Coin2Dose for Type 1 Diabetes

(Coin2Dose Trial)

No longer recruiting at 1 trial location

Overseen By Susana R Patton, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Must be taking: Insulin

Disqualifiers: Renal disease, Non-English speakers, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help adolescents with type 1 diabetes better manage their insulin levels. It combines behavioral economics incentives (BEI), which are small rewards, with text message reminders to improve daily insulin dosing. Participants will be divided into two groups: one receiving the BEI intervention, called Coin2Dose, and another receiving standard care without these extras. The trial seeks adolescents aged 11-17 who have struggled with insulin management despite using an insulin pump. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance diabetes management for many.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves using an insulin pump, you will likely continue using it as part of your diabetes management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves adolescents using an insulin pump, it seems likely that participants will continue their current insulin regimen.

What prior data suggests that this intervention is safe for adolescents with Type 1 Diabetes?

Research shows that Coin2Dose safely helps teens with Type 1 Diabetes manage their insulin use more effectively. Previous studies examined whether this program, which uses cash rewards and text reminders, is user-friendly and well-liked by participants. These studies found that participants received the program positively and reported no safety issues.

Because Coin2Dose uses behavior incentives and reminder texts, it doesn’t carry the same risks as a new drug or medical device. Without physical treatment, safety concerns are typically fewer. Participants can feel confident that Coin2Dose focuses on encouraging better habits, not introducing new medications or procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Coin2Dose is unique because it combines a digital intervention with automated text message reminders to help manage insulin dosing for people with Type 1 Diabetes. Unlike standard care, which typically relies on manual tracking and self-management of insulin doses, Coin2Dose offers a behavioral economic intervention (BEI) approach. This method aims to improve adherence by using contingent and non-contingent incentives, potentially making insulin management more effective and less burdensome. Researchers are excited about this approach because it could enhance the daily management of Type 1 Diabetes, leading to better overall blood glucose control.

What evidence suggests that the Coin2Dose intervention is effective for improving insulin use in adolescents with Type 1 Diabetes?

Research has shown that rewards can help teenagers with type 1 diabetes use insulin more effectively. In this trial, participants in the Coin2Dose arm will receive a program that combines cash rewards with automatic text reminders to encourage insulin use. Early results indicate that teens using Coin2Dose have better scores for insulin use and lower HbA1c levels, reflecting improved blood sugar control. These findings suggest that Coin2Dose could help teenagers manage their diabetes more successfully. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with type 1 diabetes for at least 6 months.

Adolescents who have a daily BOLUS score below 2.5

I use an insulin pump for my type 1 diabetes.

Exclusion Criteria

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

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

I am a teenager with a long-term health condition like kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Coin2Dose intervention or standard care for 12 weeks

12 weeks

Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Coin2Dose

Trial Overview 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.

How Is the Trial Designed?

Group I: Coin2Dose Experimental Treatment 1 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 Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Published Research Related to This Trial

A qualitative study involving 12 patients with diabetes revealed that 83% were interested in using financial incentives to enhance their self-management of the condition.

Incentives can help patients during the initial learning phase of developing healthy habits and also acknowledge their efforts during stable management phases, but careful planning is needed to prevent a decrease in intrinsic motivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of attitudes toward the use of patient incentives to support diabetes self-management. Blondon, K., Klasnja, P., Coleman, K., et al.[2018]

A monetary-based reinforcement intervention significantly increased the frequency of self-monitoring of blood glucose (SMBG) among 60 youth with poorly controlled type 1 diabetes, with the proportion of days completing ≥4 SMBG rising from 14.6% at baseline to 64.4% at 6 weeks.

While the intervention led to a decrease in average A1c levels from 9.5% to 9.0% during the reinforcement period, these improvements in metabolic control were not sustained after the withdrawal of monetary rewards, indicating a need for ongoing support to maintain benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose management for rewards: A randomized trial to improve glucose monitoring and associated self-management behaviors in adolescents with type 1 diabetes. Wagner, JA., Petry, NM., Weyman, K., et al.[2020]

A 12-week program using monetary rewards significantly increased the frequency of self-monitoring blood glucose (SMBG) tests among 10 adolescents, from an average of 1.8 to 4.9 tests per day.

The program also led to a reduction in mean A1C levels from 9.3% to 8.4%, indicating improved blood sugar control, and both adolescents and parents reported high satisfaction with the approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing for rewards: a pilot study to improve type 1 diabetes management in adolescents. Petry, NM., Cengiz, E., Wagner, JA., et al.[2022]

A study involving 549 participants from the TuDiabetes.org online community found that 75 reported device-related adverse events, with nearly half requiring intervention, highlighting the potential for online networks to capture real-world device issues.

