COMPLETED

HCT Cash-Only INcentive to Promote Mealtime Insulin DOSE Engagement

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Type 1 Diabetes (T1D) is a serious disease that happens because the body cannot control blood glucose (sugar) levels. People with T1D need insulin shots because their body does not make insulin. Insulin lowers blood sugar levels. When blood sugar levels are too high or too low it causes medical problems. Youth with T1D can really impact their own health if they follow their T1D treatment plan. However, even with the help of doctors, nurses, and family, most adolescents find it hard to follow their diabetes plan close enough to meet their A1C goal. It is very common for adolescents to forget to give an insulin bolus for meals. When insulin doses are missed, there is a greater chance for poor blood sugar control. When adolescents follow their diabetes plan closely, they have better blood sugar control and overall health. Two behavioral economic interventions will be evaluated. COIN2DOSE (Cash-Only INcentive to promote mealtime insulin DOSE Engagement) and LOAN2DOSE (Behavioral Economic concept that uses an economic loss aversion approach to promote insulin dose engagement in adolescents with Type 1 Diabetes). These programs were designed to improve blood sugar control by decreasing the number of missed mealtime boluses. For COIN2DOSE, we will offer the opportunity for youth to earn a bonus reimbursement during which they achieve at least 5 days of 3 mealtime insulin boluses. Finally, we will pay youth up for sharing their insulin use data at least two times per week with the study team during the three-month treatment phase. For LOAN2DOSE, the participants will start with a monetary "balance" and will keep it if they bolus as instructed - at least 5 days of 3 mealtime insulin boluses. If they do not do this, their balance will decrease throughout the study.

Official Title

Behavioral Incentive Meal Dose Engagement in Adolescents With Type 1 Diabetes

Quick Facts

Study Start:2022-02-14

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04621890

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.

Ages Eligible for Study:12 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Aged 12-17.99 years * The youth must have been diagnosed with T1D for at least 6 months * The youth must have attended at least 2 routine T1D standard of care visits in the past 12 months * 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). * 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. * Not pregnant or planning to become pregnant by self-report.	* Participants with any type of diabetes mellitus other than T1D * Participant has any disease causing anemia or affecting red blood cell physiology (which would impact A1C) * 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 * Participants with no internet access or ability to upload device(s) to data aggregation software that is accessible to study team.

Inclusion Criteria

Exclusion Criteria

* Aged 12-17.99 years
* The youth must have been diagnosed with T1D for at least 6 months
* The youth must have attended at least 2 routine T1D standard of care visits in the past 12 months
* 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).
* 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.
* Not pregnant or planning to become pregnant by self-report.

* Participants with any type of diabetes mellitus other than T1D
* Participant has any disease causing anemia or affecting red blood cell physiology (which would impact A1C)
* 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
* Participants with no internet access or ability to upload device(s) to data aggregation software that is accessible to study team.

Contacts and Locations

Study Locations (Sites)

Children's Mercy Kansas City

Kansas City, Kansas, 64108

United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

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 Registration Dates

Study Start Date2022-02-14

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-02-14

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Type 1 Diabetes