Effect of CGM Initiation Approach on Time In Range in People With Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: Holly Willis

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Effect of CGM Initiation Approach on Time In Range in People with Type 2 Diabetes 
 
Protocol Version Number: 5.0  
Protocol Version Date: 14Feb2024 
 Funding Mechanisms: 
• 
American Diabetes Association; Grant #7-22-JDFN-27 
• 
Dexcom 
• 
Park Nicollet Foundation 
Industry Support: Dexcom providing continuous glucose monitoring supplies 
Informal Study Names: My Diabetes Study and UNITE (Using Nutrition to Improve Time in RangE) 
ClinicalTrials.gov number: NCT05928572 
 
 
Principal Investigator: Holly Willis, PhD, RDN, CDCES 
Phone: 952-993-3219 
E-mail: holly.willis@parknicollet.com 
Co-Investigator: Richard M. Bergenstal, MD 
Phone: 952-993-1913 
Email: richard.bergenstal@parknicollet.com 
Co-Investigator: Meghan JaKa, PhD 
Phone: 952-967-5208 
Email: Meghan.M.JaKa@HealthPartners.com 
 
CONFIDENTIAL 
 
This document is confidential and the property of International Diabetes Center. No part of it may be 
transmitted, reproduced, published, or used by other persons without prior written authorization. 

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Table of Contents 
1. 
Abbreviations ................................................................................................................................... 4 
2. 
Protocol Summary ............................................................................................................................ 6 
3. 
Study Schema ................................................................................................................................... 7 
4. 
Schedule of Activities ........................................................................................................................ 8 
5. 
Phase 1 Background ....................................................................................................................... 10 
6. 
Phase 2 Background ....................................................................................................................... 12 
7. 
Rationale and Objective ................................................................................................................. 12 
8. 
Risk and Benefit .............................................................................................................................. 13 
Known Potential Risks ................................................................................................................................. 13 
Known Potential Benefits ............................................................................................................................ 14 
Analysis of Risks in Relation to Benefits ...................................................................................................... 14 
9. 
Phase 1 Study Objectives ............................................................................................................... 14 
Primary Objective ......................................................................................................................................... 14 
Secondary Objective .................................................................................................................................... 14 
Exploratory Objectives ................................................................................................................................ 14 
10. 
Phase 2 Study Objectives ............................................................................................................... 14 
Primary Objective ......................................................................................................................................... 15 
Exploratory Objectives ................................................................................................................................ 15 
11. 
Phase 1 Study Outcome Measures ................................................................................................. 15 
Primary Outcome ........................................................................................................................................ 15 
Secondary Outcome .................................................................................................................................... 15 
Exploratory Outcomes ................................................................................................................................. 16 
12. 
Phase 2 Study Outcome Measures ................................................................................................. 17 
Primary Outcome ........................................................................................................................................ 17 
Exploratory Outcomes ................................................................................................................................. 17 
13. 
Study Design ................................................................................................................................... 19 
14. 
Participant Population .................................................................................................................... 19 
Inclusion Criteria ......................................................................................................................................... 19 
Exclusion Criteria ......................................................................................................................................... 20 
15. 
Study Procedures ........................................................................................................................... 20 
Recruitment and Screening ......................................................................................................................... 20 
Consenting ................................................................................................................................................... 21 

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Screen Failure .............................................................................................................................................. 21 
CGM Device Use .......................................................................................................................................... 21 
Phase 1: Baseline Period ............................................................................................................................. 21 
Randomization............................................................................................................................................. 22 
Phase 1: Intervention .................................................................................................................................. 22 
Nutrition-Focused Approach ........................................................................................................................ 23 
Self-Directed Approach ............................................................................................................................... 23 
Phase 1: Post-Intervention Period ............................................................................................................... 24 
Phase 1: Study Completion.......................................................................................................................... 24 
Phase 2: Follow-Up Period .......................................................................................................................... 24 
Detailed Schedule of Activities ..................................................................................................................... 24 
16. 
Study Device Management ............................................................................................................ 27 
17. 
Early Termination and Participant Withdrawal .............................................................................. 27 
18. 
Lost to Follow-Up ........................................................................................................................... 27 
19. 
Protocol Deviations ........................................................................................................................ 27 
20. 
Assessment of Safety ..................................................................................................................... 27 
Adverse Event .............................................................................................................................................. 27 
Serious Adverse Event ................................................................................................................................. 27 
Unanticipated Event .................................................................................................................................... 28 
Unanticipated Problems Involving Risks to Subjects or Others ................................................................... 28 
21. 
Safety Reporting ............................................................................................................................. 29 
22. 
Study Suspension or Discontinuation .............................................................................................. 29 
23. 
Statistical Considerations ............................................................................................................... 30 
Phase 1: Statistical Hypotheses ................................................................................................................... 30 
Phase 2 Statistical Hypothesis ..................................................................................................................... 30 
Sample Size Determination ......................................................................................................................... 30 
Populations for Analysis ............................................................................................................................... 31 
General Approach for Statistical Analyses in Phase 1 ................................................................................. 31 
Analysis of Primary Endpoint ....................................................................................................................... 32 
Analysis of Secondary Endpoint .................................................................................................................. 32 
Safety Analysis ............................................................................................................................................. 32 
General Approach for Statistical Analyses in Phase 2 ................................................................................. 32 
Planned Interim Analysis ............................................................................................................................. 33 

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Sub-Group Analyses .................................................................................................................................... 33 
Analysis of Exploratory Endpoints in Phase 1 .............................................................................................. 33 
Analysis of Exploratory Endpoints in Phase 2 .............................................................................................. 33 
24. 
Data Collection and Management .................................................................................................. 34 
25. 
Data Monitoring ............................................................................................................................. 34 
26. 
Data Sharing ................................................................................................................................... 34 
27. 
Record Keeping and Retention ....................................................................................................... 35 
28. 
Confidentiality and Privacy ............................................................................................................. 35 
29. 
Ethics and Protection of Human Subjects ...................................................................................... 35 
30. 
Conflict of Interest .......................................................................................................................... 36 
31. 
References ...................................................................................................................................... 36 
1. Abbreviations 
 
Abbreviation 
Definition 
AE 
Adverse event 
ADA 
American Diabetes Association 
ASA24 
Automated self-administered 24-Hour dietary assessment tool 
BGM 
Blood glucose monitoring 
BMI 
Body mass index 
CGM 
Continuous glucose monitoring 
CI 
Confidence interval 
EMR 
Electronic medical record 
HbA1c 
Glycated hemoglobin 
HCP 
Healthcare provider 
HEI 
Healthy eating index 
HIPAA 
Health insurance portability and accountability act 
IRB 
Institutional review board 
ICF 
Informed consent form 
ID 
Identification 
IDC 
International Diabetes Center 
ITT 
Intention to treat 
MOP 
Manual of procedures 
NFA 
Nutrition-focused approach 
PP 
Per protocol 
PRO 
Patient reported outcome 
PWD 
People with diabetes 
RDN 
Registered dietitian nutritionist 
SAE 
Serious adverse event 
SDA 
Self-directed approach 
SOC 
Standards of medical care 

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T2D 
Type 2 diabetes 
TIR 
Time in range 
UPIRTSO 
Unanticipated problems involving risks to subjects or others 

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2. Protocol Summary 
 
Title: 
Effect of CGM Initiation Approach on Time In Range in People with 
Type 2 Diabetes 
Population: 
Adults >18 years with T2D who are not using insulin or other anti- 
hyperglycemic agents with a known hypoglycemia risk 
Intervention: 
Use of a nutrition-focused approach versus a self-directed approach 
during CGM initiation 
Phase 1 Objective: 
To evaluate the effect of using a nutrition-focused approach versus 
a self-directed approach during CGM initiation on CGM-derived 
metrics, dietary intake assessment, and patient reported outcomes 
Phase 2 Objective: 
To evaluate the impact of discontinuing CGM for 4 months after the 
completion of the Phase 1 study intervention on CGM-derived 
metrics, dietary intake assessment, and patient reported outcomes 
Phase 1 Outcome Measures: 
Primary: Differential change in CGM-derived TIR (% time with 
glucose 70-180 mg/dL) from baseline to post-intervention between 
NFA and SDA arms 
Secondary: Difference in total Healthy Eating Index score during the 
post-intervention period between NFA and SDA arms 
Phase 2 Outcome Measure: 
Primary: Change in CGM-derived TIR (% time with glucose 70-180 
mg/dL) from post-intervention to 4-month follow-up for combined 
NFA and SDA arms 
Design: 
Two month non-pivotal, randomized, parallel group, two-arm, 
prospective, pilot study. 1:1 randomization to either NFA or SDA 
during CGM initiation. Follow-up assessment four months after 
discontinuing CGM. 
Total Study Duration: 
Approximately 22 to 26 months (18-24 months to complete Phase 1 
and 4 additional months to complete the Phase 2 follow-up) 
Participant Duration: 
Phase 1: Approximately 60 days 
Phase 2: Approximately 120 days 

