Improving Type 2 Diabetes Management in Primary Care Through Periodic Continuous Glucose Monitoring
Phase: NA
Conditions: Type 2 Diabetes, Non Insulin Dependent Diabetes
Sponsor: University of Colorado, Denver

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Study Title: Improving type 2 diabetes management in primary care through periodic continuous 
glucose monitoring (T2D INSIGHT)  
 
Protocol (COMIRB) Number: 25-1116 
 
Principal Investigator: Tamara Oser, MD 
 
Version Number: 5 
 
Version Date: 2/4/2026 
 
Sponsor (if any): N/A 
 
 
1. Study Rationale 
 
Diabetes is the eighth leading cause of death in the U.S.1 and increased in prevalence between 2000 
and 20232 to 14.7% of adults.1 During this same time period, the proportion of adults with diabetes 
achieving glycemic control declined from 57.4% (2007 to 2010) to 50.5% (2015 to 2018)3 following 
more than a decade of improvements in this measure.3 The economic burden of diagnosed diabetes as of 
2022 was $412.9 billion in direct medical costs, reduced employment, presenteeism, and lost productivity 
resulting from premature deaths.4 Lowering A1C can significantly reduce total healthcare and diabetes-related 
costs.5 
 
Usual care for glycemic measurement to inform clinical diabetes management often consists of 
frequent self-monitoring of blood glucose. Continuous glucose monitoring (CGM) can help improve 
diabetes management, clinical care, and clinical outcomes for people with diabetes by providing immediate 
feedback on the influence of lifestyle factors and medication on glucose levels. Randomized controlled trials 
and observational studies have demonstrated its effectiveness to improve glycemic outcomes and patient 
satisfaction for people with type 2 diabetes not treated with insulin, mostly outside of primary care settings.6-9  
 
Use of OTC CGM at periodic intervals for people with non-insulin treated T2D has the potential to improve 
diabetes care and management in primary care settings by reducing and eliminating insurance- and cost-
related barriers to CGM adoption. Additionally, recent FDA clearance of over-the-counter (OTC) CGM for 
people with type 2 diabetes not treated with insulin at a fraction of the cost of prescription CGM has the 
potential to address many of the biggest barriers to CGM use in primary care settings. However, previous 
studies on the effectiveness of periodic CGM to improve glycemic outcomes for people with non-insulin 
treated type 2 diabetes are lacking: They do not compare intervals of periodic use to identify the ideal interval 
to maintain effectiveness, were conducted outside of the U.S., were not specific to primary care, or were not 
specific to people with diabetes not treated with insulin. None of the previous studies have examined the use 
of OTC CGM. Our study will compare glycemic outcomes (A1C, CGM metrics such as percent time-in-
range) associated with use of periodic, OTC CGM Dexcom Stelo) at 30- and 90-day intervals to usual 
care for people with non-insulin treated type 2 diabetes. It will also assess feasibility, acceptability, and 
reach of this intervention for patients and clinicians.  
 
This study originally proposed to recruit 4 practice sites from which to recruit 188 patient participants. We 
have since increased to a total of 6 practice sites to ensure we can recruit a sufficient number of participants 
with non-insulin-treated type 2 diabetes, given that 2 sites from the originally recruited group are fairly small 
practices. 
 
2. Background 
 
Primary care practices are uniquely positioned to improve diabetes care and management, as they provide 
care for 50% of adults with type 1 diabetes and 90% of adults with type 2 diabetes.10-12 However, CGM uptake 
has been slower in primary care than other specialty care settings due to limited insurance coverage 
(particularly for people with type 2 diabetes not treated with insulin), burdensome and time-consuming 
insurance authorization processes, and high costs to patients.13 14 

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Limited but promising evidence suggests that periodic CGM use, at intervals from three weeks to three 
months (e.g. 15-day use every three months), can support improved glycemic outcomes compared to self-
monitoring of blood glucose.15-19 Periodic CGM use requires fewer sensors for any given timeframe, lowering 
patients’ cost of using CGM. Periodic use of OTC CGM would require fewer sensors than all-the-time use for 
a given timeframe, and costs about $50 per sensor compared to over $100 per sensor for prescription 
devices when not covered by insurance. Additionally, OTC CGM negates the need for burdensome and time-
consuming ordering and insurance authorization processes on the part of clinicians. The device’s self-directed 
education alleviates the need for primary care practice teams to expend resources such as training and time 
related to initiating the device with patients.  
 
Understanding whether use of periodic OTC CGM is effective at improving glycemic outcomes in primary care 
settings and understanding evidence behind specific intervals of use would allow primary care providers to 
make evidence-based recommendations to their patients with T2D not on insulin. Demonstrating 
effectiveness of use of CGM at less than $20 or $50/month without prior authorization or insurance barriers 
could increase access to this evidence-based technology for people who previously could not access or afford 
it. 
 
3. Objectives and Endpoints 
Specific Aim 1: Conduct a two-arm, 1:1 randomized trial to determine the effectiveness of 
two intervals of periodic use of a CGM on A1C, time-in-range (TIR), and time-in-tight-range 
(TITR) among people with T2D not treated with insulin and who receive diabetes treatment in 
primary care settings. 
• 
Primary and secondary outcomes:  
o Change in A1C  
o Percent time in range (TIR): Percent of glucose values between 70 and 180 mg/dL. 
o Percent time in tight range (TITR): Percent of glucose values between 70 and 140 
mg/dL. 
Specific Aim 2: Determine feasibility, acceptability, and reach of periodic use of OTC CGM 
among 1) primary care clinicians and 2) people with T2D not treated with insulin. 
• 
Secondary outcomes: 
o Feasibility (clinicians): Feasibility of Intervention Measure (FIM)20 
o Acceptability  
▪ 
Clinicians: Acceptability of intervention measure (AIM)21  
▪ 
Patients:  
• 
Days of wear 
• 
Glucose monitoring satisfaction22  
• 
Attrition 
• 
Percentage approached who agreed to participate. 
• 
Willingness to pay / affordability: (e.g. Percent of participants willing to 
pay to continue periodic, OTC CGM use following study completion.)  
o Reach (patients): (e.g. participant demographics (age, race, gender, income, 
insurance)). 
o Adoption (practices and clinicians): practice characteristics, clinician professional 
characteristics and demographics 
o Reasons and context for implementation, feasibility, acceptability (qualitative 
interviews) 
o Intentions to continue, resources and changes needed to continue recommending 
periodic OTC CGM (qualitative interviews) 
 
4. Study Design 
 
This single-site, two-arm, 1:1 randomized clinical trial will examine the use of periodic, OTC CGM 
over a six-month period among people with T2D who do not use insulin in primary care practices. We seek to 

