Glycemic Optimization On Discharge From the Emergency Room
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: Mark O'Connor

 
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GLYCEMIC OPTIMIZATION ON DISCHARGE FROM THE EMERGENCY ROOM 
 
NCT05197829 
 
DATE: 9/29/23 
 

 
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1. TITLE 
 
Glycemic Optimization On Discharge from the Emergency Room (GOOD-ER) program 
 
2. EXTERNAL IRB REVIEW HISTORY* 
 
NA 
 
3. PRIOR APPROVALS: 
 
NA 
 
Conflict of Interest (COI):   
 
The Study Investigators have no COI to disclose.  
 
Clinical Engineering Department: 
 
The continuous glucose monitor and reader have been inspected and approved by clinical 
engineering. 
  
Biohazardous Agents: 
 
NA 
 
Radiation: 
 
NA 
 
Students as Subjects:  
 
NA 
 
Data Science Core & Recruitment Core: 
 
The Data Science Core has been consulted and their services are not required for this protocol. 
 
UMCCTS Protocol Review Committee (PRC) 
 
This project has been reviewed by the PRC and approved for submission to the IRB. Several 
revisions were made to this ISP in response to the PRC comments.  A document describing the 
PRC comments and the changes made is also included with the application. 
 
4. OBJECTIVES* 

 
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Our goal is to help people with diabetes who are treated and then discharged from the emergency 
department (ED) achieve better health outcomes. Specifically, we are interested in determining 
whether or not continuous glucose monitoring after ED discharge is useful. 
People living with diabetes, particularly those from disadvantaged socioeconomic backgrounds, 
frequently seek medical care through the emergency department (ED), but coordinated 
longitudinal follow up is often lacking. Almost 1 in 10 ED visits are related to diabetes (1), and 
rates of diabetes-related ED utilization are negatively correlated with household income (2, 3). 
Being evaluated in the ED can be a powerful motivator for patients, but this window of 
opportunity can be missed if patient activation is low or if access to ongoing medical care is 
limited. Interventions designed to improve continuity between the ED and diabetes specialty care 
have shown promise in terms of reducing hospitalizations and medical expenditures (4), but even 
at institutions with these programs in place, recurrent diabetes-related ED visits continue to be a 
problem (5). Overall, diabetes care for people in the ED remains fragmented and poorly studied. 
As we attempt to help people seeking care for diabetes in the ED, we plan to study the potential 
role of continuous glucose monitoring (CGM) in this novel context. In the outpatient setting, 
CGM has been shown to cause clinically significant reductions in hemoglobin A1c as well as 
hyper- and hypoglycemia (6-8). It can also improve a patient’s self-management skills and 
understanding of how food and activity affect blood sugar (9). CGM use, however, has never 
been studied as a tool to help people being discharged from the ED. It will be valuable to assess 
its usefulness in this setting, as patients are at high risk of recurrent hyper- or hypoglycemia 
during this transitional window (10, 11) and may be more engaged than at other times.  
Our plan is to conduct a randomized controlled trial of unblinded CGM among people with 
diabetes who are discharged home after being treated in the ED for diabetes-related emergencies.  
In conjunction with research assistants, ED clinicians at the University Campus, Memorial 
Campus, Marlborough Campus, Clinton Campus, and Leominster Campus will identify patients 
with diabetes (type 1 or 2) and hyper- or hypoglycemia who would benefit from follow up in the 
UMass Diabetes Center of Excellence (DCOE). The ED physician will place a referral, if 
necessary, and study staff will help arrange this follow up, scheduling an appointment within 2-3 
weeks. In addition to this care coordination, half of the participants will receive a CGM placed 
by the patient or study staff in the ED, and all patients will receive written instructions about how 
to handle recurrent hyper- or hypoglycemia.  
 
The primary outcomes will be the rate of attendance at the follow-up visit and be the change in 
diabetes-related quality of life as measured by the PAID-5 scale and the DDS. We hypothesize 
that having a CGM will decrease the no-show rate and increase clinic attendance and improved 
diabetes-related quality of life. Secondary outcomes will include hemoglobin A1c levels over 
time, ED utilization, emergency medical services utilization, hospitalizations, and major 
cardiovascular events within 6 months. Finally, we will assess provider satisfaction in the DCOE 
via a brief survey. 
 
Focusing on a common but rarely studied clinical problem – the ED-to-clinic transition for 
people with diabetes – this project will promote inter-departmental collaboration between the ED 
and the DCOE and will directly improve care for people with diabetes, particularly those from 
disadvantaged groups. In addition to improving care coordination, we will rigorously assess the 

 
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usefulness of CGM in a novel context, generating preliminary data for future work and serving 
as an example for other medical systems regionally and around the world. 
 
5. BACKGROUND* 
 
Emergency physicians and endocrinologists agree that the emergency department (ED) is not an 
optimal venue for delivering longitudinal medical care for people with diabetes, but diabetes-
related ED visits remain common. In the United States in 2010, for example, approximately 10 
percent of all ED visits – over 12 million in total – were for diabetes-related problems, the 
majority of which did not require hospital admission (1). Seeking emergency care for diabetes is 
associated with lower income and socioeconomic status (2, 3, 12), and this lack of continuity of 
care is associated with worse outcomes (13-15). Programs designed to improve care coordination 
between the ED and subspecialty diabetes care have shown promise (4, 5), at least in terms of 
reducing ED visits and expenditures, but significant works remains to be done, especially in 
terms of patient-centered outcomes. 
Over the last decade, the emergence of continuous glucose monitoring (CGM) technology has 
changed how many people with diabetes manage their disease, but the ideal role for these 
devices is still being established. In outpatient settings, randomized trials have shown that CGM 
reduces hemoglobin A1c as well as hyper- and hypoglycemia (6-8, 16). There is also evidence 
that CGM use is associated with a reduction in hospitalizations and emergency diabetes-related 
events (17). From the patient perspective, CGM has been shown to improve diabetes-related 
quality of life (18) and diabetes self-management skills (9). Most of these studies, however, were 
conducted in ambulatory settings. CGM has never been studied as a tool to help people seeking 
diabetes-related care in the ED, a vulnerable population in which the potential benefit could be 
high.  
At UMass Memorial Medical Center, we have an opportunity to implement and study new 
approaches to caring for people with diabetes-related emergencies. The UMass ED and the 
DCOE both serve large numbers of patients and exist within an academic environment 
conducive to patient-focused research. At the University Campus in 2019, over 1,000 people 
were treated for hyper- or hypoglycemia and then discharged home without being admitted to the 
hospital. Our goal is to help these patients avoid repeat ED visits and poor glycemic outcomes by 
bridging the gap between the ED and the DCOE. We believe that CGM during the high-risk 
period of time after ED discharge will help patients avoid recurrent glycemic problems while 
reducing their diabetes-related distress and helping their outpatient providers. 
In addition to helping patients at UMass, we hope to pave the way for implementation of such 
programs on a broader scale, as there is great agreement among stakeholders that improvement is 
needed. Emergency physicians are motivated to reduce the number of patients seeking 
emergency care, as waiting rooms at UMass and elsewhere are frequently crowded, and 
diabetologists know that continuity of ambulatory care is in the best interests of their patients. 
Health systems work to keep expenses down, and of course, most importantly, patients prefer to 
avoid the ED when possible. We believe all these factors will make our program valuable and 
exciting to other systems.  
The work we propose is innovative both in terms of its subjects and its methods. The population 
of people seeking care in the ED is more disadvantaged than the population as a whole, and it is 

 
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also a population that is studied far less often than outpatient populations. Most diabetes-related 
studies focus on patients affiliated with certain hospitals or group practices, potentially missing 
people who lack a secure relationship with longitudinal care. Our project is designed to improve 
outcomes for this large, at-risk group.  
Our desire to study the effectiveness of CGM during the ED-to-clinic transition is also novel. 
The existing CGM literature is skewed towards studies of well-connected patients being 
followed as outpatients. We feel, however, that CGM could have value for other patients, such as 
those in the ED population who have already demonstrated their risk for severe hyper- or 
hypoglycemia. We will be the first group to rigorously study CGM as tool to help people being 
discharged from the ED, and thus our work will lay groundwork for future studies, hopefully 
both here at UMass and elsewhere.  
 