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3. Study Schema 

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4. Schedule of Activities 
 
 
Baseline 
(10 days) 
Intervention 
(~50 days including 
the 10-day post- 
intervention period) 
Post-Intervention 
Assessment & 
Study Completion 
(10 days) 
Follow-Up 
Assessment 
(10 days) 
Study Phase 
Phase 1 
Phase 2 
Contact 
1 
2 
3 
4 
5 
6 
7 
Visit Type 
Clinic (Day -11) 
Clinic 
Remote 
N/A 
Clinic 
Clinic 
N/A 
Study Day(s)1 
-11 to -1 
0 
14 (+7) 
40 (+7) 
50 (+7) 
170 (+14) 
180 (+7) 
Consent 
X 
HbA1c 
X 
X 
X 
Demographics 
X 
Up to 10-Day Blinded G7 CGM Assessment 
X 
X 
Blinded G7 CGM Data Downloaded and Saved 
X 
X6 
ASA24 Diet Recall 
X 
X4 
X5 
X 
X5 
X 
DietID Diet Recall 
X 
X 
PROs: Diabetes Distress, Diet Adherence, 
Efficacy Surveys, and Diabetes Self Care 
X 
X 
X 
PROs: Intervention Fidelity and Post- 
Intervention Surveys 
X 
Diabetes Medication Assessment 
X 
X 
X 
X 
X 

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BP, Weight, Height2 
X 
X 
X 
Randomization3 
X3 
Participant Receives Randomization Assignment 
X3 
CGM Initiation / Education (based on 
randomization arm) 
X 
X 
Continuous Real-time G7 CGM Use 
X 
Real-time G7 CGM Data Downloaded and Saved 
X 
X 
Up to 10-Day Real-time G7 CGM Assessment 
Begins 
X 
Adverse Events 
X 
X 
1 If indicated, up to seven or 14 days can be added to or subtracted from the specified contact date to allow for scheduling flexibility; 2 Height at 
baseline only; 3 Randomization occurs for scheduling purposes only; the randomization assignment is not shared with the participant during Contact 
1 and will not be shared at Contact 2 until a minimum of 7 days of blinded G7 CGM data are confirmed; 4 This ASA24 is considered part of the 
baseline assessment and should occur before any of the Contact 2 activities 5 Two ASA24 assessments on non-consecutive days should be 
completed during the post-intervention and follow-up periods, one should occur on approximately Day 40 and Day 170 and one on approximately 
Day 50 and Day 180 6 Participants may have the option to return receivers via postal mail; if this occurs, data download will be delayed 

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5. Phase 1 Background 
 
More than 37 million people in the United States have diabetes, and type 2 diabetes (T2D) accounts for 
90-95% of all diagnosed cases. The number of adults diagnosed with diabetes has more than doubled in 
the last 20 years,1 which suggests increasing burden on the economy, healthcare system, and families 
affected by the disease. Options to help manage T2D are more important than ever before. 
 
Nutrition interventions have long been recognized as a critical component of diabetes management, 
with some interventions in people with T2D demonstrating up to 2% reductions in glycated hemoglobin 
(HbA1c).2 Despite knowing that nutrition can be a powerful driver for improved glycemic outcomes, like 
HbA1c, people with diabetes (PWD) have described determining what to eat as the most challenging 
part of their treatment plan.2 More specifically, one survey showed that 64% of people with T2D who do 
not use insulin rated food choices as having the “biggest impact” on their daily life.3 
 
Current guidance from the American Diabetes Association (ADA) Standards of Medical Care (SOC) states 
there is no “one-size-fits-all” eating pattern, or ideal macronutrient distribution, that works for all 
people with diabetes.2 A variety of eating patterns (e.g., Mediterranean, very-low-carbohydrate, 
vegetarian) have demonstrated good efficacy for PWD. However, diet quality is an important factor no 
matter which eating pattern someone chooses. Dose-dependent, inverse associations have been 
observed between higher diet quality and total or cause-specific mortality.4 Specifically for people with 
T2D, one study showed mortality risk was 87% greater for people with the lowest quality diet compared 
to the highest quality,5 and another study showed that higher quality diets, as part of an overall healthy 
lifestyle, were associated with a significantly lower risk of microvascular complications.6 Diet quality has 
also been shown to impact glycemia in people with T2D, with lower quality diets showing nearly three- 
fold odds of poorer glycemic measures compared to higher quality diets.7 
 
Diet quality can be assessed using several standardized approaches.8 The Healthy Eating Index (HEI), 
which assesses the degree to which an eating pattern aligns with the Dietary Guidelines for Americans, 
is one well-recognized diet quality indice.9 The HEI is a scoring method that includes (scores) 13 dietary 
components, with nine components for which greater consumption is desirable (e.g. total vegetables, 
whole grains) and four components for which lower consumption is desirable (e.g. added sugar, refined 
grains).9 The HEI is density-based, meaning it considers diet quality from the perspective of how foods 
are consumed in relation to total kcals consumed (i.e. quality not the quantity of what is eaten). 
Therefore, calculation of the HEI requires comprehensive dietary intake assessment, such as from 24- 
hour recalls or food frequency questionnaires. The ASA24 (Automated Self-Administered 24-hour) recall 
is an example of a program that uses a validated approach to collect 24-hour dietary recalls and that 
also includes statistical analysis coding support to assist with the HEI calculations.8 
 
The ADA,2 the American Heart Association (AHA),10 and other professional societies11 indirectly address 
diet quality by encouraging core principles for any eating pattern. The ADA, for example, places 
emphasis on choosing more non-starchy vegetable intake, minimizing added sugars and refined grains, 
and choosing whole foods over highly processed foods whenever possible. It is reasonable to believe 
that adherence to these principles would improve diet quality. 
 
People with T2D often learn about how food affects their glucose by performing intermittent 

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fingersticks. However, fingersticks provide only single moments in time and do not show the full extent 
of glucose changes surrounding food intake; this may partially explain why infrequent fingerstick glucose 
testing has not been associated with improved glucose management in people with T2D who do not use 
insulin.12 
 
Continuous glucose monitoring (CGM) is an alternative to fingerstick glucose monitoring. A key benefit 
of CGM is its ability to show constant, real-time glucose and granular changes in glycemia over short and 
long periods of time. The ADA recognizes CGM as an effective tool to guide medical nutrition therapy 
and other lifestyle changes, and also states that CGM can provide insights into more personalized 
diabetes care.13 The ADA calls out ten core metrics that should be considered when evaluating CGM 
data. There is specific emphasis on time in range (TIR), which is defined as more than 70% of time with 
glucose in the target range of 70-180 mg/dL; this applies to most people with T2D.14 A seven to 14-day 
TIR percentage has been shown to correlate with HbA1c15,16 and emerging data suggest TIR is also 
inversely associated with risk of diabetes-related complications.17 
 
The beneficial impact of CGM on glycemia in people with type 1 diabetes and people with T2D who use 
insulin is well established.13 However, the impact of CGM on glycemia in people with T2D who do not 
use insulin is less clear, and its effects may be somewhat different than what is seen in those who do use 
insulin (or medications with daily titrations). In the case of people with T2D who do not use insulin—and 
who remain on a stable medication regimen after starting CGM—the glycemic improvements are likely 
driven by lifestyle changes (since improvements would not be due to medication additions or daily 
medication titrations). The idea that lifestyle changes may drive glycemic improvements in people with 
T2D who use CGM has been considered by emerging research,18-20 with some research specifically 
suggesting that CGM may enhance patient engagement and motivate or modify behavior changes.19,21-24 
Because CGM provides immediate, personalized feedback (real-time and retrospectively)—in an 
accessible, convenient manor—this device could be used specifically to optimize dietary changes in 
people with T2D who do not use insulin. 
 
Limited research has been done to directly assess the impact of using CGM to guide food choices, 
specifically food changes that align with current evidence-based nutrition recommendations. Choe et al 
investigated the effect of using CGM to motivate lifestyle change focused on eating behaviors in adults 
who were T2D treated with basal insulin or less intense therapies.25 In this study, fingerstick blood 
glucose monitoring (BGM) was the comparator and change in HbA1c was the primary outcome. The 
CGM arm showed a greater improvement in HbA1c compared to the BGM arm after 12 weeks (-0.6% 
versus -0.1%; p<0.001); however, changes in CGM metrics and detailed changes in food intake between 
groups were not reported. 
 
HbA1c is commonly used to evaluate glycemic outcomes in clinical research. However, recent guidance 
recognizes TIR as an acceptable end point for clinical trials and a standardized approach to CGM data 
collection and reporting in clinical trials has been published.14,26 
 
To date, it appears no research has been done to evaluate the impact of CGM on TIR when CGM is 
introduced specifically as a tool to guide glucose and high-quality food choices in people with T2D. Phase 
1 of the following protocol describes a randomized pilot trial intended to explore the efficacy of using a 
theory-driven, nutrition-focused approach (NFA) during CGM initiation. This Phase 1 research will 
evaluate the difference between a NFA and a self-directed approach (SDA) during CGM initiation in 
people with T2D who are not using insulin. The SDA is intended to reflect usual care and the way CGM is 
often introduced to PWD. 

