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Cash Incentives for Type 1 Diabetes

N/A
Recruiting
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current A1C >7.2% and/or predicted to have a rise in A1C of 0.3% or higher in the next 90 days
Attended at least 2 routine T1D standard of care visits in the past 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 and 180 days
Awards & highlights

Study Summary

This trial will test whether these programs can improve blood sugar control for adolescents with T1D.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medications, there are no direct medical side effects from the interventions themselves; however, improved adherence could lead to better blood sugar control.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My current A1C is over 7.2% or it's expected to rise soon.
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I have been to at least 2 diabetes care appointments in the last year.
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I am between 12 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 90 and 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 90 and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in A1C (ΔA1C90-day) from baseline visit (visit 1) to 90-day visit (visit 2)
Secondary outcome measures
Change in A1C (ΔA1C180-day) from baseline visit (visit 1) to 180-day visit (visit 3).
Change in health-related empowerment from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
Change in mealtime insulin BOLUS score (BOLUS) from baseline visit (visit 1) to 90-day visit (visit 2) and to 180-day visit (visit 3).
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: LOAN2DOSEExperimental Treatment1 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: COIN2DOSEExperimental Treatment1 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: ControlActive Control1 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.

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,763 Total Patients Enrolled

Media Library

COIN2DOSE Clinical Trial Eligibility Overview. Trial Name: NCT04621890 — N/A
Type 1 Diabetes Research Study Groups: LOAN2DOSE, COIN2DOSE, Control
Type 1 Diabetes Clinical Trial 2023: COIN2DOSE Highlights & Side Effects. Trial Name: NCT04621890 — N/A
COIN2DOSE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04621890 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants in this experiment?

"As indicated on clinicaltrials.gov, this research study is recruiting participants; the trial was initially posted on February 14th 2022 and subsequently modified March 25th of that same year."

Answered by AI

Is eligibility for this medical study limited to subjects younger than thirty?

"This trial seeks adolescents aged 12 to 18 years old."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. Clinicaltrials.gov shows that this research trial, which was posted on February 14th 2022, is currently searching for participants. The study requires 36 volunteers from one centre to take part in the experiment."

Answered by AI

What are the criteria for admission in this clinical experiment?

"This clinical trial is seeking 36 individuals between the ages of 12 and 18 who have type 1 diabetes mellitus. Eligibility criteria include having an A1C score greater than 7.2%, not currently pregnant or planning to become pregnant, access to an electronic device such as an iPhone or iPad that can be used with Klue, usage of insulin delivery devices capable of recording, storing and downloading data on bolus behaviors (such as smart Bluetooth pens), and being within the age range specified above."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
Children's Mercy Kansas City
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
HCT Cash-Only INcentive to Promote Mealtime Insulin DOSE Engagement
Sarah Tsai 2022. "HCT Cash-Only INcentive to Promote Mealtime Insulin DOSE Engagement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04621890.
~1 spots leftby Jun 2024
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