6. INCLUSION AND EXCLUSION CRITERIA* 
 
Patient Subjects: 
 
Inclusion Criteria: 
• Age 18 years or older 
• Patients must be preparing for discharge from the emergency department after being 
treated for either hyperglycemia or hypoglycemia 
• Patients must be either new referrals to the DCOE or existing DCOE patients in need of 
post-ED follow up 
• Patients must have type 1 or type 2 diabetes   
• Patients must be able to provide informed consent 
• Patients must be fluent in English or Spanish 
 
Exclusion Criteria: 
 
• Current CGM use 
• Need for hospital admission 
• Upcoming computed tomography (CT) or magnetic resonance imaging (MRI) studies 
within 2 weeks, as these imaging modalities could potentially affect CGM performance 
• Pregnant patients, as the device is not approved for pregnancy 
• Any altered mental status, which would limit a patient’s ability to consent to the study 
• Patients who already have a longitudinal relationship with an outside endocrinologist 
• Patients who have not been referred to the DCOE 
• Prisoners 
• Patients under age 18 years 
• Patients who do not speak English or Spanish fluently 
 
 
Justifications for Criteria:  
 

 
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-Our intervention targets patients with diabetes who are treated and discharged from the 
emergency department after being treated for either hyperglycemia or hypoglycemia.  
 
-We will translate consent materials and patient instructions into Spanish.  No additional 
languages are included as the CGM being used for the study and its associated reader only has 
English and Spanish menus and instructional manuals. 
 
-Prisoners represent a special population that is routinely excluded from similar research studies. 
They represent an inaccessible population. 
 
-Patients under eighteen are typically treated by pediatric endocrinologists and have different 
care regimens that are beyond the scope of this study. 
 
-Pregnant women will not be included in this arm of the study as the CGM being utilized for this 
study is not FDA approved for use in pregnant women. 
 
Provider Subjects: 
 
Inclusion criteria for provider subjects will consist of licensed independent providers (NP, PA, 
MD, DO or MBBS) who provide subspecialty diabetes care to a patient subject enrolled in the 
study. Pregnant women may be included in this cohort as this study arm entails less than minimal 
risk and the study activities have no impact on pregnancy. 
 
Exclusion criteria:  Adults unable to consent, subjects under 18 and prisoners will be excluded 
from this study. Any subject that does not meet the inclusion criteria will be excluded.  Trainees, 
including medical students, resident physicians, and fellows will be excluded from this study. 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
  
NA 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
  
NA 
 
9. STUDY TIMELINES* 
 
 
Patient Subject Participant Involvement Timeline: 
- 
Enrollment & Intake Visit: (Day 0) 
→ Informed consent 
→ Non-biometric data – Contact information; Intake data points  
→ Five-question Problem Areas in Diabetes (PAID-5) scale as well as the 17-
question Diabetes Distress Scale (DDS) and supplemental questions will be 
administered  
→ Device training (if randomized to CGM)  

 
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→ Care coordination to DCOE (all patients) 
 
- 
Outpatient Blood Sugar Monitoring (for intervention group only) (day 0-14)  
→ Continuous Glucose Monitoring – Sensor worn 24 hours a day for up to 14 days. 
Data can be uploaded  
 
- 
Follow Up: (~Day 14-21 post ED visit) 
→ Study team will meet patient at follow-up appointment 
→ Biometric data – Downloaded  
→ Non-biometric data – Five-question Problem Areas in Diabetes (PAID) scale as 
well as the 17-question Diabetes Distress Scale (DDS) and supplemental survey 
questions will be administered 
→ Compensation ($10) 
 
- 
6 Months Follow up (no active patient involvement)  
→ Follow-up data points abstracted from electronic health record (EHR) 
 
 
Provider Subject Participant Involvement Timeline: 
 
- 
Follow Up: (~Day 14-21 post ED visit of patient subjects) 
→ Study team send survey questions to provider subjects immediately after they 
have a clinic encounter with a patient subject  
→ This will be the only time point of participation for provider subjects 
 
 
Study Timeline: We anticipate that recruitment will be complete by September 30, 2022. 
Primary data analysis will be complete by the end of March 2023. 
 
 
 
10. STUDY ENDPOINTS* 
 
Our primary outcome The primary outcomes will be the rate of attendance at the follow-up 
visit and be the change in diabetes-related quality of life as measured by the PAID-5 scale and 
the DDS.  
Secondary outcomes will include A1c levels, recurrent ED or EMS utilization, hospitalizations, 
and major cardiovascular events. We will also query DCOE providers regarding their satisfaction 
with the program, including a question about whether the CGM data are helpful for each patient.  
Expectation: Our hypothesis is that CGM use after ED discharge will reduce the clinic no-show 
rate and decrease diabetes-related distress compared to the group with care coordination only.  
There are no primary or secondary safety measures being recorded for the purposes of this study. 
 
Safety measures will include number of device questions/concerns expressed by subjects during 
enrollment through their two-week follow up appointment, reported blood sugar events, 

 
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(high/low values), and return visits to clinic/ED/hospitalizations within the 2 week window of 
enrollment. 
 
 
11. PROCEDURES INVOLVED* 
 
Enrollment & Intake Visit of patient subjects: 
- 
Recruitment: See Section 24. Research personnel will confirm subjects’ pregnancy status 
by subject self report. 
→ Documents: 
▪ HIPAA Waiver 
▪ Info Sheet 
▪ Screening Log 
▪ Declined/Ineligible Log 
- 
Consent: See Sections 30 & 31 
→ Documents: 
▪ Consent  
▪ HIPAA Authorization 
 
- 
Randomization: Using the Redcap randomization module, patients will be randomized to 
the care coordination-only or care coordination plus CGM group  
 
- 
Master Code Contact Information: Study Staff will obtain at least two ways (primary 
phone number and mailing address) to contact participants to schedule follow-up visits, 
completing a follow-up phone call if necessary, and to ensure the CGM equipment is 
returned.  
→ Documents: 
▪ Contact Info  
▪ Master Code 
- 
Intake: Study Staff will query EMRs to obtain the data points listed in the document 
below. Data collected will be verified with participants.  
→ Documents:  
▪ Intake Data- RA Facing 
▪ Intake Data- Patient Facing 
- 
Device Training for intervention arm (CGM Arm only): Half of the participants 
identified and enrolled as described above will be randomized to receive an unblinded 
CGM. We plan to use the 14-day Libre 2 CGM from Abbott. This device is a small disk 
(1.38 inches in diameter and 0.2 inches thick), and it weighs 0.18 ounces. After it is 
placed, a small (less than 0.4mm thick) sensor probe (not sharp) remains in the skin and 
can transmit continuous glucose data to a reader. The device can be submerged in water, 
and if it falls off, there will not be any significant bleeding. Study Staff will demonstrate 
the features and use of the CGM and sensor application (how the device should be worn, 
when it should be removed, the procedure to query the device for blood sugar readings 
using either a reader or smart phone application). After participants demonstrate an 
understanding of the use of the GCM, Study Staff will place the device on one of the 
participant’s upper arms (patient choice) and monitoring will begin immediately after a 

