NCT04621890Completed
HCT Cash-Only INcentive to Promote Mealtime Insulin DOSE Engagement
Behavioral Incentive Meal Dose Engagement in Adolescents With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 25 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 3 Oct 2020
- Start date
- 14 Feb 2022
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Diseases
- Type 1 diabetes
- NCT number
- NCT04621890
What you commit to
- Study type: Interventional
- Participants enrolled: 39
- From 14 Feb 2022 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- 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.
- For Focus Groups:
- Any parent or legal guardian whose child is eligible for the study is invited to participate in a focus group discussion.
Who the study is looking for
- 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.
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Mercy Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.