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6. Phase 2 Background 
 
Limited research has been done to evaluate the impact of discontinuing CGM in adults with T2D, and it 
appears no research has been published on the impact of discontinuing CGM in people with T2D who do 
not use insulin and who have used CGM specifically for lifestyle changes. 
The MOBILE study compared glycemic outcomes after eight months of CGM or BGM in adults with T2D 
using basal insulin.27 At the end of eight months, the use of CGM resulted in greater glycemic 
improvements than the use of BGM. In a 6-month MOBILE study follow-up, participants originally 
randomized to CGM were re-randomized to either continue their CGM or discontinue their CGM. 
Discontinuation of CGM resulted in a loss of about one-half of the initial TIR gain (i.e. the 24% gain in TIR 
from the start to the end of the MOBILE intervention was reduced to a 12% gain in TIR by 6 months after 
the intervention); whereas, continuation of CGM resulted in a stable TIR.28 Investigators speculated that 
given only minimal changes in insulin dose during the follow-up period, the reduction in TIR for the CGM 
discontinuation arm was likely due to behavioral changes related to lack of CGM data access. It is 
unclear when the TIR gain was lost over the 6-month follow-up period. It is also unclear which behaviors 
may have changed since neither objective nor subjective measurements were evaluated. 
Similarly, in a small study (n=46), adults with T2D used a real-time CGM for 90 days; 90 days later about 
half of the adults (n=21) wore a blinded CGM.29 Discontinuation of the CGM was associated with 
worsening glycemic control. Compared to the real-time CGM wear period and 90 days after CGM 
discontinuation, TIR was 15% lower during the blinded CGM wear period (67% vs. 82%; p<0.05). 
The Phase 2 research will assess the impact of discontinuing CGM 4 months after the completion of the 
Phase 1 study intervention on CGM-derived metrics, dietary intake assessment, and patient reported 
behaviors and outcomes. Both groups, those who received the NFA and the SDA during CGM initiation, 
will be invited to participate. The Phase 2 research will help describe the effect of discontinuing CGM 
therapy in people with T2D who do not use insulin and who have used CGM specifically to initiate 
lifestyle changes. Some objective and subjective behavior changes will also be assessed, which may help 
explain potential changes in TIR. 
 
7. Rationale and Objective 
 
People with diabetes want to achieve their glycemic targets. One survey showed that 93% of people 
with T2D state that they are ‘very willing’ or ‘somewhat willing’ to do more to achieve better glycemic 
control.30 Another survey reported that 42% of people with T2D said it is hard to know what food is 
healthy and 80% reported a desire for more nutrition information.31 
Nutrition plays a profound role in human health.32 Unfortunately, nutritional intake (as measured by diet 
quality) is quite poor in the United States.33 The average diet quality score based on HEI-2015 is 58 on a 
scale that ranges from 0 of 100; this is equivalent to a letter grade of D. Higher quality diets are 
associated with better glycemic outcomes and reductions in comorbidities in people with T2D. At the 
same time, observational research has shown that very few people improve their diet quality after a T2D 
diagnosis, thus suggesting that additional strategies and/or interventions are needed to help improve 
dietary intake.34 

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CGM provides personalized, accessible glucose data, and CGM use has been shown to lead to better 
glycemic outcomes.13 Various tools,22 methods,35 and programs36 exist to educate CGM users on 
effective use of the technology and its associated data. However, specific emphasis on nutrition 
guidance has not been embedded into these trainings and, thus, potentially misses the opportunity to 
achieve the additional glycemic benefits associated with improved dietary intake. 
Opportunities exist to assess whether presenting nutrition guidance during CGM initiation could 
improve glycemic outcomes and diet quality for the growing population of people with T2D. This 
research will help determine if it is useful to introduce the CGM as a device that can guide personalized 
nutrition recommendations with focus on diet quality (i.e. food choices that align with current evidence- 
based nutrition recommendations for PWD). 
This work is important because it will show how CGM users respond to CGM data with and without 
nutrition guidance and whether there is added benefit for glycemic outcomes and diet quality with a 
nutrition-focused approach. This is different from other CGM studies because it will directly address 
nutrition as a driver for improved TIR, and it will also measure how diet quality changes. 
Currently, CGM is only accessible to a limited number of people with T2D who do not use insulin but, 
there are some signs suggesting that expanded recommendations for CGM use and coverage may be 
coming.20,37,38 When (if) that time comes, the diabetes care community would benefit from being 
prepared with researched approaches for initiating the technology, especially in a way that may 
promote improved diet quality. 
This research will also fill a knowledge gap by providing insight into the dietary intake and eating 
patterns of people with T2D. Results of this research may allow future interventions in people with T2D 
to target nutrition areas where there is the greatest room for improvement and/or impact. 
The objective of the Phase 1 research is to evaluate the effect of using a NFA versus a SDA during CGM 
initiation on CGM-derived metrics, dietary intake, and patient-reported outcomes (PROs) in people with 
T2D who do not use insulin. The objective of the Phase 2 research is to help explain any impact of 
discontinuing CGM use in people with T2D who do not use insulin. 
8. Risk and Benefit 
 
Known Potential Risks 
 
CGM use: CGM use is a routine part of the care for many PWD. CGM users usually report less pain or 
discomfort with CGM than with capillary blood glucose testing. Mild pain on insertion of CGM may be 
experienced by subjects at low frequency. Known allergies to medical grade adhesives is an exclusion 
from participation. Cutaneous complications of CGM use are typically wear-related erythema, itching, 
and induration. The incidence of these complications is expected to be low, 0.13 to 0.15 events per 
week of wear-time, with the majority (79%) being mild.39 Study discontinuation rate due to skin 
reactions is expected to be very low. 
 
Blood samples: Blood sample for HbA1c is a standard care procedure which could occur regardless of 
participation in this study; however, the interval between the baseline HbA1c and the post-
intervention HbA1c is shorter than what may be recommended by routine care (approximately 60 days 
rather than 90 days). 
 
Blood samples for HbA1c may be collected by venipuncture or fingerstick. Venous blood draws may cause 
discomfort and bruising at the puncture site. Participants may also experience lightheadedness or fainting during 

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the blood draw and there is a slight risk of infection. The total blood volume needed for each HbA1c test is less 
than 5 mL. Blood sample by fingerstick may cause discomfort and bruising at the puncture site and there is 
a slight risk of infection. The total blood volume needed for each point-of-care fingerstick HbA1c test is 
minimal. 
 
Privacy: The study requires use of web-based applications, which include providing personal information 
and personal health information. There is always some risk that data will be compromised, and that 
personal information will become available to unexpected parties. Several mechanisms are in place to 
protect personal information, including use of de-identified participant identification (ID) numbers 
whenever possible. 
 
Surveys: Surveys will be used to collect information on food intake and other PROs. Sometimes survey 
questions can trigger uncomfortable feelings. Participants will be informed that they are not required to 
respond to questions that make them uncomfortable for whatever reason. 
 
Known Potential Benefits 
 
There is no guaranteed personal benefit from participating in this study. However, participants in both 
arms of the study may benefit from seeing and using their CGM data. CGM data may aid in a better 
understanding of how foods, behaviors, medications, and circumstances impact glucose values. 
Participants in the NFA arm may receive additional benefits because they will receive instruction and 
education on using CGM data specifically to adjust eating behaviors in ways that align with current 
nutrition recommendations. 
 
Additionally, information from this study could lead to new and more effective methods for helping 
people with T2D manage their diabetes and/or adhere to nutrition therapies. 
 
Analysis of Risks in Relation to Benefits 
 
In this study, risks posed beyond standard care are minimal. The rationale for exposing study 
participants to the minor risks associated with CGM use, blood samples, privacy, and survey data 
collection is that these components of usual diabetes care are outweighed by the potential benefit to 
future people with diabetes (if this study can help define ideal approaches to CGM initiation in this 
population). 
 
9. Phase 1 Study Objectives 
 
Primary Objective 
To evaluate the effect of using a NFA versus a SDA during CGM initiation on CGM-derived TIR. 
Secondary Objective 
To evaluate the effect of using a NFA versus a SDA during CGM initiation on dietary quality. 
Exploratory Objectives 
To describe the effects of using a NFA versus a SDA during CGM initiation on additional CGM-derived 
metrics, components of dietary intake, other markers of health, and PROs. To describe potential 
behavioral mechanisms associated with change in study outcomes. 
 
 
 

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10. Phase 2 Study Objectives 
Primary Objective 
To evaluate the impact of CGM discontinuation 4 months after the completion of the Phase 1 study 
intervention on CGM-derived TIR. 
Exploratory Objectives 
To describe changes in additional CGM-derived metrics, HbA1c, dietary intake assessment, medication 
use, and PROs 4 months after the completion of the Phase 1 study intervention and CGM 
discontinuation. 
 
11. Phase 1 Study Outcome Measures 
 
At the end of the Phase 1 intervention, differences from baseline will be assessed within and between 
study arms (primary outcome). The baseline period includes an approximately 10-day assessment 
before the intervention begins. The intervention begins on Day 0 and stops on approximately Day 50, 
this includes the 10-day post-intervention assessment. The post-intervention assessment period occurs 
approximately Day 40 to Day 50; during this time, participants continue in their intervention arm and 
continue using their CGM as instructed. 
 
CGM-related outcome measures include approximately 10 days of CGM data collection during the 
baseline and the post-intervention assessment periods. CGM data is collected as follows: 
 
• 
Baseline: Up to 10 days of CGM data from a Dexcom G7 sensor paired with a physically blinded 
Dexcom receiver 
• 
Post-intervention: Up to 10 days of CGM data from a Dexcom G7 sensor paired with apps on the 
participant’s personal cell phone (glucose data transferred to study team via cloud) 
 
Of note, G7 data is identical whether data is pulled through a Dexcom receiver or a participant’s 
personal cell phone. The only difference between the two scenarios is that the participant will not be 
able to view their glucose data during the baseline period (blinded data). 
 