 
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60-minute calibration period. They will be instructed to wear the CGM for two weeks 
continuously (including during sleep and hygiene), although they will also be advised 
that they can remove the sensor at any time if it causes any discomfort or distress. 
Subjects will not be removed from the study if they chose to remove the CGM. 
Participants will receive an informational sheet that explains the basic functionality of the 
CGM and lists Study Staff contact information in the event that they have questions about 
the CGM or its readings.  
→ Documents: 
▪ CGM Information for enrolled patients (CGM arm only) 
- 
Mobile Reader (CGM Arm only): Study Staff will set up the Libre dedicated reader for 
subjects. Study Staff will demonstrate the features and use of the device and provide 
participants with an informational sheet that explains how and when to use the reader. 
Currently, Abbott, the company the manufactures the Libre 2 CGM system, is developing 
a mobile phone-based app to replace the reader. This app is under FDA review but is not 
yet approved. If it is approved between now and the end of enrollment, we will give 
participants the choice of using either the designated reader or their phone, if they possess 
a compatible phone. 
→ Documents: 
▪ CGM Information for enrolled patients (CGM arm only) 
 
- 
Education on managing out of range blood sugars: All patients will receive information 
on how to respond to out of range blood sugars and emergency contact information 
→ Documents: 
▪ Information sheet: Hyperglycemia 
▪ Information sheet: Hypoglycemia  
 
 
- 
Initial questionnaires: Patients will be administered the five-question Problem Areas in 
Diabetes (PAID) scale as well as the 17-question Diabetes Distress Scale (DDS), which produces 
a total score and four subscale scores (emotional burden, regimen distress, physician distress, and 
interpersonal distress). Finally, patients will be administered several supplemental questions 
pertaining to their perceptions of their healthcare and barriers to obtaining optimal glycemic 
control. 
→ Paper Log: Study Staff will administer these questionnaires on tablets shared 
with patients 
▪ Documents: 
» Problem Areas in Diabetes (PAID-5) scale/Diabetes Distress 
Scale and supplemental questions 
 
- 
Diabetes Center of Excellence Care Coordination: Study Staff will follow up with ED 
provider to ensure that patients’ have clinically indicated referral to diabetes center of 
excellence  
→ Appointment scheduling: RA will make an appointment for the patient before ED 
discharge, if possible.  If this is not possible, RA will contact the patient after 
discharge to arrange a follow-up appointment.  
 

 
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Outpatient Blood Sugar Monitoring: The CGM will be worn on the participants’ upper arm 
continuously for 14 days (or until it falls off or the patient decides to remove it) 
 
Visit #1 (~Day 14-21 Post-Discharge of patient subjects)  
- 
Documents:  
→ Visit Data (RA facing) 
→ Problem Areas in Diabetes (PAID-5) scale/Diabetes Distress Scale and 
supplemental questions 
→ Fact sheet for provider subjects 
→ Provider satisfaction survey  
 
- 
CGM Data: Biosensor data will be downloaded and reviewed  
- 
Material Collection: Study Staff will collect CGM readers 
- 
Compensation: Participants will be offered $10 worth of gift cards to a retail store for 
completing visit #1. 
- 
Provider Survey: immediately following an encounter with a patient subject, the provider 
taking care of each patient will be contacted by the study team as potential provider 
subjects. Potential provider subjects subsequently will be sent an email solicitation to 
participate in a Redcap survey.  A fact sheet will be provided with that email.  The survey 
will consist of 4 questions pertaining to their satisfaction with patient subject care 
coordination and/or their CGM utilization.  Providers may be sent multiple surveys if 
they see multiple subjects who are enrolled in the study. This is the only involvement of 
the provider subjects.   
- 
No Shows: RAs will reach out to subjects who miss their follow-up appointment to (1) 
help them reschedule and (2) ask that they fill out the post-intervention questionnaire via 
an online link (or mailed paper copy or via phone, if desired) 
 
  
Follow up Data Collection (~6 months Post-Discharge) 
- 
) Documents:  
→ 6 month follow up datasheet  
- 
Data Collection:  The study team will query the EHR to collect follow up data points 
about enrolled subjects 

 
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Figure 1: Procedural Flow Sheet
t 
 
12. DATA AND SPECIMEN BANKING* 
 
NA 
 
13. Data Analysis and Management* 
 

 
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Feasibility: We have conducted a preliminary analysis of billing data from 2019 from the ED at 
the University Campus, and this analysis suggests that we will be able to target a large 
population of potential participants. In one year, there were 2,275 adult visits with a primary or 
secondary diagnosis of diabetes, hyper-, or hypoglycemia (Table 1). Over 60% of these patients 
were discharged home from the ED, and the majority had type 2 diabetes, although type 1 
diabetes was over-represented (15%) compared to its frequency among cases of diabetes in the 
general population (less than 10%). Emergency physicians tend not to bill for diagnoses that do 
not require active ED management, so our numbers are likely not an overestimate. We suspect 
that only a fraction of these patients will be eligible for our study, but even if we were to recruit 
one out of every four, we would exceed our recruitment goal (200) within a year. 
Sample Size: The primary outcomes are the clinic attendance rate and the change in diabetes-
related distress, as measured by the Diabetes Distress Scale (DDS) and PAID-5 scale between 
the ED visit and the follow-up appointment date (19).  Secondary outcomes include repeat 
ED/EMS utilization over 6 months, repeat hospitalizations, major cardiovascular events, and 
changes in hemoglobin A1c. For clinic attendance, we will aim to achieve attendance at 80% of 
the scheduled clinic visits. For a one-sided test at alpha=0.025 of a single proportion against a 
standard proportion (0.80), we will have 80% power to detect a difference of 0.13 (0.80 – 0.67) 
with a sample size of 83 subjects in the CGM group. Adjusted for 20% dropout, we will need 
approximately 100 subjects/group. For the DDS outcome, we will compare the change from 
baseline to the end of follow-up in the DDS between the two groups. Although we will fit the 
trajectory of the DDS change in each group using all DDS measures in a mixed effects model 
with repeated measures (MMRM), for simplicity in sample size estimation, we will calculate the 
sample size for an unadjusted comparison of the change between the two treatment groups. 
Based on a study of 267 subjects with diabetes (19), the standard deviation of the DDS was 1.0 
across the three sites in that study. The DDS is a questionnaire of 17 questions, each scored on a 
Likert scale of 1 (not a serious problem) to 6 (serious problem), with the overall score calculated 
as the mean score across the 17 items. Thus, the range of the overall score is 1.0 – 6.0. With 100 
subjects in each group, we can detect a difference of about 0.40 in the DDS change between the 
two groups. The literature on the DDS does not identify a clinically meaningful difference 
although Fisher, Polonsky, Hessler, Mullan (2012) suggest a difference of 0.5 as meaningful 
(20). Thus, our sample size will achieve power of greater than 80% to detect that difference. 
Analysis Strategy: As indicted in the Sample Size section above, for the clinic attendance rate, 
we will conduct the initial unadjusted analyses using an exact test of the frequencies under the 
presumed population proportion (0.80) and the observed proportion. Adjusted analyses will be 
conducted using a logistic regression model for the proportion of clinic visits attended as the 
outcome in the intervention group with predictors including age, gender, time since diagnosis of 
diabetes, and other factors of interest.  
For the outcome of change in DDS, we will conduct the initial unadjusted analysis as described 
above in the Sample Size section. For adjusted analyses, we will include each DDS score in the 
longitudinal MMRM, so that we can model the trajectory of change as well as the individual 
changes over the period of follow-up. The time metric in this model will be the time (months) 
since study enrollment with predictors including age, gender, time since diagnosis of diabetes 
and other factors of interest. We will also investigate subgroups of interest using a Forest plot 
approach. We will plot the means and confidence intervals for the outcome for the two groups 
using Forest plots to display the total groups and subgroups of interest. We will also generate 