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determine the frequency of use needed to affect key glycemic control metrics of A1C, time in range (TIR) and time 
in tight range (TITR), as well as feasibility, acceptability, and affordability of these devices in primary care.  
Randomization: In a 1:1 ratio, participants will be randomly assigned to use one 15-day OTC CGM every 
30 or 90 days. Randomization block sizes of 4 and 6 will be used randomly to maximize uniform distribution of 
participant characteristics while minimizing the possibility of predicting an assignment. Randomization will be 
stratified by clinical practice and GLP-1 or GLP-1/GIP dual agonist use. To minimize an imbalance in the number 
of participants assigned to each group, randomization will not be stratified by age, A1c, or other factors because 
of the small number per clinic that is possible. Any imbalances will be adjusted for in the analysis.  
Blinding: Baseline data from blinded CGM will be used as a comparator for usual care. Blinded CGM 
devices will be applied at the screening visit or within approximately one week if remote study visit) to collect a 10-
day blinded CGM run-in and again at 3- and 6-month study visits (within approximately one week if remote study 
visit). Participants will be instructed to not apply a blinded device if they are wearing an OTC CGM.  
The aims of the proposed study are: 
Specific Aim 1: Conduct a two-arm, 1:1 randomized trial to determine the effectiveness of two intervals of 
periodic use of a CGM on A1C, time-in-range (TIR), and time-in-tight-range (TITR) among people with T2D 
not treated with insulin and who receive diabetes treatment in primary care settings. Baseline data from 
blinded CGM will be used as a comparator for usual care (UC). Our hypotheses are as follows:  
1a: Periodic CGM use (one 15-day sensor) once every 30 days or once every 90 days will be associated 
with lower A1C compared to UC at 3 and 6 months. 
1b: Periodic CGM use (one 15-day sensor) once every 90 days will be associated with non-inferior A1C 
reduction at 3 and 6 months compared to periodic CGM use once every 30 days. 
1c: Periodic CGM use (one 15-day sensor) once every 30 days or once every 90 days will be associated 
with greater TIR and TITR compared to baseline. 
Specific Aim 2: Determine feasibility, acceptability, and reach of periodic use of OTC CGM among 1) 
primary care clinicians and 2) people with T2D not treated with insulin. Hypotheses are as follows: 
2a: Measures of feasibility and acceptability will be higher for OTC CGM implementation than for 
prescription CGM implementation among primary care clinicians. 
2b: Periodic OTC CGM use will have higher and more equitable reach and will be acceptable to 
participants (demographics, % recommended days worn, willingness to pay). 

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5. Study Population 
 
Population:  
 
Practices: This project will take place at up to six primary care practices in Colorado recruited 
through the Practice Innovation Program at the University of Colorado Anschutz Medical Campus.  
 
Practice Inclusion Criteria include: 
• 
Primary care specialty (e.g. family medicine, internal medicine) 
• 
Located within the state of Colorado 
• 
Practice staff and/or providers willing to answer surveys and interviews about their 
experience caring for patients using the Stelo  
 
Practice Exclusion Criteria include: 
• 
Already participating in CGM- or diabetes-focused initiative that could interfere with 
intervention and outcomes of the present study, in the opinion of study investigators 
 
Practice Members: Clinicians and staff, including physicians, PAs, NPs, diabetes care and 
education specialists/diabetes educators, pharmacists, and other team members who care for 
patients with diabetes, from participating practices will be invited to complete baseline and follow-up 
surveys and semi-structured interviews to describe implementation, feasibility, and acceptability of 
periodic OTC CGM in primary care settings. We will recruit 30-40 practice members for surveys 
(~5-7 per practice), with 30 required to achieve statistical power for planned aim 2 analyses. We will 
recruit 2-4 practice members from each practice for interviews, up to a possible total of 20. This will 
result in a total of up to 60 practice member participants, though this will likely be closer to 40 given 
extensive overlap between survey and interview participants. 
 
Practice Member Inclusion Criteria include: 
• 
Employed in a primary care practice participating in this study 
• 
Care for patients with diabetes 
 
Practice Member Exclusion Criteria include: 
• 
Lack of knowledge about clinical care and operations related to care for patients with 
diabetes 
 
Patients: We will enroll up to 188 people with type 2 diabetes who are not using insulin from up to 
six Colorado primary care practices, with the goal of 150 participants completing the study. 
Enrolling up to 188 participants provides a buffer of 25% to the target completion number of 150 to 
ensure that a sufficient number of participants remain to achieve adequate power to detect target 
effect sizes after accounting for screen failures, withdrawals, and other participant attrition. 
 
There will be approximate recruitment goals for the following: 
 
Approximate maximum: 
o 10% with screening A1c <7.0%  
o 25% with screening A1c >10%  
 
Patient Inclusion Criteria include: 
1)  ge ≥  8  ears at time of enrollment 
2) Diagnosis of type 2 diabetes 
3) Able to read and understand English (Dexcom Stelo is currently only available in English) 
4) No real-time or intermittently scanned (Flash) CGM use 12 months prior to enrollment 

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5) Stable medication regimen (medication classes) and dose (equivalent dose if medication has 
been changed within the same medication class) for any glucose lowering or weight loss 
medications for 30 days prior to enrollment and willing to not change medications prior to 
randomization unless safety concerns. 
6) Cell phone meeting minimum required OS compatibility with Stelo 
7) Willing to use the study device and download the Stelo app 
8) Willing and able to complete all study procedures per investigator discretion, including 
willingness to accept either experimental group (q30 or q90).  
9) A1C value (from lab data or chart review) greater than or equal to 6.5 in the 6 months prior to 
enrollment 
10) Currently receiving primary care in a participating study practice 
 
Patient Exclusion Criteria include: 
 
1) Use of insulin in the 12 months prior to screening or planning to initiate insulin during the next 
12 months (short-term use of insulin in an inpatient setting is acceptable) 
2) Concomitant disease or condition that in the opinion of the investigator may compromise patient 
safety including but not limited to severe mental illness, a diagnosed or suspected eating 
disorder, or any uncontrolled or chronic medical condition that would interfere with study related 
tasks or visits 
3) Use within 30 days of screening visit of any medication that in the opinion of the investigator 
may exacerbate glucose dysfunction (e.g. systemic corticosteroids) 
4) Current or planned use of hydroxyurea (due to interference with CGM) 
5) Known presence of a hemoglobinopathy or other condition that is expected to affect the 
measurement of A1C in the judgment of the investigator 
6) Known severe allergy to medical grade adhesive, a serious skin condition that could interfere 
with CGM placement, or extensive tattoos that precludes the use of CGM in an FDA approved 
location 
7) End stage renal disease currently managed by dialysis or eGFR <30 mL/min/1.73m2 
8) Current participation in another interventional study protocol that could impact participation in 
this study per investigator discretion 
9) Pregnant or planning to become pregnant within the next 6 months. 
10) Planning to switch primary care practices in the next 6 months. 
 
Strategies for Recruitment and Retention: 
 
Patient participants will be recruited from up to six participating primary care clinics. Potential 
patient participants will be identified using the UCHealth RECRUIT tool, or by participating clinics 
(e.g. using patient registries and/or reports from the electronic health record system to identify 
potential patients). Unaffiliated, non-UCHealth clinics are recruitment sites only, as they are not 
engaged in research, obtaining informed consent, or performing study procedures. Potential 
participants will be provided with a recruitment flyer from their primary care provider and/or by email 
containing an overview of the stud ’s purpose  eligi ilit  criteria  e pectations of participants, and 
study incentives. Flyers will also be placed within the clinic waiting area and exam rooms. This flyer 
will include a link for a prescreening questionnaire. Additionally, study team members will review the 
Primary Care Diabetes Lab patient registry (COMIRB # 20-2497) for patients meeting inclusion 
criteria from participating clinics. The PCDL registry is a list of individuals who have previously 
engaged with the PCDL through study screening, study participation, or other outreach, and have 
consented to being contacted with future study opportunities for which they may be eligible. The 
study team will text, email, call, and/or mail referred patients to explain the study, offer an 
opportunity to ask questions, and schedule a screening visit.  We will contact potential participants 
up to three times total by phone call, text, email, or mail for recruitment purposes.  
 

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The phone script will be used to reach out by phone call to past research participants (PCDL patient 
registry), RECRUIT referrals who do not complete online prescreening, patients who provide HIPAA 
authorization for their provider to share contact information for study recruitment purposes, and 
participants who reach out by phone via the flyer or other modes of advertisement. 
 
Other potential recruitment strategies may include: 
 
• 
IRB-approved paper and digital advertisements, brochures, postcards, flyers, and/or newsprint 
advertisements 
• 
IRB-approved digital advertisements posted on social media sites  
• 
In-person recruitment and telephone recruitment by individual clinical sites 
• 
Site specific EHR portal messaging 
 
Incentives will be delivered in the form of electronic gift card using a secure, online gift card platform 
(e.g. Tango, Amazon) or physical gift card to Walmart or Amazon.  
 