Primary Outcome 
 
Outcome 
Assessment Method 
1.  Change in CGM-derived TIR (% time with glucose 70-180 
mg/dL) from baseline to post-intervention 
See CGM-related outcome 
measures described above 
 
Secondary Outcome 
 
Outcome 
Assessment Method 
1. Difference in total HEI score between groups during the post- 
intervention period 
Automated Self-Administered 
24-hour (ASA24®) survey- 
derived total HEI-2015* score; 
score based on two diet recalls 
per assessment period, 
collected via web-based survey 
(ASA24 Version 2022 or later) 

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*Survey-derived HEI-2015 scores may be replaced with a newer scoring option if both scoring and 
 analysis code become available 
 
 
Exploratory Outcomes 
 
 
Outcome 
Assessment Method 
1. Change in other CGM-derived core metrics from baseline to 
post-intervention; including as described by the 24-hour period, 
daytime period (6AM to 11:59PM), and nighttime period (12AM 
to 5:59PM): 
• 
number of days CGM device is worn 
• 
% time CGM sensor is active 
• 
mean sensor glucose mg/dL 
• 
% coefficient of variation 
• 
glucose management indicator (GMI) 
• 
% time above >250 mg/dL 
• 
% time above >180 mg/dL 
• 
% time below <70 mg/dL 
• 
% time below <54 mg/dL 
See CGM-related outcome 
measures described above 
2. Other CGM-derived metrics: 
• 
Change in % time in tight range (% time with glucose 70- 
140 mg/dL) from baseline to post-intervention 
• 
% of participants reaching CGM-derived consensus 
targets during post-intervention26 
o % reaching >70% TIR (% time with glucose 70- 
180 mg/dL) 
o % reaching ≥5% improvement in TIR (% time 
with glucose 70-180 mg/dL) compared to 
baseline 
o % reaching >70% time TIR (% time with glucose 
70-180 mg/dL) and reaching a ≥5% 
improvement in time in range compared to 
baseline 
See CGM-related outcome 
measures described above 
3. Describe HEI component scores by group during the post- 
intervention period 
ASA24 survey-derived HEI- 
2015* component scores; 
scores based on two diet 
recalls per assessment period, 
collected via web-based 
survey (ASA24 Version 2022 or 
later) 
4. Change in additional nutrition metrics from baseline to post- 
intervention 
• 
total energy intake 
• 
macronutrients and fiber 
ASA24 survey-derived values 
based on two diet recalls per 
assessment period, collected 
via web-based survey (Version 
2022 or later) 

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• 
select micronutrients 
5. Change in patient-reported outcome survey scores from 
baseline to post-intervention 
• 
Diabetes Distress Scale-17 Score 
• 
Diet Adherence 
• 
Efficacy Survey Score 
Validated Diabetes Distress 
Scale Score,40 Diet adherence 
survey score, Efficacy survey 
scores; surveys administered 
via REDCap 
6.  Change in HbA1c from baseline to post-intervention 
HbA1c assessed by either point-
of-care fingerstick or venous draw 
7. Change in body mass index (BMI) and body weight from baseline 
to post-intervention 
Calibrated clinic scale and 
stadiometer; BMI calculated 
from measured weight and 
height 
8. Describe fidelity to the intended intervention, including dose 
and content delivered, content enacted, and satisfaction 
Data collection from study 
staff via paper 
documentation; and 
participant surveys 
administered via REDCap 
9.  Describe post-intervention patient-reported behavioral 
mechanisms 
Participant surveys 
administered via REDCap 
 
12. Phase 2 Study Outcome Measures 
 
The Phase 2 follow-up assessment period is approximately 4 months and begins the day after Phase 1 is 
complete (approximately Day 51 to Day 180). 
 
CGM-related outcome measures include approximately 10 days of CGM data collection during the 
baseline, post-intervention, and follow-up assessment periods. CGM data collection for the baseline and 
post-intervention are described under Phase 1 Study Outcomes Measures. CGM data at follow-up will 
be collected in the same way as baseline, which is up to 10 days of CGM data from a Dexcom G7 sensor 
paired with a physically blinded Dexcom receiver. 
 
Primary Outcome 
 
Outcome 
Assessment Method 
1. Change in CGM-derived TIR (% time with glucose 70-180 
mg/dL) from post-intervention to follow-up for combined NFA 
and SDA arms 
See CGM-related outcome 
measures described above 
 
Exploratory Outcomes 
 
Outcome 
Assessment Method 
1. Change in other CGM-derived core metrics from post- 
intervention to follow-up: 
• 
number of days CGM device is worn 
• 
% time CGM sensor is active 
See CGM-related outcome 
measures described above 

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• 
mean sensor glucose mg/dL 
• 
% coefficient of variation 
• 
glucose management indicator (GMI) 
• 
% time above >250 mg/dL 
• 
% time above >180 mg/dL 
• 
% time below <70 mg/dL 
• 
% time below <54 mg/dL 
2. Other CGM-derived metrics: 
• 
Change in % time in tight range (% time with glucose 70- 
140 mg/dL) from post-intervention to follow-up 
• 
% of participants reaching CGM-derived consensus 
targets during follow-up26 
o % reaching >70% TIR (% time with glucose 70- 
180 mg/dL) 
See CGM-related outcome 
measures described above 
3.  Change in HbA1c from post-intervention to follow-up 
HbA1c assessed by either point-
of-care fingerstick or venous draw 
4.  Describe total HEI score by NFA and SDA group during the 
follow-up period 
Automated Self-Administered 
24-hour (ASA24®) survey- 
derived total HEI-2015* score; 
score based on two diet 
recalls per assessment period, 
collected via web-based 
survey (ASA24 Version 2022 or 
later) 
5. Describe HEI component scores by NFA and SDA group during 
the follow-up period 
ASA24 survey-derived HEI- 
2015* component scores; 
scores based on two diet 
recalls per assessment period, 
collected via web-based 
survey (ASA24 Version 2022 or 
later) 
6. Change in additional nutrition metrics from post-intervention to 
follow-up 
• 
total energy intake 
• 
macronutrients and fiber 
• 
select micronutrients 
ASA24 survey-derived values 
based on two diet recalls per 
assessment period, collected 
via web-based survey (Version 
2022 or later) 
7.  Change in diabetes medication by class and dose from post- 
intervention to follow-up 
8. Change in body mass index (BMI) and body weight from post- 
intervention to follow-up 
Calibrated clinic scale and 
stadiometer; BMI calculated 
from measured weight and 
height 
9.  Change in patient-reported outcome survey scores from post- 
intervention to follow-up 
Validated Diabetes Distress 
Scale Score,40 Diet adherence 

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• 
Diabetes Distress Scale-17 Score 
• 
Diet Adherence 
• 
Efficacy Survey Score 
survey score, Efficacy survey 
scores; surveys administered 
via REDCap 
10. Describe patient-reported behaviors/behavioral mechanisms at 
follow-up 
Participant surveys 
administered via REDCap 
 
13. Study Design 
 
Phase 1: This is a non-pivotal, randomized, parallel group, two-arm, prospective study. This 60-day pilot 
study will evaluate the effect of a NFA versus a SDA during CGM initiation in people with T2D. It is 
hypothesized that the NFA arm will see greater improvement in TIR than the SDA arm, due to the 
potential for dietary improvements that come from the use of the NFA and its associated nutrition- 
focused CGM initiation materials. To test this hypothesis, participants will be randomized 1:1 to either 
the NFA or the SDA arm. 
 
The intervention begins on Day 0, which is the day the G7 sensor is paired with apps on the participant’s 
personal cell phone. The intervention follows participants for approximately 50 days, which includes an 
up to 10-day CGM wear period that is part of the post-intervention assessment (approximately Days 40 
to 50). During the final 10 days, the participant is instructed to continue using the CGM device in 
accordance with the guidance provided based on randomization arm. 
 
Phase 2: The follow-up period is designed to evaluate the impact of discontinuing CGM use. The follow- 
up assessment period begins the day after the Phase 1 post-intervention period ends, approximately 
Day 51. The follow-up assessment period passively follows participants for 4 months, which includes the 
10-day blinded CGM wear period from approximately Day 170 to 180. 
On approximately Day 170, participants will return to the clinic to initiate a Dexcom G7 sensor paired 
with a physically blinded Dexcom receiver and to complete additional assessments. It is hypothesized 
that glycemic improvements made during the Phase 1 intervention will be reduced during the Phase 2 
follow-up due to the removal of real-time glucose feedback and other associated CGM data. 
14. Participant Population 
 
Phase 1: To be eligible for the Phase 1 study intervention, all participants must meet the following 
inclusion and exclusion criteria. 
 
Inclusion Criteria 
• 
Adults >18 years of age 
• 
T2D diagnosis 
• 
HbA1c 7.0%-10.0% at the time of screening. If a participant has an investigator-approved HbA1c test 
that was lab-analyzed within the sponsoring institution and that is within 7 days of the screening 
date, this value may be used. 
• 
Taking no diabetes medication or taking stable-dose diabetes medication(s) for at least 30 days; 
willing to maintain stable diabetes medication regimen for the duration of the study 
• 
Has a personal cellular-plan or wifi-connected smartphone that is compatible with required 
CGM apps and which will be consistently available for duration of the study 
• 
Has not used a personal CGM system within 90 days 
• 
Willing and able to wear CGM and use the associated CGM mobile apps throughout the duration 
of the study 

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• 
Willing and able to make diet/lifestyle modifications in response to CGM data 
• 
Able to read and understand English 
• 
Able to attend study visits and complete the requirements of study 
 
Exclusion Criteria 
• 
Currently taking or planning to take any form of insulin, sulfonylureas, meglitinides, or other 
anti-hyperglycemic diabetes medication that carry a known hypoglycemia risk 
• 
Has used a personal CGM in the 90 days prior to consent 
• 
Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin 
• 
Skin conditions that are not compatible with CGM wear 
• 
Intended use of > 4g acetaminophen/day or hydroxyurea during the study 
• 
Planning to become pregnant; pregnant; or lactating 
• 
Current participation in another interventional clinical trial 
• 
Unsuitable for participation due to any other cause, including but not limited to significant 
comorbidities, as determined by Investigator 
 
Phase 2: To be eligible for Phase 2, participants must complete Phase 1 of the study. 
 