 
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longitudinal plots of A1c over time with the means and appropriate exact 95% confidence 
intervals at each time point. In addition, with the DDS trajectories available, we are able to use 
machine-learning approaches, such as growth mixture models, to identify clusters of patients 
with similar trajectories but who are not members of previously defined subgroups. Finally, we 
will conduct sensitivity analyses to determine if missingness of DDS scores are missing at 
random or missing not at random. For these analyses, we will use several methods, including the 
jump-to-reference imputation and the pattern mixture model approaches, to determine if the 
results using the sensitivity analyses are consistent with the MMRM results, indicating that the 
missingness is missing at random.  
For the secondary outcomes, the change in HbgA1c will be modeled as for the DDS above. The 
other secondary outcomes can be modeled as binary outcomes and will be modeled as 
longitudinal logistic models.  
Data Management Plan: 
All study data will be recorded on a REDCap database established on a secure encrypted server 
on AWS. All access to the database will be through permissions established by the IT REDCap 
administrator. Investigators will have to log into the REDCap database to enter or view data. The 
REDCap database will be developed and implemented by the data management staff of the 
UMMS Quantitative Methods Core (QMC) with the direction of Dr. Bruce Barton, QMC 
Director. Logic data checks will be built into the data entry process to help clean the data at 
entry. Quality control edits will be run to identify inconsistencies and questionable values in the 
data. The audit trail will be activated for the duration of the study. 
Data for analysis will be downloaded directly from REDCap and converted to SAS datasets or R 
data frames for analysis. The downloaded datasets will be deidentified and are HIPPA as well as 
21 CFR Part 11 compliant. 
 
Provider Data: 
 
We will present the data from the provider surveys in a descriptive fashion. For example, we will 
report the percentage of patients in the CGM arm whose provider found the data useful. We will 
also do subgroup analyses. Potential subgroups include the type of diabetes, whether or not the 
diabetes diagnosis is new, and whether or not the participant presented to the ED with hypo- or 
hyperglycemia.  
 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
 
 
In accordance with HRP-801 Prompt Reporting Requirements, any unanticipated adverse 
events will be reported and the PIs will closely monitor all aspects of the study.  
 
The PIs will be responsible for monitoring adverse events during the study. If an adverse event 
occurs, their role will be to identify the concern, to develop an appropriate response to alleviate 
or minimize any adverse event, and to ensure that the adverse event is reported in a timely 
manner to the appropriate authority. Participants will be monitored for the occurrence of any 

 
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undesirable experience or unanticipated benefit. Events may occur during recruitment, during 
home CGM use, and during the initial follow-up visit. We anticipate that these effects will be 
limited. We will assess whether an undesirable experience (adverse event) occurred and will 
record details of all adverse events on an adverse event case report form. We do not anticipate 
that any serious adverse events (death, life threatening illness, new serious or permanent 
disability) will occur. However, should such an event occur, we will report the event within 24 
hours to the University of Massachusetts Medical School (UMMS) Institutional Review Board. 
 
The adverse event case report form will include a description of all undesirable experiences, 
required interventions, and an assessment of the participant after the event if possible. An 
estimate of the extent of injury and prevention strategies will be reported. The principal 
investigators will classify the relationship of the study protocol to the event as follows: 
 
• Not related: The event is clearly related to factors not related to the study protocol. 
• Remote: The event was most likely related to factors not related to the study protocol. 
• Possible: The event follows a reasonable temporal sequence associated with participating in the 
study and/or is consistent with events related to the study protocol but is possibly related to 
factors such as the participant’s clinical state. 
• Probable: The event follows a reasonable temporal sequence associated with participating in 
the study and/or is consistent with events related to the study protocol and cannot be reasonably 
explained by factors such as the participant’s clinical state. 
 
The severity of an adverse event in both groups is defined as a qualitative assessment of the 
degree or intensity of an adverse event as determined by the principal investigator as follows: 
 
• Mild: No impact (in any way) on the participant. 
• Moderate: Impacts on the participant but is not life-threatening or incapacitating. 
• Severe: Fatal, life threatening, permanently disabling; severely incapacitating; 
requires/prolongs inpatient hospitalization. 
 
All adverse events will simultaneously be reported to institutional officials. The report will 
summarize the facts of the case, including the date and a description of the participant; whether 
the event is related to the study’s protocols; the steps that have been taken to address the issue; 
whether the event provides emerging knowledge about the risks of the study that should be 
conveyed to participants; and whether the consent form should be revised. 
 
Due to the relatively low risk of adverse events with using a CGM, which are FDA-approved for 
people with both type 1 and type 2 diabetes, and the relatively short duration of the study, we do 
not plan on having a data safety monitoring board review. 
 
The frequency of data review for this study is summarized in the following table: 
 
Data Type: 
Frequency of Review: 
Participant recruitment (adherence to protocol 
on inclusion & exclusion criteria) 
The PI will directly observe recruitment for 
the first five cases, then will observe random 

 
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cases bi-monthly once the study is 
established.  
Data collection methods 
The PI will directly observe data collection on 
the first five cases, then will observe random 
cases bi-monthly once the study is 
established.  
Integrity of data storage procedures 
The PI will directly monitor data storage the 
first five cases, and then will review all data 
monthly once the study is established.  
 
 
 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
 
NA 
 
16. RISKS TO SUBJECTS* 
 
The main risks to participants in care coordination-only cohort are: 
1) Loss of confidentiality or privacy given that their contact information will be collected 
2) Psychological distress from filling out diabetes-related surveys.  
 
 
The main risks to participants in the CGM arm include the risks above plus risks associated with 
the CGM. These risks include: 
1) Local erythema (redness), local infection, inflammation, pain or discomfort, bleeding at 
the glucose sensor insertion site, bruising, itching, scarring or skin discoloration, 
hematoma, and adhesive irritation. 
2)  There is a remote risk of sensor or needle fracture during insertion, wear or removal, 
with fragments retained under the skin.  
3) Distress from seeing abnormal values and potential confusion about how to treat 
abnormal values.  
 