Only 4% of these adverse events were reported to the FDA, suggesting that online participatory surveillance can provide more comprehensive outcome data compared to traditional reporting methods, which often lack detailed information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. Mandl, KD., McNabb, M., Marks, N., et al.[2021]

Faster aspart insulin led to a 0.13 quality-adjusted life-year increase compared to insulin aspart, indicating better long-term health outcomes for patients with type 1 diabetes.

Patients using faster aspart experienced cost savings of £1715 due to fewer diabetes-related complications and lower treatment costs, making it a more economical option in the UK healthcare setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Projected long-term outcomes in patients with type 1 diabetes treated with fast-acting insulin aspart vs conventional insulin aspart in the UK setting. Russell-Jones, D., Heller, SR., Buchs, S., et al.[2022]

A study involving 60 African American adults with type 2 diabetes found that financial incentives can effectively reduce HbA1c levels, with a cost-effectiveness of $1,100 per 1% reduction in HbA1c across three different incentive structures over a 3-month period.

Multi-component incentive structures, which included home testing and educational support, showed the least variation in cost-effectiveness, making them a promising approach for diabetes management compared to simpler incentive models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of financial incentives to improve glycemic control in adults with diabetes: A pilot randomized controlled trial. Egede, LE., Walker, RJ., Dismuke-Greer, CE., et al.[2022]

In a study involving 48 adults with type 1 diabetes, the use of mini-dose glucagon significantly reduced the incidence of exercise-associated hypoglycemia (EAH) during aerobic exercise, with only 12% experiencing hypoglycemia when using glucagon compared to 39% with a placebo.

Both glucagon treatment arms showed a lower incidence of hypoglycemia without significant differences in adverse events, suggesting that mini-dose glucagon is a safe and effective option for managing blood sugar levels during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mini-Dose Ready-to-Use Liquid Glucagon on Preventing Exercise-Associated Hypoglycemia in Adults With Type 1 Diabetes. Aronson, R., Riddell, MC., Conoscenti, V., et al.[2023]

A national survey of 153 adults with diabetes revealed that 96% were interested in financial incentives to improve their self-management, indicating a strong willingness to use monetary rewards for behavior change.

The study found that the perceived challenge of diabetes self-management tasks influenced the likelihood of using financial incentives, with participants expecting relatively modest amounts of money to motivate significant weight loss (e.g., $258 for a 5 lb loss).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient attitudes about financial incentives for diabetes self-management: A survey. Blondon, KS.[2020]

Initiating insulin aspart therapy with a pen significantly reduces the risk of hypoglycemic episodes compared to using a vial/syringe, with a 35% lower risk in one database and 44% lower in another.

Patients using vials/syringes incurred substantially higher healthcare costs related to hypoglycemic events, with costs increasing by 89% and 62.7% compared to those using pens, indicating that pen use is not only safer but also more cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in rates of hypoglycemia and health care costs in patients treated with insulin aspart in pens versus vials. Asche, CV., Luo, W., Aagren, M.[2013]

Insulin therapy for type 1 diabetes has evolved with the introduction of various insulin analogs, but hypoglycemia remains a significant concern, especially for individuals at increased risk.

Including people at high risk of hypoglycemia in insulin trials reveals greater absolute reductions in hypoglycemia compared to standard trials, highlighting the need for their inclusion to fully understand the benefits of new insulin treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia. Broeng-Mikkelgaard, S., Brøsen, JMB., Kristensen, PL., et al.[2023]

Severe hypoglycaemia events in diabetes patients often require significant healthcare resources, with 29.3% of events necessitating ambulance assistance and 6.7% leading to hospital admissions lasting more than 24 hours, indicating a substantial economic burden.

Type 2 diabetes patients experienced fewer severe hypoglycaemia events than Type 1 diabetes patients, but when such events occurred, they required more healthcare resources, particularly in the basal-oral therapy group, where 47.6% needed extended hospital treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe hypoglycaemia in adults with insulin-treated diabetes: impact on healthcare resources. Heller, SR., Frier, BM., Hersløv, ML., et al.[2021]

Citations

1. 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, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36396067/

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)

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. researchgate.net researchgate.net/publication/365388991_Cash-Only_INcentives_to_promote_insulin_DOSE_engagement_A_protocol_paper_for_the_pilot_randomized_controlled_trial_of_COIN2DOSE

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

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

Coin2Dose for Type 1 Diabetes · Info for Participants Trial Overview The Coin2Dose program uses behavioral economics incentives to encourage teens with Type 1 Diabetes to increase their daily insulin BOLUS usage.