15. Study Procedures 
 
Recruitment and Screening 
 
Several strategies will be used to identify prospective participants for Phase 1. The primary participant 
identification methods may include targeted query within the HealthPartners electronic medical record 
(EMR), health plan member database, and available research-specific databases (e.g. International 
Diabetes Center (IDC) research participant database, HealthPartners research databases). Additional 
recruitment methods, including several methods not listed here, may include use of study invitations 
shared in health clinics and in the community. Recruitment materials may be presented to potential 
participants as physical or electronic documents (e.g. via email, on websites, etc). All recruitment 
materials will be approved by the institutional review board (IRB). 
Potentially eligible participants will have the option to complete online self-screeners (e.g. a brief 
questionnaire in REDCap) or undergo brief telephone screening. Any participants who meet initial 
screening criteria will be further screened by study staff for eligibility. Those who are eligible and 
express interest in study participation will receive additional study-related information, including a copy 
of the informed consent form (ICF). The ICF and other study-related materials may be shared by mail or 
electronically (e.g. email, EMR message, etc). 
Up to 300 participants may be consented in order to obtain 120 participants who provide at least seven 
days of baseline and post-intervention CGM assessment data. It is assumed that some participants will 
consent, but they will not be eligible for participation based on the required HbA1c inclusion criteria; 
some participants will consent but may be withdrawn (e.g. due to inadequate days of CGM data at 
baseline); and that there may be approximately 10% attrition during the intervention period. 

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Consenting 
 
All participants must meet all eligibility criteria and sign the IRB-approved ICF to participate in the study. 
During the consent process, study staff will explain the research to the participant and the participant 
will have ample opportunity to review the ICF and ask questions before deciding whether or not to 
participate in the study. The participant must sign the ICF before any study procedures are initiated. 
Of note, during the screening and consenting process, Phase 1 of the study will be described to potential 
participants as a study evaluating the effect of two different approaches used for introducing and 
initiating CGM. Details of the NFA and the SDA will not be described to participants in order to reduce 
the potential for influence if details of both study arms are described to all participants before 
randomization assignments are given. Phase 2 of the study will be described as an opportunity to 
understand what happens when someone who has used CGM stops using it. 
Once the ICF is signed, a copy of the ICF will be given to the participant and a participant ID number will 
be assigned. 
 
Screen Failure 
 
Participants who sign the consent to participate and who do not meet inclusion criteria in the baseline 
assessment period (e.g. HbA1c or tolerance to CGM) will be considered a screen failure. 
 
CGM Device Use 
 
In alignment with guidance from the international consensus statement on CGM use in clinical trials,26 
CGM devices will be kept consistent between study arms and throughout the study. 
 
The Dexcom G7 system will be used during the baseline, intervention, post-intervention, and follow-up 
assessment periods. The G7 system is commercially available and includes an all-in-one wearable sensor 
with transmitter, an overpatch, and either a Dexcom receiver device or two associated smartphone 
applications, G7 and Clarity, which send data via cloud. The G7 system will be used in accordance with 
the manufacturer-provided instructions throughout the study; however, during the baseline period and 
follow-up period, the glucose data will be physically blinded, and participants will not be able to see 
glucose data. 
 
Phase 1: Baseline Period 
 
Baseline assessments will begin during Contact 1. Any participant who meets HbA1c criteria is 
considered enrolled. Participants who do not meet HbA1c criteria will be considered a screen failure and 
will not be considered enrolled in the study. Demographic and anthropometric information will be 
assessed to describe the participants. At a minimum, age at enrollment, race, ethnicity, year of type 2 
diagnosis, gender identity, sex assigned at birth, weight, height, blood pressure, medication assessment, 
education, and food security status will be collected. 
 
Baseline assessments also include dietary assessments, PRO surveys, and a 10-day blinded G7 CGM 
assessment. Study staff will apply the G7 sensor for the participant and pair it with a Dexcom receiver 

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that will be physically blinded by the study team. The participant will receive instructions on how to care 
for the receiver and will wear the G7 sensor for up to 10 days; however, participants will not be able to 
see their glucose data during this time. Participants will be instructed to contact the study team if the 
sensor comes loose or falls off earlier than 10 days or for any other sensor-related concerns. A minimum 
of seven days of G7 sensor data is required. If a participant does not capture at least seven days of 
sensor data, the participant will have an option for study staff to pair another G7 sensor with the 
physically blinded Dexcom receiver, or the participant can choose to exit the study. 
 
Randomization 
 
Once at least seven days of baseline G7 sensor data are confirmed, participants will receive their 
randomization assignment to either the NFA or the SDA arm. 
 
Given that enrolling participants takes several months to complete, randomly permuted blocks of size 
two, four, and six will be used to ensure that participants are assigned to the NFA and SDA arms in 
approximately equal proportions over time. Randomization will be carried out within strata defined by 
participant’s most recently available HbA1c >8.5% vs. <8.5%. The participant randomization schedule 
will be generated by the study statistician using a random number generator. Participants will remain in 
their assigned study arm throughout the intervention. 
 
Blinding procedures are not described since blinding is not possible in a study comparing two different 
instructional approaches; the study staff and participants will know what type of instruction they give or 
receive. However, study participants will not know the details of the type of education provided to the 
other study arm (i.e. participants in the self-directed approach arm will not know the other arm is 
receiving a nutrition-focused approach and vice-versa). 
 
Phase 1: Intervention 
 
The intervention compares the effects of two different approaches used during CGM initiation, the NFA 
or SDA. For both arms, the intervention will include one in-person and one remote study appointment. 
All care and instruction will be provided by IDC research staff serving as interventionists. Intervention 
study staff will receive verbal training and written materials describing how to deliver the NFA and SDA; 
and checklists will be used to ensure consistent delivery among study staff and within each study arm. 
 
On study Day 0, participants who have met all eligibility criteria and who have at least seven days of blinded 
CGM data will receive Dexcom G7 systems that will be paired with apps on their personal cell phone. 
Study staff will assist the participant in applying the G7 sensor, as needed. All participants will be 
instructed to wear and use the G7 and the associated phone apps continuously throughout the 
intervention, including changing out the sensors every 10 days or as needed. 
Intervention duration is expected to last approximately 50 days. 
 
During the study intervention, participants in both arms will be instructed to remain on a stable diabetes 
medication regimen. Participants will be instructed to contact the study team for study-related 
questions, device-related adverse events, or changes in their diabetes care. Care related to the 
treatment of diabetes-related adverse events or adverse events associated with study-supplied devices 
may be provided by qualified and delegated IDC staff. Medical care that does not pertain to diabetes 
management will not be provided to study participants as a part of this protocol. 

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Nutrition-Focused Approach 
 
Both the in-person (contact 2) and the remote (contact 3) intervention visits will be conducted by a 
registered dietitian nutritionist (RDN) with diabetes care experience. Full details for the NFA 
intervention components can be found in the NFA manual of procedures (NFA-MOP), which was 
designed specifically for this study. Use of the manual will help ensure that each participant receives 
similar messaging and materials. 
 
In brief, the NFA arm participants will receive introduction to CGM with emphasis placed on using the 
CGM data to adjust food choices. The NFA will encourage food choices that align with evidence-based 
nutrition recommendations for PWD,41 and that achieve internationally recognized glucose targets (e.g. 
glucose 70-180 mg/dL, and TIR > 70%).42 The NFA does not include a rigid food plan, but rather a flexible 
eating pattern that can meet the needs of diverse participants. The theory-driven intervention content 
was designed to address the barriers believed to impact the use of CGM data to guide food choices and 
recognized behavior change techniques were applied across all intervention components. 
 
Materials used to support the NFA include: 
• 
Nutrition-focused CGM initiation guide 
• 
Interactive CGM initiation presentation (used by the RDN during the in-person intervention visit) 
• 
Non-starchy vegetable list (optional) 
• 
Dexcom G7 manufacturer-provided materials 
 
Optional educational materials or instructional resources may also be used from the following 
organizational websites: 
• 
American Diabetes Association (https://diabetes.org/) 
• 
Dexcom (https://www.dexcom.com/en-us) 
 
Self-Directed Approach 
 
Both the in-person (contact 2) and the remote (contact 3) intervention visits will be conducted by 
research study staff with diabetes care experience (e.g. registered nurse or RDN). Full details of the SDA 
intervention components can be found in the SDA manual of procedures (SDA-MOP), which was 
designed for this study. Use of the manual will help ensure that each participant receives similar 
messaging and materials. 
 
In brief, the SDA arm participants will receive introduction to the Dexcom G7 and its accompanying 
phone apps using manufacturer-provided materials and resources. The SDA will encourage participants 
to use the device and apps in the way they feel most useful to them. The SDA is intended to reflect 
current CGM initiation practices, which focus on technical use of the CGM and a general review of CGM 
data. 
 
Materials used to support the SDA include: 
• 
Dexcom G7 manufacturer-provided materials 
• 
Educational materials or instructional resources found on the Dexcom website 
(https://www.dexcom.com/en-us) 

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Phase 1: Post-Intervention Period 
 
The post-intervention period is part of the intervention and is defined as approximately the final 10 days 
of study participation (approximately Day 40 to Day 50). During this time, the participant is instructed to 
continue to use the CGM device in accordance with the guidance provided based on randomization arm. 
The participant will also complete one of the two required ASA24 diet recalls during this time. 
 
