Behavioral Incentive Meal Dose Engagement in Adolescents With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Children's Mercy Hospital Kansas City

SHORT TITLE: HCT COIN2DOSE 
 
IRB #STUDY00001086  
 
 
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Version 5.08 dated 12.26.2023 
PROTOCOL TITLE:  HCT Cash-Only INcentive to promote mealtime insulin 
DOSE Engagement (HCT COIN2DOSE) 
 
 
 
PRINCIPAL INVESTIGATORS: 
 
Sarah Tsai, MD, FRCPC, CPI 
Pediatric Endocrinologist 
Division of Endocrinology 
Assistant Direct of Clinical research 
Children’s Mercy Kansas City 
Email: sltsai@cmh.edu 
Phone: 816-960-8952 
 
Ryan McDonough, DO, FAAP 
Pediatric Endocrinologist 
Division of Endocrinology & Diabetes 
Co-Medical Director, Children’s Diabetes Center 
Children’s Mercy Hospital Kansas City 
Email: rjmcdonough@cmh.edu 
Phone: 816-960-8974 
 
Mark Clements, MD, PhD 
Endocrinologist 
Pediatric Clinical Research Unit 
The Children’s Mercy Hospital 
Email: maclements@cmh.edu 
Phone: 816-983-6982 
 
 
 
 
VERSION NUMBER/DATE: 
Protocol Version:  5.08 
Protocol Date:  26DEC2023 
 
 
 
 
 
 
 
 
 
 

SHORT TITLE: HCT COIN2DOSE 
 
IRB #STUDY00001086  
 
 
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Version 5.08 dated 12.26.2023 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
June 2, 2021 
Revision of protocol to exclude the 
AIM2DOSE intervention and add 
LOAN2DOSE.  
Protocol Title Change. 
YES 
3 
September 
22, 2021 
Update to the number of participants 
enrolled 
Update to pg. 13 Study timelines 
Yes 
4 
January 26, 
2022 
Changed the word ‘Dexcom’ to ‘CGM’ on 
pages 10,11, 13, & 15 
Yes 
5 
May 12, 2022 
Update the use of a recruitment flyer and 
use of POC a1c if research a1c not received 
No 
5 
Feb 23, 2023 
Updated bolus scoring protocol, the dinner 
window is changed to end at 2200 H. 
No 
6 
April 5, 2023 
Updated the use of email to invite potential 
subjects to participate. 
No 
7 
July 19, 2023 
Remove that parents can participate in 
study focus group even if their child does 
not participate (page 12). Parents may 
participate in focus group if their child is 
enrolled in the study. 
Removed study AIM 4 (page 6). 
1 sentence added to clarify insulin delivery 
system deliver tracking (page 13).  
Remove artificial intelligence aspect of focus 
group consent. 
 
yes 
8 
Dec 26, 2023 
Correct conflicting information in Section 
25.0 about Telephone Consent process. 
 
Update policy reference from 10.05 to “IRB 
Permission/Assent/Consent Policy” in Section 
25.0 and 26.0. 
No 
 
 

SHORT TITLE: HCT COIN2DOSE 
 
IRB #STUDY00001086  
 
 
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Table of Contents 
1.0 
Study Summary .......................................................................................................................... 4 
2.0 
Objectives ...................................................................................................................................... 5 
3.0 
Background .................................................................................................................................. 6 
4.0 
Study Endpoints ......................................................................................................................... 8 
5.0 
Study Intervention ................................................................................................................. 10 
6.0 
Procedures Involved .............................................................................................................. 11 
7.0 
Data and Specimen Banking ............................................................................................... 13 
8.0 
Genetic Analysis Information ............................................................................................. 13 
9.0 
Sharing of Results with Subjects ....................................................................................... 13 
10.0 Study Timelines ....................................................................................................................... 14 
11.0 Inclusion and Exclusion Criteria ....................................................................................... 15 
12.0 Vulnerable Populations ........................................................................................................ 16 
13.0 Local Number of Subjects .................................................................................................... 16 
14.0 Screening and Recruitment Methods .............................................................................. 17 
15.0 Reimbursement, Payment and Tangible Property provided to subjects .......... 18 
16.0 Withdrawal of Subjects......................................................................................................... 18 
17.0 Risks to Subjects ...................................................................................................................... 18 
18.0 Potential Benefits to Subjects ............................................................................................ 19 
19.0 Investigator Assessment of Risk/Benefits Ratio: (IRB makes the final 
determination) ...................................................................................................................................... 20 
20.0 Data Management and Confidentiality ........................................................................... 20 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects ......................... 20 
22.0 Provisions to Protect the Privacy Interests of Subjects ........................................... 20 
23.0 Compensation for Research-Related Injury – NA, Minimal Risk .......................... 21 
24.0 Economic Burden to Subjects ............................................................................................ 21 
25.0 Permission/Assent/Consent Process ............................................................................. 22 
26.0 Process to Document Permission/Assent/Consent .................................................. 23 
27.0 Setting ......................................................................................................................................... 23 
28.0 Resources Available ............................................................................................................... 25 
29.0 Multi-Site Research ................................................................................................................ 28 
30.0 International Research ......................................................................................................... 28 
31.0    References Cited……………...…………………………………………………..26 
 
 
 

SHORT TITLE: HCT COIN2DOSE 
 
IRB #STUDY00001086  
 
 
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Version 5.08 dated 12.26.2023 
1.0 
Study Summary 
 
Study Title 
 HCT Cash-Only INcentive to promote mealtime insulin 
DOSE Engagement (HCT COIN2DOSE): a pilot trial 
Study Design 
Pilot randomized controlled trial  
Primary Objective 
To determine the impact of HCTCOIN2DOSE and 
LOAN2DOSE compared to control on the trajectory of 
glycemic control and treatment engagement among 
adolescences age 12-17 years who are at risk for a near-
term rise in A1C. 
Secondary 
Objective(s) 
To determine both the feasibility and usability of 
HCTCOIN2DOSE and LOAN2DOSE intervention 
compared to control in adolescents age 12-17 years who are 
at risk for a significant near-term rise in A1C. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
HCT COIN2DOSE: Utilization of immediate financial 
incentives to promote mealtime insulin dose delivery, with 
weekly bonuses for sustained meal dosing behavior 
LOAN2DOSE: Utilization of loss aversion approach to 
promote mealtime insulin dose delivery. Participants will 
start with a virtual bank balance and will have money 
deducted from the balance when mealtime insulin doses are 
missed. Additional amounts will be deducted when sustained 
meal dosing goals are not met. 
IND/IDE #  
NA 
Study Population 
Individuals identified by artificial intelligence who are 
predicted to experience a rise in A1C of greater than or 
equal to 0.3% in the next 70-110 days using a validated 
predictive algorithm created via advanced machine 
learning (random forest) and natural language 
processing. Individuals must have had the diagnosis of 
T1D for 6 months and be 12-17.99 years old. Parents of 
children who meet inclusion criteria may choose to 
participate in the focus group 
Sample Size 
A minimum of 36 and a maximum of 72 youth 
randomized in a 1:1:1 ratio to either the treatment or 
usual care (control). 
  
Participants and their parents may choose to participate 
in the focus group. Parents may enroll in the focus group 
if their child is enrolled in the study. Our aim will be to 
enroll 5 to 30 parents.  
Study Duration for 
Individual 
Participants 
26 weeks (11-13 weeks intervention and 11-13 weeks 
observation  
Participants and/or their parents may choose to participate in 
a focus group at the end of the study (week 26). 