Patient participants will receive up to the following incentives: 
 
Completion of baseline study visit tasks (e.g. demographics, A1c, blinded CGM collection): $30 
Completion of 3-month study visit tasks (e.g. A1c, blinded CGM data collection): $30 
Completion of 6-month study visit tasks (e.g. surveys completion, A1c, blinded CGM data 
collection): $50 
 
Clinician participants will receive up to the following incentives: 
 
Completion of baseline survey: $25 
Completion of end of study survey: $25 
Completion of interview: $50 
   
6. Study Intervention 
 
Patients participating in this study will be randomized 1:1 to receive a 15-day session of periodic, OTC 
CGM either every 30 days or every 90 days for a six-month period at intervals of 30 or 90 days. Three- 
and six-month outcomes associated with periodic   TC CGM use will  e compared to participants’ own 
baseline usual care, measured through A1c and blinded 10-day CGM data collection. 
 
Dexcom Stelo is a 15-day OTC (over-the-counter available without a prescription) CGM that is built on 
the same technology used in the prescription-only Dexcom G7 CGM.23 It is intended for adults who do 
not use insulin, which includes most people diagnosed with T2D.23 24 It is the first OTC CGM to be 
cleared by the U.S. Food and Drug Administration.24 The Dexcom Stelo does not have any alarms, and 
only reads from 70-250 mg/dL. Dexcom Stelo uses an applicator applied to the skin of the upper arm 
containing a small sensor inserted into the interstitial fluid directly under the skin, from which glucose 
levels are measured and transmitted to the user’s phone application. It is based on the Dexcom G7 
platform described below. 
 
The Dexcom G7 will be used to collect blinded CGM data. The Dexcom G7 CGM System comprises 
three subsystems: Glucose Sensing Subsystem (GSS), Mobile Application System, and the Receiver 
Subsystem. The GSS consists of an applicator and a wearable encompassing a sensor, a transmitter, 
and an adhesive patch. The GSS houses and deploys a wearable medical device onto a patient’s  od  
for the purpose of measuring the concentration of glucose in the patient’s interstitial fluid in real-time 
and wirelessly communicating estimated glucose information to receiving devices (in this study, the 
Receiver). It consists of an applicator that inserts the sensor, releases the wearable, and places the 
adhesive patch on the user’s s in. The wearable is composed of the sensor, transmitter, and an 

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adhesive patch as one unit. All the wearable components can be used for one single session. The 
sensor is a small, flexible wire sensor that can continuously measure glucose levels in the interstitial 
fluid for up to 10 days, plus an extra 12-hour grace period at the end. The transmitter is attached to the 
sensor, and employs an algorithm to calculate estimated glucose values. After insertion, the transmitter 
automatically detects deployment, verifies wake-up, and begins a sensor session. The sensor’s  uilt-in 
transmitter connects to the Receiver via a Bluetooth Low Energy(BLE). The transmitter logs/saves the 
data to internal memory and does not transmit any information to a display device when used to collect 
blinded data, as in this study. The supplemental  e com  verla   atch  “ verpatch”  is a standalone, 
single-use, polyurethane medical tape provided with the System to accompany the wearable device 
and increase adherence to the skin. Participants will be provided with overpatches for use during the 
study during both the blinded data collection and use of the OTC CGM.  
Device accountability procedures will be followed throughout the study in accordance with SOPs of the 
Primary Care Diabetes Lab (e.g. inventory, shipping). 
 
Regulatory Concerns: 
This study is FDA regulated but is considered IDE exempt because it does not seek to determine the 
safety or effectiveness of a device. The effectiveness of CGM as a device has been established. 
Further, periodic use of CGM is within the label of FDA approval for OTC CGM for people with non-
insulin treated T2D and this would qualify as testing a modification of the device (periodic use vs. more 
traditional continuous use). As a result, we are investigating the OTC CGM device in accordance with 
its FDA labeling, and the study is exempt from IDE regulations. The intervention (the Dexcom Stelo) is 
an over-the-counter device available without a prescription. 
 
7. Discontinuation and Participant Withdrawal 
 
Discontinuation of study intervention: Participants who discontinue the study intervention will not be 
discontinued from study participation and will be encouraged to complete study activities (e.g. A1C 
collection, surveys) through the end of their originally planned participation period. 
 
Use of the Stelo or blinded Dexcom G7 by a participant will be discontinued if any of the following 
occur: 
• 
The investigator believes it is unsafe for the participant to continue on the intervention. This 
could be due to the development of a new medical condition or worsening of an existing 
condition; or participant behavior contrary to the indications for use of the device that 
imposes on the participant’s safet . 
• 
The participant requests that the treatment be stopped 
• 
Pregnancy 
 
Participant discontinuation/withdrawal from the study: Participants are free to withdraw from 
participation in the study at any time upon request. 
 
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
• 
Pregnancy 
• 
Significant study non-compliance (e.g. refusal to follow randomized interval for CGM use, 
not following study procedures) 
• 
If any clinical AE, laboratory abnormality, or other medical condition or situation occurs such 
that continued participation in the study would not be in the best interest of the participant, in 
the judgment of the PI. 
• 
If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded. Subjects 
who sign the informed consent form and are randomized but do not receive the study intervention 

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may be replaced if needed to assure that 150 participants complete the study. Subjects who sign 
the informed consent form and are randomized and receive the study intervention, and 
subsequently withdraw, or are withdrawn or discontinued from the study, may be replaced if needed 
to assure that 150 participants complete the study. 
 
Lost to follow-up: Substantial effort will be made to contact a participant in the case of a missed 
scheduled visit, as detailed below. A participant will be considered lost to follow-up if he or she fails 
to present for two scheduled visits and is unable to be contacted by the study site staff via two or 
more different methods (e.g., email, telephone, text message). 
 
The study team will take the following actions if a participant fails to present for a required study 
visit: 
• 
The study team will attempt to contact the participant to reschedule the missed visit, counsel 
the participant on the importance of maintaining the assigned visit schedule and ascertain if 
the participant wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant. This may include email, telephone call, text 
message  up to   attempts each   outreach to the patient’s primar  care clinician  and, if 
necessar   a certified letter to the participant’s last  nown mailing address or local 
equivalent methods. These contact attempts should  e documented in the participant’s 
study file. 
• 
Should the participant continue to be unreachable two weeks after the certified letter is sent, 
he or she will be considered to have withdrawn from the study with a primary reason of lost 
to follow-up. 
 
 
8. Study Assessments and Procedures 
 
 
Outcome Measures: Primary and secondary outcomes of effectiveness are changes in 1) A1C and 
2) CGM metrics of time-in-range (TIR), time-in-tight-range (TITR), mean glucose, and time >180 
mg/dL (T>180) from baseline to 3 and 6 months. TIR measures the percentage of time that a 
person spends with their CGM glucose levels between 70 and 180 mg/dL, with a consensus target 
of over 70% TIR for most people with diabetes.25 26 TITR measures the percentage of time spent 
within a narrower blood glucose range of 70 to 140 mg/dL. Mean glucose measures the mean CGM 
glucose levels. T>180 measures the percentage of time that a person spends with their CGM 
glucose above 180 mg/dL. 
 
