Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: Stanford University

NCT05074667 
 
October 18, 2021 
Use of Continuous Glucose Monitors in Publicly-Insured Youth with Type 2 Diabetes 
– A Pilot and Feasibility Study. 
 
PI: Sejal Shah MD 
Division of Pediatric Endocrinology 
Stanford University 
Stanford, CA 94304 
E-mail: sshah2@stanford.edu  
 
Co-Investigators: 
Korey Hood, PhD 
Professor of Pediatrics 
Professor of Psychiatry and Behavioral Sciences 
Lucile Packard Children’s Hospital, Stanford Children’s Health 
Palo Alto, CA 94305 
E-mail: Kkhood@stanford.edu 
 
Funding source: MCHRI Structural Racism Social Injustice Health Disparities Pilot Grant 
Summary 
The prevalence of type 2 diabetes in youth is rising in all age, sex, and race/ethnicity groups that 
disproportionately effects minority youth and those of lower socioeconomic status.  Type 2 diabetes in 
youth is a more aggressive disease compared to adult-onset type 2 diabetes.  Youth with type 2 diabetes 
have higher rates of diabetes complications, specifically cardiovascular and kidney disease compared to 
youth with type 1 diabetes and similar duration of disease.  Diabetes care is a difficult, life-long 
undertaking by patients, their caregivers and their healthcare team.  Treatment of type 2 diabetes 
includes lifestyle and diet management along with medications including multiple daily injections of 
insulin, often occurring in a complex psychosocial and cultural environment that make durable 
adherence to medical recommendations challenging. In the last few years continuous glucose monitors 
(CGMs) have become available for clinical use by children with type 1 diabetes as an alternative to self-
monitoring blood glucoses, improving blood sugar control and quality of life for youth with type 1 
diabetes. However, our patients with type 2 diabetes and public insurance have not been able to benefit 
from this technology due to a lack of insurance coverage for CGM in this patient population. We propose 
a pilot and feasibility trial to start CGM in youth with type 2 diabetes and public insurance, using 
established clinic workflows within our clinic.  This feasibility trial would fill a gap in the literature with 
respect to CGM use in youth with type 2 diabetes in a real-world setting.  The findings from this trial can 
provide much needed data to impact CGM coverage policy for publicly insured youth with type 2 
diabetes in California and pave the way for future studies using CGM technology in this population. 
 
 
 

Specific Aims 
We propose a pilot and feasibility trial to use continuous glucose monitoring (CGM) in youth with type 2 
diabetes (T2D) and public insurance.  This feasibility trial would fill a gap in the literature with respect to 
CGM use in youth with type 2 diabetes.  The findings from this trial can provide much needed data to 
pave the way for future studies using CGM technology in this population.  Our proposal is focused on 
youth with public insurance, seeking to provide diabetes technology for patients and their families to 
use in daily diabetes management.  This pilot is an expansion of our existing program of CGM access to 
youth with type 1 diabetes which has led to an improvement HbA1C of 0.5% over 1 year and positive 
feedback from patients and families.1,2  
 
Specific Aim 1: Evaluate the feasibility of CGM start and continuation in youth with T2D and describe 
glucose metrics and patient reported outcomes (PROs). We will pilot and refine a program to test the 
hypothesis that CGM start and continuation in youth with T2D is feasible and then evaluate glucose 
metrics and PROs.  
 
Hypothesis 1a: In phase 1, CGM use exceeding >50% of participants will be feasible and sustainable in 
youth with T2D, measured by days of CGM use per 2-week period (>75%).  H1b: Following an additional 
needs assessment after phase 1, in phase 2 sustained CGM use per 2-week period (>75%) will exceed 
75% of participants. H1c: Based on completion of PROs surveys, it is expected that diabetes-specific 
distress will decline, and overall well-being/quality of life will improve. Secondary outcome PROs (see 
protocol synopsis) collected at baseline will be associated with HbA1c and diabetes management 
outcomes.  Data on glucose metrics, SDOH, and needs and barriers will be described.  
 
