Abstract
BACKGROUND: Most adolescents with type 1 diabetes (T1D) do not achieve a glycated hemoglobin (HbA1c) <7.0%, which is the current clinical target. mHealth can offer a scalable and age-appropriate delivery method for behavioral interventions to lower adolescents' HbA1c levels, while applying established behavior change and behavioral economics theories can enhance scientific rigor. METHODS: We aim to conduct a pilot randomized clinical trial of a novel mHealth intervention called Coin2Dose (Cash-Only INcentives To promote insulin DOSE engagement), in a sample of youth with T1D: 1) to obtain measures of feasibility and acceptability and 2) to examine preliminary efficacy versus a standard care control group based on differences in youth's daily BOLUS scores, HbA1c levels, and Time in Range (TIR) at post-intervention and 3-month post-intervention follow-up. This pilot RCT is already registered in http://ClinicalTrials.gov (NCT#05280184). RESULTS: Our pilot will recruit youth with T1D 11-17 years-old who use an insulin pump or Bluetooth connected insulin pen and have an average daily BOLUS score ≤2.5. Youth randomized to Coin2Dose will receive the intervention for 12 weeks followed by a 12-week maintenance period. The pilot is scheduled to start July 2022 and to conclude in 2025. DISCUSSION: At the conclusion of the pilot, we will have information about the feasibility and acceptability of two different behavioral economic incentive structures for improving BOLUS scores. The work is anticipated to progress to final efficacy trial. We will disseminate study results through presentations at local, national, and international conferences and through peer-reviewed diabetes and psychology journals.