The main risks to participants in the provider subject cohort include: 
1) Loss of confidentiality or privacy given that their contact information will be collected 
 
Protections against the specific risks identified above include the following: 
 
• Loss of Privacy/Confidentiality 
o Subjects will be approached privately in the ED and all data will be managed 
securely as noted above. The CGMs being used are small and unobtrusive. 
Because of the size of biosensor, we do not anticipate that a bystander would 
know that a patient is wearing a CGM nor would they be able to “eavesdrop” on 
the data being transmitted to the subject’s phone or reader. Consequently, the use 
of CGM in a public location will not be problematic. We anticipate that the CGM 

 
Page 16 of 27 
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will attract little attention and will not lead to a loss of confidentiality, especially 
as these sensors are widely used in clinical practice for people with diabetes. We 
view this risk to be minimal. All data and personal information pertaining to 
subjects from both cohorts will be managed securely and accessible only by 
authorized members of the study team.  All identifiers will be disposed of as soon 
as appropriate (see section 26). 
 
• Psychological Distress from Diabetes-Related Surveys 
o The informed consent process will discuss the potential that filling out surveys 
related to diabetes could cause distressing rumination about living with a chronic 
disease. We will limit the length of surveys to approximately five minutes to 
minimize the effort that participants need to expend filling them out. We view this 
risk as minimal.  
 
• Physical Discomfort 
o The CGM is comfortable to wear. Local reactions are rare and generally mild. If a 
participant no longer wishes to use or wear the CGM s/he can simply remove the 
sensors to truncate data collection while still being a participant in the study. We 
consider this risk to be minimal. 
 
 
• Psychological Effects of CGM 
o Participants in the study may develop increased stress or awareness of their blood 
sugar as a response to the flow of data from the CGM.  They may seek care or 
adjust their treatment regimen (correctional insulin, for example) based on CGM 
values. To mitigate this type of risk, all subjects will be supplied with extensive 
written information on how to manage hypo- and hyperglycemia, including clear 
instructions to check a finger-stick blood sugar level if there is any question of 
CGM inaccuracy, and will have the contact information for the study team if they 
have questions or concerns about the CGM or its readings. We have classified this 
risk to be minimal. 
o An endocrinologist will be “on call” 24 hours a day, 7 days a week, and the study 
pager number will be provided to all participants. The study pager will be carried 
during business hours by a study team member, who will pass all medical calls to 
the on-call doctor. After hours, the on-call endocrinologist will carry the pager.  If 
subjects encounter a blood sugar value or other adverse event that they need 
assistance with, they will be encouraged to call their primary care physicians.  If 
they are unable to reach their PCPs or don’t have one, they will have the ability to 
page the provider on call, who will provide appropriate clinical guidance as to 
how to manage the adverse event. The provider on call will be a qualified 
endocrinologist who will be able to provide counseling on managing out of range 
blood sugars.  If the complaint is too acute or complex to be managed on the 
telephone, the patient will be referred to the emergency department. 
 
o The CGM sensor to be used in the proposed study is a commercially available 
device and will be used to obtain patterns in blood glucose monitoring. The Libre, 

 
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made by Abbott, does not qualify as an implant or life-sustaining device, nor does 
it pose a serious health risk to study participants. Because of this, the Libre CGM 
meets requirements for a Non-Significant Risk Device under FDA 21 CFR 
812.3(m). 
 
 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
 
This project investigates an intervention that is intended to help people with diabetes navigate 
between the ED and specialty diabetes care. Within this program, we will provide care 
coordination and support for potentially vulnerable patients.  We expect that patients will directly 
benefit from participating in the study because they will receive detailed written instructions 
relevant to diabetes and hyper- and hypoglycemia and will also receive assistance arranging the 
initial follow-up appointment. Subjects in the intervention group will benefit from closer 
monitoring of their blood glucose, which may help them avoid recurrent hyper- or hypoglycemia 
and will also provide real-time feedback about the impact of their dietary choices and exercise 
habits, which may impact their long-term lifestyle choices and empower them to participate more 
actively in their care management 
 
As a thank you for their time and participation in this study, patients will also be gifted a $10.00 
gift card  
 
There is no anticipated direct benefit to the provider subject cohort. 
 
18. VULNERABLE POPULATIONS* 
 
 No vulnerable populations will be included in this study. Pregnant patients, patients under 18, 
adults unable to consent, and prisoners are all excluded.  
 
In the provider subject cohort, no subjects will be approached who are directly or indirectly 
supervised by any member of the study team. 
 
19. MULTI-SITE RESEARCH* 
 
NA 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
 
NA 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
At subjects’ follow up appointments in the DCOE, if subjects are randomized to the CGM arm, 
the results of their blood sugar readings will be reviewed and discussed with the subject. No 
other research results will be shared with subjects. 
 
22. SETTING 

 
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- 
Enrollment & Intake Visit: UMMMC EDs (University Campus, Memorial Campus, 
Leominster Campus, Marlborough Campus, and Clinton Campus)  
- 
Visits #1 and physician cohort recruitment: Diabetes Center of Excellence, University 
Campus   
- 
Follow up data collection: Private offices at the University Campus in the departments 
of medicine and emergency medicine  
 
 
23. RESOURCES AVAILABLE 
 
Study Staff: All Study Staff members are up to date on CITI certification and are aware that this 
training must be renewed every three years. They will conduct this research in accordance with 
the current, IRB approved protocol.  
- 
Study Investigators: 
→ Principle Investigator (PI): The PIs are a board-certified Endocrinologist and 
Emergency Medicine physician with experience in human subjects’ research.  
▪ Responsibilities: The PIs will be responsible for overseeing the entire 
study including, but not limited to (1) dissemination of the research 
protocol to all Study Staff; (2) recruitment; (3) enrollment; (4) data 
collection; (5) data analysis; and, (6) dissemination of results. The PI will 
ensure all Study Staff are adequately trained and monitor their progress to 
ensure they are following the protocol. 
→ Co-Investigators (Co-Is): The Co-Is are physicians from the departments of 
Emergency Medicine, and Endocrinology  
▪ Responsibilities: The Co-Is will assist the PI with all aspects of the study 
including, but not limited to: (1) recruitment; (2) enrollment; (3) 
administering questionnaires; (4) interpretation of results; and, (5) 
preparation of the resulting manuscripts.  
- 
Additional Study Staff Roles:  
→ Research Assistants (RAs): The RAs will have basic training in research methods 
and human subjects’ research, as well as a bachelor’s degree in a human science 
field or equivalent.  
▪ Responsibilities: They will be trained by the PI and Research Coordinator 
to complete most aspects of the study including, but not limited to: (1) 
explaining the study to eligible individuals; (2) obtaining informed 
consent; (3) training participants in the use of the CGM sensor and reader; 
(4) how to conduct a chart review; (5) data handling; (6) arranging follow-
up visits; and, (7) administering questionnaires.  
→ Research Coordinator (RC):  
▪ Responsibilities: In addition to the responsibilities described for the RAs, 
the RC will train and monitor the RAs and assist with regulatory 
requirements and communications with the IRB.  
 
 
 

 
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24. LOCAL RECRUITMENT METHODS 
 
Patient Subjects 
 
Feasibility: As per Section 13, based on the number of patients presenting to the University ED 
with the qualifying chief complaint, the study team is confident that the appropriate number of 
subjects can be recruited during the study period. 
 