Specific Aim 2: To assess the clinical outcomes (HbA1C, time in range [70-180 mg/dL], time in 
hypoglycemia [<70 mg/dL]) of individuals participating in this trial compared to clinic historical controls.   
Hypothesis 2: Use of CGM will improve HbA1C and other clinical metrics of diabetes glucose control. 
Measured Outcomes: 
1. Sustained use of CGM by patients over one year measured by days of CGM use per every 2-week 
period with >80% as goal. 
2. Change in HbA1C over first year of CGM use 
3. Glucose profile metrics: percentage time in range, time in hypoglycemia, and time in hyperglycemia 
obtained from CGM. 
4. Change in weight and BMI over first year of CGM use using clinic visit weight and BMI 
measurements. 
5. PROs  
Unmeasured, but documented metrics: 
 
Reported challenges with CGM use as documented by clinical team (MD/NP, CDE) 
 
Tracking of patients who are able to obtain insurance coverage for CGM at completion of study 
 

 
Background and Significance 
T2D is increasingly affecting children of minority and lower SES backgrounds, with higher rates of 
diabetes complications, specifically cardiovascular and renal co-morbidities in youth with T2D 
compared to youth with T1D and similar duration of disease 3–6. Two national multi-center studies, the 
RISE Consortium and the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) 
Study reported more rapid beta-cell damage, disease progression, and diabetes-related complications in 
youth compared to adults, highlighting the need for improved clinical management and treatment for 
these patients6–8.    By one year after diagnosis, a majority of youth with T2D are not meeting HbA1c 
targets recommended by the ADA and the International Society of Pediatric and Adolescent Diabetes 
(ISPAD)9–11 
 
Treatment of T2D includes lifestyle and diet management along with medications often including 
multiple daily injections of insulin, frequently in a complex psychosocial and cultural environment that 
challenge durable adherence to medical care.  CGM is available for youth with T1D as an alternate to 
self-monitoring blood glucoses (SMBG) and data in adults with T2D demonstrates efficacy and cost 
effectiveness12–14.  Youth with T2D have similar SMBG and insulin requirements, but have little to no 
access to CGM due to a lack of insurance coverage, usually public insurance, for CGM in this patient 
population.  
 
Data from the SEARCH for Diabetes in Youth study found that over 50% of youth with T2D had <3 SMBG 
per day and almost 25% had <1 daily15.  Diabetes distress is well recognized as a factor that impacts both 
glycemic outcomes and diabetes self-care behaviors, such as SMBG16.  The use of digital health tools and 
technology in T2D care has the potential to increase access but also to widen disparities in care, 
highlighting the need for further study of CGM use in youth with T2D.  Use of CGM and digital health 
tools in Latinx adults with T2D has been shown to be effective in short-term pilot studies17.  The benefit 
of CGM has expanded to adults with T2D using basal insulin only. In a recent randomized controlled trial 
of CGM use compared with SMBG in adults with T2D (53% minority race/ethnicity) showed a significant 
reduction in HbA1c of 0.4%, demonstrating benefit of CGM use in a broader population of adults with 
T2D18.  The evaluation of CGM use in youth with T2D, with specific attention to factors that influence 
uptake and sustained use of diabetes technology in this population is necessary due to rising incidence 
of T2D in youth and higher rates of diabetes complications manifesting at earlier ages thereby depriving 
Latinx youth with T2D of a healthy future.  
 
In the last few years continuous glucose monitors (CGMs) have become available for clinical use by 
children with type 1 diabetes as an alternative to self-monitoring blood glucoses.  The use of CGM has 
consistently demonstrated an improvement in glycemic control and quality of life in youth with type 1 
diabetes.19,20  CGMs are revolutionizing pediatric diabetes care with significant gains for youth with type 
1 diabetes and are now the recommended standard of care for youth with diabetes.20  CGM initiation in 
youth with type 1 diabetes is feasible and well accepted and our clinic is a leader in doing so.21  While 
there has been an exponential rise in CGM use in youth with type 1 diabetes, youth with type 2 diabetes 
who have similar SMBG and insulin requirements, have had little to no access to CGM.  CGM use in 
adults with T2D has proven to be both efficacious and cost effective.12–14  However, our patients with 
T2D and public insurance (California Children’s Services and/or Medi-Cal) have not been able to benefit 
from this technology due to a lack of insurance coverage for CGM in this patient population.   

