Peer Mentorship for Type 1 Diabetes

Overseen By Paul Enlow, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Cystic fibrosis, Intellectual disability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

106 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 using continuous glucose monitoring systems, so it's likely you can continue your current medications, but please confirm with the trial coordinators.

What data supports the effectiveness of the treatment Type 1 Together for type 1 diabetes?

Research shows that peer mentorship programs can help people with type 1 diabetes manage their condition better. For example, a study found that college students in a peer support group had improved blood sugar control, and another program showed increased hope and clinic attendance among teens. ^{1 2 3 4 5}

How does the peer mentorship treatment for type 1 diabetes differ from other treatments?

The peer mentorship treatment for type 1 diabetes is unique because it involves pairing individuals with mentors who have similar experiences, providing support through text reminders, social events, and clinic visits. This approach focuses on social support and education rather than medication, aiming to improve emotional well-being and clinic attendance, which are not typically addressed by standard medical treatments. ^{1 2 3 6 7}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM). Families who participate will be assigned by chance to one of two groups. One group will continue to see their Endocrinology provider who can give recommendations on ways to use CGM. The other group will be in our Type 1 Together program for 6 months. This will include: 1. Monthly meetings with a community health worker with expertise in type 1 diabetes self-management, 2. Access to CGM-specific educational resources hosted on a mobile app, and 3. Meeting at least monthly with a mentor family who will provide mentorship on using CGM consistently. The main questions the study aims to answer are: 1. Do families like the Type 1 Together program? 2. Do more families in the Type 1 Together program have better attitudes towards CGM, use CGM more consistently, and have lower HbA1c? 3. Does the Type 1 Together program reduce racial and ethnic differences in attitudes towards CGM, consistent use of CGM, and HbA1c?

Eligibility Criteria

This trial is for adolescents aged 12-17 with type 1 diabetes who haven't been using a continuous glucose monitoring system (CGM) regularly. They should be diagnosed for at least 6 months and able to read/write in English. It's not suitable for those with diabetes due to other conditions, intellectual disabilities, or severe psychiatric issues.

Inclusion Criteria

I am between 12 and 17 years old.

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

Does not use CGM OR uses CGM < 24 out of the past 30 days

Exclusion Criteria

Intellectual disability

Severe psychiatric comorbidities

I have type 1 diabetes caused by another condition like cystic fibrosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the Type 1 Together program receive monthly mentorship and access to educational resources for 6 months

6 months

Monthly meetings with community health worker and mentor family

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Quarterly clinic visits with endocrinology provider

Treatment Details

Interventions

• Type 1 Together

Trial Overview The study compares standard care from an Endocrinology provider against the 'Type 1 Together' program which includes monthly meetings with health workers, educational resources on a mobile app, and mentorship from experienced families on CGM use over six months.

Participant Groups

Group I: Type 1 Together Experimental Treatment 1 Intervention

In Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker.

Group II: Standard of Care Active Control 1 Intervention

Quarterly clinic visits with endocrinology provider.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Findings from Research

An internet-based mentoring program for adults with type 1 diabetes did not significantly improve glycemic control (HbA1c levels) after 12 weeks compared to a control group.

Despite the lack of improvement in HbA1c, the mentored group showed a higher frequency of blood glucose monitoring and website logins, suggesting that increased engagement may have potential clinical benefits in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an internet-based mentoring program for type 1 diabetes patients with inadequate glycemic control. Suh, S., Jean, C., Koo, M., et al.[2021]

A study involving 54 adolescents and 46 young adults with type 1 diabetes showed strong interest in a peer mentoring program, indicating a desire for support in managing their condition.

Participants identified various social barriers to diabetes management, such as inflexible schedules and embarrassment about blood glucose monitoring, highlighting the need for tailored support and education in peer mentoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives on peer mentoring: type 1 diabetes management in adolescents and young adults. Lu, Y., Pyatak, EA., Peters, AL., et al.[2022]

The All for ONE mentoring program, which paired college students with teenagers who have type 1 diabetes, showed feasibility as an intervention to promote health equity, with 22 mentors and 42 teens participating over 9 months.

While the program did not significantly lower HbA1c levels in the treatment group compared to controls, it did improve the teens' hope for the future and increased their attendance at clinic visits, suggesting positive psychosocial impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing health disparities in type 1 diabetes through peer mentorship. Walker, AF., Haller, MJ., Gurka, MJ., et al.[2022]

A coaching intervention for 10 patients with type 1 diabetes led to a significant reduction in HbA1c levels from 8.0% to 7.78% after 3 months, indicating improved blood sugar control.

The frequency of self-monitoring of blood glucose (SMBG) also increased significantly, from a median of 16.5 tests per week at baseline to 29.0 tests at 3 months, suggesting enhanced self-management among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 diabetes mellitus: can coaching improve health outcomes? Magalhães, TPC., Fóscolo, RB., Soares, AN., et al.[2023]

A pilot study involving college students with insulin-dependent diabetes showed that participation in a peer support group significantly improved their management of diabetes, as indicated by a drop in average hemoglobin A1c levels from 8.16 to 6.10 after 10 weeks (p < .001).

The results suggest that peer support groups can be an effective strategy for helping young adults with diabetes gain better metabolic control during a critical time when they are learning to manage their illness independently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of support and education groups for college students with insulin-dependent diabetes mellitus. Shalom, R.[2022]

A systematic review of 12 studies on technology-mediated peer support for children with type 1 diabetes found that while these interventions show potential, they did not significantly improve psychosocial outcomes like quality of life or stress management.

Some mixed results were noted regarding HbA1c levels, with 28.5% of studies reporting a reduced incidence of hypoglycemia, indicating that while peer support may help in some areas, more robust research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of technology-mediated peer support interventions in paediatric type 1 diabetes care. Titoria, R., Fung, A., Tang, TS., et al.[2023]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an internet-based mentoring program for type 1 diabetes patients with inadequate glycemic control. [2021]

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

Patient perspectives on peer mentoring: type 1 diabetes management in adolescents and young adults. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Addressing health disparities in type 1 diabetes through peer mentorship. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Type 1 diabetes mellitus: can coaching improve health outcomes? [2023]

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

A pilot study of support and education groups for college students with insulin-dependent diabetes mellitus. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Patient perspectives on peer support for adults with type 1 diabetes: a need for diabetes-specific social capital. [2022]

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

Systematic review of technology-mediated peer support interventions in paediatric type 1 diabetes care. [2023]