Procedures: We have created a one-page basic information sheet to hand out to both potential 
and enrolled participants that outlines the study details in an easy-to-read format.  
- 
Study staff will identify potentially eligible individuals through EHRs  
- 
They will initially view:  
→ (ED-Based) The individual’s name, age, sex, presenting complaint, ED bed 
location, and treating physician’s name from the ED tracking board 
→ If the individual seems eligible based on the above information, Study Staff will 
query other portions of the EMR (medical history, current medications, past 
medications) to verify EMR-based eligibility.  
→ If the individual still seems eligible, the data points initially viewed will be 
recorded on the Screening Log.  
→ Study Staff will notify the potential participant’s treating physician of eligibility, 
and ask if the treating physician plans to refer the patient to the DCOE 
→ If the physician is not familiar with the DCOE, the study staff member will 
educate the physician as to the purpose and availability of the DCOE to help the 
physician determine if a referral is appropriate for the patient. The study staff will 
also be prepared to show physicians how to place a referral order 
→ If the physician replies in the affirmative, the study staff will then request their 
permission to approach their patient and ensure that there are no additional 
barriers to enrollment from a clinical standpoint.   
→ Potential participants will be approached by a member of the Study Staff 
regarding this research. Study Staff will ask for the individuals’ permission to 
explain our study, give them time to read our information sheet and offer them the 
opportunity to participate.  
 
 
Destruction of Identifiers:  
- 
Declined or Ineligible: Identifiers from the Screening Log will be deleted within 24 
hours and de-identified demographic information, along with any noted barriers to 
participation, will be transferred to Declined/Ineligible Log.  
- 
Agree to Participate: Following the enrollment and intake visit, identifiers from the 
Screening Log will be transferred to the Master Code and de-identified demographic 
information will be transferred to Intake Data. Medical record number (MRN) will be 
directly entered into the Master Code.  
 
Compensation: Participants will be compensated for their time at their follow up each visit. 
A $10 Bank of America card will be given to each participant at his or her follow up visit. To be 
eligible to receive the research stipend - the subject’s name, address, phone number, and type of 

 
Page 20 of 27 
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phone (mobile, landline) will be provided to the UMMS business office to procure the Bank of 
America card.  Bank of America will mail the card directly to the subject. Once this information 
is provided to the business office – this identifying information will be destroyed by the PI. 
 
 
Provider Referred Recruitment: We also plan to make the emergency providers aware of our 
program via announcements at resident conference and at monthly faculty meetings, and as has 
been done for prior ED-based studies, we will place signs in the “doc boxes” where charting 
takes place. These presentations and materials will include information about criteria that would 
make a DCOE referral appropriate. If an attending or resident identifies a potentially appropriate 
patient, they will page a member of our study staff, usually a research assistant (RA). When 
receiving a referred patient, the RA or other study staff member will proceed as above.  
 
In a similar fashion, we will make the Diabetes Consult Service aware of our project as well so 
that potentially eligible patients can be referred.  
 
Provider Subjects 
 
Immediately following the office encounter with a patient subject, the study team will abstract in 
Redcap the provider taking care of each patient as potential provider subjects. Potential subjects 
subsequently will be sent an email solicitation to participate in a Redcap survey.  A fact sheet 
will be provided with that email.  The survey will consist of 4 questions pertaining to their 
satisfaction with patient subject care coordination and/or their GCM utilization.  This is the only 
involvement of the provider subjects.  The solicitation email, fact sheet, and provided survey are 
included with this application. 
 
 
25. LOCAL NUMBER OF SUBJECTS 
 
We expect to recruit patient 200 patients in the one-year period (100 in each arm). As per the 
power analysis described in section 13, this will allow us to measure our described outcomes.  
We expect to recruit approximately 8 provider subjects. 
 
26. CONFIDENTIALITY  
 
Procedures to Secure the Data:  
- 
Participants will be assigned a unique Study ID# and most data related to a given 
participant will use this ID (see table below).  
- 
We may quote participant comments in presentations and publications; however, any 
direct quotations will be carefully reviewed to ensure that they do not include any 
potentially identifiable content.  
- 
UMMS/UMMMC computers are password-protected and encrypted.  
- 
Data will be stored in REDCap 
 
 
Coding 
Access 
Storage 
Destruction 
HIPAA Waiver 
- N/A 
- N/A 
- N/A 
- N/A 
Info Sheet 
- N/A 
- N/A 
- N/A 
- N/A 

 
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Screening Log  
1) While screening 
2) Status assigned – 
All data points will 
either be deleted or 
transferred to 
different documents 
(also see Section 
24) 
1) *Identifiable 
information 
2) N/A  
 
1) Authorized 
Study Staff  
2) N/A 
1) Securely stored 
on a password-
protected 
UMMMC/UMMS 
computer  
2) N/A 
  
1) See Section 24 
2) N/A 
  
Declined Ineligible  
- De-identified 
demographic 
information will be 
transferred to this 
document from the 
Screening Log; 
Noted barriers to 
participation will 
be directly entered  
- Will not contain 
any of the 18 
HIPAA 
identifiers  
- Authorized 
Study Staff & 
Support 
Personnel  
- Securely stored on 
a password-
protected 
UMMMC/UMMS 
computer 
- Will be archived 
once results have 
been published  
Consent 
- Written 
documentation 
- *Identifiable 
information 
- Authorized 
Study Staff 
- Securely stored in 
the PI’s locked 
office 
- In accordance 
with HRP-800 
Investigator 
Obligations, paper 
forms will be 
retained for 3 years 
following 
completion of this 
research 
HIPAA 
Authorization 
- Written 
documentation 
- *Identifiable 
information 
- Authorized 
Study Staff 
- Securely stored in 
the PI’s locked 
office 
- In accordance 
with HRP-800 
Investigator 
Obligations, paper 
forms will be 
retained for 6 years 
following 
completion of this 
research 
Master Code 
- Contact 
information will be 
collected using the 
paper form 
(Contact Info) and 
then transferred to 
the Master Code; 
Identifiers will be 
transferred to this 
document from the 
Screening Log; 
MRN will be 
directly entered  
 - *Identifiable 
information; The 
only place that 
identifying 
information will 
be linked with 
Study ID# 
- Authorized 
Study Staff 
 
- Securely stored on 
a password-
protected 
UMMMC/UMMS  
- Contact 
information will be 
deleted for each 
participant once 
data collection is 
complete and the 
biosensor has been 
returned; MRN and 
name will be 
deleted upon data 
collection 
verification 
Contact Info 
- Contact 
information will be 
collected using the 
Redcap (Contact 
- *Identifiable 
information 
- Authorized 
Study Staff 
- N/A 
- Contact 
information will be 
transferred to the 
Master Code 
following 

 
Page 22 of 27 
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Info) and then 
transferred to the 
Master Code 
completion of the 
enrollment and 
intake visit and the 
Redcap form will 
be destroyed  
Intake Data 
Collection Sheet – 
RA Facing 
Collected using the 
Redcap form 
 
*Also see Section 
12 
Study ID# only 
 
Authorized Study 
Staff  
 
Directly entered by 
the RA into Recap 
1) Destroyed upon 
completion of data 
collection 
verification  
2) REDCap 
database will be 
archived once 
results have been 
published  
Intake Data 
Collection Sheet- 
Patient Facing 
Collected using the 
Redcap form 
 
*Also see Section 
12 
Study ID# only 
 
Authorized Study 
Staff  
 
Directly entered by 
the participant into 
a secure online 
database using 
survey mode 
(REDCap) 
1) Destroyed upon 
completion of data 
collection 
verification  
2) REDCap 
database will be 
archived once 
results have been 
published  
Info Sheet- 
Hyperglycemia 
- N/A 
- N/A 
- N/A 
- N/A 
Info Sheet- 
Hypoglycemia 
- N/A 
- N/A 
- N/A 
- N/A 
Info Sheet- CGM 
- N/A 
- N/A 
- N/A 
- N/A 
Baseline Problem 
Areas in Diabetes 
(PAID) scale/ 
Baseline Diabetes 
Distress Scale and 
supplemental 
questions 
 