SHORT TITLE: HCT COIN2DOSE 
 
IRB #STUDY00001086  
 
 
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Version 5.08 dated 12.26.2023 
Study Specific 
Abbreviations/ 
Definitions  
T1D = Type 1 diabetes  
COIN2DOSE = Behavioral Economic Incentives to promote 
insulin Dose Engagement in Adolescents with Type 1 
Diabetes 
LOAN2DOSE = Behavioral Economic concept that uses an 
economic loss aversion approach to promote insulin dose 
engagement in adolescents with Type 1 Diabetes 
CGM = continuous glucose monitoring 
AI = artificial intelligence 
SOC = Standard Care Diabetes Clinic Visit 
Twilio= cloud-based communication platform that enables 
clinic staff to send secure SMS text messages to participants 
 
2.0 
Objectives 
 
2.1 
Primary Objectives 
The long-term goal is to develop effective ways to improve glycemic control in 
youth with T1D. To that end, we propose to specifically evaluate the 
effectiveness, feasibility, and usability of two new interventions in diabetes care: 
an economic incentive (COIN2DOSE) and an approach that uses an economic 
loss aversion (LOAN2DOSE) to promote patient engagement with mealtime 
insulin dosing behavior. If initially efficacious, our results will serve as the basis 
for an R01 submission(s) to conduct a fully powered efficacy trial of 
COIN2DOSE and LOAN2DOSE. This study is significant as omission of 
mealtime boluses is one of the common reasons for suboptimal diabetes control in 
youth. This project is highly innovative because it will: 1) target youth who are 
predicted by artificial intelligence to experience a worsening in glycemic control,  
2) use an economic incentive intervention to improve mealtime insulin dosing 
behavior and 3) use an economic loss aversion to improve mealtime insulin 
dosing behavior. 
 
2.2 Hypotheses 
Aim 1: To determine the impact of COIN2DOSE and LOAN2DOSE as 
compared to control on the trajectory of glycemic control and treatment 
engagement among adolescents age 12-17 years who are at risk for a near-
term rise in A1C. 
Hypothesis 1: Use of COIN2DOSE will result in a lower rise in A1C 
compared to the controls. 
Hypothesis 2: Use of COIN2DOSE will improve engagement as measured 
by mealtime insulin BOLUS score compared to controls.  
Hypothesis 3: Use of COIN2DOSEwill yield sustained improvements in 
A1C trajectory for 12 weeks after the intervention. 
Hypothesis 4: Use of COIN2DOSEwill yield sustained improvements in 
BOLUS score for 12 weeks after the intervention. 
Hypothesis 5: Use of LOAN2DOSE will result in a lower rise in A1C 
compared to the controls. 

SHORT TITLE: HCT COIN2DOSE 
 
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Hypothesis 6: Use of LOAN2DOSE will improve engagement as measured 
by mealtime insulin BOLUS score compared to controls.  
Hypothesis 7: Use of LOAN2DOSEwill yield sustained improvements in 
A1C trajectory for 12 weeks after the intervention. 
Hypothesis 8: Use of LOAN2DOSEwill yield sustained improvements in 
BOLUS score for 12 weeks after the intervention. 
 
 
 
Aim 2: To determine the feasibility of COIN2DOSE and LOAN2DOSE 
interventions in adolescents age 12-17 years who are at risk for a significant 
near-term rise in A1C. 
Hypothesis 9: The COIN2DOSE intervention will be feasible as determined 
by 1) ≥75% of participants in the intervention group will complete all study 
procedures for the duration of the intervention and post-intervention study 
periods, 2) ≥75% of parents will endorse the feasibility of providing an 
equivalent economic incentive plan, and 3) no decrease in quality of life at 
visit 2 compared to baseline (visit 1). 
Hypothesis 10: The LOAN2DOSE intervention will be feasible as 
determined by 1) ≥75% of participants in the intervention group will 
complete all study procedures for the duration of the intervention and post-
intervention study periods, 2) ≥75% of parents will endorse the feasibility of 
providing an equivalent economic loss aversion plan, and 3) no decrease in 
quality of life at visit 2 compared to baseline (visit 1). 
 
 
Aim 3: To determine user satisfaction with the COIN2DOSE and 
LOAN2DOSE intervention in adolescents age 12-17 years who are at risk for 
a significant near-term rise in A1C. 
Hypothesis 11: COIN2DOSE will be usable as determined by using the 
Diabetes Treatment Satisfaction Questionnaire (change version).  
Hypothesis 12: LOAN2DOSE will be usable as determined by using the 
Diabetes Treatment Satisfaction Questionnaire (change version). 
 
 
 
3.0 
Background 
 
3.1 Background 
Individuals with T1D can have a tremendous impact on their own health outcomes if they 
follow their T1D treatment regimen (2) (3) (4). Unfortunately, many adolescents do not 
adhere to their treatment and experience increased risk for both immediate medical 
emergencies, long-term T1D-related complications, and mortality (3) (5). Diabetic 
ketoacidosis (DKA) occurs at a rate of 4.81/100 patient-years in individuals with 
established T1D and at a rate of 15.83/100 patient years in youth with an A1C >9% (6). 
Adolescents who have poorly controlled T1D are much more likely to develop DKA (3) 

SHORT TITLE: HCT COIN2DOSE 
 
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Version 5.08 dated 12.26.2023 
(7).  While health care professionals can offer guidance and recommendations, it is clear 
that traditional clinical interactions are not sufficient to promote optimal self-care and 
adherence for many adolescents (8) with the majority not reaching A1C targets (3). In fact, 
adolescents with T1D exhibit significant deterioration in glycemic control (aka rising A1C) 
from age 8 to 18 (9), as shown below.  
 
 
 
A number of behavioral interventions have demonstrated utility in improving adherence 
behaviors in youth with T1D13-19. Improved adherence behaviors are associated with better 
glycemic control and short and long-term health outcomes (3). On the other hand, lack of 
adherence can have serious consequences both acutely (DKA or severe hypoglycemic 
events) and long-term (retinopathy, neuropathy, nephropathy, and cardiovascular disease) 
(3). Missed mealtime boluses can have devastating metabolic consequences (16).  
 
Adolescence is a particularly challenging time for individuals with T1D, with average A1C 
values that are 5% higher than during other periods of childhood and 14% higher than 
adults (22) (2). Glycemic control worsens from early childhood through age 16-18 (23). It 
is critically important to develop interventions to prevent deterioration in glycemic control. 
High glycemic variability is also associated with increased risk of long-term diabetes 
complications, such as microalbuminuria (24). Lack of adherence to diabetes treatment 
plans is one of the main causes of sub-optimal glycemic control (3) (25) (7).  A significant 
part of this non-adherence is omission of insulin for ingested carbohydrates at snacks and 
meals, both by missing boluses entirely and by inaccurate carbohydrate counting (26) (16) 
(27) (28) (29). Studies have shown significant underestimation of carbohydrate content in 
meals of up to 20% (26). Furthermore, greater than 33% of adolescents fail to give insulin 
for >15% of their meals and snacks (16). Adolescents, on average, miss boluses for meals 
two times per week (28). In one study, youth who omitted insulin at least one time per 
week had an A1C of 8.8-9.5%, while those who consistently took meal-time insulin had a 
significantly lower A1C of 7.8-8.0% (28) (30). This is of great significance as poor 
glycemic control increases risk of both acute and chronic diabetes related complications 
(31). Meal bolus alarms on insulin pumps, which alarm at a preset time, lead to transient, 
modest changes in dosing behavior (32). “Lost focus” has been identified as a significant 
reason for missed meal-time boluses in adolescents (33).  Exactly how to effectively 
maximize engagement with mealtime insulin dosing behavior among adolescents with T1D 
represents a critical gap in knowledge.  
 