Secondary outcomes of implementation are feasibility, acceptability, and equitable reach. These 
measures provide insight into factors that may affect successful implementation of intermittent CGM 
in primary care settings. Feasibility refers to the extent to which an intervention can be successfully 
utilized in a particular setting.20 Acceptability is defined as the perception of stakeholders that the 
intervention is agreeable or satisfactory.20 Clinician-level outcomes of feasibility and acceptability 
will be collected through a mixed methods assessment consisting of clinician surveys and semi-
structured interviews. Survey measures of clinician-level feasibility and acceptability will be 
assessed using validated measures--the 4-item Feasibility of Intervention Measure (FIM) and the 4-
item Acceptability of Intervention Measure (AIM).20 Clinician interviews will provide additional 
context about acceptability, feasibility, and implementation affecting recommendation of periodic 
use of CGM and its use for diabetes management among people with T2D not using insulin. Semi-
structured clinician interviews will include questions assessing barriers and facilitators associated 
with implementation, including reasons for (in)feasibility, (un)acceptability, and intention to continue 
to use/not use OTC CGM after the study ends. Patient-level acceptability will be measured using 
the proportion of approached participants who agree to participate, days of wear, attrition rates, and 

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surveys collected at 6 months, including questions assessing willingness to pay and affordability, 
and Glucose Monitoring Satisfaction Survey (type 2 diabetes version) measures.22 Reach refers to 
the number, proportion, and representativeness of intervention participants.27 Equitable Reach to 
historically marginalized and economically vulnerable groups will be measured through participant 
demographics (age, gender, race, income, insurance). 
 
Instruments & corresponding measures: 
Instrument 
Measures 
Timing 
Patient 6-
month survey 
Glucose Monitoring Satisfaction Survey (Version: Type 2 
Diabetes)22 
Willingness to pay 
6-month visit 
Practice survey 
Organizational characteristics of practice sites (ownership 
structure, specialty, characteristics of patient population, 
number of patients with type 2 diabetes) 
Practice 
enrollment 
Clinician 
survey 
Clinician demographic characteristics 
Feasibility of Intervention Measure (FIM)20 
Acceptability of Intervention Measure (AIM)20 
Year 3 
Clinician 
interview 
Reasons and context for implementation, feasibility, 
acceptability 
Intentions to continue, resources and changes needed to 
continue recommending periodic OTC CGM 
Year 3 
 
OTC CGM data collection (Dexcom Stelo). We will mail Stelo devices to patients at time points 
determined by randomization. Participants will apply devices according to instructions and other 
educational material provided by manufacturer with device. Participants will be provided with study 
team contact information in case of questions or problems with application. 
 
Blinded CGM data collection (Dexcom G7). We will use Precision Digital Health software to blind 
Dexcom G7 devices for blinded data collection. This will allow us to collect baseline data without the 
effect of OTC CGM, and ensure that follow-up data collection at 3 and 6 months is comparable to 
baseline. Stelo was based on Dexcom G7, but neither are available as blinded devices. Precision 
Digital Health offers software that blinds G7 receivers so that real-time readings are not available. 
After the 10-day sensor period, the receiver is returned to the study team and readings are 
uploaded to study datasets. 
 
De-identified Stelo and G7 data will be shared with Dexcom, Inc. as specified in contract between 
Dexcom, Inc. and University of Colorado for purchase of study devices. The study team will provide 
participants with instructional materials developed by the manufacturer providing information on 
proper use of and contact information for questions and problems with the Stelo and G7 devices. 
 
A1C testing. A1C will be collected using venous point-of-care testing (for in-person visits) or home 
A1C test kits (for virtual study visits with participants unable to travel to an in-person site). For in-
person study visits, venous A1C will be collected in the course of screening, 3-month, and 6-month 
study visits conducted at the University of Colorado Clinical and Translational Research Center 
(CTRC). For virtual study visits, capillary A1C will be collected using home test kits through an 
agreement with the University of Minnesota Advanced Research and Diagnostic Laboratory 
(ARDL), which is certified by the National Glycohemoglobin Standardization Program (NGSP). The 
study team will provide participants with instructional sheets for use of A1C home test kits 
developed by the manufacturer. 
 
Survey data collection. An initial Practice Survey will be completed by a clinician and/or practice 
administrator at each participating practice site. The Practice Survey will collect practice 
characteristics such as size (number of clinicians), ownership structure, specialty (e.g. family 
medicine, internal medicine), and number of people with T2D served. Clinician Surveys will assess 

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clinician demographics and measures of implementation including feasibility and acceptability. 
Based on our experience with these practices and prior completion rates, we expect to receive 40 
completed Clinician Surveys. Patient Surveys will include questions assessing willingness to pay 
(affordability) that we have used in previous studies and the 15-item Glucose Monitoring 
Satisfaction Survey for T2D, a validated scale assessing emotional burden, behavioral burden, 
openness, and worthwhileness of glucose device satisfaction.22 Surveys will be administered via 
REDCap or hard copy and returned via postage-paid envelopes provided to participants. Patient 
demographics will be collected as part of the baseline study visit.  
 
Interview data collection. The interview guide will consist of semi-structured questions to solicit 
information about study outcomes across the identified RE-AIM domains while allowing for 
exploration of additional topics that participants may indicate are important to discuss. Specifically, 
up to 20 interviews will be conducted with practice providers and staff to explore the frequency and 
consistency of recommending periodic OTC CGM for patients with non-insulin treated T2D 
(Adoption), descriptions of implementation, feasibility, and acceptability (Implementation); 
perceptions of Reach for patients with non-insulin treated T2D; and explanations and context for 
each of these topics. We will select 2-4 practice members from each practice (up to 20 total, with 
fewer participants in smaller practices) for interviews using purposive sampling to ensure input from 
participants with higher and lower adoption of periodic OTC CGM. Interviews will take place in the 
last year of the study when most participants will have had some opportunity to care for patients 
using OTC CGM for this study. Interviews will be conducted via Zoom or telephone and audio 
recorded with participant permission. 
 
Study Visits 
 
Study visits and procedures will be conducted in-person or via HIPAA-compliant Zoom depending 
on patient preference.  
 
Prescreening (Visit preparation) 
1. Participants are recruited and directed to prescreening form to assess eligibility via one of 
the following methods: 
a. RECRUIT tool 
b. HIPAA authorization form for non-UCHealth provider to share contact information 
with study team 
c. PCDL registry 
d. Flyers  
2. Potential participants complete prescreening form (online or over phone with study team 
member) to assess eligibility. 
3. Participants complete medical records release form (administered and collected by practice 
according to organizational policies) to authorize release of medical records for research 
recruitment purposes. 
4. Upon receipt of relevant medical records from practice, PI Oser will review medical records 
to determine participant eligibility.  
5. Upon confirmation of participant eligibility, study team member to schedule screening visit 
with patient, at which participants will first complete informed consent before beginning any 
study procedures. 
 
Consent and Screening (Visit 1) 
 
Study procedures will be performed by study staff and will include: 
 
1. Complete informed consent process, including verification of understanding of protocol and 
willingness to accept assignment to either treatment group. 
2. Basic demographic information 

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3. Medical history  
4. Current medications taken (prescription and non-prescription), including approximate date of 
start, last dose change, and reason for taking. 
5. Outcome measure collection 
a. A1c (Venous A1c or POC certified by the National Glycohemoglobin Standardization 
Program (NGSP)) or for remote participants unable to travel to an in-person site, 
capillary A1C through the University of Minnesota Advanced Research and Diagnostic 
Laboratory (ARDL) which is a NGSP certified lab). For each participant, the same 
method will be used for all three time points. For each participant A1c will be collected 
within 5 days of the visit. 
6. Placement of blinded Dexcom CGM sensor (within approximately 7 days if the visit is being 
conducted remotely) 
a. Set up Dexcom Clarity account for data collection 
b. A minimum of 2400 glucose values must be collected prior to randomization. Additional 
blinded sensors/and or additional days may be needed if there are technical issues in 
collecting the blinded data and this will not result in a protocol deviation.   
c. CGM training will be conducted by a qualified trainer and will include instructions in how 
to insert the sensor, including observation of placement and instructions on care of the 
sensor. Glucose readings will not be visible to the participant during blinded wear. 
 
The screening visit may be completed over several days if necessary (e.g. if participant prefers to do 
informed consent at a separate in-person or remote visit prior to completing the rest of the study visit 
procedures due to scheduling). 
 
No glucose lowering or weight loss medication changes should occur (removal, addition, change in 
dose) prior to randomization unless related to safety. 
 
