Financial Incentives for Type 1 Diabetes

Overseen By Faisal Malik, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Pilgrim Health Care

Must be taking: Insulin

Disqualifiers: Severe comorbidities, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12-18 months

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on diabetes management and financial incentives, so it's likely you can continue your current treatment.

What data supports the effectiveness of the treatment InvesT1D for Type 1 Diabetes?

The research suggests that financial incentives can be cost-effective in improving diabetes management, as seen in a study where financial incentives led to better blood sugar control in adults with diabetes. Additionally, structured education programs have shown to improve diabetes control and quality of life, which may indirectly support the effectiveness of treatments like InvesT1D. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

SGLT inhibitors, when used with insulin for type 1 diabetes, have shown some safety concerns such as an increased risk of genital infections and diabetic ketoacidosis (a serious diabetes complication), but they do not increase the risk of low blood sugar. They also slightly increase the risk of serious adverse events and drug-related side effects. ^{6 7 8 9 10}

How does the financial incentives treatment for Type 1 diabetes differ from other treatments?

The financial incentives treatment for Type 1 diabetes is unique because it uses monetary rewards to encourage patients to maintain better blood sugar control, unlike traditional treatments that focus solely on medication or lifestyle changes. This approach aims to improve adherence to diabetes management by providing a direct financial motivation. ^{1 3 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes. Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.

Eligibility Criteria

This trial is for adolescents with type 1 diabetes who use a continuous glucose monitor (CGM) but have an average daily CGM use of ≤70% or administer insulin boluses ≤3 times a day. They must be able to participate in the incentive program, complete surveys, and have mobile phone access. Parents must also agree to participate.

Inclusion Criteria

I have a mobile phone to receive updates.

I have been diagnosed with type 1 diabetes for over a year.

My parents agree to join the study and fill out surveys.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals

12-18 months

Routine diabetes clinic appointments and 24/7 telephone consultations

Follow-up

Participants are monitored for changes in glucose levels and person-reported outcomes

4-6 weeks

Treatment Details

Interventions

• InvesT1D

Trial Overview The InvesT1D clinical trial tests if financial rewards can help teenagers manage their type 1 diabetes better. Participants will either continue usual care or get money for meeting self-care and health targets. Researchers will track changes in blood sugar levels and feedback from teens and caregivers.

Participant Groups

Group I: Group D (high-value incentive, 12 months [48 weeks]) Experimental Treatment 1 Intervention

If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks.

Group II: Group C (low-value incentive, 12 months [48 weeks]) Experimental Treatment 1 Intervention

If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks.

Group III: Group B (high-value incentive, 6 months [24 weeks]) Experimental Treatment 1 Intervention

If the participant is assigned to Group B, they would receive $3.50 for each day that they meet their diabetes self-management goal. This equates to up to $98 every 4 weeks ($3.50 x 28 days = $98), or up to $588 over a period of 24 weeks. They would also receive $5.50 for each week that they meet their clinical outcome goal. This equates to up to $22 every 4 weeks ($5.50 x 4 weeks), or up to $132 over a period of 24 weeks. In total, they could earn up to $120 ($98 + $22) every 4 weeks, or up to $720 over a period of 24 weeks.

Group IV: Group A (low-value incentive, 6 months [24 weeks]) Experimental Treatment 1 Intervention

If the participant is assigned to Group A, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $294 over a period of 24 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $66 over a period of 24 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $360 over a period of 24 weeks.

Group V: Group E (usual care, 6 months [24 weeks]) Active Control 1 Intervention

Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits.

Group VI: Group F (usual care, 12 months [48 weeks]) Active Control 1 Intervention

Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits.

Who Is Running the Clinical Trial?

Harvard Pilgrim Health Care

Lead Sponsor

Trials

61

Recruited

27,990,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Findings from Research

Maintaining a lower HbA1c level of 42 mmol/mol (6.0%) compared to 86 mmol/mol (10.0%) can lead to significant cost savings of £12,649 per person over a lifetime, along with a gain of 2.80 quality-adjusted life-years (QALYs).

