Coin2Dose: Behavioral Economics to Promote Insulin BOLUS Activity and Improve HbA1c in Teens
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Nemours Children's Clinic

 
 
 
 
 
 
Official Title: Coin2Dose: Behavioral Economics to Promote Insulin BOLUS Activity and Improve 
HbA1c in Teens 
NCT# NCT05280184 
Review Date: 12/21/2023 
 
 
 
 

Protocol Summary 
Official Title 
NIH Cash-Only Incentive to Promote Mealtime Insulin Dose Engagement (NIH COIN2DOSE): Phase 2 
Randomized Controlled Trial 
Brief Title 
NIH COIN2DOSE 
Brief Summary 
This pilot randomized controlled trial will evaluate the feasibility, acceptability, and preliminary efficacy of a 
behavioral economic incentive intervention (COIN2DOSE) to improve mealtime insulin dosing behaviors 
among adolescents with type 1 diabetes. The study will compare two active treatment arms (Contingent vs 
Non-Contingent incentives) to Standard Care. 
Detailed Description 
Individuals with T1D can have a tremendous impact on their own health outcomes if they follow their T1D 
treatment regimen (1-3). 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 (2-
4). 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% (5). Adolescents who have poorly controlled 
T1D are much more likely to develop DKA (2,6).  While health care professionals can offer guidance and 
recommendations, traditional clinical interactions are not sufficient to promote optimal self-care and adherence 
for many adolescents (7) with the majority not reaching A1c targets (2). In fact, adolescents with T1D exhibit 
significant deterioration in glycemic control (aka rising A1c) from age 8 to 18 (8), as shown below.  
 
 
 
A few behavioral interventions have demonstrated utility in improving adherence behaviors in youth with T1D (9-
14). Improved adherence behaviors are associated with better glycemic control and short and long-term health 
outcomes (2). 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) (2). 
Missed mealtime boluses can have devastating metabolic consequences (15).  
 
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 (1,21). Glycemic control worsens from 
early childhood through age 16-18 (22). 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 (23). Lack of adherence to diabetes treatment plans is one of the main 
causes of sub-optimal glycemic control (2,6,24).  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 (15,26-29). Furthermore, greater than 33% of adolescents fail to give insulin for >15% of 
their meals and snacks (15). 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% (30-31). This is of great significance as poor 
glycemic control increases risk of both acute and chronic diabetes related complications (32). Meal bolus alarms 
on insulin pumps, which alarm at a preset time, lead to transient, modest changes in dosing behavior (33). “Lost 
focus” has been identified as a significant reason for missed meal-time boluses in adolescents (34).  Exactly how 
to effectively maximize engagement with mealtime insulin dosing behavior among adolescents with T1D 
represents a critical gap in knowledge.  
 
Rationale 
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 Behavioral Economics Incentives (BEI) can successfully increase adherence to 
blood glucose monitoring among adolescents and young adults with type 1 diabetes with moderate to large 
treatment effect sizes (36-42). Specifically, one study of 10 adolescents evaluated a BEI 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 (38). 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 checks 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 (38). 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), though 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 (42). The evidence, to date, suggests that it is feasible to increase 
adherence behaviors among adolescents and young adults with type 1 diabetes. However, it is unclear whether 
targeting blood glucose monitoring behaviors is always associated with an improvement in A1c and whether BEI 
can produce a sustained improvement in monitoring. Additionally, these methods have not been applied to 
mealtime insulin use, so whether BEI improve adherence to mealtime insulin dosing among adolescents remains 
unknown.  
 
There is a strong rationale for targeting adherence to mealtime insulin dosing to promote more optimal A1c. 
Specifically, prior observational research suggests a 1.5% decrease in A1c levels for every one-bolus increase 
in daily mealtime doses, supporting our premise (30,31).  
 
There is a strong rationale for exploring a treatment arm that does not use Contingent BEI. Contingent BEI 
implies that the participant earns the incentive Contingent on the performance of the target behavior (36,41,43). 
In contrast, Non-Contingent BEI implies the incentive is paid out irrespective of the performance of the target 
behavior (43). There are some studies, particularly in adult smoking cessation, that show a better outcome for 
Contingent BEI (e.g., received vouchers specifically for not smoking) versus Non-Contingent BEI (e.g., received 
vouchers irrespective of smoking behaviors) (44-45). However, in youth with T1D there is one study that tested 
the incremental benefit of Contingent BEI versus Non-Contingent BEI on daily SMBG frequency and found 
virtually no benefit (36). It is harder to deliver Contingent BEI than Non-Contingent BEI for the completion of T1D 
self-care behaviors and this would negatively impact future scalability to the real world (e.g., Contingent BEI 
requires individual monitoring of the target behavior, while Non-Contingent BEI does not). Thus, in an exploratory 
aim, our RCT Pilot trial proposes to compare two active treatments: a Contingent COIN2DOSE version and a 
Non-Contingent COIN2DOSE version to explore if contingency is necessary to promote daily BOLUS scores 
and improved A1c in adolescents with T1D.  
 