 
Preliminary Studies 
Significant improvements in HbA1C have been shown in youth with type 1 diabetes with public 
insurance with uninterrupted CGM use.22  This real-world data in youth with type 1 diabetes has 
complimented research study data and paved the way for earlier and easier CGM approval for youth, 
particularly publicly insured youth. 
Our team has shown that youth with T1D with public insurance who have uninterrupted CGM use 
compared to those who lose CGM coverage due to insurance issues have significant improvements in 
HbA1c22,23.  This real-world data in youth with T1D has complimented research study data and paved the 
way for earlier and easier CGM approval for youth, particularly publicly insured youth.  We aim to 
translate these learnings to our T2D population.  In our clinic, youth with T2D have a mean HbA1c of 
8.6% with only 35% at goal HbA1c of <7% (n=311 HbA1c values), indicating that the majority of youth 
with T2D are not meeting this significant diabetes therapy goal.  Reflective of the national data 
demonstrating youth with T2D are overwhelmingly minorities and from families of lower SES, a 
significant portion of our T2D patient population (n=131) is publicly insured (77%), minority status (73% 
and Latinx 66%), and has Spanish-speaking parents or guardians (56%), all groups which have lower 
rates of diabetes technology use11,24.  
 
Design:  This will be a two-phase pilot program focused on youth with T2D to evaluate initiation and 
sustained use of CGM.   The focus of phase 1 will be a feasibility trial to use CGM in 30 youth with T2D 
and public insurance over a 12-month period.  CGM will be provided to all participants.  Education for 
youth and their families about CGM integration in diabetes care will be provided throughout the study.  
Barriers to CGM adoptions and sustained CGM use will be tracked throughout this phase to inform the 
further refinement of the program in phase 2 in 50 youth with T2D.  As part of closing the disparities in 
diabetes technology use in youth with T2D, QoL and PROs will be evaluated.  The goals of phase 2 are to 
utilize human factors design data, QoL and PRO metrics collected in phase 1 to address identified needs 
and barriers to increase initiation and continued use of CGM in this population. 
Inclusion criteria 
1. Diagnosis of T2D (diabetes autoantibody negative) followed in the Pediatric 
Endocrinology clinic at Stanford Children’s Health 
2. HbA1C greater than 6.5% at enrollment. This is to enroll patients who are working on 
improving glucose control but are still not meeting HbA1c targets.9,25 
3. Interested in starting on a continuous glucose monitor  
4. Access to a mobile device that is compatible with CGM applications or willing to use 
CGM receiver which will be provided.  Both the receiver and mobile device allows 
patients to view glucose data and alerts from the CGM and upload glucose data during 
or in between in-person or virtual clinic visits, not necessitating that the participant have 
access to a mobile device. 
5. Public insurance 
6. Age 4-20 years inclusive 
 
Exclusion criteria 

1. Non-T2D diagnosis 
2. HgA1C < 6.5% 
3. Participant not willing to wear CGM 
4. Private insurance 
 
Procedures and Methods 
 
Recruitment:  The study team will review clinic schedules to identify youth with T2D from the patients in 
our clinic who would qualify.  The informed consent process with be conducted prior to initiating the 
study.  Following CGM initiation by a CDE, youth will have a routine 1-week clinic follow up with our 
diabetes team and then will be seen per clinic standard of care, every 3 months thereafter for the 12 
months of the study duration.  At each visit we will collect descriptive data on CGM use, CGM glucose 
metrics, and provide CGM supplies.  PROs will be evaluated at three time points during the study.  In 
phase 2, we will identify a new cohort of eligible patients who will be evaluated at a similar cadence as 
phase 1.  
 
 
 
Visit 1: 
- 
Participants will be offered the opportunity to start on CGM at their scheduled clinic visit 
- 
Participants will receive CGM education from a certified diabetes educator (CDE) 
- 
The care team member initiating the CGM will ask patients and their caregivers if they are 
interested in hearing about this study to understand the use of CGM in youth with type 2 diabetes 
- 
If a patient and/or caregiver is interested in this study, one of the study team members will discuss 
the study with the participant and obtain informed consent and assent (if needed). 
- 
Participants who consent to be part of this study will have the appropriate CGM applications and 
readers active (Libre 2 CGM, LibreView, LibreLink) as per standard clinical care. 
 
1. Informed consent and assent - this can be done in person or virtually 
2. CGM start – done by CDE in clinic 
a. 4 weeks of supplies given – CRC to confirm with family preferred way to get supplies 
every 6 weeks and best way to contact them. 
b. Standard clinic CGM education 
3. Routine clinic visit 
Visit
1
2
2a
3
3a
4
4a
5
5a
6
Weeks from start
x
2 weeks 4-6 weeks
12 weeks
4-6 weeks
12 weeks 4-6 weeks 12 weeks 4-6 weeks 12 weeks
Informed consent and assent
x (can be done In 
person or via TH)
Visit Type ** this will be modified if 
LibreView App is available during study 
duration, can move visits to TH with lab 
A1C
In person
IP/TH
phone/IP
IP
phone/IP
IP
phone/IP
IP
phone/IP
IP
Demographics
x
Diabetes History
x
HbA1C
x
x
x
x
x
CGM start
x
PROs
x
x
x
CGM metrics
x
x
x
x
x
x
CGM education
x
x
x
x
x
x
CRC check on supplies 
(confirm use and shipment) 
x 
x
x
x
x
x
x
x
x
x
Final study visit
x

