Trial Outcomes & Findings for Coin2Dose: Behavioral Economics to Promote Insulin BOLUS Activity and Improve HbA1c in Teens (NCT NCT05280184)
NCT ID: NCT05280184
Last Updated: 2026-02-11
Results Overview
valid, objective measure of insulin use in youth with type 1 diabetes; range 0-3, higher scores reflect greater adherence to mealtime insulin use
COMPLETED
NA
173 participants
change in week 0 outcome at week 13
2026-02-11
Participant Flow
Recruited participants from 2023-2024. We included youth between 11-17.99 years old with a physician confirmed type 1 diabetes diagnosis of at least 6 months duration prior to study enrollment. Youth needed to be using an insulin pump or Bluetooth connected insulin pen. Parents were eligible if they consented to participate and had a youth who met our inclusion criteria. We used both in-clinic and remote recruitment procedures through a national registry.
After obtaining parent informed consent and permission and youth assent, we enrolled youth in a brief run-in period so they could practice sharing device data with the study team. Once youth had successfully shared two weeks of data, they moved on to complete the baseline assessment. We randomized youth following completion of the baseline assessment. Eighteen youth did not complete the run-in period and therefore did not continue with the trial.
Participant milestones
| Measure |
Standard Care
Adolescents randomized to standard care received a weekly text message reminder to share insulin pump or Bluetooth connected insulin pen data with the research team. Youth received up to $2.00/week \* 12 weeks for sharing their data with the research team.
|
Coin2Dose
Adolescents randomized to Coin2Dose received weekly automated text message reminders to bolus when eating, a text message reminder to share their data with the study team, and a cash incentive for bolusing insulin at mealtimes and sharing their data. Adolescents received up to $17.50 \* 12 weeks. Within this group, adolescents either received a personalized cash incentive for bolusing (Contingent) or a non-personalized cash incentive for bolusing (Non-Contingent). To ensure equality in the total amount of money paid to youth in the Contingent and Non-Contingent arms, we applied a yoked control design.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
102
|
|
Overall Study
COMPLETED
|
47
|
92
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
Standard Care
Adolescents randomized to standard care received a weekly text message reminder to share insulin pump or Bluetooth connected insulin pen data with the research team. Youth received up to $2.00/week \* 12 weeks for sharing their data with the research team.
|
Coin2Dose
Adolescents randomized to Coin2Dose received weekly automated text message reminders to bolus when eating, a text message reminder to share their data with the study team, and a cash incentive for bolusing insulin at mealtimes and sharing their data. Adolescents received up to $17.50 \* 12 weeks. Within this group, adolescents either received a personalized cash incentive for bolusing (Contingent) or a non-personalized cash incentive for bolusing (Non-Contingent). To ensure equality in the total amount of money paid to youth in the Contingent and Non-Contingent arms, we applied a yoked control design.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
10
|
Baseline Characteristics
Coin2Dose: Behavioral Economics to Promote Insulin BOLUS Activity and Improve HbA1c in Teens
Baseline characteristics by cohort
| Measure |
Standard Care
n=53 Participants
Adolescents randomized to standard care received a weekly text message reminder to share insulin pump or Bluetooth connected insulin pen data with the research team. Youth received up to $2.00/week \* 12 weeks for sharing their data with the research team.
