Coin2Dose: Behavioral Economics to Promote Insulin BOLUS Activity and Improve HbA1c in Teens (Coin2Dose)

February 9, 2026 updated by: Susana Patton, Nemours Children's Clinic
Our objective is to test the feasibility, acceptability, and initial efficacy of using behavioral economics incentives (BEI) in a novel, semi-automated intervention to target daily insulin BOLUS scores in adolescents with suboptimal insulin use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This R01 responds to PAS-20-160 (Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK). Our objective is to test the feasibility, acceptability, and initial efficacy of using behavioral economics incentives (BEI) in a novel, semi-automated intervention to target daily insulin BOLUS scores in adolescents with suboptimal insulin use. There is a critical need for efficacious and easy to implement interventions targeting self-management behaviors in adolescents with type 1 diabetes (T1D). This is because national registry data suggest that only between 15-28% of adolescents achieve their glycated hemoglobin (HbA1c) target, thereby placing the majority of them at increased risk for serious acute and long-term complications. BEI interventions are efficacious for promoting health behaviors including frequency of self-monitoring blood glucose (SMBG) in youth. Moreover, there is evidence that BEI can be relatively easy to implement, especially when using Non-Contingent BEI. But with the uptake of integrated insulin pump and continuous glucose monitor (CGM) systems and the new FDA approval enabling youth to dose for insulin based solely on CGM, we believe the long-term value of targeting SMBG alone in BEI interventions is limited and that daily insulin use is the next logical self-management target. Building off of our prior work, the insulin BOLUS score offers a specific, measurable, and valid treatment target for daily insulin use that is also more closely related to HbA1c than SMBG or Total insulin boluses per day. Thus our Aims are: 1) examine the feasibility and acceptability of our semi-automated BEI intervention (called Coin2Dose) that targets daily BOLUS scores in adolescents and 2) examine the preliminary efficacy of Coin2Dose versus a standard care control (SC) group on youth daily BOLUS scores, HbA1c, and glucose time in range (TIR). We also include an exploratory aim to examine the incremental impact of using Contingent versus Non-Contingent BEI within our Coin2Dose intervention on youth's BOLUS scores, HbA1c, and TIR. Coin2Dose will deliver automated text messages to cue adolescents to bolus for insulin, plus BEI for daily BOLUS activity. To enhance the scientific rigor of this R01, we will use the ORBIT Model for behavioral intervention development. Consistent with this model, we will recruit 180 adolescents and a parent to participate in 1- a telehealth focus group (ORBIT Phase 1a: Define; n= 20), 2- a formative pre-test (ORBIT Phase 1b: Refine; n=10), or 3- a pilot randomized clinical trial (ORBIT Phase 2: RCT Pilot; n=150). Our RCT Pilot will randomize teens with suboptimal insulin use (BOLUS score <2.5; 70% of teens based on pilot data) to a SC or 1 of 2 versions of Coin2Dose that only differ based on our use of personalized (Contingent) v. non-personalized (Non-Contingent) BEI. Adolescents will participate in 12-weeks of active treatment, plus a 12-week follow-up period. This small R01 is Significant for its potential to yield: 1- preliminary data supporting our new BEI intervention targeting daily BOLUS scores, which may also improve youth HbA1c, 2- novel data exploring the incremental impact of Contingent v. Non-Contingent BEI, which has implications for Coin2Dose as well as the broader uptake of BEI interventions.

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Health
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adolescents between 11.0-17.0 years old and their parent/guardian;
  • adolescents have a physician confirmed diagnosis of type 1 diabetes of at least 6 months duration;
  • adolescents use an insulin pump for daily type 1 diabetes self-management;
  • adolescents evidence sub-optimal daily BOLUS scores (a mean daily BOLUS score <2.5)

Exclusion Criteria:

  • adolescents who do not use an insulin pump; adolescents who have an allergy or sensitivity to the adhesive and/or skin preparation used for CGM;
  • adolescents with a comorbid chronic condition (e.g., renal disease);
  • adolescents and parents who do not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coin2Dose
BEI intervention that also combines automated text message reminders to dose for insulin; will test Contingent and Non-Contingent BEI
Behavioral: Coin2Dose
Behavioral Economics incentive intervention that also combines automated text message reminders to dose for insulin
No Intervention: Standard Care Control
Standard care control group; will not receive automated text message reminders to dose for insulin nor BEI for daily BOLUS scores

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycated Hemoglobin- HbA1c
Time Frame: change in week 0 outcome at week 13
proxy measure of average glycemic levels
change in week 0 outcome at week 13
Change in Daily Insulin Bolus Score
Time Frame: change in week 0 outcome at week 13
valid, objective measure of insulin use in youth with type 1 diabetes; range 0-3, higher scores reflect greater adherence to mealtime insulin use
change in week 0 outcome at week 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glucose Time in Range (70-180 mg/dL)
Time Frame: change in week 0 outcome at week 13
Change 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.
change in week 0 outcome at week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1770218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided. Will not share data that may make it possible to identify individual participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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