There is a strong rationale for using a yoked control design to explore for any benefit of the Contingent 
COIN2DOSE versus Non-Contingent COIN2DOSE. In a yoked control design, a participant in one group is 
matched to a participant in a second group such that the participant’s behavior in the first group determines the 
outcome for the participant in the second group (45). In our proposed use of a yoked control design, adolescents 
randomized to Contingent COIN2DOSE will receive BEI based on their own daily insulin BOLUS scores. In 
contrast, adolescents randomized to Non-Contingent COIN2DOSE will not receive BEI based on their own 
BOLUS scores, instead they will receive BEI based on the BOLUS scores of their matched counterpart in the 
Contingent COIN2DOSE group. This design will enable us to promote equivalence in the level of BEI earned 

across the two groups (45), which may further help isolate any incremental effect of Contingent BEI (personalized) 
versus Non-Contingent BEI (non-personalized). Alternative Non-Contingent designs (e.g., variable-ratio 
schedule) could also offer non-personalized BEI but may not achieve equivalence in the level of BEI earned 
across the two groups (46-47).  
 
To conclude, the objective of the present study is to obtain initial feasibility, acceptability, and efficacy data to  
test if COIN2DOSE can promote daily insulin BOLUS scores, A1c, and TIR in adolescents with suboptimal insulin 
use. 
Study Design 
Study Type: Interventional (Clinical Trial) 
Allocation: Randomized 
Intervention Model: Parallel Assignment 
Masking: None (Open Label) 
Primary Purpose: Behavioral 
Estimated Enrollment: 150 adolescents + 150 parents (up to 300 participants) 
Arms 
Arm 1: COIN2DOSE - Cash incentives either based on participant’s own mealtime insulin dosing behavior 
(Contingent) or based on yoked partner’s dosing behavior (Non-Contingent). 
Arm 2: Standard Care - Weekly text reminders and small incentives for data sharing only. 
Interventions 
Behavioral: COIN2DOSE - Incentives tied to insulin bolus behavior and data sharing. 
Behavioral: Standard Care - Weekly reminders and minimal incentive for data sharing. 
Primary Outcome Measures 
1. Change in Hemoglobin A1c from baseline to 90 days [Time Frame: 3 months] 
2. Change in mealtime insulin bolus score from baseline to 90 days [Time Frame: 3 months] 
Secondary Outcome Measures 
Change in A1c and bolus score at 180 days 
Change in Time in Range (70–180 mg/dL) 
 
Eligibility Criteria 
Inclusion: Adolescents aged 11–17.99 years, T1D ≥6 months, insulin pump or Bluetooth-enabled pen, mean 
daily bolus score <2.5 or HbA1c >8.0%, English-speaking, parent willing to participate. 
Exclusion: Diabetes other than T1D, conditions affecting A1c accuracy, no internet access, comorbid chronic 
conditions. 
Study Timeline 
Duration per participant: 26 weeks (12-week intervention + 14-week observation) 
Estimated Study Start: 2/2023 
Estimated Primary Completion: 11/2024 
Estimated Study Completion: 9/2025 
 
 