3.2 Rationale 

SHORT TITLE: HCT COIN2DOSE 
 
IRB #STUDY00001086  
 
 
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Version 5.08 dated 12.26.2023 
 
There is an urgent need for a sustainable method that improves patient engagement with 
delivering mealtime insulin boluses. Improved engagement with mealtime boluses will 
lead to better glycemic control and will ultimately help reduce the risk of acute and chronic 
diabetes related complications.  
 
 
Recent evidence suggests that financial incentives can successfully increase adherence to 
blood glucose monitoring among adolescents and young adults with type 1 diabetes with 
moderate to large treatment effect size. Specifically, one study of 10 adolescents 
evaluated a financial incentive program that delivered $0.10 per fingerstick blood glucose 
test, with bonus incentives for ≥4 tests per day and a maximum achievable incentive of 
$251.40 over 12 weeks. The authors found that SMBG increased from 1.8 ± 1.0 to 4.9 ± 
1.0 tests per day (P < 0.001) with 90% completing four or more tests per day; that mean 
A1C fell from 9.3 ± 0.9% to 8.4 ± 1.5% (P = 0.05); and that adolescents and parents 
reported high satisfaction with procedures. In another study, 90 adolescents and young 
adults demonstrated that a $60 monthly incentive opportunity significantly increased 
adherence to glucose monitoring goals in the 90-day incentive period (50.0% vs 18.9%; 
adjusted difference, 27.2%; 95% CI, 9.5% to 45.0%; P = .003). The effect was not 
sustained during the post-interventional 90-day observation period (15.3% vs 8.7%; 
adjusted difference, 3.9%; 95% CI, -2.0% to 9.9%; P = .20), and A1C did not improve. 
The evidence to date suggests that it is feasible to increase adherence behaviors among 
adolescents and young adults with type 1 diabetes. It is unclear whether targeting blood 
glucose monitoring behaviors is always associated with an improvement in A1C. 
Whether financial incentives produce a sustained improvement in adherence is also an 
open question. These methods have not been applied to mealtime insulin dosing 
behaviors, so whether financial incentives improve adherence to mealtime insulin dosing 
among adolescents and young adults is also unknown.  
 
There is a strong rationale for targeting adherence to mealtime insulin dosing for 
improvement. Prior observational research suggests a 1.5% decrease in A1C levels for 
every one-bolus increase in daily mealtime doses, supporting our premise that increasing 
mealtime insulin use might help youth who are at risk of increasing A1C(1).  
 
The objective of the present study is to obtain pilot feasibility data to 1) determine whether 
COIN2DOSE and/or LOAN2DOSE show a preliminary trend for improvement in the 
outcomes of interest, 2) perform power calculations that will inform the design of a 
definitive trial(s) and 3) establish feasibility of the interventions and study procedures to 
inform the design of a definitive trial(s). 
 
4.0 
Study Endpoints 
Outcome Measures 
Primary outcome:  
1) Change in A1C (ΔA1C90-day) from baseline visit (visit 1) to 90-day visit (visit 2).  
 

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Secondary outcomes: 
1) Change in A1C (ΔA1C180-day) from baseline visit (visit 1) to 180-day visit (visit 
3).  
2) Change in percent time in range 70-180 mg/dL (%TIR70-180) from baseline visit 
(visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3). 
3) Change in percent time hyperglycemic (>180 mg/dL; %Hyper>180) from baseline 
visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3). 
4) Change in percent Time hypoglycemic (<70 mg/dL; %Hypo<70) from baseline 
visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3). 
5) Change in percent Time severely hypoglycemic (<54 mg/dL) (%Hypo<54) from 
baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3). 
6) Change in mealtime insulin BOLUS score (BOLUS) from baseline visit (visit 1) 
to 90-day visit (visit 2) and to 180-day visit (visit 3). 
7) For COIN2DOSE treatment group, proportion of participants who complete 
>90% of study procedures throughout the intervention and post-intervention study 
procedures. 
8) For COIN2DOSE treatment group, proportion of parents who endorse the 
feasibility of providing an economic incentive equivalent to that used in the 
intervention. 
9) For COIN2DOSE treatment group, >75% of participants will exhibit a 
score of >80% total possible points on Diabetes Treatment Satisfaction 
Questionnaire (teen version) 
10) Change in trust in provider from baseline visit (visit 1) to 90-day visit (visit 2) and 
to 180-day visit (visit 3). 
11) For LOAN2DOSE treatment group, proportion of participants who complete 
>90% of study procedures throughout the intervention and post-intervention study 
procedures. 
12) For LOAN2DOSE treatment group, proportion of parents who endorse the 
feasibility of providing an economic incentive equivalent to that used in the 
intervention. 
13) For LOAN2DOSE treatment group, >75% of participants will exhibit a 
score of >80% total possible points on Diabetes Treatment Satisfaction 
Questionnaire (teen version) 
14) Change in perceived involvement in care from baseline visit (visit 1) to 90-day 
visit (visit 2) and to 180-day visit (visit 3). 
15) Change in health-related empowerment from baseline visit (visit 1) to 90-day visit 
(visit 2) and to 180-day visit (visit 3). 
 
 
Outcome Measures 
 
Hemoglobin A1C will be measured via a fingerstick capillary blood collection and 
analyzed on the Tosoh G8 HPLC. This approach is validated ant traceable to DCCT 
standards. 
 

SHORT TITLE: HCT COIN2DOSE 
 
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CGM-derived glycemic metrics. Participants will have the Dexcom G6 Pro (blinded 
CGM) inserted 1 week after enrollment and at visit 1, and at visit 2. Participants will 
wear the CGM for 10 days following each insertion. We will consider >120 hours (>50% 
of total possible capture) of CGM data to be analyzable, otherwise data will be 
considered missing. Percent time in range (70-180), percent time >180, percent time 
>250, percent time <70, and percent time <54 mg/dL will be collected.  
 
Participants who already have their own CGM will wear and use it as usual. They will 
not require a blinded Dexcom.  
 
For patient-reported outcomes, questionnaires may be completed on iPad for in-person 
visit or via email or text via Twilio for remote visits.  If completing by email or text, a 
link to REDCap will be sent to participant. 
 
 
Quality of Life will be assessed using the MIND Youth Questionnaire (My-Q), which is a 
valid measure of quality of life for teenagers with diabetes (49).  
 
Acceptability will be assessed based on treatment satisfaction scores using the Diabetes 
treatment Satisfaction Questionnaire, DTSQ-Teen, which has been validated for use in 
youth with T1D (50). 
 
 
Trust in provider: Will be measured as a change score (visit 2-visit 1; visit 3-visit 1) with 
10-items from the validated Wake Forest Physician Trust Scale (58). 
 
Perceived Involvement in Care: Will be measured as a change score (visit 2-visit 1; visit 
3-visit 1) with 13-items from the Perceived Involvement in Care Scale (59). 
 
Health-related empowerment: Will be measured as a change score (visit 2-visit 1; visit 3-
visit 1) with 8-items from the Health-related empowerment scale (60).  
 
Covariate Measures 
 
Demographics: Age, sex, race, duration of diabetes.  
 
Depression will be measured as a covariate using the validated PHQ-A (which is the 
Patient Health Questionnaire, PHQ-9, adapted for adolescents) (51). Note: no notification 
of medical personnel is necessary if adolescents endorse depressive symptoms because a) 
the survey does not ask about current suicidal ideation, and b) adolescents in the 
Children’s Mercy Diabetes Center are monitored for depression symptoms at every 
clinical encounter, with clinical encounters occurring every 3-4 months typically. 
 
