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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a peer mentorship program helps teens with type 1 diabetes use their continuous glucose monitoring systems (CGM) more consistently. Participants will join one of two groups: one will receive usual care with their endocrinologist, while the other will participate in the "Type 1 Together" program for six months. The program includes monthly meetings with a diabetes expert, access to educational resources via a mobile app, and mentorship from families experienced with CGM. Teens aged 12 to 17 who have had type 1 diabetes for at least six months and struggle with CGM usage or have high blood sugar levels may qualify. The study seeks to improve attitudes toward CGM, increase usage, and reduce disparities in outcomes across different racial and ethnic groups. As an unphased trial, this study offers teens a unique opportunity to potentially enhance their diabetes management with innovative support.

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 prior data suggests that the Type 1 Together program is safe for adolescents with type 1 diabetes?

Research has shown that peer mentorship programs like Type 1 Together are safe for participants. Studies have found that having a mentor helps people manage their type 1 diabetes more effectively. No reports have linked any harmful effects directly to these mentorship programs.

The Type 1 Together program includes meetings with experienced families, access to educational resources, and support from a community health worker. These activities focus on diabetes management and do not involve new medications or medical procedures, resulting in a low risk of unwanted side effects or complications.

In simpler terms, experiences from similar programs suggest that Type 1 Together is safe and well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Type 1 Together program because it offers a fresh approach to managing Type 1 Diabetes through peer mentorship. Unlike the standard care of regular clinic visits with an endocrinologist, this program connects families with experienced peers, helping them navigate the challenges of using continuous glucose monitors (CGMs). Additionally, it provides educational materials, a digital journal for better communication with healthcare providers, and addresses social determinants of health with support from a diabetes community health worker. This holistic and community-based strategy has the potential to significantly improve adherence to CGM use and overall diabetes management.

What evidence suggests that the Type 1 Together program is effective for improving CGM use in adolescents with type 1 diabetes?

Research has shown that peer mentorship programs for people with type 1 diabetes can be very helpful. In this trial, participants in the "Type 1 Together" arm will work with peer mentors to overcome common barriers to using continuous glucose monitors (CGM). Programs like Type 1 Together have helped people feel more positive about using diabetes tools like CGM. By offering social support and practical tips, these programs help families use CGM more regularly and manage diabetes better. Early results are promising, showing less stress and better use of CGM, which is important for keeping blood sugar levels under control. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10646266

DiaBetter Together: A Strengths-Based Peer Mentor ... The goal of the proposed study is to evaluate a new intervention for young adults with T1D that maximizes diabetes-related social support. The proposed ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424002969

Clinical trial protocol for a strengths-based Peer Mentor ... DiaBetter Together: Clinical trial protocol for a strengths-based Peer Mentor intervention for young adults with type 1 diabetes transitioning to adult care.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12267957/

Peer Mentoring Improves Diabetes Technology Use and ... Results: DSC intervention participants reported significantly lower diabetes distress than the comparison group (DDS-17 score mean = 1.6 vs. 2.1, p < 0.001), ...

4. sciencedirect.com sciencedirect.com/science/article/am/pii/S1551714424002969

Peer mentor intervention for diabetes transition This paper reports on the design of DiaBetter. Together, a randomized controlled trial to evaluate a 12-month Peer Mentor-delivered intervention ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/jdr/1970247

Peer Mentoring Improves Diabetes Technology Use and ... Results: DSC intervention participants reported significantly lower diabetes distress than the comparison group (DDS-17 score mean = 1.6 vs. 2.1 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06203067

Type 1 Together: A Peer Mentorship Program to Bolster ... 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) ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39395533/

Clinical trial protocol for a strengths-based Peer Mentor ... Results: The primary outcome of the trial is HbA1c, and secondary outcomes include time to adult care, engagement in diabetes self-management ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pedi.12935

Addressing health disparities in type 1 diabetes through ... Outcome measures included HbA1c and the Children's Hope Scale. The intervention included automated text reminders for blood glucose monitoring, ...