Cash Incentives for Type 1 Diabetes

Overseen By Sarah Tsai, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Must be taking: Insulin

Disqualifiers: Other diabetes, Anemia, Disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adolescents with Type 1 Diabetes (T1D) better manage their health by encouraging adherence to insulin plans. Researchers are testing two cash incentive programs: COIN2DOSE rewards consistent insulin use with meals, while LOAN2DOSE uses a virtual balance that decreases if doses are missed. The goal is to determine which approach improves blood sugar control by reducing missed insulin doses. Teens aged 12-17 who have had T1D for at least 6 months and use an insulin device that tracks doses may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance diabetes management in everyday life.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, since the study focuses on improving insulin use, you will likely continue your current insulin regimen.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that specific safety data for the COIN2DOSE and LOAN2DOSE programs is unavailable because they are strategies to encourage healthy behavior, not medical treatments. COIN2DOSE offers cash rewards to motivate teens with Type 1 Diabetes to take their insulin at mealtimes. LOAN2DOSE allows participants to keep a money balance if they adhere to their insulin schedule but lose money if they don't. These programs use incentives and do not involve new drugs or physical procedures, so they are generally considered low risk. Reports of negative effects from these types of programs have not been documented. They primarily aim to improve habits rather than introduce new medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cash Incentives for Type 1 Diabetes trial because it explores innovative behavioral approaches to improve insulin management in young people. Unlike traditional treatments that focus on medication adjustments, COIN2DOSE offers cash rewards for timely insulin dosing, encouraging adherence through positive reinforcement. On the flip side, LOAN2DOSE uses a virtual bank, deducting money for missed doses, which motivates consistent insulin use by introducing a financial consequence. These strategies aim to enhance self-management and potentially improve long-term health outcomes for those with Type 1 Diabetes.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

In this trial, participants will be assigned to one of two experimental arms, COIN2DOSE or LOAN2DOSE, both using financial incentives to motivate young people to follow their diabetes care plan. A previous study showed that COIN2DOSE increased the frequency of blood sugar checks through cash rewards, which is crucial for managing diabetes. This finding suggests that financial incentives can encourage better insulin use in teenagers with Type 1 Diabetes. For LOAN2DOSE, research has shown that starting with a set amount of money that decreases if insulin doses are missed can help teens adhere to their insulin schedule. These strategies are based on behavioral economics, which examines how psychological factors influence decisions, aiming to improve health habits. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for youths aged 12-17.99 with Type 1 Diabetes who have had the condition for at least 6 months, are not pregnant, and have an A1C level over 7.2% or expected to rise. Participants must use an insulin pump or smart pen and own a device compatible with Klue software.

Inclusion Criteria

You must have an iPhone or iPad that can use Klue.

My current A1C is over 7.2% or it's expected to rise soon.

I have been to at least 2 diabetes care appointments in the last year.

Exclusion Criteria

I cannot feed myself or use my hands to eat due to a physical disability.

Physical or developmental disability that would interfere with ability to interpret and/or respond to messages from the Klue software on the Apple watch

I have diabetes, but it's not type 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person or remote)

Baseline and Randomization

Participants are randomized to treatment arms and trained on procedures; baseline measures are completed

1 day

1 visit (in-person or remote)

Treatment

Participants receive COIN2DOSE or LOAN2DOSE interventions, or continue usual care in the control group

12 weeks

Weekly procedures (in-person or remote)

Post-Treatment Monitoring

Participants are monitored without treatment interventions

12 weeks

1 visit at week 24 (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

• COIN2DOSE
• LOAN2DOSE

Trial Overview The study tests two programs, COIN2DOSE and LOAN2DOSE, designed to encourage adolescents with Type 1 Diabetes to take their mealtime insulin doses regularly by offering financial incentives or maintaining a monetary balance as rewards.

How Is the Trial Designed?