 
5.0 
Study Intervention 
 

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To identify an at-risk population for more intensive intervention opportunities, the 
Children’s Mercy Diabetes Center now routinely uses a validated prediction model 
based on advanced machine learning (random forest method) and natural language 
processing to identify individuals who are predicted experience a rise in A1C in the 
next 90 days. The model analyzes all patients who presented for a diabetes visit in 
the prior week.  To accomplish this task, the complete health record for the CMH 
Diabetes Center registry is analyzed. We will select patients from this cohort for 
recruitment into the present study. 
 
 
COIN2DOSE intervention: From one-week post-randomization to the 12-week study 
visit, youth randomized to this treatment arm will receive personalized feedback via 
monetary incentives for dosing insulin at mealtimes. We will define mealtimes based on 
hour of the day and the presence of a carbohydrate entry associated with the insulin 
bolus. According to the methodology for calculating BOLUS(1) breakfast will be 0600-
1000, lunch will be 1100-1500, and dinner will be 1600-2200. Thus, we will reimburse 
youth up to $0.50 per mealtime with at least one meal-associated (carbohydrate-
associated) insulin bolus completed (maximum $1.50/day). We will offer the opportunity 
for youth to earn a bonus reimbursement of up to $5.00/week for weeks during which 
they achieve at least 5 days of 3 mealtime insulin boluses. Finally, we will pay youth up 
to $2.00 per week for sharing their insulin use data at least two times per week with the 
study team during the three-month treatment phase (maximum $24.00). Therefore, 
maximum total incentive available is $210.  
 
LOAN2DOSE intervention: From one-week post-randomization to the 12-week study 
visit, youth randomized to this treatment arm will receive personalized feedback via 
monetary deductions from a virtual bank of $210 for missed doses of insulin at 
mealtimes. Participants will receive a weekly email or text message using Twilio to 
communicate their current virtual bank balance. We will define mealtimes based on hour 
of the day and the presence of a carbohydrate entry associated with the insulin bolus. 
According to the methodology for calculating BOLUS (1) breakfast will be 0600-1000, 
lunch will be 1100-1500, and dinner will be 1600-2200. Thus, we will deduct $0.50 per 
mealtime with at least one meal-associated (carbohydrate-associated) insulin bolus 
missed (maximum -$1.50/day). Youth can also lose an additional amount of up to 
$5.00/week for weeks during which they don’t achieve at least 5 days of 3 mealtime 
insulin boluses. Finally, we will deduct the virtual account up to $2.00 per week for 
failing to share their insulin use data at least two times per week with the study team 
during the three-month treatment phase (maximum deduction of $24.00). Therefore, 
maximum total deductions is $210. 
 
6.0 
Procedures Involved 
 
Study Design 
The study is an unblinded, 3-arm, randomized, controlled trial. After successful 
screening and consent, individuals will wear a blinded Dexcom G6 Pro CGM 
inserted 1 week after consent. Families who have previously used a CGM device 

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Version 5.08 dated 12.26.2023 
will be allowed to insert the G6 Pro during a remote visit. At the baseline visit 
(visit 1; day 1), participants will be randomized to the COIN2DOSE, 
LOAN2DOSE, or control treatment arms and will be trained on the procedures 
appropriate to their treatment arm.  Participants will also complete baseline 
measures by questionnaire.  Participants will complete procedures specific to their 
treatment arm weekly. Visit 2 will occur after 12 weeks (90 days).  Participants 
will stop any treatment interventions after this visit. A1C and questionnaire 
measures will be completed, and participants will again wear the Dexcom G6 Pro 
CGM for 10 days (the device will be returned by mail post-visit). Participants will 
receive no treatment intervention from week 13 to week 24. Visit 3 will occur 
after week 24. Again, A1C and questionnaire measures will be completed and 
participants will wear the Dexcom G6 Pro CGM for 10 days.  
Participants who have their own CGM will wear it as usual and will not require a 
blinded Dexcom.  
 
All study participants will also have the option to participate in a focus group 
discussion (FGD) regarding study participation. 
 
Parents of children who meet inclusion criteria and participate in the study may 
also elect to participate in a focus group.  
 
Study Visits 
Study visits may occur in-person or remotely (i.e., from home). Procedures will 
be adapted to accommodate both scenarios. 
 
7.0 
Data and Specimen Banking 
 
Data Collection 
Demographic data: Demographic data will be collected from the participant via an 
electronic data collection form in REDCap which shall serve as the source. 
Demographic data will be verified with review of electronic medical record data. 
For remote visits, a web URL linking to the REDCap survey will be shared with 
participants. 
 
A1C data: Participants will use a capillary A1C kit to collect a fingerstick A1C sample. 
An educational document and video (YouTube https://youtu.be/e9loR3N4Rho) 
have been created to educate approved study staff and participants on collection of 
the sample. The A1C is analyzed in a CMH lab by automated high performance liquid 
chromatography (reference range 4.0-6.0%, Tosoh 2.2, Tosoh Corporation, San 
Francisco, CA), which is a measurement method reliable to DCCT standards. The 
CMH A1C mail-in kit has excellent reliability to fresh samples (r=0.98). Samples will 
be delivered to the Broadway lab by approved study staff for in-person study visits; 
samples will be mailed to the Broadway lab by participants completing remote visits 
from home. Sample tubes will be pre-labeled by study staff with the participant’s 
study ID. If insufficient sample for analysis is collected at any time point, 
participants may be asked to repeat the sample collection to rescue data collection. 

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If participant does not return A1C mail-in-kit, point-of-care A1C or serum A1C may be 
used instead if available.  
 
CGM data: Participants will use the Dexcom G6 Pro in blinded mode for data 
collection purposes only. If insufficient data for analysis are collected at any time 
point, participants may be asked to replace the CGM device to rescue data 
collection. No treatment decisions will be based on G6 Pro data. Dexcom G6 Pro 
data will be uploaded from the Dexcom receiver to Dexcom Clarity using the 
participant’s personal, CMH-connected Dexcom Clarity account; data will then be 
collected as a .csv file for analysis. Files will be aggregated into a study database 
using MS Excel or equivalent software.  Participants with their own CGM will 
use it as usual. They will be asked to share their CGM information with the study 
team per the usual procedure for diabetes clinic visits.  
 
Insulin delivery data: Participants will use their personal, prescribed insulin 
delivery device throughout the study. Insulin delivery devices will be uploaded to 
Children’s Mercy-approved software compatible with the specific device. Data 
will be uploaded to the participant’s personal, CMH-connected account in the 
relevant upload system.  Data will then be collected as a .csv file for analysis. 
Files will be aggregated into a study database using MS Excel or equivalent 
software. Insulin delivery systems and/or any date of system change will be noted 
at enrollment and on REDCap questionnaires.  
 
Questionnaire data: All questionnaire data will be collected directly from 
participants via electronic (REDCap). 
 
Focus group discussions: Focus group discussions (FGD) will optional and 
stratified by intervention arm. As the ideal size for FGDs are 6-8 participants, it is 
possible that we will conduct two FGDs per arm if there is enough interest among 
participants. Thus, we anticipate conducting 3-6 FGDs. FGDs will be 
approximately 90 minutes in duration, conducted by a trained moderator using a 
semi-structured guide. Both youth and their parents will be invited to participate 
in the focus groups.  
 
FGDs will be conducted virtually on Microsoft Teams according to Standard Operating 
Procedures currently in pilot testing with the CMH Formative Research Team. De-
identified data will be transcribed using Teams software and uploaded into Dedoose 
software for analysis.  
 