4. PRO completion - participants who speak and write English and Spanish will be asked to 
complete PROs surveys 
Visits 2a,3a,4a,5a: 
1. CRC check in with family/patient 
a. Confirm CGM use 
b. Address CGM issues – CRC to address or forward to CDE if clinical question 
c. Ship or arrange for supply pick up (6 weeks of supplies) 
d. Confirm next clinic visit 
 
Visits 2,3,4,5,6: 
1. Routine Clinic visit including CDE visit.  The purpose of these visits is to reinforce prior 
teaching, answer questions, and review CGM data, making changes as necessary to the 
patient’s care regimen to better control their diabetes. 
2. CRC check in, supplies provided (for all visits except visit 6) 
3. PRO questionnaires administered for visits 3 and 6 
 
 
Biostatistical plan 
Statistical methods: We will generate descriptive statistics for all participants included in the study and 
will create a STROBE diagram26 to describe participants screened, recruited, and followed in both study 
phases. To address the feasibility of CGM use in T2D, we will estimate the proportion of participants 
who have sustained CGM use in both phase 1 and 2. Our feasibility analysis will include all participants. 
To address H1c, we will fit linear regression models using GEE to estimate the association of PROs with 
longitudinal HbA1c. Logistic regression models fit with GEE will be used to estimate the association of 
PROs with dichotomous diabetes management outcomes (e.g., presence of diabetes distress).  
At each visit we will collect descriptive data on CGM use, clinical glucose outcome metrics, and provide 
CGM supplies.  Mixed affects modeling will be used to characterize the trajectory of measured variables 
and to account for patient-level correlation of this data. To account for gaps in CGM use we will use 
intention to treat analysis and consider a censoring method for a patient who leaves the practice or are 
lost to follow up.  We will also perform an exploratory analysis of the relationship at a patient-level 
between days of CGM wear and time in range. 
 
 
 
 
 
 
 

Study Timeline 
 
 
Data Collection and Entry 
1. Study participant data entry will be collected and entered in Stanford RedCap by the study team. 
2. PRO will be collected in RedCap 
The initial survey is filled out in person during the CGM visit during which, parents provide an email that 
will be the platform for contact for the future surveys. At the follow up points, the RedCap data base will 
automatically trigger survey link to the email on file. If the survey is not completed, a second email is sent 
as a reminder followed by provider team reminders. Participant data will be included for analysis for the 
time frames that are available when. 
These measures will assess issues of adherence or illness distress and provide valuable information for 
providers to better understand the impact of early CGM initiation. The patient/guardian will have the 
option of filling out the questionnaires in English or Spanish. Based on the evidence in the PROs literature 
and our clinical experiences, we have developed an algorithm for responding to PROs screen scores that 
are outside of the normative range triggers a response from social worker and/or diabetes psychologist27. 
Study personnel will complete a chart review to collect relevant health information including diagnosis, 
duration of disease, indicators of health status, and regimen information (e.g. medication, doses). These 
medical record data are required to assess the validity and usefulness of the clinical PROs screening 
measures. Additionally, reliability analysis will be conducted to examine the psychometric properties of 
the PROs measures, and the satisfaction questionnaire data will be aggregated to assess the acceptability 
of the PROs procedure from the patient’s perspective. 
• 
PROMIS global health (youth): BELOW 22 for the PROMIS global health scale. Anyone who 
scores 21 or lower would trigger an alert to place a diabetes psychology referral. 
 
When psychosocial issues are identified through screening, referrals will be made to the psychology 
service staffed by 4 licensed psychologists. Treatment will follow guidelines provided in the ADA Position 
Statement on Psychosocial Care of People with Diabetes28. 