Group I: LOAN2DOSE Experimental Treatment 1 Intervention

From one-week post-randomization to the 12-week study visit, youth randomized to this treatment arm will receive personalized feedback via monetary deductions from a virtual bank of $210 for missed doses of insulin at mealtimes. According to the methodology for calculating BOLUS(1) breakfast will be 0600-1000, lunch will be 1100-1500, and dinner will be 1600-2000. Thus, we will deduct $0.50 per mealtime with at least one meal-associated (carbohydrate-associated) insulin bolus missed (maximum -$1.50/day). Youth can also lose an additional amount of up to $5.00/week for weeks during which they don't achieve at least 5 days of 3 mealtime insulin boluses. Finally, we will deduct the virtual account up to $2.00 per week for failing to share their insulin use data at least two times per week with the study team during the three-month treatment phase (maximum deduction of $24.00). Maximum total deductions is $210.

Group II: COIN2DOSE Experimental Treatment 1 Intervention

From one-week post-randomization to the 12-week study visit, youth randomized to this treatment arm will receive personalized feedback via monetary incentives for dosing insulin at mealtimes. Mealtimes will be defined based on hour of the day and the presence of a carbohydrate entry associated with the insulin bolus. Breakfast will be 0600-1000, lunch will be 1100-1500, and dinner will be 1600-2000. Thus, we will reimburse youth up to $0.50 per mealtime with at least one meal-associated (carbohydrate-associated) insulin bolus completed (maximum $1.50/day). We will offer the opportunity for youth to earn a bonus reimbursement of up to $5.00/week for weeks during which they achieve at least 5 days of 3 mealtime insulin boluses. Finally, we will pay youth up to $2.00 per week for sharing their insulin use data at least two times per week with the study team during the three-month treatment phase (maximum $24.00). Therefore, maximum total incentive available is $210.

Group III: Control Active Control 1 Intervention

This group will engage have usual diabetes care without intervention. They will fill out all questionnaires, attend clinic visits and provide A1C samples at the same times as the participants in the other groups.

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

A study involving 100 individuals with type 2 diabetes in Lima, Peru, found that 95% of participants found weight loss difficult, highlighting the challenges in achieving and maintaining weight loss.

Eighty-five percent of respondents expressed willingness to join a financial incentive program for weight loss, preferring direct cash payments of approximately USD $30 for every 1 kg lost, indicating strong support for incentivized weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A descriptive study of potential participant preferences for the design of an incentivised weight loss programme for people with type 2 diabetes mellitus attending a public hospital in Lima, Peru. Akehurst, H., Pesantes, MA., Cornejo, SDP., et al.[2020]

Citations

1. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/251-OR/156588/251-OR-COIN2DOSE-Proof-of-Concept-That-a

251-OR: COIN2DOSE—Proof of Concept That a Behavioral ... We designed a novel mHealth intervention, called COIN2DOSE, that uses behavioral economics theories to promote mealtime insulin use among adolescents.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10043759/

Cash-Only INcentives To promote insulin DOSE engagement Our central hypotheses are that Coin2Dose will be feasible and acceptable and that adolescents who receive Coin2Dose will have higher BOLUS scores, lower HbA1c, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003342

Cash-Only INcentives to promote insulin DOSE engagement We aim to conduct a pilot randomized clinical trial of a novel mHealth intervention called Coin2Dose (Cash-Only INcentives To promote insulin DOSE engagement)

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04621890

HCT Cash-Only INcentive to Promote Mealtime Insulin ... If initially efficacious, our results will serve as the basis for an R01 submission(s) to conduct a fully powered efficacy trial of LOAN2DOSE and COIN2DOSE.

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-5-2022-790b1

Coin2Dose for Type 1 Diabetes · Info for Participants A study found that monetary rewards increased the frequency of checking blood sugar levels, which is important for managing diabetes effectively. This suggests ...

6. reporter.nih.gov reporter.nih.gov/project-details/10597657

Coin2Dose: Behavioral economics to promote insulin ... Our objective is to test the feasibility, acceptability, and initial efficacy of using behavioral economics incentives (BEI) in a novel, semi-automated ...