Data and Specimen Banking 
 
8.0 
Genetic Analysis Information 
N/A 
 
9.0 
Sharing of Results with Subjects 

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Results will not be shared with subjects. 
 
10.0 Study Timelines 
 
 
Table 1. Schedule of events 
 
visit # 
Visit 1 
CGM 
placement 
Intervention 
Visit 2 
Maintenance 
Visit 3 
 
 
1 week 
post 
enrollment 
1-12 week 
post CGM 
placement 
3 
months 
(+/-14 
days)  
12 weeks post 
visit 2 
 6 months 
(+/-14 days)  
Consent  
x 
 
 
 
 
 
Randomization  
x 
 
 
 
 
 
CGM (10-day) 
 
x* 
 
x* 
 
x* 
A1C 
x 
 
 
x 
 
x 
Demographic 
x 
 
 
x 
 
x 
PHQ9 
x 
 
 
x 
 
x 
DTSQteen 
x 
 
 
x 
 
x 
MyQ 
x 
 
 
x 
 
x 
Wake Forest 
Physician 
Trust Scale 
x 
 
 
x 
 
x 
Perceived 
Involvement in 
Care Scale 
x 
 
 
x 
 
x 
Health-related 
empowerment 
scale. 
x 
 
 
x 
 
x 
Concerns 
about AI 
x 
 
 
x 
 
x 
Pump/pen** 
download 
x 
 
x 
x 
x 
x 
Focus Group 
Participation - 
Youth 
 
 
 
 
 
x 
Focus Group 
Participation - 
Parents 
 
 
 
 
 
x 
 
*CGM will be returned by pre-paid, registered delivery service with tracking. 
** Control: pump/pen upload will occur monthly; COIN2DOSE and LOAN2DOSE 
pump/pen upload will occur twice weekly. 
 
 
 
 
 
 
 
Participant activities: 

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Participants enroll 
in COIN2DOSE 
Participants randomized and fill out questionnaires Setting: at regularly scheduled 
standard of care (SOC) visit, in-person or virtual visit utilizing a CMH IRB approved 
remote platform.  
1 week post 
enrollment 
All groups will have Dexcom sensor inserted and will be worn x 10 days. Setting: in-
person at the PCRU or virtual meeting.**  Dexcom sensor may be mailed to 
participants.  If mailed, the 1-week visit may take place via virtual visit utilizing a 
CMH IRB approved remote platform. 
Participants with their own CGM will wear it as usual.  
3 months post 
enrollment 
Participants fill out questionnaires + have blinded Dexcom sensor inserted during 
SOC visit or virtual visit. Participants will wear Dexcom x 10 days. Setting: SOC visit, 
in-person or virtual visit utilizing a CMH IRB approved remote platform.  
6 months post 
enrollment 
Participants fill out questionnaires and wear Dexcom x 10 days. Dexcom inserted 
during SOC visit or virtual visit utilizing a CMH IRB approved remote platform. 
Setting: clinic or remote visit utilizing a CMH IRB approved remote platform. 
Finally, participants return CGM by mail. (Not applicable to participants with their 
own CGM.) 
Focus group discussions are conducted. Both youth and parents will be invited to 
participate.  
 
**Participants may choose to have in-person Dexcom insertion instruction at the PCRU 
or online via virtual instruction. If participant is Dexcom naive, they may insert Dexcom 
for the first time via online instruction, as it is a relatively simple procedure. If a 
participant is uncomfortable inserting the Dexcom for the for the first time virtually, they 
will have the option to do this with in-person instruction at the PCRU.  
 
The link that patients will be sent for learning to use Dexcom is: 
https://www.dexcom.com/training-videos 
 
Participants with their own CGM will not be anticipated to require training; however, this 
will be offered if needed.  
 
11.0 Inclusion and Exclusion Criteria 
Individuals who have been predicted via an artificial intelligence-intelligence based 
model to experience a rise in A1C in the near future (90 days) will be approached for 
recruitment. 36 participants will be recruited from the Children’s Mercy Diabetes Center 
(any clinic or hospital location). Based on preliminary data review of our clinic 
population, there were at least 81 individuals who met inclusion criteria who were seen in 
clinic in the month of May 2019 alone. Patients will be randomized to, COIN2DOSE, 
LOAN2DOSE, or control group using a 1:1:1 randomization scheme.   
 
Inclusion Criteria:  
1) Aged 12-17.99 years 
2) The youth must have been diagnosed with T1D for at least 6 months 
3) The youth must have attended at least 2 routine T1D standard of care visits in the 
past 12 months 

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4) The youth must be using an insulin delivery device capable of recording, storing, 
and downloading insulin bolus behaviors (insulin pump or smart Bluetooth insulin pen 
that can be uploaded to standard clinic upload software).  
5) The youth must have a current A1C >7.2% and/or be predicted to have a rise in 
A1C in of 0.3% or higher the next 90 days. 
6) Not pregnant or planning to become pregnant by self-report. 
 
 
 
Exclusion Criteria:  
1) Participants with any type of diabetes mellitus other than T1D 
2) Participant has any disease-causing anemia or affecting red blood cell physiology 
(which would impact A1C) 
3) Participant has a physical disability, which in the opinion of the investigator would 
interfere with individual’s ability to feed themselves or use one’s hands to facilitate 
eating 
4) Participants with no internet access or ability to upload device(s) to data 
aggregation software that is accessible to study team. 
 
For Focus Groups: 
 
Any parent or legal guardian whose child is participating in the study is invited to 
participate in a focus group discussion.  
 
 
12.0 Vulnerable Populations 
 
This study will include children. Parent/LAR permission will be sought before a child 
may be enrolled. Written assent of children 7 and older will be obtained per CMH policy; 
all children in this study will be above the age of assent and therefore required to assent 
for participation.   
 
If a child subject reaches the age of majority (18 years old) during the study, he or she 
will be asked to consent to further participation using an Adult Addendum.  
 
Parents or legal guardians of youth who are eligible to participate in this study will be 
eligible to participate in a focus group. It is possible that a parent or legal guardian will be 
pregnant at the time of focus group participation.  
 
We will not enroll other vulnerable populations, i.e.  prisoners, neonates, and/or adults 
lacking capacity.  
 
Children’s Mercy Kansas City employees or children of employees will not be 
recruited. 
 
13.0 Local Number of Subjects 

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Target sample size is 36 adolescents. The maximum number of subjects enrolled 
will be 72. 
 
Parents or legal guardians of youth eligible for inclusion in the study may choose to 
participate in a focus group. We may enroll up to 30 parents or legal guardians.  
 
 
14.0 Screening and Recruitment Methods 
 
Patients will be prescreened to see if they meet enrollment criteria by a member of 
the research team. Patients who appear to meet criteria may be contacted by 
telephone, email or approached during a standard of care visit by a study team 
member and informed about this study.  Patients and their parent/legal guardian 
will be given information about the study and they will determine if they wish to 
participate. Recruitment will also take place via telephone utilizing an IRB-approved 
telephone script.  
 
Flyers will be used as a means of advertising the study to help with recruitment.   IRB 
approved flyers will be used to advertise via email invitation and at all CMH locations.  
Recruitment will then be in person or via phone call.  A copy of the flyer is attached to 
the submission. 
 
Parents/legal guardians of children who meet enrollment criteria and are approached for 
the study will be invited to participate in a focus group at the end of the study.  
Recruitment for the parent/legal guardian focus group participation will occur at the same 
time and using the same method for recruiting the pediatric patient (i.e. by telephone or in 
person).  
 
Prescreening may involve either a review of clinic schedules or a report generated 
by IT that will involve a review of the electronic medical record (EMR) system to 
generate a list of potentially eligible participants.  
 