Statistical Plan 
Primary Outcomes: 
Mean Daily Insulin BOLUS scores: objective measure of insulin use. We will use 14-days of insulin pump 
downloads to calculate a mean daily insulin BOLUS score for adolescents.   
HbA1c: proxy measure of glycemic control. We will use fingerstick blood samples and a valid mail-in dried blood 
spot kit to measure adolescent’s HbA1c at a central laboratory. 
Secondary Outcomes: 
Time in Range (TIR): measure of glycemic control. We will use the CGM data we collect from adolescents to 
calculate TIR. We will define TIR based on Bergenstal et al. or glucose values falling between 70-180mg/dl.  
Other Variables: 
Parent: 
Demographics and T1D History: study specific measure to capture family/adolescent demographics, use of 
personal CGM, history of T1D-related acute complications (e.g., hypoglycemia/diabetes ketoacidosis).  
Problem Areas in Diabetes-Parent Revised (PAID-PR)50: 18-item survey of diabetes distress (DD) validated for 
parents. PAID-PR yields a total score and two subscale scores reflecting immediate and long-term distress.  
Diabetes-Specific Family Conflict Scale (DSFC)49: 19-item survey of perceived family conflict validated for use 
in parents and youth. DSFC yields a total score and two subscale scores reflecting direct and indirect conflict.  
Treatment Satisfaction Measure: 14-item survey to assess satisfaction with Coin2Dose treatment. Yields a total 
score. 
Adolescent: 
Problem Areas in Diabetes-Pediatric Version (PAID-Peds)48: 20-item survey of DD validated for youth 8-17-years 
old. PAID-Peds yields a total score. 
Diabetes-Specific Family Conflict Scale (DSFC)49: 19-item survey of perceived family conflict validated for use 
in parents and youth. DSFC yields a total score and two subscale scores reflecting direct and indirect conflict.  
Treatment Satisfaction Measure-Child: 8-item survey to assess satisfaction with Coin2Dose treatment. Yields a 
total score. 
Statistical Plan by Aims/Hypotheses: 
Aim 1: Examine the feasibility and acceptability of our semi-automated BEI intervention (Coin2Dose) to target 
daily BOLUS scores in adolescents with T1D.  
H1: Coin2Dose will be feasible, acceptable, and easy to use. 
Analysis Plan. We will assume the Coin2Dose is feasible adolescents share weekly insulin pump data with the 
research team for >75% of weeks across the Phase 2: RCT Pilot trial and we have <20% attrition after 
randomization. We will calculate mean and SD for the responses that youth and parents provide on our 
Treatment Satisfaction survey (post-treatment). We will assume acceptability if scores reflect >85% acceptability. 
Aim 2: Examine the preliminary efficacy of our semi-automated BEI intervention (Coin2Dose) versus a standard 
care control on youth daily BOLUS scores, HbA1c, and TIR.  
H2a: Adolescents receiving Coin2Dose will demonstrate improvements in BOLUS scores, HbA1c, and TIR when 
compared to SC adolescents corresponding to at least medium effect sizes.  
H2b: At 3-month follow-up, adolescents who received Coin2Dose will demonstrate greater improvements in 
BOLUS scores, HbA1c, and TIR than SC adolescents. 
 
Analysis Plan. We will score primary and secondary outcome measures as continuous variables and calculate 
within-group standardized effect sizes (in SD units) for youth based on data collected at baseline, post-treatment, 
and 3-month follow-up. We will do this for youth randomized to our standard care control group (n=50) and for a 
Coin2Dose group that combines both the Contingent and Non-Contingent versions (n=100) because our only 
goal for Aim 2 is to test for the overall effect of BEI. We will also use Generalized Estimating Equations (GEE) to 
test for any between-group differences on our primary and secondary outcomes at post-treatment and 3-month 
follow-up. In between-group models, we will control for baseline values of our dependent measures. We will also 
we will consider covariates (e.g., age) in our between-group models. 

Exploratory Aim: Examine the incremental impact of using Contingent versus Non-Contingent incentives on 
youth’s BOLUS scores, HbA1c, and TIR.  
 
Analysis Plan. To test our Exploratory Hypothesis that there will be a beneficial incremental effect of using 
Contingent versus Non-Contingent BEI in Coin2Dose, we will calculate within-group standardized effect sizes 
(in SD units) for our primary outcomes for youth randomized to the Contingent C2D and Non-Contingent C2D 
groups. Plus, we will use another series of GEE to explore any between-group differences in our primary 
outcomes for youth randomized to the Contingent C2D and Non-Contingent C2D groups. 
  
Power/Sample Size Justification 
The purpose of our Phase 2 RCT Pilot trial will be to generate data to support a full randomized clinical trial. 
However, based on comparing youth HbA1c differences as a primary outcome, n=150 adolescents randomized 
to a control group (n=50) or our Coin2Dose group (n=100), and study assessment points at equally spaced (12-
week) time intervals for baseline, post-treatment, and follow-up, we would have a power of 0.80 when using a 
two-sided Wald Test from a generalized estimating equation (GEE) analysis to test whether the time-average 
difference in HbA1c between Coin2Dose participants differs from that of control participants by more than 0.50 
at a significance level of 0.05. In calculating power for the GEE, we assumed a residual standard deviation of 
the errors was 0.90 and we expressed measurements as proportions of the total study time: 0.00, 0.50, and 1.00 
with the assumed proportions missing at each measurement time equal to 0.20. We conducted our power 
analysis using PASS 2019, v19.0.5. 
 
If we assume an attrition rate of 20% and we propose to recruit n=150, we may assume to only have data from 
at least n=120 adolescent/parent dyads to analyze. While at this smaller sample size we will no longer have the 
power to test for a between-group difference in youth HbA1c for our Coin2Dose and standard care control 
adolescents, we would still retain a sample size that is sufficient to estimate effect sizes for all of our study 
outcomes, which is a goal of this FOA.  
Locations 
Children’s Mercy Hospital (Kansas City, MO) 
Nemours Children’s Health (Jacksonville, FL) 
Contacts 
PI: Mark Clements, MD, PhD (Children’s Mercy) 
PI: Susana R. Patton, PhD (Nemours) 
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