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

36 Participants Needed

Trial Summary

How does the treatment COIN2DOSE, LOAN2DOSE for type 1 diabetes differ from other treatments?

COIN2DOSE, LOAN2DOSE is unique because it involves using cash incentives to encourage better self-management behaviors in individuals with type 1 diabetes, which is different from traditional treatments that focus solely on medication or lifestyle changes without financial motivation. ¹

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England 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. [2020]