Participants may be rescreened at a later date if they do not initially meet study eligibility per 
investigator discretion. 
 
Randomization (Visit 2) 
 
During Visit 2, the following study procedures will occur: 
 
1. Study staff will verify that baseline data has been collected (e.g. A1c result available and 
adequate baseline CGM data obtained).  
a. If more than 45 days elapse between Screening and Randomization Visits, eligibility will 
be reassessed.  
2. Review medical history and medications and record changes and verify no changes to eligibility 
3. Assess for and record any adverse events (AEs) that have occurred since Visit 1 
4. In a 1:1 ratio, participants will be randomly assigned to use one 15-day OTC CGM every 30 or 
90 days.  
5. Study staff will provide, or mail OTC CGM supplies to participants (for in-person and remote 
visits, respectively).  
6. Participants will be given information about existing patient education (that is part of the OTC 
CGM system) for how to use the OTC CGM.  
7. Participants will be instructed that OTC CGM devices should not be in place during follow-up 
blinded data collections.  
8. For in-person visits, the first OTC CGM will be placed by the participant. For remote visits, the 
first OTC CGM will be placed within 7 days.  
9. CGM data connection to study account 
a. The study team will assist participants in connecting their OTC CGM to Dexcom Clarity. 
Although the blinded Dexcom G7 CGM data will be used to analyze the primary outcome 
of CGM metrics, the OTC CGM data will provide descriptive data such as days of wear, 

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time within the q30 and q90 time periods that the OTC CGM was used, and provide a 
further fidelity check to assure that the OTC CGM was not worn at the same time as the 
blinded Dexcom G7. 
 
Participant contact with the study team for assistance with using the OTC CGM outside of study 
visits will be tracked to assess feasibility in primary care settings (e.g., percent of participants able 
to use OTC CGM without additional resources, percent of participants needing additional help). 
 
Mid-Period Follow-up Visits (Phone or Video) (Visits 3, 4, 5, 7, 8) 
The schedule for follow-up visits is the same for both treatment groups. 
 
Mid-period visits will be conducted by study staff for the purpose of assessing whether the 
participant is using the OTC CGM (and reasons for discontinuation if not), AEs, device issues, 
changes in medical conditions/medications, resources used (provided or additional), and PCP 
contacts by participants (including whether CGM data was discussed). 
 
Timing for these visits will be based on the day the first OTC CGM was applied. 
 
These visits will occur after: 
 
• 
7 days (±2) (Visit 3) 
• 
30 days (±7) (Visit 4) 
• 
60 days (±7) (Visit 5) 
• 
120 days (±7) (Visit 7) 
• 
150 days (±7) (Visit 8) 
 
3- Month Study Visit (Visit 6) 
Prior to Visit 6, study staff will mail remote participants a blinded CGM. This visit will take place 90 
days (±7) following application of the first OTC CGM. 
 
During Visit 6, the following study procedures will occur: 
1. Review medical history and medications and record changes 
2. Assess use and reasons for discontinuation, if applicable 
3. Assess for and record any adverse events (AEs) that have occurred since Visit 5 
4. Assess for and record device issues 
5. Solicit contact with the PCP, existing OTC CGM educational material used, and additional 
resources used since Visit 5. 
6. Assure the participant is not currently using an OTC CGM and solicit date of last use (confirmed 
by review of Dexcom Clarity data).  
7. Outcome measure collection 
a. A1c (Venous A1c or POC certified by the National Glycohemoglobin Standardization 
Program (NGSP)) or for remote participants unable to travel to an in-person site, 
capillary A1C through the University of Minnesota Advanced Research and Diagnostic 
Laboratory (ARDL) which is a NGSP certified lab. For each participant, the same method 
will be used for all three time points. For each participant A1c will be collected within 5 
days of the visit. 
8. Placement of blinded Dexcom CGM sensor (within approximately 7 days if the visit is being 
conducted remotely) 
 
After the collection period, study staff will assure that adequate blinded CGM data has been 
collected, or the session will be repeated.  
 
6-Month Study Visit (Visit 9) 

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Prior to Visit 9, study staff will mail remote participants a blinded CGM. This visit will take place 180 
days (±7) following application of the first OTC CGM. 
 
During Visit 9, the following study procedures will occur: 
1. Review medical history and medications and record changes 
2. Assess use and reasons for discontinuation, if applicable 
3. Assess for and record any adverse events (AEs) that have occurred since Visit 8 
4. Assess for and record device issues 
5. Solicit contact with the PCP, existing OTC CGM educational material used, and additional 
resources used since Visit 8 
6. Assure the participant is not currently using an OTC CGM and solicit date of last use (confirmed 
by review of Dexcom Clarity data).  
7. Outcome measure collection 
a. A1c (Venous A1c or POC certified by the National Glycohemoglobin Standardization 
Program (NGSP)) or for remote participants unable to travel to an in-person site, 
capillary A1C through the University of Minnesota Advanced Research and Diagnostic 
Laboratory (ARDL) which is a NGSP certified lab. For each participant, the same method 
will be used for all three time points. For each participant A1c will be collected within 5 
days of the visit. 
b. Completion of Glucose Monitoring  atisfaction  urve  and the “ illingness to  a  
 urve ” 
8. Placement of blinded Dexcom CGM sensor (within approximately 7 days if the visit is being 
conducted remotely) 
 
After the collection period, study staff will assure that adequate blinded CGM data has been 
collected, or the session will be repeated.  
 
 
Schedule of patient study visits and procedures: 
 
Visits 
Procedures 
Screening 
Visit 1 
Randomization  
Visit 2 (≥+   da s  
[Between] 
Follow-up 
Visit 3, day 7 (±2) 
1-month  
Visit 4, day 30 (±7)  
[Between] 
2-month  
Visit 5, day 60 (±7) 
[Between] 
3-month 
Visit 6, day 90 (±7) 
[Between] 
4-month 
Visit 7, 120 days (±7) 
[Between] 
5-month 
Visit 8, 150 days (±7) 
[Between] 
6-month 
Visit 9, 180 days (±7) 
[Follow-up] 
Assess 
eligibility, 
informed 
consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A1C 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Blinded CGM 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Verify collection 
of A1C, blinded 
CGM 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
Assess for AEs 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Medical history 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidance on 
frequency of 
OTC CGM use 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OTC device 
application 
(within 7 days 
 
X 
 
 
 
X
* 
 
X
* 
 
X 
 
X
* 
 
X
* 
 
 

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for remote 
participants) 
Assess OTC 
CGM 
use/discontinuat
ion 
 
 
 
X 
X 
 
X* 
 
X* 
 
X 
 
X* 
 
X* 
 
Record contacts 
with PCP 
 
 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Record 
resources used 
 
 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Patient survey: 
glucose 
monitoring 
satisfaction, 
affordability/ 
willingness to 
pay 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Note: X = both study arms, X* = 30-day study arm only. 
 
 
• 
7 days (±2) (Visit 3) 
• 
30 days (±7) (Visit 4) 
• 
60 days (±7) (Visit 5) 
• 
120 days (±7) (Visit 7) 
• 
150 days (±7) (Visit 8) 
 
9. Risk/Benefit Assessment 
 
Risks:  
This study represents no greater than minimal risk to participants. All devices (blinded Dexcom G7, OTC 
Stelo) will be used consistently with FDA guidelines and approvals. People with non-insulin treated type 2 
diabetes (T2D) will be randomized to over-the-counter CGM use for periodic 15-day sessions every 30 or 90 
days for six months. Use of the OTC CGM device, Stelo, has been approved by the FDA for people with T2D 
not using insulin. Use of CGM is consistent with American Diabetes Association Standards of Care for this 
stud ’s target population: ADA Standards of Care for Diabetes recommend periodic use of CGM for people 
with non-insulin-treated type 2 diabetes when all-the-time use is not available or not preferred by the patient.28 
Study participation would not expose participants to any greater risk than usual care for their diabetes. Data 
collection will include A1C and CGM device metrics of time in range (TIR) and time in tight range (TITR), all of 
which are collected in the normal course of clinical care for people with diabetes using CGM devices. Patients 
will continue to receive routine care from their usual providers and practice teams. Other patient-level data 
collection will include surveys (e.g. device satisfaction, willingness to pay). It is possible people may find these 
questionnaires to be mildly upsetting, but these have been used in previous research, and these types of 
reactions have been very uncommon. 
 