Reducing BMI and avoiding hypoglycaemic events also provide economic benefits, with estimated savings of £120 per person for each unit reduction in BMI and up to £197 for each non-severe hypoglycaemic event avoided, highlighting the importance of these factors in managing Type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the economic value of maintained improvements in Type 1 diabetes management, in terms of HbA1c , weight and hypoglycaemic event incidence. McEwan, P., Bennett, H., Bolin, K., et al.[2022]

A 5-day structured education program for Type 1 diabetes significantly improved diabetes control, with a notable reduction in glycated hemoglobin (HbA1c) by 0.42% in 63 patients after one year, especially among those with initially high HbA1c levels.

The program also led to a significant decrease in severe hypoglycemia incidents, dropping from 10 episodes in the year prior to just 1 episode after the course, alongside improvements in quality of life measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. Rogers, H., Turner, E., Thompson, G., 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 437 adults with type 1 diabetes, group follow-up after the DAFNE education program resulted in a slight reduction in quality-adjusted life years (QALYs) gained, indicating it may not be as effective as individual follow-up.

Despite showing a mean reduction in healthcare costs of €772 per patient, the overall findings suggest that group follow-up should not be the only method used post-DAFNE, and further research is needed to explore other cost-effective models of diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost effectiveness of group follow-up after structured education for type 1 diabetes: a cluster randomised controlled trial. Gillespie, P., O'Shea, E., O'Hara, MC., et al.[2022]

Patients with young-onset diabetes (ages 20-40) who received Pay-for-Performance (P4P) care had significantly lower risks of mortality (31% lower) and hospitalization for cardiovascular events (37% lower) compared to those without P4P care, based on a study of 3088 matched patients.

However, these patients also experienced a higher risk of major microvascular outcomes (31% higher), although those with longer durations of P4P care had even lower risks for both mortality and cardiovascular events, suggesting that the benefits of P4P care may increase over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of the pay-for-performance program for patients with young-onset (20-40 years of age) type 2 diabetes. Yen, FS., Cheng-Chung Wei, J., Hung, YT., et al.[2022]

In a study involving approximately 32,800 users of exenatide, there was a modestly higher incidence of claims for thyroid malignancies compared to users of metformin or glyburide, but this association was not significant when focusing on inpatient claims.

Exenatide use was not linked to an increased risk of benign thyroid neoplasms or pancreatic cancer, suggesting it may be a safe option regarding these specific cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. Dore, DD., Seeger, JD., Chan, KA.[2021]

SGLT-2 inhibitors and dual SGLT-1/2 inhibitors, when used alongside insulin, significantly improve glycaemic control in type 1 diabetes patients, leading to reductions in glycated hemoglobin and glucose variability over trials lasting up to 52 weeks.

While these medications can reduce body weight and insulin requirements, they are associated with a higher risk of genitourinary infections and a low incidence of diabetic ketoacidosis, necessitating careful monitoring and risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium-glucose co-transporter inhibitors as adjunctive treatment to insulin in type 1 diabetes: A review of randomized controlled trials. Boeder, S., Edelman, SV.[2022]

SGLT inhibitors, when added to insulin therapy for type 1 diabetes, significantly reduced HbA1c levels by -0.39% and improved glucose control without increasing the risk of hypoglycemia, based on a meta-analysis of 10 trials involving 5961 patients.

While SGLT inhibitors were associated with some adverse effects, such as an increased risk of genital infections and diabetic ketoacidosis, the very low dose of empagliflozin (2.5 mg) did not raise the risk of ketoacidosis, indicating a potential safe option for managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sodium-glucose cotransporter (SGLT) inhibitors in addition to insulin therapy on glucose control and safety outcomes in adults with type 1 diabetes: A meta-analysis of randomized controlled trials. Lu, J., Tang, L., Meng, H., et al.[2020]

This study aims to recruit individuals with new-onset type 1 diabetes, including children and adults, to better understand the variations in clinical presentation and facilitate participation in future intervention studies.