Phase 1: Study Completion 
 
Study completion occurs approximately Day 50. At the study completion visit, the participant will 
complete the final post-intervention assessments, including an HbA1c, remaining dietary assessments, 
and PRO surveys. 
 
Phase 2: Follow-Up Period 
 
The Phase 2 follow-up is approximately four months and it begins the day after the Phase 1 post- 
intervention period ends; approximately Day 51 to Day 180. There is no intervention during Phase 2. 
Participants will manage their diabetes with their usual care team (not the study team), this may include 
adjustments to medications as needed; however, participants are asked not to use CGM during this 
follow-up period. 
During contact 6 (approximately Day 170), participants will be asked to report any serious changes to 
health, changes to diabetes-related medications, and diabetes device use during the previous 4 months. 
Participants will complete additional assessments and study staff will apply a 10-day G7 sensor paired 
with a physically blinded receiver; the process and devices are the same as baseline. 
 
The participant will receive instructions on how to care for the receiver and will wear the G7 sensor for 
up to 10 days; however, participants will not be able to see their glucose data during this time. 
Participants will be instructed to contact the study team if the sensor comes loose or falls off earlier 
than 7 days or for any other sensor-related concerns. If a participant reports fewer than seven days of 
sensor wear, the participant will have an option to return to the clinic so that study staff can pair 
another G7 sensor with the physically blinded receiver. 
 
On approximately Day 180, participants will receive a study reminder to complete a final ASA24 diet 
recall and to return their physically blinded receiver to the study team (e.g. postal mail or in person). 
 
Detailed Schedule of Activities 
 
The study includes approximately seven contacts between study staff and study participants. 
Contact 
Key tasks 
Contact 1: Baseline 
assessments 
Day -11 to Day -1 (plus 
additional days, if needed, 
to obtain at least seven 
days of G7 sensor data) 
• 
Preliminary eligibility confirmed, consent signed 
• 
HbA1c to confirm eligibilitya 
• 
Demographic/Diabetes self-care data assessment 
• 
Diabetes medication assessment 
• 
Height, weight, BP 
• 
Study team applies G7 sensor and pairs it with a physically 
blinded Dexcom receiver 
• 
ASA24 and DietID assessments 

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Baseline Assessment 
• 
PRO surveys (Diabetes distress, diet adherence, efficacy) 
• 
Participant wears G7 sensor paired with a physically blinded 
Dexcom receiver for up to 10 days and returns to clinicb 
• 
Participant completes second ASA24 recall immediately before 
Contact 2 
a As needed, participants will be contacted by study staff if their HbA1c 
does not meet inclusion criteria; instructions for sensor removal and 
options for returning the blinded receiver to the study team will be 
provided.  
 
b At least seven days of G7 sensor data must be obtained on the 
physically blinded Dexcom receiver. If a participant contacts the clinic to 
report the sensor has fallen off early/failed in fewer than seven days, the 
participant will be provided an option to return to clinic to pair another 
G7 sensor with the physically blinded Dexcom receiver, or the 
participant may choose to exit the study. Data from more than one G7 
sensor may be an option to reach a total of seven days. 
Contact 2: Participant 
receives randomization 
assignment and 
intervention begins 
Day 0 
Intervention 
• 
Eligible participants return to clinic with the physically 
blinded Dexcom receiver 
• 
Study team confirms at least seven days of CGM data were 
obtained* 
• 
Study team saves participant’s CGM data 
• 
Diabetes medication assessment 
• 
Participant receives randomization assignment 
• 
Participant applies G7 sensor and pairs it with apps on their 
personal cell phone 
• 
Participant receives CGM instruction based on study arm 
assignment, NFA or SDA 
• 
Participant wears the G7 sensor and uses the real-time glucose 
data from the associated apps until study completion 
• 
Study team documents measures of intervention fidelity 
*Confirmation of at least seven days of G7 sensor data is required before 
the participant can receive their randomization assignment. If seven 
days of G7 sensor data are not obtained, no Contact 2 assessments will 
be completed. The participant will be provided an option to pair another 
G7 sensor with the physically blinded Dexcom receiver and return for 
Contact 2 assessments in approximately 10 days, or the participant can 
choose to exit the study. Data from more than one G7 sensor may be an 
option to reach a total of seven days. 

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Contact 3: Remote Follow- 
up 
Day 14 (+7 days) 
Intervention 
• 
Study team saves participant’s CGM data from Clarity website 
immediately before remote contact 
• 
Study staff contacts participant 
• 
Diabetes medication assessment 
• 
Study staff reviews CGM data with participant and reinforces the 
NFA or SDA messages based on participant’s randomization arm 
• 
Participant wears the G7 sensor and uses the real-time glucose 
data from the associated apps until study completion 
• 
Study team documents measures of intervention fidelity 
Contact 4: Post- 
intervention assessments 
begin 
 
Day 40 (+7 days) 
 
Intervention 
• 
Participant receives reminder from study team on approximately 
Day 40 to: 
o Wear G7 sensor and use data from the associated apps 
for final 10-days of the study 
o Complete first post-intervention ASA24 diet recall 
Contact 5: Post- 
intervention assessments 
ends 
 
Day 50 (+7 days) (plus 
additional days, if needed, 
to obtain at least seven 
days of G7 sensor data) 
 
Post-Intervention 
Assessments & Study 
Completion 
• 
Study team confirms at least seven days of G7 CGM data 
collected between approximately Day 40 and Day 50 
o If a participant has fewer than seven days of CGM data, 
the participant will be provided an option to continue in 
the study until seven days of data are obtained or the 
participant can choose to exit the study 
• 
Study team saves participant’s CGM data from Clarity website 
• 
Participant completes post-intervention assessments, including: 
o HbA1c 
o Diabetes medication assessment 
o Weight, BP 
o Complete second ASA24 diet recall and 
DietID assessment 
o PRO surveys (Diabetes distress, diet adherence, efficacy, 
intervention fidelity, post-intervention survey) 
Contact 6: Follow-up 
assessments begin 
 
Day 170 (+14 days) 
 
 
Follow-up Assessment 
• 
HbA1c 
• 
Diabetes medication assessment 
• 
Adverse event assessment 
• 
Weight, BP 
• 
Complete first follow-up period ASA24 diet recall 
• 
PRO surveys (Diabetes distress, diet adherence, efficacy, 
diabetes self-care) 
• 
Study team applies G7 sensor and pairs it with a physically 
blinded Dexcom receiver 
• 
Participant wears G7 sensor paired with a physically blinded 
Dexcom receiver for up to 10 days* 
 
*If a participant contacts the clinic to report the sensor has fallen 
off early/failed in fewer than seven days, the participant will 
be provided an option to return to clinic to pair another G7 
sensor with the physically blinded Dexcom receiver. A 

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minimum of seven days of sensor data is desired, but not 
required. Data from more than one G7 sensor may be an 
option to reach 10 days. 
Contact 7: Follow-up 
assessments end 
 
Day 180 (+7 days) (plus 
additional days, if needed, 
to obtain at least seven 
days of G7 sensor data) 
Follow-up Completion 
 
• 
Participant receives reminder from study team on approximately 
Day 180 to: 
o Return the physically blinded receiver to the clinic (e.g. 
postage-paid envelope) 
• 
Complete second follow-up period ASA24 diet recall 
 
16. Study Device Management 
 
Participants who terminate early or who are withdrawn at any point during Phase 1 or Phase 2 will be 
asked to return the Dexcom G7 receiver to the clinic, if applicable. Any unused G7 sensors may be 
returned to the clinic or disposed of properly by participant. 
 
17. Early Termination and Participant Withdrawal 
 
A participant can choose to terminate study participation and exit the study at any time and for any 
reason. Participants who request early termination will be asked for a reason for their decision. 
A participant can be withdrawn from the study with or without their consent if deemed necessary based 
on adverse event(s) or for any other reason deemed appropriate by Investigators, such as non- 
compliance with study instructions. If a participant chooses early termination or is withdrawn, the 
Investigators will decide whether the participant may be eligible to complete final assessments. 
 
18. Lost to Follow-Up 
 
Multiple attempts will be made to contact participants who become lost to follow-up. Investigator 
discretion will determine whether a participant should be withdrawn if reasonable attempts for contact 
are unsuccessful. 
 
19. Protocol Deviations 
 
A protocol deviation occurs when the study is not conducted according to this protocol. All deviations 
will be documented in a study deviation log. Investigators and study staff will not knowingly deviate 
from this protocol except in the cases of protecting participant safety. The Investigators or delegated 
study staff will notify the IRB of protocol deviations in accordance with IRB policies and procedures. 
 
20. Assessment of Safety 
 
The following definitions will be used in the assessment of safety. 
 
Adverse Event 
 

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Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom or disease temporally associated with the intervention, regardless of whether it is considered 
related to the intervention. 
Serious Adverse Event 
 
Serious Adverse Event (SAE) is any adverse event that 
(1) results in death; 
(2) is life-threatening; 
(3) results in inpatient hospitalization or prolongation of existing hospitalization; 
(4) results in a persistent or significant disability/incapacity; 
(5) results in a congenital anomaly/birth defect; or 
(6) based upon appropriate medical judgment, may jeopardize the participant's health and may 
require medical or surgical intervention to prevent one of the other outcomes listed in this 
definition. 
 
Life-threatening means the event places the subject at immediate risk of death from the event as it 
occurred. 
 