Loss of confidentiality is a potential risk; however, data are handled to minimize this risk.  
Minor potential risks to participants are minor discomfort and skin rash associated with CGM use for some 
people. However, this risk is no greater than the risk associated with FDA-approved use of the device outside 
of the study. Further, participants in both study arms will be monitored through study visits on a monthly basis 
in which study team members will solicit information about any adverse events (AEs) and relevant changes to 
medical treatment or medications. This will provide the opportunity to promptly discontinue study participation 
if concerns arise and direct the participant to their primary care or other healthcare provider as appropriate. 
The greatest potential risk of this study is the inadvertent loss of confidentiality. 
 
Similarly, for practice staff and clinicians, surveys and interviews will cover topics consistent with those 
encountered in the normal course of clinical operations, presenting no greater risk than their normal workday. 
These minor risks are outweighed by the potential benefits of this study, which include evidence to support 
increased and more affordable access to evidence-based technology to control A1C for people with diabetes. 
 
The following risks of  telo are identified in the manufacturer’s pac age insert: 

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• 
Sensor insertion issues (adhesive reactions, retained sensor wire): In rare cases, inserting the sensor 
can cause infection, bleeding, or pain, and wearing the adhesive patch can irritate your skin. For most 
people, the adhesive reactions are mild and resolve within a week. Only a few participants in the 
clinical studies got slight redness and swelling. Although uncommon, some people get a significant 
reaction from the sensor adhesive that may take weeks to resolve. If a sensor wire breaks off or 
detaches under  our s in and  ou canʼt see it  donʼt tr  to remove it. Contact  our healthcare provider 
if you have symptoms of infection or inflammation — redness, swelling, or pain — at the insertion site. 
• 
Interfering substances: 
o 
Acetaminophen: With the Stelo Glucose Biosensor System you can take a standard or 
maximum acetaminophen dose of 1 gram (1,000mg) every 6 hours and still use the Stelo 
Glucose Biosensor System. Taking higher than the maximum dose of acetaminophen (e.g. > 
1 gram every 6 hours in adults) may affect the sensor readings and make them look higher 
than they really are. 
o 
Hydroxyurea: Hydroxyurea makes your sensor readings look higher than they really are. How 
much higher depends on the amount of hydroxyurea in your body. If you are taking 
hydroxyurea, talk to your healthcare provider about alternative glucose monitoring 
approaches. However, it should be noted that taking hydroxyurea is exclusion criteria for this 
study. 
• 
Inaccurate sensor readings: Inaccurate sensor readings may lead to inappropriate lifestyle decisions. 
For more reliable decisions, review your readings and trends over time. Always consult your 
healthcare provider before making any changes to your medication based on your sensor readings. 
 
Benefits: Potential benefits of this study to society in general are knowledge generation to improve 
care and management for type 2 diabetes. Potential benefits to patient participants are improved 
clinical health outcomes related to glycemic management (e.g. A1C, time-in-range) and improved 
satisfaction with glycemic monitoring and management resulting from periodic, OTC CGM use. 
Potential benefits to participating clinicians and clinical staff are an improved understanding of 
effective and accessible strategies to improve access to technology to improve diabetes care and 
management for their patients. 
 
The following  enefits of  telo are identified in the manufacturer’s pac age insert: 
• 
No fingersticks: There is no need to take fingersticks to track your glucose levels as Stelo 
Glucose Biosensor System provides accurate and reliable glucose measurements. In addition, 
the Stelo Glucose Biosensor provides functions not feasible using traditional blood glucose 
monitoring. Traditional blood glucose meters only provide information about discrete, 
intermittent blood glucose levels and therefore are unable to provide information regarding 
patterns of glycemic excursions throughout the day and night when people may be unable to 
test their blood glucose (go to Glucose to find out more). 
• 
Knowing your glucose trends: The Stelo Glucose Biosensor System can help you analyze past 
glucose data. You can look at trends and patterns over days, weeks, and even months to better 
understand how your glucose changes over time. This lets you see the overall picture and how 
changes to your daily habits impact your glucose levels over time. This information may prompt 
you to discuss your glucose trends with your healthcare provider which can be useful for early 
detection of abnormal glucose control and behavior modification which may lead to potential 
avoidance of prediabetes management.29 
• 
Making healthy lifestyle decisions: The Stelo Glucose Biosensor System empowers you to make 
lifestyle decisions on your own. Clinical studies suggest that continuous glucose monitoring can 
 e helpful for people with or without dia etes in connecting the dots of an individualʼs lifest le 
choices and their glucose control.29 30 Many users felt that continuous glucose monitoring 
contributed to a healthier lifestyle, such as being more likely to go for a walk or do physical 
activity if they saw a rise in their glucose, and modifying their food choices. Monitoring the way 
food, physical activity, medication adherence, stress and emotions, sleep, or other behavioral 
and lifestyle factors that impact your glucose can also help inform a conversation with your 
healthcare provider. 

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• 
Informing a medication regimen: Continuous glucose monitoring can be important in 
understanding the impact of medications, such as diabetes and non-diabetes related pills or 
injections and in adherence to those medications.30 In addition, review of sensor readings with a 
healthcare provider can address any changes to medication needs, especially if target goals 
canʼt  e met through lifest le changes. 
 
10. Safety Monitoring Plan 
The study intervention is an over-the-counter product with no greater risk than usual care and 
therefore minimal risk. No DSMB or external monitor will be utilized for this study. AEs and device 
issues will be solicited regularly as per above, but because this study poses minimal risk to the 
subject, adverse events will only be collected or recorded if a causal relationship to the study 
intervention is suspected. However, any adverse event that is serious and unexpected, will be 
reported to COMIRB within 5 days of the PI becoming aware of the event, regardless of whether it 
is related to the intervention. 
 
Adverse Events and Serious Adverse Events 
 
Adverse Event (AE): Any untoward medical occurrence (including laboratory findings) associated with 
study procedures or occurring during the course of a study in which a device, biologic, or drug is used 
in humans, including any comparator used, whether or not the event is considered related (i.e., 
irrespective of the relationship between the adverse event and the device(s) under investigation).  
• 
To further clarify, an adverse event is any unintended disease or injury, or untoward clinically 
significant clinical sign (including abnormal laboratory findings) in a research participant that 
manifests while in the study if it was not present before enrolling in the study, or if it was present 
before enrolling, it has increased in severity, frequency or type since enrolling in the study. For 
this purpose, a participant is considered enrolled once the participant has signed the consent 
form.  However, abnormalities identified as part of study screening are not considered adverse 
events (e.g., physical examination abnormalities or laboratory testing abnormalities) even 
though they may have been identified after consent was signed.  Reportable AEs for this 
protocol are defined in section below. 
• 
Medical interventions such as surgeries, diagnostic procedures, and therapeutic procedures are 
not AEs but the action taken to treat a particular medical condition. If the medical intervention 
relates to a pre-existing medical condition that has not worsened since enrollment, the 
intervention does not need to be reported unless an AE occurs as a result of the procedure or 
study drug/device needs to be temporarily discontinued due to the procedure. Also, if the 
intervention is done in the absence of a condition meeting the definition of an AE, such as for 
prevention (e.g. colonoscopy) or cosmetic surgery, the intervention should not need to be 
reported as an AE.  If a pre-existing medical condition worsens after enrollment, this will be 
reported as an AE and the medical intervention will be recorded on the AE form as treatment of 
the AE.  
Serious Adverse Event (SAE): Any untoward medical occurrence that results in any of the following 
outcomes:  
• 
Death.  
• 
A life-threatening adverse event; (a non-life-threatening event which, had it been more severe, 
might have become life threatening, is not necessarily considered a serious adverse event).  
• 
Inpatient hospitalization or prolongation of existing hospitalization.  
• 
A persistent or significant disability/incapacity or substantial disruption of the ability to conduct 
normal life functions.  