Participants will provide clinical and demographic data, along with optional blood samples for research, creating a valuable resource for ongoing studies on type 1 diabetes and potential immunotherapy treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and protocol for the After Diabetes Diagnosis REsearch Support System (ADDRESS): an incident and high risk type 1 diabetes UK cohort study. Walkey, HC., Kaur, A., Bravis, V., et al.[2022]

In a study involving nearly 50,000 users of exenatide BID and over 692,000 users of other antihyperglycemic drugs, current use of exenatide BID was not associated with an increased risk of acute pancreatitis, suggesting it is relatively safe in this regard.

However, after correcting for potential misclassification, there was a slight increase in the risk estimates for both current and past use of exenatide BID, indicating that while the overall risk appears low, further investigation into the potential for pancreatitis after stopping the medication is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pooled analysis of exenatide use and risk of acute pancreatitis. Dore, DD., Hussein, M., Hoffman, C., et al.[2018]

Continuous subcutaneous insulin infusion (CSII) treatment for type 1 diabetes significantly improves life expectancy and quality-adjusted life expectancy while reducing the incidence of diabetes-related complications compared to multiple daily injections (MDI).

Although CSII treatment incurs higher lifetime costs than MDI, it is considered good value for money based on cost-effectiveness ratios, indicating that the benefits in health outcomes justify the additional expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cost-effectiveness of continuous subcutaneous insulin infusion therapy for type 1 diabetes]. Nørgaard, K., Sohlberg, A., Goodall, G.[2022]

The DAFNE structured education program for adults with Type 1 diabetes leads to greater life expectancy and a reduction in diabetes-related complications compared to no training, based on a simulation of 5000 adults.

DAFNE is considered cost-effective, generating an additional 0.0294 quality-adjusted life years at an incremental cost of £426 per patient, with a 54% probability of being cost-effective at a threshold of £20,000 per quality-adjusted life year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of the Dose Adjustment for Normal Eating (DAFNE) structured education programme: an update using the Sheffield Type 1 Diabetes Policy Model. Kruger, J., Brennan, A., Thokala, P., et al.[2022]

Intensive insulin strategies in Type I diabetes can achieve normal blood glucose levels, significantly reducing the risk of major complications and improving quality of life, including years of sight and reduced risk of severe conditions like end-stage renal disease and amputations.

While the evidence for Type II diabetes is less definitive, there are suggestions that starting insulin-based strategies earlier could be beneficial, and despite higher costs (about 50% more than conventional strategies), these costs may be offset by savings from reduced hospitalizations and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The economic implications of implementing evidence-based diabetic treatment strategies. Phillips, CJ.[2011]

References

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

Assessing the economic value of maintained improvements in Type 1 diabetes management, in terms of HbA1c , weight and hypoglycaemic event incidence. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. [2022]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Cost effectiveness of group follow-up after structured education for type 1 diabetes: a cluster randomised controlled trial. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Long-term outcomes of the pay-for-performance program for patients with young-onset (20-40 years of age) type 2 diabetes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. [2021]

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

Sodium-glucose co-transporter inhibitors as adjunctive treatment to insulin in type 1 diabetes: A review of randomized controlled trials. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of sodium-glucose cotransporter (SGLT) inhibitors in addition to insulin therapy on glucose control and safety outcomes in adults with type 1 diabetes: A meta-analysis of randomized controlled trials. [2020]

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

Rationale and protocol for the After Diabetes Diagnosis REsearch Support System (ADDRESS): an incident and high risk type 1 diabetes UK cohort study. [2022]

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

A pooled analysis of exenatide use and risk of acute pancreatitis. [2018]

11. Denmark pubmed.ncbi.nlm.nih.gov

[Cost-effectiveness of continuous subcutaneous insulin infusion therapy for type 1 diabetes]. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of the Dose Adjustment for Normal Eating (DAFNE) structured education programme: an update using the Sheffield Type 1 Diabetes Policy Model. [2022]

13. India pubmed.ncbi.nlm.nih.gov

The economic implications of implementing evidence-based diabetic treatment strategies. [2011]