What side effects are associated with this type of intervention?

The most common treatment for Type 1 Diabetes involves insulin therapy, which can be administered through multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) via an insulin pump. Known side effects of insulin therapy include hypoglycemia (low blood sugar), weight gain, and potential skin irritation or infection at the injection or infusion site. Behavioral interventions, such as those using Behavioral Economics Incentives (BEI) to improve insulin BOLUS scores, aim to enhance adherence to insulin regimens but do not inherently carry additional side effects beyond those associated with insulin therapy itself.

What prior FDA approvals exist?

FDA-approved treatments for Type 1 Diabetes primarily include various forms of insulin therapy, such as rapid-acting, long-acting, and premixed insulins. These treatments aim to manage blood glucose levels effectively. While the Behavioral Economics Incentives (BEI) approach is novel and focuses on influencing behavior through rewards or penalties to improve insulin bolus scores, there is no direct mention of FDA-approved treatments that use this specific method. However, traditional insulin therapies remain the cornerstone of Type 1 Diabetes management.

What other types of research exist?

Promising novel alternatives to Behavioral Economics Incentives (BEI) for improving insulin BOLUS scores in Type 1 Diabetes patients include: 1) The Correction Insulin Bolus (CIB) delivery strategy proposed by Aleppo et al., which aims to counteract hyperglycemia. 2) The use of interactive computer games to decrease behavioral distress associated with insulin injections, which can improve adherence to insulin therapy. 3) Group education and support interventions that leverage peer encouragement and competition to enhance motivation and adherence to insulin regimens.

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Coin2Dose for Type 1 Diabetes (Coin2Dose Trial)

N/A

Recruiting

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adolescents who use an insulin pump for daily type 1 diabetes self-management

Be younger than 18 years old

Must not have

Adolescents who do not use an insulin pump

Adolescents who have an allergy or sensitivity to the adhesive and/or skin preparation used for CGM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in week 0 outcome at week 13

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if rewards and reminders can help teenagers with type 1 diabetes take their insulin more regularly. The goal is to improve their health by making it easier for them to manage their condition.

Who is the study for?

This trial is for English-speaking teens aged 11-17 with Type 1 Diabetes who use an insulin pump but have a low daily BOLUS score, indicating they're not using enough insulin. They must be diagnosed for at least 6 months. Teens with allergies to CGM adhesives or other chronic conditions like renal disease can't join.

What is being tested?

The Coin2Dose program uses behavioral economics incentives to encourage teens with Type 1 Diabetes to increase their daily insulin BOLUS usage. The study will assess if this approach is practical, acceptable, and effective in improving diabetes management.

What are the potential side effects?

Since the intervention involves behavioral incentives rather than medication, traditional side effects are not expected. However, there may be psychological impacts from participating in the incentive program that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I use an insulin pump for my type 1 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a teenager who does not use an insulin pump.

Select...

I am allergic to the adhesive used for continuous glucose monitoring.

Select...

I, or my parent, do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in week 0 outcome at week 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in week 0 outcome at week 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in week 0 outcome at week 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Glucose time in range

Change in Glycated Hemoglobin- HbA1c

Change in daily insulin Bolus score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Coin2DoseExperimental Treatment1 Intervention

BEI intervention that also combines automated text message reminders to dose for insulin; will test Contingent and Non-Contingent BEI

Group II: Standard Care ControlActive Control1 Intervention

Standard care control group; will not receive automated text message reminders to dose for insulin nor BEI for daily BOLUS scores

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Type 1 Diabetes is insulin therapy, which involves administering insulin to replace the hormone that the body can no longer produce. This is essential for regulating blood glucose levels and preventing complications. Behavioral interventions, like Behavioral Economics Incentives (BEI), complement insulin therapy by encouraging adherence to insulin regimens through rewards or penalties. These strategies improve self-management behaviors, such as consistent insulin bolus administration, leading to better glycemic control and overall health outcomes for patients.

Glucose management for rewards: A randomized trial to improve glucose monitoring and associated self-management behaviors in adolescents with type 1 diabetes.The effect of individual and mixed rewards on diabetes management: A feasibility randomized controlled trial.Exploring effects of self-management on glycemic control using a modified information-motivation-behavioral skills model in type 2 diabetes mellitus patients in Shanghai, China: A cross-sectional study.