- Direct entry into 
REDCap 
- Study ID# only 
- Authorized 
Study Staff & 
Support 
Personnel 
- Directly entered 
by the participant 
into a secure online 
database using 
survey mode 
(REDCap) 
- REDCap database 
will be archived 
once results have 
been published  
2 Week Follow up 
Data Collection 
Sheet 
1) Collected using 
the paper form 
2) Entered into 
REDCap 
 
*Also see Section 
12 
1) Study ID# only 
2) Same as above 
1) Authorized 
Study Staff  
2) Authorized 
Study Staff & 
Support 
Personnel 
1) Securely stored 
in the PI’s locked 
office 
2) Secure online 
database (REDCap) 
1) Destroyed upon 
completion of data 
collection 
verification  
2) REDCap 
database will be 
archived once 
results have been 
published  
2 Week Problem 
Areas in Diabetes 
(PAID) 
scale/Diabetes 
Distress Scale and 
supplemental 
questions 
- Study ID# only 
- Authorized 
Study Staff & 
Support 
Personnel 
- Directly entered 
by the participant 
into a secure online 
database using 
survey mode 
(REDCap) 
- REDCap database 
will be archived 
once results have 
been published  

 
Page 23 of 27 
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- Direct entry into 
REDCap 
Provider subject 
email solicitation  
-N/A 
- Authorized 
Study Staff & 
Support 
Personnel 
-N/A 
-N/A 
Provider Fact 
Sheet 
-N/A 
- Authorized 
Study Staff & 
Support 
Personnel 
-N/A 
-N/A 
Provider Survey 
-Direct entry into 
REDCap 
- Study ID# only 
- Authorized 
Study Staff & 
Support 
Personnel 
- Directly entered 
by the participant 
into a secure online 
database using 
survey mode 
(REDCap) 
- REDCap database 
will be archived 
once results have 
been published  
Follow up Data 
Collection Sheet 
- Direct entry into 
REDCap  
 
Study ID# only 
 
1) Authorized 
Study Staff  
2) Authorized 
Study Staff & 
Support 
Personnel 
1) Securely stored 
in the PI’s locked 
office 
2) Secure online 
database (REDCap) 
1) Destroyed upon 
completion of data 
collection 
verification  
2) REDCap 
database will be 
archived once 
results have been 
published  
Devices: 
CGMs 
CGM Readers 
Tablets 
- N/A 
- Authorized 
Study Staff 
- Stored in the PI’s 
locked office when 
not in use 
- N/A 
 
 
 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
. 
 
Procedures to Protect Subjects: 
- 
To make participants feel at ease, Study Staff will clearly explain the function of the ED 
care coordination program and the CGM if applicable 
- 
 Participants will be informed that they can remove or the CGM at any time if they feel 
uncomfortable or have concerns, and can skip any question in the questionnaires that they 
feel uncomfortable answering.  
- 
Study Staff will remind participants that their participation is voluntary and withdrawal of 
participation at any time will not involve any penalty or loss of benefits to which they are 
otherwise entitled.  
- 
Participants will be offered copies of all signed forms (Consent and HIPAA 
Authorization) and given contact information for Study Staff should they have any 
questions or concerns at any time while wearing the CGM, or if they wish to withdraw 
from the study.  
- 
Study Staff members directly involved with recruiting and consenting participants will 
not be involved in their clinical care.  

 
Page 24 of 27 
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- 
The collection of sensitive information (e.g., questions regarding substance use history) 
will be limited to the information that is necessary to conduct this research.  
 
Protected Health Information:  
- 
A HIPAA Waiver of Authorization has been obtained to allow Study Staff to query EMRs 
to identify eligible participants for recruitment (see Section 24).  
- 
Following consent, a signed HIPAA Authorization will be obtained to access and record 
additional information from the participant’s EMR. This information will be limited to 
information directly related to the study. 
 
 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
 
No funds have been set aside for research related injury. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
 
There are no anticipated costs for which participants will be responsible because of participation 
in this research. Follow-up visits in the DCOE will take place as part of routine clinic care. Any 
charges associated with the CGM, such as physician interpretation of the CGM, will be covered 
by the study. 
 
 
30. CONSENT PROCESS 
 
 
Study Staff Education: Only Study Staff with prior approval who have reviewed HRP-802 
Informed Consent will be obtaining consent. 
 
Consent Process:  
- 
We will be obtaining informed consent.  
- 
All of the potential risks, reasoning, and goals of this research will be explained to each 
individual prior to obtaining consent. They will be informed that enrollment is voluntary 
and declining to participate will not affect their treatment. Ample time will be given to 
answer any questions and they will be informed that they may opt out of this voluntary 
study at any point.  
- 
All consent will be collected electronically via the Redcap application. Patients will be 
able to review, sign, and date consent electronically 
- 
-A printed copy of the consent will be provided to patients after the electronic signature 
o The electronic consent document/process allows subjects to proceed forward or 
backward or pause for review later if they choose. 
o Several measures are present to ensure that subjects have access to all of the 
consent related materials, including hyperlinks or other external documents. 
These measures include active guidance from the study team while reviewing the 
consent form to point out salient sections and key language, and access to paper 

 
Page 25 of 27 
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copies of all relevant documents that patients may need to make their decision 
about participation. Patient will be allowed to read a paper copy of the consent 
before signing electronically if they prefer. 
 
Non-English Speaking Patients 
- 
The full consent form and all subject facing materials will be available in Spanish 
- 
Recruitment and consent will be obtained with assistance from live or video/audio 
certified medical interpreters who will also be available at all follow up visits  
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
 
Study Staff Education: Only Study Staff with prior approval who have reviewed HRP-803 
Documentation of Informed Consent will be obtaining consent. 
 
Documentation of Consent: Informed consent will be documented in writing for patient 
subjects. Written consent will not be obtained for provider subjects as the study activities for this 
cohort entail less than minimal risk and do not entail any activities that would normally require 
written consent outside of the research setting.  We request a waiver of written consent for 
provider subjects. 
 
 
32. DRUGS OR DEVICES 
 
Abbott Libre 2 
→ The device is FDA-approved for people with type 1 and type 2 diabetes 
→ The device does not qualify as an implant or life-sustaining device, nor does it 
pose a serious health risk to study participants. Therefore, the E4 meets 
requirements for a non-significant risk device under FDA 21CFR 812.2(b).  
 
- 
Additional Device Information: The Abbot Libre 2 (Figure 3), which is a clinical grade 
commercially available device, is a small disk (1.38 inches in diameter and 0.2 inches 
thick), and it weighs 0.18 ounces. After it is placed, a small (less than 0.4mm thick) 
sensor probe (not sharp) remains in the skin and can transmit continuous glucose data to a 
reader. The device can be submerged in water, and can be worn continuously for up to 2 
weeks. 
- 
The device can wirelessly stream data to a smart phone application or dedicated reader 
device Bluetooth  
 
 
 
 
References 
 
1. 
Washington R, Andrews R, Mutter R. Emergency Department Visits for Adults with Diabetes, 
2010: HCUP Statistical Brief #167: Agency for Healthcare Research and Quality; 2013 [March 24, 2021]. 
Available from: http://www.hcup-us.ahrq.gov/reports/statbriefs/sb167.pdf. 

