study investigators must follow accepted standard practices regarding the 
management of collected data about these subjects, as follows:  
• 
Investigators must document in the research record each instance of a subject withdrawal, including the 
reasons for the withdrawal, if known. 
• 
If the subject withdraws and does not consent to continued follow-up and collection of clinical information, 
the investigator(s) will discontinue access to the subject’s medical record or other confidential records, for 
purposes related to the study. 
• 
Following the subject’s withdrawal from the study, the Study Team will no longer contact the subject nor have 
access to his/her medical records for research purposes (unless specific informed consent has been 
obtained as described above). 
5.3 
Early Termination 
The study sponsor or Principal Investigator of the study may decide to suspend or terminate a study for various 
reasons, including but not limited to the occurrence of an unanticipated problem, evidence of noncompliance, or 
serious adverse events and/or continuing noncompliance. If this occurs, the subject’s designated Research  
Coordinator will send a certified letter to the patient explaining unsuccessful attempts were made to contact the 
patient to gain compliance and will therefore be terminated from the study. The Principal Investigator or an 
appointed study staff member will then notify the IRB in writing within three days of the suspension/termination. 
This communication will include a description of what steps have or will be taken to protect the welfare of currently 
enrolled participants, and what corrective actions, if applicable, will be taken to address the root cause for the 
suspension/termination.  
5.4 
Lost to Follow-Up Subjects 
Because this is a 13-month study, with periods of time between research-related interactions, retention of 
participating subjects until study completion could be a challenging element. To facilitate subject retention, 
specific information will be obtained during the first research encounter and updated at all subsequent 
encounters.  Although critically important to the successful completion of the study, if a participant expresses 
concern and/or refuses to provide this information, they will be excluded from the research.   

15 
The following specific information will be collected and used for this purpose: 
• Contact information of the participant (i.e. phone number, email) 
This contact information will be stored in a secure database and will not be shared outside of the study-specific 
research staff. If a research participant becomes lost to follow-up, the research team will contact the subject or 
designated individuals named by the participant. A maximum of 3 telephone calls and/or email will be attempted 
for non-compliance purposes. If there is no response, an IRB-approved certified letter signed by the Principal 
Investigator requesting for a response may be sent. If contact is reestablished, interest in continued participation 
will be verbally confirmed and documented, and the participant will return to active study participation as 
appropriate, based on their status/time point in the research. With failure to re-establish contact after three direct 
attempts and a certified letter in the mail, and failure to find new contact information, the subject will be 
considered lost to follow up. 
5.5 
Records Retention  
The Principal Investigator and his/her designated research staff are responsible for maintaining accurate, 
complete, and current records relating to the conduct of the investigation, in accordance with ICH Good Clinical 
Practice guidelines (E6) and the Code of Federal Regulations (CFR) (refer to ICH GCP 8.1 to 8.4 for a list of 
essential documents for retention).   
6.0 MONITORING AND SAFETY REPORTING 
6.1 
Monitoring 
Internal monitoring of the study will be done weekly by the research coordinators assigned to the study. He/she 
will verify the accuracy of recruitment, ensure complete data entry, etc. These results will be shared monthly with 
the Savvysherpa Chair, Dr. Mark Briesacher, in the form of an emailed report or available hyperlink which 
updates in real-time. If patients are not entering their data, the research coordinator may call/email the subject 
to remind them about this ask.  
6.2 
Safety Reporting 
Since all devices used in this study are FDA approved and commercially available, it is anticipated that no safety 
reporting will be required. However, in the event of a safety issue, safety-related data for this study will be 
collected on standardized reporting forms (paper and/or electronic). Safety-related events will be defined in 
accordance with ICH GCP E6 R2, the Code of Federal Regulations, Intermountain research policy, Intermountain 
SOPs, and all current applicable regulations. These will be reported to the study Principal Investigator and 
Institutional Review Board within 24 hours. An issue would be tracked via REDCap from the Research 
coordinator and an alert triggered for key research personnel.  
Study participants who have not previously used a CGM to monitor blood glucose levels are likely to have 
questions and/or concerns about their blood glucose levels. These are most likely to occur if blood glucose levels 
decline during sleep or following exercise. Participants will be instructed to call their primary care doctor for 
advice.  
In the event any device recalls or new information pertaining to the safety/accuracy of the devices is obtained, 
the study team shall take appropriate action to ensure subject safety which will be delegated by the Principal 
Investigator. 
7.0 STATISTICAL ANALYSIS 
This study is a parallel randomized control trial that will evaluate the impact of CGM versus a standard fingerprick 
protocol, between and within randomized groups. The primary analysis (Specific Aim 1a) will measure the 
intervention effect on six-month change in HbA1c. The quantitative secondary analyses will measure the 
withinpatient longitudinal change in glycemic variability among CGM patients (Aims 1b-d) as well as the 
intervention effect on hypoglycemic events, healthcare utilization and cost (Aims 1e, 2a-b) between randomized 
groups. Additionally, for each of these aims, we will conduct exploratory sensitivity analyses: measuring provider 
variability and its effect, as well as looking at patient-level heterogeneity of treatment effect (HTE) to describe 