Unanticipated Event 
 
An unanticipated event is defined as an event, experience, or outcome that meets all three of the 
following criteria: 
● 
is unexpected; AND 
● 
is related or possibly related to participation in the research; AND 
● 
suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
Unexpected means the nature, severity, or frequency of the event is not consistent with either: 
• 
the known or foreseeable risk of adverse events associated with the procedures involved in the 
research that are described in the protocol-related documents, such as the IRB-approved research 
protocol, the ICF, and/or other relevant sources of information, such as product labeling and 
package inserts 
• 
the expected natural progression of any underlying disease, disorder, or condition for the 
participant experiencing the adverse event, and/or the participant’s predisposing risk factor 
profile for the adverse event. 
 
Unanticipated Problems Involving Risks to Subjects or Others 
 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) means: 
• 
any problem or event which in the opinion of the Investigator was unanticipated, serious; AND 
• 
at least possibly related to the research procedures 
 
Possibly related means there is a reasonable possibility that the incident, experience, or outcome may 
have been caused by the procedures involved in the research. 
 
Severity of events will be defined as: 
• 
Mild requires minimal or no treatment and does not interfere with the participant’s daily 
activities. 

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• 
Moderate results in a low level of inconvenience or concern with therapeutic measures. 
Moderate events may cause some interference with the participant’s functioning. 
• 
Severe interrupts a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. 
21. Safety Reporting 
 
AEs and SAEs may be obtained by participant report, EMR notification, or incidental finding throughout 
the study. Participants will be asked to report changes to health or concerns related to study devices 
during study visits. AEs and SAEs will be documented in the participant’s EMR; however, only reportable 
AEs and SAEs will be described in end-of-study reporting. 
Reportable AE’s include the following: 
• 
Sensor-related reactions or infections requiring treatment by a medical provider and/or 
prescription medication 
• 
Severe hypoglycemia defined as requiring assistance of another person due to altered 
consciousness, and requiring another person to actively administer carbohydrate, glucagon, or 
other resuscitative actions 
• 
Severe hyperglycemia if the event involves diabetic ketoacidosis (DKA) or hyperosmolar 
hyperglycemic state (HHS), as defined in detail in Kitabchi et al43 and summarized here: 
Table taken from Kitabchi et al43 
 
Only reportable AEs and all SAEs will be recorded within an adverse event log with a description 
including the nature of the event, the date and time of onset and/or frequency, determination of non- 
serious versus serious, intensity (mild, moderate, severe), duration of the event, relationship to the 
intervention, the expectedness of the event, and outcome of the event. All reportable AEs and all SAEs 
will be reviewed and confirmed by a delegated medical doctor or equivalent. All AEs and SAEs must be 
resolved or deemed stable by a delegated medical doctor or equivalent before a participant completes 
or withdraws from the study. 
 
Delegated study staff will report all reportable AEs, SAEs, and UPIRTSOs to the IRB in accordance with 
IRB policies. 
 
22. Study Suspension or Discontinuation 
 
This study will be suspended or stopped prior to completion if information becomes available during the 
study that indicates as such, this may include information related to adverse events or the potential for 
adverse events. The study may also be suspended or stopped prior to completion if recruitment 

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challenges or retention issues will impact the ability to properly analyze defined endpoints or for other 
reasons determined by the Investigator. 
 
23. Statistical Considerations 
 
Phase 1 Statistical Hypotheses 
 
Primary Endpoint: Change in CGM-derived TIR (% time with glucose 70-180 mg/dL) from baseline to 
post-intervention. 
 
Hypothesis (alternative): Participants randomized to a nutrition-focused approach (NFA) will 
show a larger increase in CGM-derived TIR from baseline to post-intervention than participants 
randomized to a self-directed approach (SDA). 
 
Secondary Endpoint: Difference in total HEI score between groups during the post-intervention period. 
 
Hypothesis (alternative): Participants randomized to a nutrition-focused approach (NFA) will 
show a higher total HEI score during the post-intervention than participants randomized to a 
self-directed approach (SDA). 
 
Phase 2 Statistical Hypothesis 
 
Primary Endpoint: Change in CGM-derived TIR (% time with glucose 70-180 mg/dL) from post- 
intervention to follow-up 
 
Hypothesis (alternative): Participants will show a reduction in CGM-derived TIR from post- 
intervention to follow-up. 
Sample Size Determination 
 
Phase 1 of the study will enroll at least N=132 participants with the expectation for an analytic sample 
size of N=120. This sample size is based on the N needed to adequately power the primary hypothesis 
with a realistic and clinically meaningful effect size for % TIR. Specifically, existing research on CGM 
initiation in people with T2D shows mean TIR of 59% with SD of 25% after intervention. 
An analytic sample size N=60 participants per arm has 80% power (alpha=.05, two-sided) to detect an 
absolute differential change by study arm (i.e., more improvement in the NFA than SDA arm) of 12.9% 
from baseline to post-intervention (day 50). Justification to support a 12.9% difference in TIR requires 
converting A1c study data to TIR. The Mobile study showed a 0.4% decrease in A1c after CGM initiation 
in people with T2D using insulin; we expect a slightly smaller, 0.3%, improvement in our non-insulin 
using population. An eight-week nutrition intervention study showed a 1.2% decrease in A1c with the 
DASH diet; we expect a more conservative, 0.7%, improvement (in the NFA arm). 
Using the A1c to TIR conversion (0.5% A1c reduction equals 10% TIR increase) suggests a 14% increase 
(difference) in TIR. 
To account for approximately 10% attrition, the enrollment target will be set at N=66 per arm; total 
N=132. 

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The Phase 2 sample is dependent on the number of participants that complete Phase 1 and continue 
through the Phase 2 follow-up assessment period. It is expected that 90% of those completing Phase 1 
(n=54/arm) will complete Phase 2 and have CGM data at follow-up. It is expected that 85% of those 
completing Phase 1 (n=51/arm) will complete Phase 2, have at least 7 days of CGM data at follow-up, 
refrain from CGM use during the follow-up period, and have no glucose-lowering medication changes 
during the follow-up period. 
With an expected sample size of n=54 per arm for the intention to treat (ITT) sample in Phase 2, the 
primary analysis has 80% power (alpha=.05, two-sided) to detect an absolute change for pooled study 
arms of 0.27 standard deviation units of change in TIR from the end of the intervention to follow-up. For 
within-arm tests of change in this sample the primary analysis has 80% power (alpha=.05, two-sided) to 
detect an absolute change within a study arm of 0.39 standard deviation units of change in TIR from the 
end of the intervention to follow-up. 
Populations for Analysis 
 
The analysis for Phase 1 will follow a modified intention to treat perspective, with an analysis of CGM 
metrics that includes only participants with at least seven days of CGM data at both baseline 
(approximately day -11 to -1) and post-intervention (approximately day 40 to 50). 
 
The analysis for Phase 2 will follow a modified intention to treat perspective, with an analysis of CGM 
metrics that includes only participants with at least seven days of CGM data at both post-intervention 
and follow-up. This sample is utilized to assess the effect of discontinuation of CGM utilized in phase 1. A 
per-protocol (PP) analytic sample will consist of participants with at least seven days of CGM data at 
both post-intervention and follow-up who did not use CGM, and who did not require changes to 
glucose-lowering medications during the follow-up period. This PP sample is utilized to assess the effect 
of discontinuation on patients not utilizing CGM and having no medication adjustments during the 
follow-up period. 
 
General Approach for Statistical Analyses in Phase 1 
 
Baseline characteristics of study participants will be summarized with mean and standard deviation for 
interval data and proportions for categorical data. For analyses that do not concern total HEI or HEI 
component scores, the analytic models will utilize general and generalized linear mixed model repeated 
measures analysis to estimate differential change by study arm from baseline to post-intervention 
period. The link function and error distribution selected for each model will be based on the distribution 
of the endpoint. Each model will include fixed effects for study arm, time, their interaction, variables 
used in stratification, and a random intercept for patient. Each model will report the model-derived 
estimate (and 95% confidence interval) for the endpoint by study arm and by time period (baseline, day 
50). 
 
The key analytic test for the primary endpoint will be based on planned contrasts reflecting the 
interaction of study arm and time period and will report and test model-derived estimates of differential 
change by study arm along with 95% confidence intervals. For the primary outcome, statistical 
comparisons will be made between and within arms and for study arm by time interaction with 
significance assessed at p <0.05. A final Statistical Analysis Plan will specify further analytic detail and 
inclusion of any additional covariates. 
 
For analyses of total HEI score and HEI component scores, mean scores will be computed separately at 

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each time point (pre-intervention, post-intervention) and for each study group. Confidence intervals for 
means will be based on a Monte Carlo approach implemented with code developed for the HEI-2015 
utilizing a population ratio method appropriate for ASA24 data (e.g. HEI2015_ASA24- 
2016_MC_PopulationScore.sas). Note: if additional versions of HEI scoring, coding, and analysis become 
available, these may be used (e.g. HEI-2022). 
 
Analysis of Primary Endpoint 
 
The analysis of the primary endpoint tests whether patients randomized to a nutrition-focused approach 
(NFA) will have a larger increase in CGM-derived TIR from baseline to post-intervention than patients 
randomized to a self-directed approach (SDA). A general linear mixed model repeated measures analysis 
will estimate differential change by study arm from baseline to post-intervention period in TIR. The 
analytic model will include fixed effects for study arm, time, their interaction, variables used in 
stratification, and a random intercept for patient. A final Statistical Analysis Plan will specify any 
additional covariates to be included in the model. 
 