A HIPAA waiver is requested for the purpose of generating a pre-screening list of 
qualified candidates for research recruitment as described above. Information 
collected to track recruitment will be included in the pre-screening log for 
determining and tracking eligibility and tracking clinic visits where participants 
may be approached about the study. PHI on non-participants will be kept until 
completion of enrollment. Upon the completion of enrollment, the study team will 
also request a de-identified, aggregate report containing demographic information 
on individuals who declined enrollment. This information will be used to compare 
recruited individuals to non-recruited individuals in dissemination work products 
(e.g., manuscripts, presentations) so that any biases in sampling the eligible 
population can be reported.  
 

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15.0 Reimbursement, Payment and Tangible Property provided to 
subjects 
 
Participants in all groups will be compensated a total of $120 for their time and 
participation. They will receive $40 for study visit attendance and questionnaire 
completion. The 40 participants will each participate in 3 visits. It is possible that we may 
need to enroll additional participants if subjects withdraw, therefore additional funds for 
stipends for 4 additional subjects have been added.  
 
Participants in the COIN2DOSE arm may earn up to an additional $210 as incentive for 
completing mealtime insulin doses; the incentive payment is the intervention in this case. 
The total compensation for this group would be $330.  
 
Participants in the LOAN2DOSE arm will begin the study with a virtual bank balance of 
$210 and will keep this amount if mealtime boluses and data sharing are completed as 
study activities are scheduled. They will also receive $40 for study visit attendance and 
questionnaire completion. The total compensation for this group could be $330. 
 
Youth who are enrolled in the study and who elect to participate in a focus group 
discussion will receive an additional $35 for doing this.   
 
Parents/legal guardians who participate will also receive $35 for participating.  
 
16.0 Withdrawal of Subjects 
 
Participants may withdraw from the study at any time and this will not affect their 
medical care. No additional study related data will be collected on participants after 
withdrawal from the study, but previously collected information will be retained. All 
participants who enroll into the study will be included in the primary analysis, with the 
exception of those who are withdrawn from the study for not meeting eligibility criteria.  
 
 
17.0 Risks to Subjects 
The overall risks of participation in this project are no more than minimal. 
Because the research requires the collection of personally identifying data, there is 
a risk breach of confidentiality. Participants will be requested to disclose 
information about their diabetes adherence, blood glucose values, regimen 
knowledge, and psychological and behavioral functioning. Disclosing this 
information may potentially lead to emotional discomfort. If a participant reports 
any concerning symptoms regarding his or her emotional stature, the participants 
and his/her parent/guardian will be provided with information on how to get help. 
If a participant has a positive screen on the PHQ-A (depression), social work will 
be notified and will see the participant during the study visit. Social work will 
assess the patient and develop a plan of action in conjunction with the attending 
physician based on the clinical situation. Participants may also feel 
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experience some discomfort with Dexcom insertion, which is similar to insulin 
pump site insertions. Participants will be instructed on proper care of the Dexcom 
site.  
 
In the virtual focus group discussions, there is minor risk of unauthorized 
disclosure of confidential information, which would be made known to 
participants and will be minimized by the research team’s efforts to ensure 
confidentiality (see section 20.0). Every effort will be made to keep data de-
identified, including having participants use pseudonyms for the discussion and 
being reminded not to respond in a way that might include personal identifying 
information. Risks are greatly reduced by using secure files, storing data on 
secure computers, de-identification of data. Subjects and/or their parents/legal 
guardians may choose not to participate in the focus groups. There may be a risk 
that some of the questions make participants feel uncomfortable. Participants may 
skip a question or stop the study at any time.   
 
18.0 Potential Benefits to Subjects 
 
Participants could benefit by responding to the financial incentives (COIN2DOSE or 
LOAN2DOSE) and improve their mealtime dosing behaviors. With improved insulin 
dosing behaviors, the participants may improve their overall glycemic control. It is 
possible that participants will not derive any benefit from participation.  
 
Parents/legal guardians who choose to participate in the focus group may or may not gain 
useful information to help their child improve diabetes care. It is possible that 
parents/legal guardians will not derive any benefit from participation.  
 
 

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19.0 Investigator Assessment of Risk/Benefits Ratio: (IRB makes the 
final determination)  
 
 
Select as applicable: 
Pediatric Risk Category: 
x 
Category 1  Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
 
Category 2 
Research involving greater than minimal risk but 
presenting the prospect of direct benefit to the 
individual 
subjects. (45 CFR §46.405 and 21 CFR §50.52) 
 
Category 3 
Research involving greater than minimal risk and no 
prospect of direct benefit to individual subjects, but 
likely to yield generalizable knowledge about the 
subject's disorder or condition.  
(45 CFR §46.406 and 21 CFR §50.53) 
 
Category 4 
Research not otherwise approvable which presents 
an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of 
children. (45 CFR §46.407 and 21 CFR §50.54) 
Select if applicable: 
Adult Risk Category: 
x 
Not Greater than Minimal Risk 
 
Greater than Minimal Risk 
 
 
 
20.0 Data Management and Confidentiality 
  
20.1 
Statistical Analysis Plan 
 
Database construction and management will involve acquisition of data from each source 
(see above), imported into Microsoft Excel or an equivalent database program. All 
analysis will be completed using Stata/SE 15.1 (StataCorp. 2017. Stata Statistical 
Software: Release 15. College Station, TX: StataCorp LLC), SPSS version 20, SAS 
version 9.4, other statistical programs as needed. Univariate analysis will be performed 
on all dependent and independent variables. Analysis includes determining whether the 
variables have non-normal distributions or outliers. Determinations then will be made as 
to whether the data transformations are needed. For example, if variance 
heteroscedasticity, exists, data will be analyzed using log-transformed or other 
transformations based upon Box-Cox approximations to normal distributions. Measures 
of other central dependency and dispersion will be evaluated. Primary analyses will be 
modified intention to treat analysis. All individuals who are randomized will be included 
in the analysis. A secondary per-protocol analysis may also be performed. Multivariable 
regression models will be examined to estimate the effects of study variables on the 
primary outcome – predicted trajectory of glycemic control base on A1C over 90 days – 
for this sample of T1D patients’ data collected at three time points: baseline, 3 months, 
and 6 months. If the independent variables are highly correlated, we will explore General 
Linear Models (GLM) or other models. It is possible that Generalized Estimating 

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Equations (GEE) will be explored for their appropriateness in a larger study and/or for 
comparisons with the GLM results. Demographic and clinical variables will be entered 
into models following the independent variable: treatment group assignment. Since time 
effects may be important in the analyses due to treatments, censoring of data, time 
sequences, or other reasons, time of observation (i.e. visit 1[day 0], visit 2 [day 90], or 
visit 3 [day 180]) will also be explicitly accounted for in the regression models. All 
models will account for the clustering effect of participants having more than one clinic 
visit during the study timeframe. Additional variables will be collected as listed above. 
Statistical significance will be p<0.5 (one-sided).  
 
20.2 
Power analysis 
 
To evaluate the primary outcome: glycemic control (measures as predicted trajectory of 
A1C over 90 days), a multivariable regression model will be developed that accounts for 
seven independent variables: two primary – adherence and quality of life – and an 
additional five covariates: participant age, sex, insurance status, intervention/control 
group status, and time (52). Using an F-test and significant level (alpha) of 0.025, a 
sample of 20 T1D patients per treatment arm would achieve 74% power to detect an 
effect size of 0.35 (53). Findings from this pilot study will be used as estimates in 
planning future studies including recruitment of enough patients to achieve a power of 
greater than or equal to 80% to evaluate glycemic control (54).  
20.3 Data security 
Study information will be collected electronically and stored on a secure division drive 
on the CMH network domain or on Microsoft OneDrive or equivalent; access will be 
restricted to research team members.  All the questionnaires listed above will be collected 
in REDCap if possible. 
 