All aspects of data collection and data storage will be carefully monitored to ensure rapid detection of 
errors, inconsistencies or other problems. Data are reviewed systematically on a monthly basis 
throughout the data collection period so that data cleaning will happen close to “real time”. The data 
collectors will follow a strict written protocol that describes study measures and details for conducting 
measures accurately and in a manner that protects data privacy. They will explain to each participant that 
s/he has the right to refuse to participate or to refuse to answer any individual question that s/he finds 
objectionable, and emphasize the importance of telling the truth. All institutions associated with this 
application are experienced in training data collection fieldwork personnel how to handle, store, and 
process sensitive and confidential data. 
Certain routine administrative, personnel, physical security, information management, and computer 
system or network security practices are always in place. These practices include security, nondisclosure 
pledges, and account/keyword security on computer networks. In addition, we take multiple project 
specific steps to protect subjects from the risk of a breach in confidentiality. All data will be collected using 
study identification numbers. Thus, no questionnaire will contain identifying information, and the list that 
links identification numbers to names will be kept in a password-protected file that is accessible only to 
authorized staff at the respective clinical sites. Only aggregate data that cannot be used to identify 
individuals will be included in any reports released to other agencies or for publication. 
PRO Surveys will be completed via RedCap and according to the following table: 
Measure 
Respondent 
Construct Measured / Relevant Points 
Paediatric Quality of Life 
Inventory (PedsQL) 
Diabetes 
All youth 
and All 
parents 
YOUTH - All youth ages 6-18 will complete age-appropriate PedsQL Diabetes 
module. Versions are included for 6-7 year-olds, 8-12 year-olds, and 13-18 year-
olds. 
PARENTS – All parents complete a proxy version reporting on their child’s quality 
of life. Versions of the parent proxy correspond to age of child. 
Problem Areas in 
Diabetes – Pediatric 
(Diabetes Burden) 
Youth 8-17 
and all 
parents 
YOUTH – Youth will complete this survey on psychological distress and burden 
associated with taking care of diabetes. Child survey for 8-11 years, Teen survey 
for 12-17 years. 
PARENTS – complete a proxy version as well as a report of their own distress. 
Use of and Comfort with 
Technology 
Youth >11, 
All parents 
YOUTH – Youth ages 11-18 will complete this survey on use of and comfort with 
general technology and diabetes devices. 
PARENT – All parents complete the same questions on technology and devices. 
PROMIS Global Health 
scale (PGH-7) 
Youth ≥ 11  
YOUTH – Youth will complete this survey on their overall health, integrating 
patient experiences across physical, mental and social health  
 
 

 
Community Partnership and Engagement 
Once complete, results from this study will be shared with medical leadership of California Children’s 
Services (public insurance which provides coverage of diabetes-related care for our youth with type 2 
diabetes) at the state and county level to advocate for coverage and access to CGM technology for all 
youth with type 2 diabetes.  We will also engage with the Pediatric Endocrinology Family Advisory 
Counsel at Stanford Children’s Health to combine results from this study with patient/parent advocacy 
efforts to gain insurance coverage for CGM in all youth with T2D. 
Potential Pitfalls and Contingency Plans 
Study participants are asked to attend clinic appointments as recommended by their care provider.  Our 
clinic standard is to have patients attend at least 4 visit per year, on average 1 clinic visit every 3 months. 
There may be missed appointments. Efforts will be made to remind families of appointments the day 
before the visit by phone or MyChart messaging. If a patient misses an appointment, the team will make 
efforts to re-schedule the appointment and address barriers to attending clinic appointments.  
Participants may have challenges with CGM supplies, upload of glucose data, or questions about CGM 
use. Our team will be available to patients and their families to address these issues including attempts 
to avoid gaps in CGM supplies to support continuous use of CGM.  If a patient misses more than 3 
appointments or decides to stop using CGM they will be withdrawn from the study and asked to resume 
usual care.  We are in the process of obtaining CGM supplies for all participants for the duration of the 
study to ensure continued access to CGM supplies.  If we are not able to secure funding for CGM 
supplies we will use budgeted funds from this grant to cover the cost of CGM supplies for 50 participants 
over 6 months in place of salary support for a research assistant and home HbA1C kits, with the PI salary 
support going towards PI FTE towards completing study related tasks and working with participants to 
facility an in-person clinic visit.  Even with a shorter duration, the study can provide meaningful pilot 
data about the feasibility of CGM use and key clinical outcomes in youth with T2D. 
Future Steps 
Data from this feasibility trial would fill a gap in the literature with respect to CGM use in youth with 
type 2 diabetes.  The findings from this trial can provide much needed data to impact CGM coverage 
policy for publicly insured youth with type 2 diabetes in California and pave the way for future studies 
using CGM technology in this population. 
 
 
 
 
 
 
 

 
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