Analysis of Secondary Endpoint 
 
The analysis of the secondary endpoint tests whether patients randomized to a nutrition-focused 
approach (NFA) will have higher total HEI score at post-intervention than patients randomized to a self- 
directed approach (SDA). Mean total HEI scores and 95% confidence intervals computed for each study 
group will be compared to understand study group differences. 
 
Safety Analysis 
 
The trial does not have formal safety endpoints or formal rules or statistical guidance on stopping due to 
safety concerns. The review and reporting of AEs and SAEs is detailed in the Assessment of Safety and 
Safety Reporting sections. 
 
General Approach for Statistical Analyses in Phase 2 
 
The general approach for the analysis of Phase 2 will follow the approach used for Phase 1, but with 
modifications to the contrasts computed. The analytic models will utilize general and generalized linear 
mixed model repeated measures analysis and include fixed effects for study arm, time, their interaction, 
variables used in stratification, and a random intercept for patient. Each model will report the model- 
derived estimate (and 95% confidence interval) for the endpoint by study arm and by time period. The 
link function and error distribution selected for each model will be based on the distribution of the 
endpoint. Analysis will be conducted with both the modified ITT sample for Phase 2 and the PP sample. 
 
The key analytic test for the primary endpoint will be based on planned contrasts (effect slices) 
reflecting the change from the end of the intervention period to the follow-up period, with study arm 
data pooled. Model-derived estimates of change across these two periods will be reported along with 
95% confidence intervals. For the primary outcome, effect slices will also be tested for within-study arm 
change from the end of the intervention period to the follow-up period. A final Statistical Analysis Plan 
will specify further analytic detail and inclusion of any additional covariates. 

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Planned Interim Analysis 
 
Not applicable 
 
Sub-Group Analyses 
 
There are no planned sub-group analyses or analyses to assess heterogeneity of treatment effects. 
 
Analysis of Exploratory Endpoints in Phase 1 
 
Exploratory endpoints are listed in the section Phase 1 Study Outcome Measures: Exploratory 
Outcomes. 
 
Analysis of exploratory endpoints will follow the analytic framework used for the primary endpoint and 
will report model-derived estimates and statistical testing of the interaction contrast. However, the test 
of this interaction is considered hypothesis-generating and is not necessarily powered adequately. Some 
exploratory analyses will be post-only analyses using the same analytic framework but will include only 
fixed effects for study arm and stratification factors, but not an effect for time or their interaction. There 
will be no control for multiple testing in exploratory analyses. In sensitivity analysis, models will adjust 
for key prognostic factors selected a-priori. 
 
Analysis of HEI component scores will include computing mean component scores and 95% confidence 
intervals for each study group; these will be compared to understand study group differences. Radar 
plots will be used to display differences. Summaries of intervention fidelity and potential behavioral 
mechanisms will utilize descriptive statistics computed within each study group. 
 
Linear regression and Pearson or Spearman correlations will assess associations between TIR and HEI, 
HbA1c and HEI, participant perception of diet quality and calculated total HEI score. Additional analysis 
specifications involving study arm comparisons for exploratory endpoints and detailed specifications of 
other exploratory analyses will be described in a final Statistical Analysis Plan. 
 
Analysis of Exploratory Endpoints in Phase 2 
 
Exploratory endpoints are listed in the section Phase 2 Study Outcome Measures: Exploratory 
Outcomes. 
 
Analysis of exploratory endpoints will follow the analytic framework for Phase 2 used for the primary 
endpoint and will report model-derived estimates and statistical testing of the change from the end of 
the intervention to follow-up period in the pooled study arms and within each study arm via pre- 
specified contrasts. Some exploratory analyses will be post-only analyses using the same analytic 
framework but will include only fixed effects for study arm and stratification factors, but not an effect 
for time. There will be no control for multiple testing in exploratory analyses. In sensitivity analysis, 
models will adjust for key prognostic factors selected a-priori. 
 
Analysis of HEI component scores will include computing mean component scores and 95% confidence 
intervals for each study group at follow-up. Summaries of potential behavioral mechanisms will utilize 
descriptive statistics computed within each study group. 

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24. Data Collection and Management 
 
Source data for the study will be collected verbally, physically, or electronically direct from the 
participant, from the participant’s EMR, from the participant’s G7 CGM system and the Clarity website, 
from web-based platforms where data is entered directly by the participant or with assistance of study 
staff (e.g. ASA24, DietID, REDCap, etc). 
 
Study staff will record data in accordance with the UNITE Study MOP (UNITE MOP). Study data will be 
stored as follows: 
• 
on paper case report forms 
• 
in the participant EMR 
• 
as downloaded data files saved on secure, password-protected institutional computers (e.g. 
CGM data, dietary recall data, etc) 
o Diet recall via ASA24 and DietID will be directly entered into each website. ASA24 is a 
free, web-based dietary assessment tool that is run by the National Institutes of Health. 
ASA24 data is associated with study ID and does not capture any personally identifiable 
information from participants. DietID is a web-based dietary assessment tool used for 
clinical and research purposes. DietID is associated with unique access and does not 
require identifiable information from participants. Completed ASA24 and DietID surveys 
will be stored on web-based servers and periodically downloaded throughout the study. 
• 
in REDCap, a 21 CFR Part 11-compliant data capture system. REDCap includes password 
protection and internal quality checks, including field validation to help identify inconsistent, 
incomplete, or inaccurate data. Data entered into REDCap will come directly from the original 
source data; or in some cases, REDCap may serve as the source data (e.g. protocol deviations; 
participant response to surveys via REDCap; participant supply management, etc.). REDCap 
maintains a built-in audit trail that logs all user activity and all pages viewed by every user, this 
includes entering data, exporting data, modifying a field, running a report, or adding/modifying 
a user, etc. 
 
Data collection is the responsibility of the delegated study staff under the supervision of the 
Investigator. The Investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
25. Data Monitoring 
 
Investigators and delegated study staff will monitor study data for completeness and quality. Several 
strategies will be used to cross-check data accuracy and integrity, including staff checklists for each 
participant contact. 
 
26. Data Sharing 
 
As allowable by the governing IRB and organizational legal requirements, select, de-identified datasets 
for the completed project will be made available. All datasets will be shared in compliance with human 
subject protection and Health Insurance Portability and Accountability Act (HIPAA) privacy regulations. 
 
This trial will be registered at ClinicalTrials.gov; trial results will be added to ClinicalTrials.gov after study 
completion.

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27. Record Keeping and Retention 
 
Clinical research records, including IRB records, and other records related to the study will be stored in a 
manner that ensures privacy, confidentiality, security, and accessibility while the clinical research is 
being conducted and after the study is completed. 
 
The site will retain all study records, including HIPAA-related documents, after the study completion per 
institutional policy. Physical documents will be consolidated and stored in boxes in a secure location 
after study completion and electronic documents will be maintained in designated research study 
folders on the institutional drive in accordance with the institutional data retention guidelines. 
After the record retention period has been met, study-related materials may be destroyed. 
 
28. Confidentiality and Privacy 
 
Participants will be assigned a unique ID number after consent. Whenever possible, participant records 
and datasets will contain the unique ID only. The participant will be informed during the study screening 
process and via the ICF that their personal study-related data will be accessible by study staff and 
individuals within the International Diabetes Center throughout the duration of and after the study. 
Participants will be informed that by using CGM, their information will also be available to the CGM 
device manufacturer, Dexcom. Participants will need a personal account for use with the Dexcom 
systems. Participants will need to provide personal information (e.g. name, date of birth, email, etc) for 
the Dexcom accounts. Data in the Dexcom apps and associated websites is secure to the extent 
provided by the manufacturer. Participant data and any related records may also be made accessible to 
regulatory authorities or as required by law. 
 
The confidentiality of all participant information and data are protected to the extent allowed by law. 
Records will be kept confidential in accordance with HIPAA privacy regulations. Investigators and 
personnel will not use data or records for any purpose other than conducting the study; however, de- 
identified participant data may be used for educational purposes and shared in medical journals, at 
scientific meetings, or in similar settings. No identifiable data will be used for future study without first 
obtaining IRB approval. 
 
29. Ethics and Protection of Human Subjects 
 
This protocol and any amendments, ICFs, recruitment materials, and all participant-facing materials will 
be submitted to the IRB for review and approval. Approval of the protocol and consent forms will be 
obtained before any participant is enrolled. Approval of protocol amendments and changes to the 
consent forms will be obtained before any changes are implemented. The decision of the IRB concerning 
the conduct of the study will be made in writing to the Investigator. A copy of the initial IRB approval 
letter will be provided to the study funder (American Diabetes Association) before commencement of 
this study. 
 
This study will be conducted in full accordance with all applicable Federal and state laws and regulations 
including 45 CFR, and the HIPAA Privacy Rule. Any episodes of non-compliance will be documented. The 
Investigators will perform the study in accordance with this protocol, will obtain consent, and will report 
unexpected problems in accordance with IRB policies and procedures. Collection, recording, and 

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reporting of data will be accurate and will ensure the privacy, health, and welfare of research 
participants during and after the study. 
 
30. Conflict of Interest 
 
Study leadership in conjunction with the HealthPartners Institute has policies and procedures for all 
study group members to disclose conflicts of interest and to establish a mechanism for the management 
of all reported dualities of interest. Persons who have a perceived conflict of interest will be required to 
have such conflicts managed in a way that is appropriate to their participation in the design and conduct 
of this trial. 
31. References 
 
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Martens T, Beck RW, Bailey R, et al. Effect of Continuous Glucose Monitoring on Glycemic 
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