16 
subgroups of patients in whom the benefit of CGM might be amplified or attenuated. Technical details are 
provided in Section 7.1 Statistical Considerations. 
7.1 
Statistical Considerations 
The primary analysis (Aim 1a) will measure the intervention effect on the patient-level six-month absolute 
reduction in mean HbA1c. Since not all patients will have their final HbA1c test at six months exactly, we will 
estimate each patient’s six-month reduction in HbA1c by interpolating/extrapolating from their assessments, 
given that their HbA1c levels were assessed on at least two occasions: baseline, and >3 months post baseline. 
Then, among patients with a sufficient number of occasions of HbA1c assessments, we will estimate their 
sixmonth HbA1c using generalized linear mixed models with patient-level random slopes and intercepts, with 
appropriate link function and distributional family [8]. The quantitative secondary analyses (Aims 1b-e, 2a-b) will 
use outcomes related to the longitudinal change in various metrics of glycemic variability (MAGE, Cv, range) as 
well as the frequency of hypoglycemic events, healthcare utilization, and cost. The secondary analyses will also 
use longitudinal data analysis to assess whether there is a significant reduction in glycemic variability over six 
months (Aims 1b-d) among those randomized to CGM, whether there is a significant reduction in hypoglycemic 
events over six months (Aim 1e) among those randomized to CGM, and to assess whether overall healthcare 
utilization and costs differ between randomized groups [9]. Accordingly, specific aims 1b-e will rely heavily on 
longitudinal data analysis within a multilevel/hierarchical framework [10], specifically using generalized linear 
mixed models. In the sensitivity analyses, provider variability will be accounted for using three-level (provider, 
patient, occasion), quasi-Bayesian generalized linear mixed models [11]. Finally, the sensitivity analyses 
exploring HTE will use generalized additive models (GAM) to identify subgroups of patients for whom CGM is 
likely to have a differential effect [12-13]. 
7.2 
Sample Size and Power 
Based on 2018 data pulled from Intermountain’s diabetes registry, we estimate that the four RPC clinics 
(Cottonwood FM, Cottonwood Sr, Holladay IM, and Avenues IM) will see about 30, 22, 17, and 6 study-eligible, 
unique patient encounters per month, respectively, yielding up to about 75 recruitable patients per month (up to 
225 over three months of enrollment). We estimate that enrolling 125 patients – expecting 20% attrition by the 
sixth-month follow-up, yielding 100 patients for analysis – would be sufficient to achieve >80% power for the 
primary analysis (absolute reduction in HbA1c) if the standardized difference d of the effect size is >0.8 (Figure 
2). Here, the standardized difference d is measured in terms of the difference between the randomized 
grouplevel means of six-month changes in HbA1c. So, for example, a standardized difference d in the effect size 
of 0.8 might be observed if the true effect size is, say, -1 (that is, if the difference between the means is -1) and 
the standard deviation of change is 1.25. Details of the power analysis will be made available upon request. 

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18 
Opportunity will be given for Savvysherpa to also review the content and the conclusions drawn before the 
abstracts, papers or visual presentations are finalized, in accordance with the clinical research contract.   
9.0 FINANCIAL CONSIDERATIONS 
9.1 
Funding Source 
This project will be internally funded through the Business Development group at Intermountain Healthcare.  
9.2 
Compensation 
Subjects will not receive any monetary or other forms of compensation for participating in this research study. 
Likewise, the investigators and their research staff will not receive any monetary or other forms of direct 
compensation for conducting this research study. Subjects who receive the Contour Next ONE will be asked to 
mail the device back to The Business Development Department at Intermountain Healthcare in a prepaid mailing 
envelope supplied to the patient upon study completion to ensure no compensating factors took part in the 
research study. 
9.3 
Disclosure of Conflicts of Information 
The Principal Investigator, Co-Principal Investigator, Sub-Investigators and protocol authors declare that they 
have no conflicts of interest relevant to this study. 
 