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• 
A congenital anomaly or birth defect.  
• 
An important medical event that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, it 
may jeopardize the patient or subject and may require medical and surgical intervention to 
prevent one of the outcomes listed in this definition.  
Study site will document all SAEs that occur (whether or not related to study intervention). These 
will be reported to COMIRB within 5 days of the PI becoming aware of the event. 
Severity of Event 
For adverse events (AEs), the following guidelines will be used to describe severity.  
  
• 
Mild –  vents require minimal or no treatment and do not interfere with the participant’s dail  
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe –  vents interrupt a participant’s usual dail  activit  and ma  require s stemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.  
 f note  the term “severe” does not necessaril  equate to “serious”. 
 
Relationship to Study Intervention 
 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the participant based on temporal relationship and his/her clinical judgment. The 
degree of certainty about causality will be graded using the categories below: 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event, including an abnormal 
laboratory test result, occurs in a plausible time relationship to study intervention administration 
and cannot be explained by concurrent disease or other drugs or chemicals.  
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of 
other factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs 
within a reasonable time after administration of the study intervention, is unlikely to be attributed 
to concurrent disease or other drugs or chemicals. 
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of the study intervention). However, other 
factors ma  have contri uted to the event  e.g.  the participant’s clinical condition  other 
concomitant events .  lthough an    ma  rate onl  as “potentially related” soon after discover   
it can  e flagged as requiring more information and later  e upgraded to “pro a l  related” or 
“definitel  related”  as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study intervention administration makes a causal relationship 
improbable (e.g., the event did not occur within a reasonable time after administration of the 
study intervention) and in which other drugs or chemicals or underlying disease provides 
plausi le e planations  e.g.  the participant’s clinical condition  other concomitant treatments . 
• 
Not Related – The AE is completely independent of study intervention administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
Unanticipated Problem:  
Any event or information that was unforeseen and indicates that the research procedures caused harm 
(including physical, psychological, economic, or social harm) to participants or others or indicates that 
participants or others are at increased risk of harm than was previously known or recognized. 

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Unanticipated Event: 
Any adverse experience where the nature, severity or frequency is not identified in the investigational 
brochure described in the application form or detailed in the consent form. This can also include non-
compliance issues such as over-enrollment of subjects without prior COMIRB approval. 
 
Device Complaints and Malfunctions: 
Device complaints and device malfunctions will be reported except in the following circumstances. 
These occurrences are expected and will not be reported on a Device Issue Form: 
• 
Skin reaction or pain from CGM sensor if not severe and not requiring pharmacologic treatment 
• 
CGM sensor or transmitter needing replacement prior to labelled maximum use duration 
• 
CGM tape adherence issues 
• 
Battery lifespan deficiency due to inadequate charging or extensive wireless communication 
• 
Intermittent device component disconnections/communication failures not requiring system 
replacement or workaround/resolution not specified in user guide/manual. 
• 
Device issues clearly addressed in the user guide manual that do not require additional 
troubleshooting 
 
The following will be reported within 5 days to COMIRB: 
• 
An SAE 
• 
An actual unforeseen harmful or unfavorable occurrence to participants or others that relates to 
the research protocol (injuries, psychological events, drug errors). 
• 
Adverse events which in the opinion of the principal investigator are both unexpected and 
probably related to the intervention/ drug or device. 
• 
An unforeseen development that potentially increases the likelihood of harm to 
participants or others in the future. 
• 
A problem involving data collection, data storage, privacy or confidentiality. 
• 
Incarceration of a participant in a protocol not approved to enroll prisoners. 
• 
Pregnancy of a participant or spouse in a protocol that specifically excludes pregnancy 
due to the potential risks of the intervention or treatment on the fetus. 
• 
Change to the protocol taken without prior COMIRB review to eliminate an apparent 
immediate hazard to a research participant. 
• 
Complaint of a participant when the complaint indicates unexpected risks or cannot be 
resolved by the research team. 
• 
Protocol violation (meaning an accidental or unintentional change to the COMIRB 
approved protocol) that harmed participants or others or that indicates 
participants or others may be at increased risk of harm. 
 
All reportable AEs will be captured on a study case report form (CRF) with documentation of event 
description  time of onset  clinician’s assessment of severit   relationship to stud  intervention, 
actions taken, and time of resolution/stabilization of the event. All AEs will be followed to adequate 
resolution. 
 
Reportable AEs will be compiled and reported to COMIRB as soon as possible, but in no event later 
than 5 working days after the PI first learns of the event. 
 
 

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11. Data Analysis 
 
We aim to enroll 188 patients in this study to obtain completed data from 150 patients after potential 
attrition in order to have adequate power to test key study hypotheses. We anticipate that this will 
require recruitment outreach to approximately 377 patients and screening approximately 257 
patients, based on recent similar studies by our team. 
Specific Aim 1: Conduct a two-arm, 1:1 randomized trial to determine the effectiveness of 
two intervals of periodic use of a 15-day CGM on A1C, time-in-range (TIR), and time-in-tight-
range (TITR) among people with T2D not treated with insulin and who receive diabetes 
treatment in primary care settings.  
1a: Periodic CGM use (one 15-day sensor) once every 30 days or once every 90 days will be 
associated with lower A1C compared to UC at 3 and 6 months. 
1b: Periodic CGM use (one 15-day sensor) once every 90 days will be associated with non-
inferior A1C reduction at 3 and 6 months compared to periodic CGM use once every 30 days. 
1c: Periodic CGM use (one 15-day sensor) once every 30 days or once every 90 days will be 
associated with greater TIR and TITR compared to baseline. 
 
Primary Outcome 
The primary outcome is the change from baseline to 6-month A1C. This outcome will be analyzed 
in the following hierarchical fashion: 
1. Change from baseline to 6-month A1C in the q30 group 
2. Change from baseline to 6-month A1C in the q90 group 
3. Difference in change from baseline to 6-month A1C between q90 and q30 group tested for 
non-inferiority with a non-inferiority margin of 0.4% 
Sample Size for Primary Outcome 
The standard deviation (SD) of change in A1C was estimated from three published studies: 
COMMITTED, Wada et al. study, and MOBILE 18 31 32. The change in A1C SD was 0.9% in the 
COMMITTED study, 0.5% in the Wada et al. study, and 1.5% in the MOBILE study for the CGM 
group and was 0.7%, 0.9%, and 1.2%, respectively, for the SMBG group (Table 1). The median 
estimated A1C SD was 0.9% for both treatment groups, and this estimate was used for the sample 
size derivation. 
 
The sample size for testing change in A1C for each group was determined for various effect sizes 
(0.4%, 0.5%, or 0.6%) and power (80%, 85%, and 90%; Table 1).  
 
Table 1. Sample size estimates for testing change in A1C (%) in each group. 
Mean 
Change 
in A1C 
Sample Size in Each Group a 
80% 
Power 
85% 
Power 
90% 
Power 
0.4% 
42 
48 
56 
0.5% 
28 
32 
37 
0.6% 
20 
23 
26 
a Sample size in each group assumes a change in A1C SD of 0.9% with a two-sided test at α  .  .  
Sample sizes do not adjust for any dropouts. 
 
