Coin2Dose for Type 1 Diabetes

(Coin2Dose Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nemours Children's Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Coin2Dose for Type 1 Diabetes is an effective treatment?

The available research shows that using financial incentives, like those in Coin2Dose, can help improve self-monitoring of blood glucose in adolescents with type 1 diabetes. A study found that monetary rewards increased the frequency of checking blood sugar levels, which is important for managing diabetes effectively. This suggests that Coin2Dose can be an effective treatment by encouraging better diabetes management behaviors. ^{1 2 3 4 5}

What safety data is available for Coin2Dose treatment in Type 1 Diabetes?

The provided research does not directly mention safety data for Coin2Dose or Cash-Only INcentives To promote insulin DOSE engagement. The studies focus on insulin analogs, device safety, glucagon use, and hypoglycemia management, but do not specifically address Coin2Dose. Therefore, no specific safety data for Coin2Dose is available in the provided research. ^{6 7 8 9 10}

Is Coin2Dose a promising treatment for Type 1 Diabetes?

Yes, Coin2Dose is a promising treatment for Type 1 Diabetes because it uses financial rewards to encourage people to manage their diabetes better. Studies show that offering money can motivate patients to monitor their blood sugar levels more frequently, which is important for managing diabetes effectively. ^{1 2 3 4 11}

Research Team

Eligibility Criteria

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.

Treatment Details

Interventions

• Coin2Dose (Behavioural Intervention)

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.

Participant Groups

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+

R. Lawrence Moss

Nemours Children's Clinic

Chief Executive Officer since 2018

MD, FACS, FAAP

Matthew Davis

Nemours Children's Clinic

Chief Medical Officer since 2023

MD, MAPP

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

An exploration of attitudes toward the use of patient incentives to support diabetes self-management. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Denmark 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of financial incentives to improve glycemic control in adults with diabetes: A pilot randomized controlled trial. [2022]

5. England 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. [2021]

8. United States 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Severe hypoglycaemia in adults with insulin-treated diabetes: impact on healthcare resources. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Differences in rates of hypoglycemia and health care costs in patients treated with insulin aspart in pens versus vials. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Testing for rewards: a pilot study to improve type 1 diabetes management in adolescents. [2022]