HCT Cash-Only INcentive to Promote Mealtime Insulin DOSE Engagement

NCT04621890 | Completed DMC

• 1 other identifier: STUDY00001086
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in A1C (ΔA1C90-day) from baseline visit (visit 1) to 90-day visit (visit 2)

  A1C is a validated indicator of glycemic control.

  baseline and 90 days

Secondary Outcomes (14)

• Change in A1C (ΔA1C180-day) from baseline visit (visit 1) to 180-day visit (visit 3).

  baseline and 180 days

• Change in percent time in range 70-180 mg/dL (%TIR70-180) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).

  baseline, 90 and 180 days

• Change in percent time hyperglycemic (>180 mg/dL; %Hyper>180) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).

  baseline, 90 and 180 days

• Change in percent Time hypoglycemic (<70 mg/dL; %Hypo<70) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).

  baseline, 90 and 180 days

• Change in percent Time severely hypoglycemic (<54 mg/dL) (%Hypo<54) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).

  baseline, 90 and 180 days

Study Arms (3)

LOAN2DOSE

EXPERIMENTAL

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.

Behavioral: LOAN2DOSE and COIN2DOSE

COIN2DOSE

EXPERIMENTAL

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.

Behavioral: LOAN2DOSE and COIN2DOSE

Control

NO 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.

Interventions

LOAN2DOSE and COIN2DOSE BEHAVIORAL

This is a behavioral economics intervention designed to help improve meal time bolusing behaviors in youth with type 1 diabetes.

COIN2DOSE; LOAN2DOSE

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• For Focus Groups:
• Any parent or legal guardian whose child is eligible for the study is invited to participate in a focus group discussion.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Kansas, 64108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Model Details: There will be 3 arms to this study. Two of these will involve behavioral interventions - LOAN2DOSE and COIN2DOSE. The remaining arm will be the control group.

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: November 9, 2020
• Study Start: February 14, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)