Assuming a mean change in A1C of 0.5% with an SD of 0.9% and a two-sided test at α  .    a 
sample size of 37 participants in each group is required to have 90% power of detecting a 
significant change from baseline in each group. 
 
The total sample size was increased to 168 participants (84 in each group) to account for dropouts 
and increase power for testing non-inferiority of the two groups. 

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Assuming 75 participants complete the study in each treatment group with the above assumptions 
(mean±SD change in A1C of 0.5% ± 0.9%), the study has >99% power for detecting a significant 
change in A1C in each treatment group. 
 
The difference in mean A1C at 6 months will be tested for non-inferiority with a 0.4% non-inferiority 
margin adjusting for baseline A1c. The estimated 6-month A1C SD adjusted for baseline A1C was 
0.9%.  Assuming no treatment group difference and 150 completers (75 in each group) and a one-
sided test at α  .     the power of detecting a non-inferior difference in mean A1C at 6-months is 
77%. 
 
Statistical Analysis – Aim 1: The primary outcome of change from baseline to 6-month A1C will 
be assessed using a mixed effect model adjusting for GLP-1 use and clinical practice (random 
effect) using an unstructured covariance structure to account for the repeated measurements. The 
comparison of change in A1C between q30 and q90 groups will also adjust for the baseline A1C.   
The primary outcome will be analyzed using a hierarchical method testing the change in A1C in the 
q30 group first, followed by testing the change in A1c in q90 group, and then testing non-inferiority 
of change in A1C between q30 and q90 groups. Testing will stop once a hypothesis fails to reach 
statistical significance. This gatekeeping strategy will control for the family-wise error rate at α=0.05.  
A subgroup analysis will be assessed for the primary outcome by adding baseline characteristics 
(demographics, medical conditions and medications) along with its interaction with the treatment 
group to the mixed model.  
 
The secondary outcomes of TIR, TITR, mean glucose, and T>180 will be analyzed using a similar 
mixed effect model as the one for A1C, except the dependent variable of A1C will be replaced by 
the secondary outcome. The false discovery rate will be controlled using the Benjamini-Hochberg 
method.  
 
Measures derived from device data (TIR, TITR, mean glucose, T>180) will be calculated by a 
biostatistician from the Jaeb Center for Health Research. Device data will be securely shared with 
only the Jaeb statistician working on this study using secure, encrypted University folders. Jaeb 
Center for Health Research will perform data cleaning and calculation of device metrics for 
statistical analysis by the CU study team.  
 
Specific Aim 2: Determine feasibility, acceptability, and reach of periodic use of OTC CGM 
among 1) primary care clinicians and 2) people with T2D not treated with insulin.  
2a: Measures of feasibility and acceptability will be higher for OTC CGM implementation than 
for prescription CGM implementation among primary care clinicians. 
2b: Periodic OTC CGM use will have higher and more equitable reach and will be acceptable to 
participants (demographics, % recommended days worn, willingness to pay). 
 
Statistical Analysis – Aim 2: Measures of feasibility, acceptability, reach of periodic use of OTC 
CGM, and other outcomes are obtained from a clinician survey, practice survey, and patient survey 
respectively. These measures will be defined as numerical variables or binary variables. All the 
numerical variables will be summarized using mean ± standard deviation and median (min, max) for 
clinicians and patients respectively. Binary variables will be summarized using frequency (in %). For 
2a, paired t tests, Wilcoxon signed rank tests, and/or linear mixed models will be used to compare 
means of numerical measures of feasibility and acceptability for OTC CGM than prescription CGM. 
One sample t tests or 95% confidence intervals will be used to infer the population means of the 
numerical measures. When a binary measure is used, the frequencies for OTC and prescription 
CGM will  e compared using a McNemar’s test. The population mean of the binary measure will be 
inferred using a one sample exact test or a 95% confidence interval under the binomial distribution. 
The same statistical plans in 2a will be applied to the measures used in 2b.  

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Power and Sample Size – Aim 2: HT2a will be tested based upon a minimum sample size of 30 
clinicians who complete the survey (though we anticipate 40, which will increase power). An effect 
size (difference of means / standard deviation of difference) of 0.53 can be detected with 80% 
power using a paired t test. For HT2b, the same power can detect a targeted acceptance rate of 
80% against a null rate of 70% using a normal test.  
 
Qualitative Analysis Plan. Interviews will be professionally transcribed and loaded into ATLAS.ti 
software (ATLAS.ti Scientific Software Development, GmbH). We will use a grounded hermeneutic 
editing approach incorporating inductive and deductive strategies to qualitatively analyze 
interviews.33 This involves coding text to organize it into categories based on topics of discussion 
using pre-determined codes (e.g., facilitators, barriers, acceptability, practice context) based on 
research questions while allowing for emergent codes based on other relevant topics discussed by 
participants. This will help us understand specifically how clinician and patient characteristics and 
preferences and other contextual factors support or hinder use of intermittent CGM for management 
of T2D not requiring insulin use. 
 
12. Informed Consent Process 
 
Informed consent – Patients 
 
Before completing any procedures or collecting any data, informed consent will be obtained. 
 
The potential participant will be provided the IRB-approved Informed Consent Form to read and study 
staff will review the consent form with the potential participant, including review of study procedures 
and risks. Participants will have the opportunity to carefully review the consent and ask questions 
prior to signing. Potential study participants will be encouraged to discuss the study with family 
members prior to deciding to participate in the study. Participants will have the opportunity to ask 
questions prior to signing. The participant will sign the informed consent document electronically or 
in ink. Participants must be informed that participation is voluntary and that they may withdraw from 
the study at any time, without prejudice. The rights and welfare of the participants will be protected 
by emphasizing to them that the quality of their medical care will not be adversely affected if they 
decline to participate in this study. The consent form will also include contact information for the study 
PI and COMIRB. A copy of the consent form will be provided to the participant. This process will be 
documented in the study records (e.g. Documentation of Consent Process).  
 
A participant is considered enrolled when the informed consent form has been signed. 
 
 
Informed consent – Clinicians & Staff  
We are requesting a waiver of documentation of consent for surveys and interviews conducted with 
clinicians and staff in participating practices. This portion of the study (data collected from practice 
members) is minimal risk, as it only collects information related to activities conducted in the normal 
course of work duties (offering standard-of-care, FDA-cleared device). We propose using postcard 
consent for surveys and interviews with practice clinicians and staff. Postcard consent will be provided 
prior to completion of surve s and interviews and su jects’ signatures will not  e o tained on consent 
documents. We have included a postcard consent document that follows the COMIRB postcard 
consent template (9/10/25). 
 
13. Confidentiality and Privacy 
 

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The greatest potential risk of this study is the inadvertent loss of confidentiality. All reasonable 
efforts will be made to protect the confidentiality of participant identities and study data. Survey and 
laboratory data will be collected and stored in REDCap and will be accessible only to the study 
team. However, the   c values will  e provided to the participants’ primar  care provider with 
patient participant permission. CGM data will be accessed via Dexcom Clarity, which is HIPAA 
compliant. Survey, device, and laboratory data used for analysis will not contain personally 
identifiable information and will be reported in aggregate. Downloaded surveys, clinical data, and 
interview data (audio files and transcripts) will be stored on secure, password-protected servers 
with access limited to study personnel. All paper consent forms and data will be stored in locked 
filing cabinets accessible only to a limited subset of relevant study personnel. We will de-identify 
interview transcripts for analysis and will use password-protected analytical files using ATLAS.ti 
qualitative data analysis software. Should participants withdraw from the study, no further study 
data about those subjects will be gathered from CGM devices or surveys. 
 
 
14. References 
 
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2. Gwira J, Fryar C, Gu Q. Prevalence of total, diagnosed, and undiagnosed diabetes in adults: United States, 
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3. Fang M, Wang D, Coresh J, et al. Trends in Diabetes Treatment and Control in U.S. Adults, 1999-2018. N Engl 
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