Paper data collection forms will be stored in the Endocrine Research Coordinator secure 
office where only research staff have access.  Research records containing PHI will be 
transported when necessary and will be transported in hospital approved PHI lockboxes 
per CMH policy.   A Certificate of Confidentiality has not been issued for this study. 
 
Data will be stored per the Record Retention and Management Policy and the 
Record Retention Schedule. 
 
Approved study staff will have access to research records.  Lab & study staff will 
have access to samples. 
 
The PI is ultimately responsible for receipt or transmission of the data or specimens. 
Families will mail in the A1C kit which will only contain the Subject ID. When the 
sample arrives in the lab, research staff is contacted so that the sample can be 
matched to the MRN so that the sample can be resulted as a “research result” in the 
electronic health record. 
 
 

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Virtual focus groups will be conducted on a CMH Microsoft Teams channel. 
Parents/legal guardians and/or participating youth may be in the focus groups.  
Participants will be instructed to not include any identifying information in their 
responses. After participants are instructed to change their screenname to a pseudonym, 
the meeting will be recorded and transcribed directly into the Teams folder, accessible 
only to the research team. Files will be scrutinized to ensure there is no PHI, censored if 
necessary, and uploaded directly into Dedoose for coding. 
 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
N/A 
 
The proposed project is a new intervention, therefore we will recruit a Data Safety 
and Monitoring Board (DSMB) to oversee and monitor the treatment implementation 
and data collection. We proposed members of the DSMB will include an 
endocrinologist, a biostatistician, and a certified diabetes educator. Members of the 
DSMB will be employees of CMH but will not be involved in this study in any way. As 
part of the DSMB oversight, we propose to meet by every 6 month during the conduct 
of the study. For each of the meetings, the PIs (Dr. Tsai and Dr. McDonough) and 
biostatistician (Mr. David Williams) will jointly prepare a summary of the following 
topics: performance monitoring (a report of subject recruitment/retention, protocol 
adherence, and quality of data collection procedures), safety monitoring (a review of 
safety of the participants, including confidentiality and any adverse events or side 
effects related to the study procedures).   
 
22.0 Provisions to Protect the Privacy Interests of Subjects 
Participation in this research study is voluntary. Participants and their parents/legal 
guardians will be notified of the voluntary status of the research at the onset of the study 
enrollment and content in process. Any participant or parent who declines to participate 
will not incur any penalty or loss of benefits to which they are already entitled. No 
change to the patient’s medical care will occur as a result of the participation, or 
nonparticipation in the study. 
 
Prior to enrollment, participants and their parents/legal guardians will have all risks and 
benefits clearly explained to them. After explanation for study and consent, subjects and 
their parents/legal guardians will be offered an opportunity to discuss participation in 
private, without a study team member present, in order to avoid any potential feelings of 
bias or coercion. They will be given time to ask questions. They may come back to 
participate at a later date if they would like to take the study materials home for review 
prior to agreeing to participate in this study. 
 
For subjects that enroll in the study, they will be informed that they may withdraw at any 
time without penalty or loss of benefits. Any new information gathered during the course 
of the study that may impact the subject desire to continue in the study, will be revealed 
as soon as it becomes available. 
 

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All the study information will be kept confidential. Data collected as part of routine 
diabetes care is protected by CMH’s Cerner Electronic Health Record (EHR) and 
associated policies from the Health Information Management Department (HIM). Data 
collected specifically for this study will be stored securely as described above.  
Participation in this study will be recorded into the EHR in accordance for CMH policy. 
Any of the research data collected, with the exception of personal health information 
(PHI), maybe shared in aggregate form in presentations and publications. At the 
termination of the study, the enrollment, prescreening, and master logs will be destroyed.  
During the course of the study, the PHI (with the exception of name and MRN) that is 
collected on individuals who do not wish to participate will be deleted from the 
prescreening log. The name and MRN will be kept until enrollment is complete so that 
individuals not interested in participating will not be re-approached for recruitment, and 
so that MIT can prepare a deidentified, aggregate report of demographic data on 
individuals who declined participation in the study.  
 
Any PHI in the data collection files will be removed and/or converted to a deidentified 
number upon completion of the study. 
 
Name, initials, dates of service, date of birth, medical record number, hospital 
account number, street address, telephone number, and email address may be 
accessed and/or recorded for research purposes. 
HIPAA Authorization for research collection of PHI will be obtained with the 
permission assent/consent forms.   
Focus group participants will be instructed to not include any identifying 
information in their responses and to use a pseudonym. They will also be 
instructed not to talk about the discussion outside of the virtual focus group, 
particularly not to reveal the participation of any other participant that they might 
know or recognize. They the meeting will be recorded and transcribed directly 
into the Teams folder, accessible only to the research team. Files will be uploaded 
directly into Dedoose for coding. 
 
23.0 Compensation for Research-Related Injury – NA, Minimal Risk 
N/A 
 
24.0 Economic Burden to Subjects 
 
Subjects will not have any additional costs associated with participation. Participants may 
complete study visits in the PCRU, via Microsoft Teams, or InTouch Solo (telemedicine 
platform used at Children’s Mercy Hospital that is designed to be used in a clinical 
setting with a tele-facilitator).  There will not be any additional costs to participants 
associated with study-related procedures. 
 
If the participant damages the Dexcom, they will be asked to return the device to the 
study team. If a participant loses a device, a note to file will be documented in the 
participant binder. The participant will be given replacement devices if study budget 

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allows. They will not be asked to pay for a replacement device or pay for repairs. All 
participants will be informed that they are expected to return their devices when they 
have completed the study at the time of informed consent/assent.  
 
25.0 Permission/Assent/Consent Process 
 
Permission Assent/Consent will be obtained in the CMH Endocrine Clinic, PCRU, via 
telephone, or using approved Children’s Mercy teleconferencing platforms.  
 
When obtaining consent via telephone, the study team will follow CMH “IRB 
Permission/Assent/Consent Policy”.  Permission Assent/Consent will be reviewed 
thoroughly and participants will be given the opportunity to ask questions.  Study 
staff will emphasize the voluntary nature of participating in research when 
obtaining consent.  CMH Research Policies will be followed. 
 
Assent of children 7 and older will be obtained per CMH policy.  Parental/LAR 
permission will be obtained for all participants 
 
Parents or legal guardians who choose to participate in the focus group discussions will 
also sign an informed consent.  
Consent at 18 years of age, when minor subjects become adults 
 
Participants who turn 18 while actively participating in study, will sign an Adult 
Addendum if they choose to continue participation.  We are requesting a Waiver of 
Documentation of Consent for continued use of identifiable data for participants whose 
active participation has ended. 
This protocol, and any subsequent modifications, will be reviewed and approved by 
the Pediatric IRB at The Children’s Mercy Hospital & Clinics.  Qualifying patients will 
be identified by review of daily clinic schedules by research team personnel.  Only 
study personnel will give details about the study to subjects and families.    The 
study will be explained briefly and subjects/parents/legal guardians will be asked 
whether they are interested in the study.  All interested subjects and parents/legal 
guardians will have the study thoroughly explained using the consent (or 
permission/assent form as applicable) including risks and benefits.  They will then 
be given copies of the consent to review without staff present so that they have time 
to discuss with each other.  Subjects and parents/legal guardians will also be given 
the opportunity to ask additional questions after they have read the consent.  If 
subjects and parent agree to participate then consent (or permission/assent form as 
applicable) will be signed by all required parties and a copy will be given to them. 
Alternatively, subjects and parents/legal guardians will be given the opportunity to 
take consents home for further reading, discussion, and decision making at a later 
date.  No pressure will be placed on any subject or family to enroll.  All questions 
will be answered and signatures will be obtained by study staff form the parent 
before study enrollment.  