 
Page 26 of 27 
Template Revised 03/15/2021 
2. 
McCoy RG, Lipska KJ, Van Houten HK, Shah ND. Association of Cumulative Multimorbidity, 
Glycemic Control, and Medication Use With Hypoglycemia-Related Emergency Department Visits and 
Hospitalizations Among Adults With Diabetes. JAMA Netw Open. 2020;3(1):e1919099. Epub 
2020/01/11. doi: 10.1001/jamanetworkopen.2019.19099. PubMed PMID: 31922562; PMCID: 
PMC6991264. 
3. 
Booth GL, Hux JE. Relationship between avoidable hospitalizations for diabetes mellitus and 
income level. Arch Intern Med. 2003;163(1):101-6. Epub 2003/01/14. doi: 10.1001/archinte.163.1.101. 
PubMed PMID: 12523923. 
4. 
Palermo NE, Modzelewski KL, Farwell AP, Fosbroke J, Shankar KN, Alexanian SM, Baker WE, 
Simonson DC, McDonnell ME. Open Access to Diabetes Center from the Emergency Department 
Reduces Hospitalizations in the Susequent Year. Endocr Pract. 2016;22(10):1161-9. Epub 2016/10/13. 
doi: 10.4158/E161254.OR. PubMed PMID: 27732094. 
5. 
Blair RA, Palermo NE, Modzelewski KL, Alexanian SM, Baker WE, Simonson DC, McDonnell ME. 
Reduced Impact of Diabetes Clinic Referral on High-Frequency Emergency Department Users. Endocr 
Pract. 2018;24(12):1043-50. Epub 2018/10/06. doi: 10.4158/EP-2018-0161. PubMed PMID: 30289310. 
6. 
Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, 
McGill JB, Polonsky W, Toschi E, Wolpert H, Price D, Group DS. Effect of Continuous Glucose Monitoring 
on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized 
Clinical Trial. JAMA. 2017;317(4):371-8. Epub 2017/01/25. doi: 10.1001/jama.2016.19975. PubMed 
PMID: 28118453. 
7. 
Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price 
D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R, Group DS. Continuous Glucose Monitoring 
Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A 
Randomized Trial. Ann Intern Med. 2017;167(6):365-74. Epub 2017/08/23. doi: 10.7326/M16-2855. 
PubMed PMID: 28828487. 
8. 
Park C, Le QA. The Effectiveness of Continuous Glucose Monitoring in Patients with Type 2 
Diabetes: A Systematic Review of Literature and Meta-analysis. Diabetes Technol Ther. 2018;20(9):613-
21. Epub 2018/08/11. doi: 10.1089/dia.2018.0177. PubMed PMID: 30095980. 
9. 
Lawton J, Blackburn M, Allen J, Campbell F, Elleri D, Leelarathna L, Rankin D, Tauschmann M, 
Thabit H, Hovorka R. Patients' and caregivers' experiences of using continuous glucose monitoring to 
support diabetes self-management: qualitative study. BMC Endocr Disord. 2018;18(1):12. Epub 
2018/02/21. doi: 10.1186/s12902-018-0239-1. PubMed PMID: 29458348; PMCID: PMC5819241. 
10. 
Yan JW, Gushulak KM, Columbus MP, van Aarsen K, Hamelin AL, Wells GA, Stiell IG. Risk factors 
for recurrent emergency department visits for hyperglycemia in patients with diabetes mellitus. Int J 
Emerg Med. 2017;10(1):23. Epub 2017/07/14. doi: 10.1186/s12245-017-0150-y. PubMed PMID: 
28702883; PMCID: PMC5507935. 
11. 
Yan JW, Gushulak KM, Columbus MP, Hamelin AL, Wells GA, Stiell IG. Sentinel visits in 
emergency department patients with diabetes mellitus as a warning sign for hyperglycemic 
emergencies. CJEM. 2018;20(2):230-7. Epub 2017/07/26. doi: 10.1017/cem.2017.338. PubMed PMID: 
28738911. 
12. 
Villani M, Earnest A, Smith K, de Courten B, Zoungas S. Geographical variation of diabetic 
emergencies attended by prehospital Emergency Medical Services is associated with measures of 
ethnicity and socioeconomic status. Sci Rep. 2018;8(1):5122. Epub 2018/03/25. doi: 10.1038/s41598-
018-23457-5. PubMed PMID: 29572530; PMCID: PMC5865134. 
13. 
Yan JW, Liu S, Van Aarsen K, Columbus MP, Spaic T. Do Adult Patients With Type 1 or 2 Diabetes 
Who Present to the Emergency Department With Hyperglycemia Have Improved Outcomes if They Have 
Access to Specialized Diabetes Care? Can J Diabetes. 2021;45(1):59-63. Epub 2020/08/28. doi: 
10.1016/j.jcjd.2020.05.011. PubMed PMID: 32847767. 

 
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Template Revised 03/15/2021 
14. 
Burner E, Terp S, Lam CN, Neill E, Menchine M, Arora S. Access to care, nativity and disease 
management among Latinos with diabetes in a safety-net healthcare setting. AIMS Public Health. 
2019;6(4):488-501. Epub 2020/01/08. doi: 10.3934/publichealth.2019.4.488. PubMed PMID: 31909069; 
PMCID: PMC6940585. 
15. 
Worrall G, Knight J. Continuity of care is good for elderly people with diabetes: retrospective 
cohort study of mortality and hospitalization. Can Fam Physician. 2011;57(1):e16-20. Epub 2011/01/22. 
PubMed PMID: 21252120; PMCID: PMC3024182. 
16. 
Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson 
A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, 
Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, 
Miller KM, Wireless Innovation for Seniors With Diabetes Mellitus Study G. Effect of Continuous Glucose 
Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 
2020;323(23):2397-406. Epub 2020/06/17. doi: 10.1001/jama.2020.6928. PubMed PMID: 32543682; 
PMCID: PMC7298607. 
17. 
Bergenstal RM, Kerr MSD, Roberts GJ, Souto D, Nabutovsky Y, Hirsch IB. Flash CGM Is Associated 
With Reduced Diabetes Events and Hospitalizations in Insulin-Treated Type 2 Diabetes. J Endocr Soc. 
2021;5(4):bvab013. Epub 2021/03/02. doi: 10.1210/jendso/bvab013. PubMed PMID: 33644623; PMCID: 
PMC7901259. 
18. 
Polonsky WH, Hessler D, Ruedy KJ, Beck RW, Group DS. The Impact of Continuous Glucose 
Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the 
DIAMOND Randomized Clinical Trial. Diabetes Care. 2017;40(6):736-41. Epub 2017/04/09. doi: 
10.2337/dc17-0133. PubMed PMID: 28389582. 
19. 
Wardian J, Sun F. Factors associated with diabetes-related distress: implications for diabetes 
self-management. Soc Work Health Care. 2014;53(4):364-81. Epub 2014/04/11. doi: 
10.1080/00981389.2014.884038. PubMed PMID: 24717184; PMCID: PMC4029338. 
20. 
Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: 
establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012;35(2):259-64. Epub 
2012/01/10. doi: 10.2337/dc11-1572. PubMed PMID: 22228744; PMCID: PMC3263871.