|
Coin2Dose
n=102 Participants
Adolescents randomized to Coin2Dose received weekly automated text message reminders to bolus when eating, a text message reminder to share their data with the study team, and a cash incentive for bolusing insulin at mealtimes and sharing their data. Adolescents received up to $17.50 \* 12 weeks. Within this group, adolescents either received a personalized cash incentive for bolusing (Contingent) or a non-personalized cash incentive for bolusing (Non-Contingent). To ensure equality in the total amount of money paid to youth in the Contingent and Non-Contingent arms, we applied a yoked control design.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.92 years
STANDARD_DEVIATION 1.96 • n=4 Participants
|
13.77 years
STANDARD_DEVIATION 2.00 • n=4 Participants
|
13.83 years
STANDARD_DEVIATION 1.98 • n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=4 Participants
|
46 Participants
n=4 Participants
|
72 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=4 Participants
|
56 Participants
n=4 Participants
|
83 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=4 Participants
|
95 Participants
n=4 Participants
|
145 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=4 Participants
|
96 Participants
n=4 Participants
|
145 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Baseline daily insulin Bolus score
|
2.03 score on a scale
STANDARD_DEVIATION 0.79 • n=4 Participants
|
1.79 score on a scale
STANDARD_DEVIATION 0.89 • n=4 Participants
|
1.87 score on a scale
STANDARD_DEVIATION 0.86 • n=8 Participants
|
PRIMARY outcome
Timeframe: change in week 0 outcome at week 13Population: Lost to follow between baseline and post-treatment: 3 youth assigned to standard care; 4 youth assigned to Coin2Dose
proxy measure of average glycemic levels
Outcome measures
| Measure |
Standard Care
n=50 Participants
Adolescents randomized to standard care received a weekly text message reminder to share insulin pump or Bluetooth connected insulin pen data with the research team. Youth received up to $2.00/week \* 12 weeks for sharing their data with the research team.
|
Coin2Dose
n=98 Participants
Adolescents randomized to Coin2Dose received weekly automated text message reminders to bolus when eating, a text message reminder to share their data with the study team, and a cash incentive for bolusing insulin at mealtimes and sharing their data. Adolescents received up to $17.50 \* 12 weeks. Within this group, adolescents either received a personalized cash incentive for bolusing (Contingent) or a non-personalized cash incentive for bolusing (Non-Contingent). To ensure equality in the total amount of money paid to youth in the Contingent and Non-Contingent arms, we applied a yoked control design.
|
|---|---|---|
|
Change in Glycated Hemoglobin- HbA1c
|
-0.14 Change in A1c (%)
Standard Deviation 0.58
|
-0.09 Change in A1c (%)
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: change in week 0 outcome at week 13Population: Lost to follow from baseline to post-treatment: 3 youth assigned to standard care; 4 youth assigned to Coin2Dose. There was also a data attribution issue between June 6 and July 24, 2024 that affected our ability to accurately link youth with their insulin pump data. We do not include BOLUS data from youth impacted by this issue.
valid, objective measure of insulin use in youth with type 1 diabetes; range 0-3, higher scores reflect greater adherence to mealtime insulin use
Outcome measures
| Measure |
Standard Care
n=45 Participants
Adolescents randomized to standard care received a weekly text message reminder to share insulin pump or Bluetooth connected insulin pen data with the research team. Youth received up to $2.00/week \* 12 weeks for sharing their data with the research team.
|
Coin2Dose
n=88 Participants
Adolescents randomized to Coin2Dose received weekly automated text message reminders to bolus when eating, a text message reminder to share their data with the study team, and a cash incentive for bolusing insulin at mealtimes and sharing their data. Adolescents received up to $17.50 \* 12 weeks. Within this group, adolescents either received a personalized cash incentive for bolusing (Contingent) or a non-personalized cash incentive for bolusing (Non-Contingent). To ensure equality in the total amount of money paid to youth in the Contingent and Non-Contingent arms, we applied a yoked control design.
|
|---|---|---|
|
Change in Daily Insulin Bolus Score
|
-0.11 score on scale
Standard Deviation 0.56
|
-0.08 score on scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: change in week 0 outcome at week 13Change in percent time spent with glucose levels between 70-180mg/dL. Time in Range (TIR) data were unavailable for all participants due to unresolved legal/contractual barriers with external CGM vendors. Efforts to resolve these issues are ongoing, we will update with results if data access becomes possible.
Outcome measures
Outcome data not reported
Adverse Events
Standard Care
Coin2Dose
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place