19 
10.0 
REFERENCES 
1. https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes 
2. http://www.diabetes.org/advocacy/news-events/cost-of-diabetes.html 
3. https://www.cdc.gov/diabetes/basics/prediabetes.html 
4. Lee PA, Greenfield G, Pappas Y. BMC Health Services Research (2018) 18:495. 
5. Home Telemonitoring for Type 2 Diabetes. Ontario Health Technology Assessment Series 2009; Vol. 9, 
No. 24. 
6. https://professional.diabetes.org/diapro/glucose_calc 
7. Eklaspour L, Mondesir D, Lautsch N, Balliro C, Hillard M, Magyar K, Gorergen Radocchia K, Esmaeili A, 
Sinha M, Russel S. J Diabetes Sci Technol. 2017 May; 11(3): 558–566. 
8. Rabe-Hesketh S, Skrondal A. Generalized latent variable modeling: Multilevel, longitudinal, and structural 
equation models. Chapman and Hall/CRC; 2004 May 11. 
9. Gelman A, Hill J. Data analysis using regression and multilevel/hierarchical models. New York, NY, USA: 
Cambridge University Press; 2014. 
10. Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis. John Wiley & Sons; 2012 Oct 23. 
11. Fong Y, Rue H, Wakefield J. Bayesian inference for generalized linear mixed models. Biostatistics. 2010 
Jul 1;11(3):397-412. 
12. Wood SN. Generalized additive models: an introduction with R. Chapman and Hall/CRC; 2006 Feb 27. 
13. Stasinopoulos MD, Rigby RA, Heller GZ, Voudouris V, De Bastiani F. Flexible regression and smoothing:  
using GAMLSS in R. Chapman and Hall/CRC; 2017 Apr 21. 
11.0 
    PROTOCOL SIGNATURE PAGE 
 PROTOCOL IDENTIFICATION  
Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Clinics 
PRINCIPAL INVESTIGATOR AGREEMENT  
I agree to conduct this research study in accordance with the design and specific provisions of this protocol.  
Deviations from the protocol are acceptable only with a mutually agreed upon protocol amendment and approval 
by the Institutional Review Board (IRB). I also agree to report all information or data in accordance with the 
protocol. I agree to report any serious adverse experiences as defined in the Safety Reporting section of this 
protocol to the Intermountain IRB, and in accordance with the IRB’s reporting requirements.  
____________________  
____________________ 
____________________ 
Principal Investigator 
Principal Investigator 
              Date 
(Printed Name) 
(Signature) 
 

20 
12.0 
    APPENDIX A 
This section provides the questions which will be entered into REDCap and patients asked to complete at the 
end of the CGM study. There will be branching logic used based on the specific group assigned.  
1. 
Which group were you assigned to? 
a. Group 1 (Dexcom G6) 
b. Group 2 (ContourNext One) 
2. 
What was the main reason that you signed up for this trial? _______________________. 
3. 
What was your biggest concern when you considered participating in this trial? 
______________. 
4. 
Were you initially disappointed with your group assignment?  
a. Yes 
b. No 
4b. Why were you disappointed with your group assignment? _______________________. 
5. 
(For Group 1 participants): Did the Dexcom G6 impact your glucose management? For 
example, did it change your diet? 
a. Yes 
b. No 
6. 
(For Group 1 participants): Did the Dexcom G6 impact your glucose management? For 
example, did it change your exercise regimen? 
a. Yes 
b. No 
7. 
How did Dexcom G6 impact your glucose management? ________________________. 
8. 
(For Group 1 and 2 participants): On a scale of 1-5, where 1 is not helpful and 5 is extremely 
helpful, how would you rate the device?  
9. 
(For Group 1 and 2 participants): On a scale of 1-5, where 1 is extremely poor and 5 is 
extremely healthy, how would you rate your health BEFORE starting this study? 
10. (For Group 1 and 2 participants): On a scale of 1-5, where 1 is extremely poor and 5 was 
extremely healthy, how would you rate your health AFTER starting this study was completed? 
11. (For Group 2 participants): Did the ContourNext One impact your glucose management? For 
example, did it change your diet? 
12. (For Group 2 participants): Did the ContourNext One impact your glucose management? For 
example, did it change your exercise regimen? 
13. How did the ContourNext One impact your glucose management? ___________________. 
14. Did your glucose levels decrease between the initial enrollment and the end of the study?  
(Suggest inserting this filter question.) 
a. They increased 
b. The decreased 

21 
c. No change 
15. Would you be willing to participate in future Intermountain pilots in your primary care clinic?a. 
Yes 
b. No 
16. General Comments. In the space provided, please feel free to add any other comments 
regarding your participation in this study. _______________________________________.