Coin2Dose for Type 1 Diabetes (Coin2Dose Trial)
Palo Alto (17 mi)Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
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.
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.1351011
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.24789
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.24689
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 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, or my parent, do not speak English.
Treatment Details
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.
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Nemours Children's HealthJacksonville, FL
Children's Mercy Kansas CityKansas City, MO
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Who is running the clinical trial?
Nemours Children's ClinicLead Sponsor
References
Differences in rates of hypoglycemia and health care costs in patients treated with insulin aspart in pens versus vials. [2013]To study whether initiation of insulin aspart therapy with a pen vs. a vial/syringe has an impact on the risk of subsequent hypoglycemic episodes and health care costs.
An exploration of attitudes toward the use of patient incentives to support diabetes self-management. [2018]To improve our understanding of the potential of incentives to enhance diabetes self-management (type 1 and type 2) and to integrate incentives into a conceptual model of diabetes self-management over time.
Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. [2021]Malfunctions or poor usability of devices measuring glucose or delivering insulin are reportable to the FDA. Manufacturers submit 99.9% of these reports. We test online social networks as a complementary source to traditional FDA reporting of device-related adverse events.
Patient attitudes about financial incentives for diabetes self-management: A survey. [2020]To study the acceptability of incentives for behavior changes in individuals with diabetes, comparing financial incentives to self-rewards and non-financial incentives.
Severe hypoglycaemia in adults with insulin-treated diabetes: impact on healthcare resources. [2021]To assess resource utilization associated with severe hypoglycaemia across three insulin regimens in a large phase 3a clinical programme involving people with Type 1 diabetes treated with basal-bolus insulin, people with Type 2 diabetes treated with multiple daily injections and people with Type 2 diabetes treated with basal-oral therapy.
Testing for rewards: a pilot study to improve type 1 diabetes management in adolescents. [2022]To evaluate the effectiveness of monetary reinforcement to increase the frequency of self-monitoring blood glucose (SMBG).
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]To assess the impact of faster aspart vs insulin aspart on long-term clinical outcomes and costs for patients with type 1 diabetes mellitus (T1DM) in the UK setting.
Glucose management for rewards: A randomized trial to improve glucose monitoring and associated self-management behaviors in adolescents with type 1 diabetes. [2020]This randomized, controlled trial evaluated a monetary-based reinforcement intervention for increasing self-monitoring of blood glucose (SMBG) among youth with poorly controlled type 1 diabetes.
Cost-effectiveness of financial incentives to improve glycemic control in adults with diabetes: A pilot randomized controlled trial. [2022]Determine the cost-effectiveness of three financial incentive structures in obtaining a 1% within group drop in HbA1c among adults with diabetes.
Effect of Mini-Dose Ready-to-Use Liquid Glucagon on Preventing Exercise-Associated Hypoglycemia in Adults With Type 1 Diabetes. [2023]To determine effect of mini-dose, ready-to-use glucagon on incidence of exercise-associated hypoglycemia (EAH) in adults with type 1 diabetes.
The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia. [2023]Type 1 diabetes is characterized by insulin deficiency, and treatment is to supply insulin mimicking the physiological endogenous insulin secretion. Since its discovery, insulin therapy has evolved, and since the 1990s, an increasing number of insulin analogs with various pharmacokinetic and pharmacodynamic profiles have become available. Despite the improvement of insulin therapy, hypoglycemia remains the main side effect and is a daily concern for many people with diabetes and their families. A proportion of people with type 1 diabetes are at increased risk of hypoglycemia and experience recurring episodes. When designing insulin trials, this group of people is most often excluded in order to reduce the risk of adverse study outcomes, even though it may be the group that may benefit the most from treatment with new insulins. The results of the phase III trials, therefore, underestimate the clinical impact and pharmacoeconomic effect of the implementation of new insulins in the broader type 1 diabetes population. This paper reviews the four insulin trials that include people at increased risk of hypoglycemia. In general, the studies confirm the results from phase III trials in terms of similar reduction and maintenance of HbA1c, as well as relative rate reductions of hypoglycemia. However, the absolute treatment differences in the reduction of hypoglycemia are even greater in the trials, including people at high risk of hypoglycemia. This emphasizes the importance of including people at high risk of hypoglycemia to assess the full clinical and pharmacoeconomic benefit of new insulins.