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Non-English Speaking Subjects - NA 
Cognitively Impaired Adults - NA 
Adults Unable to Consent - NA 
 
 
26.0 Process to Document Permission/Assent/Consent 
 
In addition to the permission assent/consent document itself, the consent process will be 
documented in the medical record and/or research record per CMH policy. 
 
Study personnel will follow CMH “IRB Permission/Assent/Consent Policy” to collect 
participant written informed consent for their own participation, and parent/caregiver 
permission for child participation.  All of these will be documented on the study informed 
consent document.   
 
27.0 Setting 
The study visits will take place at Children’s Mercy Kansas City diabetes 
clinics in the Kansas City Metro area, the PCRU, or using approved Children’s 
Mercy teleconferencing platforms including Microsoft Teams, Polycom, 
InTouch, Doximity.  
 
 
28.0 Resources Available 
 
 
Data resources and tools:  
 
• REDCap (Research Electronic Data Capture) – an internet-based software solution 
and workflow methodology for designing clinical and translational research 
databases that is widely used in the academic community 
 
• Library subscriptions to online medical and research websites including Lexicomp, 
PubMed, Ovid, Google Scholar, and CINAHL will allow for literature review and 
aid in manuscript development 
 
• Statistics applications such as SAS, SPSS and R will be utilized for data 
management and analysis  
 
• Approved Children’s Mercy teleconferencing platforms including Microsoft  
Teams, Polycom, InTouch, Doximity, or other approved platforms 
 
Office: Drs. Tsai and McDonough will utilize office spaced allocated to them through 
their appointment as faculty in the Division of Pediatric Endocrinology & Diabetes.  
No additional space is requested as part of this grant proposal. 

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Pediatric Clinical Research Unit (PCRU): The PCRU, constructed in 2012 and opened 
in January 2013, is located on the ground floor of the Hall Inpatient Tower.  Occupying 
approximately 4,500 ft2, it was designed based on the primary goal of creating an ideal 
environment for all types of clinical research investigation.  The unit includes three 
private patient rooms and one larger three-bed room suited ideally for overnight and 
multiple sibling studies.  The layout of all patient rooms was specifically designed to 
facilitate patient and family comfort throughout the duration of their stay.  The unit 
includes a large playroom, office space for clinical research faculty and staff members, 
an exam room, a small laboratory for processing, nutrition room, medication room, 
soiled utility room, and significant storage space for both patient care supplies and 
clinical research documents.  Facilities are available for phlebotomy, urine collection, 
initial specimen processing, and temporary specimen storage prior to delivery to the 
research laboratory.  The space is in close proximity to other institutional resources 
such as the cafeteria, gift shop, and new 3,000 ft2 Inter-Faith Chapel.  Recreational 
items such as games, crafts, TV, Nintendo, Playstation, and videos are available to 
entertain children during their stay. In addition, Child Life staff may assist with 
constructive activities for children.  The unit is located one floor below the Pediatric 
Intensive Care Unit which affords immediate proximity to critical care medicine 
services should they be required in emergent situations.  The unit has been constructed 
to meet all applicable FDA/ICH guidelines for an early phase study unit and fully meets 
accreditation standards by The Joint Commission. 
 
General Computer and Network Infrastructure: All faculty and staff have desk top 
computers running on Windows7 or Windows10 connected to a Children’s Mercy 
client/server LAN with word processing, spreadsheet, database, electronic mail, 
presentation, and graphical software. Hospital Information Services professional staff 
support the network, including security and regular backups. 
 
The Windows-based network is configured with security such that a user logging onto 
the system has a personalized desktop displayed and access to a personal directory on 
a server that is backed up daily, regardless of which computer in the hospital the user 
is using. Resources provide full support for electronic data collection, storage, analysis, 
and exchange. The network is maintained by the Hospital Information Services 
professional staff.   
 
In addition, CMH has two firewall protected Internet connections that allow 
transmission of large data and graphics files between CMH investigators and 
collaborators with I-2 connections. A site on the World Wide Web 
(http://www.childrensmercy.org) is maintained. 
 
Electronic Medical Record (EMR): Children’s Mercy uses Cerner Millennium, a 
limited access EMR protected by a closed system with a dual firewall and user sign on 
authorization. CMH utilizes rigorous security measures, change management 
procedures, system testing, and a variety of other measures to protect the security and 
integrity of clinical information in the EMR.  

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Electronic signatures in the EMR are validated by assignment to unique individuals, 
and this system employs a secure, computer-generated, time-stamped audit trail. CMH 
maintains written policies holding study team members accountable and responsible 
for their actions under their electronic signature and while using the EMR while 
employed at CMH. 
 
CMH patient care records can be generated and complete copies may be obtained for 
inspection, review, and copy by a sponsor or their designated representative, as 
appropriate.  
 
Cerner Millennium complies with the Health Information Portability and 
Accountability Act (HIPAA) and has been certified to fulfill the HITECH Act of 2009 
Meaningful Use requirements. 
 
Children's Mercy Hospital Clinical Facilities: 
Ambulatory: Ambulatory pediatric diabetes care is predominantly delivered in 
ambulatory buildings across the Kansas City Metro and Regional Sites. Metro sites in 
which diabetes care is provided include the Clinics on Broadway, Northland, East, and 
College Boulevard. Regional (“outreach” or “outpost”) care is provided in St. Joseph, 
MO, Joplin, MO, Junction City, KS, Great Bend, KS, and Wichita, KS.  Each of these 
sites may be used to recruit potential subjects for this study. 
 
Main Clinical Laboratory: The clinical laboratory is a full service laboratory operated 
by the Department of Pathology which occupies 8,000 ft2 on the second floor of the 
hospital and provides laboratory services to the hospital and ambulatory clinics 24 
hours/day, 7 days per week. Areas of clinical service provided include routine and 
special chemistry, endocrinology, flow cytometry, coagulation, hematology, histology, 
diagnostic immunology, microbiology, transfusion services, toxicology/TDM, in vitro 
nuclear medicine, cytogenetics, biochemical genetics and urinalysis. The laboratory is 
fully accredited by CAP #19365-01 and licensed by CLIA #26DO443323. It is capable 
of providing clinical laboratory testing required for clinical research protocols, 
specifically including the Hemoglobin A1C included in this study.  
 
 Children’s Research Institute: 
   Health Services and Outcomes Research:  
The department of Health Services and  Outcomes Research (HSOR) is committed to 
scientific discovery that enhances the delivery of evidence-based care and optimizes the 
outcomes that patients and parents/legal guardians value most. Distinct from traditional 
biomedical research that relies solely on biomedical measures of success to determine 
whether a health intervention is necessary and/or successful, outcomes researchers include 
a broader focus that includes the clinical outcomes that matter most to patients. In addition 
to disease outcomes, HSOR includes a focus on patients’ biopsychosocial functioning, 
quality of life, barriers to care and experience with care which are often key to addressing 
chronic disease, as well as, health disparities. A multi-disciplinary effort, HSOR focuses 

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on discoveries that improve key aspects of the healthcare system (e.g., patient/parent-
provider communication, treatment engagement, medication adherence), while reducing 
health disparities and inappropriate use of health care resources. 
 
 
29.0 Multi-Site Research 
N/A 
 
30.0 International Research 
N/A 
 
 

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