Peer Mentor Program for Type 1 Diabetes

(TEAM Trial)

Recruiting at 1 trial location

Overseen By Andrea MacIntosh, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Recent T1D diagnosis, Cancer, Eating disorder, others

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

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost the mental and emotional well-being of teens with type 1 diabetes by pairing them with young adult mentors. These mentors will help adolescents increase their daily physical activity over 12 weeks. Two groups exist: one participates immediately in the 12-week TEAM peer mentor program, while the other waits and receives regular care before joining later. Teens who want to be more active and already use a continuous glucose monitor may be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for teens to enhance their well-being with personalized mentor 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 focuses on improving psychosocial health and physical activity for adolescents with type 1 diabetes.

What prior data suggests that this peer mentor program is safe for adolescents with type 1 diabetes?

Research has shown that peer mentoring programs, such as the 12-week TEAM peer mentor program, are generally well-received by participants. In past studies, similar peer-led programs for type 1 diabetes produced positive outcomes without safety issues. Participants often reported feeling supported and motivated, which improved their diabetes management. No major negative effects have been linked to these programs, as they emphasize social support and behavior changes rather than medical treatments. This suggests that the TEAM peer mentor program is safe for teenagers with type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 12-week TEAM peer mentor program for Type 1 Diabetes because it offers a fresh approach to boosting physical activity among adolescents. Unlike traditional methods that primarily rely on standard educational resources, this program uses peer mentors with Type 1 Diabetes to guide participants through regular interactions. These mentors help adolescents set goals and overcome personal barriers by fostering autonomy and motivation. This peer-led approach is designed to make lasting behavioral changes, potentially leading to better health outcomes and quality of life for young people with Type 1 Diabetes.

What evidence suggests that the 12-week TEAM peer mentor program is effective for improving psychosocial health in adolescents with type 1 diabetes?

Research has shown that peer mentoring programs can improve the mental and emotional well-being of teenagers with type 1 diabetes (T1D). One study found that teens with peer mentors felt less stressed about their diabetes compared to those without mentors. This stress was measured using a standard questionnaire, where a lower score indicates less stress. In this trial, participants in the 12-week TEAM peer mentor program will receive support to encourage better diabetes management habits, such as setting goals and increasing physical activity. These programs also provide crucial social support, which is essential for effective T1D management. Overall, evidence suggests that a structured peer mentor program can positively impact teenagers living with T1D. ^{1 2 3 6 7}

Who Is on the Research Team?

Jonathan McGavock

Principal Investigator

University of Manitoba / the Children's Hospital Research Institute of Manitoba

Are You a Good Fit for This Trial?

This trial is for adolescents with type 1 diabetes who want to boost their daily physical activity and currently use a continuous glucose monitor. There's no mention of specific exclusions, so it seems open to those meeting the inclusion criteria.

Inclusion Criteria

I want to increase my daily physical activity.

I currently use a device to monitor my blood sugar levels continuously.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A 12-week peer-led behavioural intervention to increase physical activity, guided by self-determination theory, with 3 weekly contacts between participants and peer mentors.

12 weeks

3 weekly contacts (mix of in-person, virtual, and texting)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at week 12 and week 24.

12 weeks

Assessments at week 12 and week 24

Extension

Adolescents in the wait-list control arm will be offered the 12-week intervention following the 24-week follow-up time point.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 12-week TEAM peer mentor program

Trial Overview The study tests a new care model where trained young adult mentors help teens with type 1 diabetes increase their physical activity over a 12-week program, aiming to improve both psychosocial health and self-management of T1D.

How Is the Trial Designed?

Group I: 12-week TEAM peer mentor program Experimental Treatment 1 Intervention

A 12-week peer-led behavioural intervention that supports increased physical activity. It will consist of 3 weekly contacts between participants and peer mentors that will be a mix of in-person, virtual, and texting. The intervention components and communication between adolescents and peer mentors with T1D will be guided by SDT, and designed to overcome the key psychosocial barriers to PA. The peer mentors that complete the training will deliver a 12-week intervention to increase behavioural skills that foster autonomy for goal setting and overcoming barriers to PA.

Group II: 12-week waitlist control Active Control 1 Intervention

A 12-week waitlist control group that receives usual care, including standard educational resources developed by the Canadian Society of Exercise Physiology for adopting and sustaining daily PA. Adolescents randomized to the control arm will be offered the 12 week intervention following the 24 week follow-up time point.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

In a real-world evaluation of a remote diabetes intervention involving 974 patients, 71% enrolled and 90% of those participated in coaching, demonstrating high engagement in the program.

Participants who completed the program showed a significant reduction in hemoglobin A1c levels by 1.71%, indicating improved diabetes management through remote peer mentoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world insights from launching remote peer-to-peer mentoring in a safety net healthcare delivery setting. Lyles, CR., Sarkar, U., Patel, U., et al.[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]

A two-year peer support intervention for patients with type 2 diabetes, involving 395 participants across 20 practices, did not show significant improvements in key health measures like HbA1c, blood pressure, or cholesterol levels compared to a control group.

While there was a slight trend towards better control of blood pressure in the intervention group, the overall results indicate that peer support may not be effective for all patients with type 2 diabetes, suggesting limited benefits for widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support for patients with type 2 diabetes: cluster randomised controlled trial. Smith, SM., Paul, G., Kelly, A., et al.[2022]

The Peer-Mentor Support Scale (PMSS) is a reliable and valid tool developed to measure the specific support provided by peer mentors to parents and youths with type 1 diabetes, consisting of 17 items with a high reliability score (Cronbach's alpha of .85).

The PMSS is distinct from general social support, as it measures a unique aspect of support, and it effectively captures the contributions of peer mentorship, explaining 59.3% of the variance in peer-mentor support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Psychometric Testing of the Peer-Mentor Support Scale for Parents of Children With Type 1 Diabetes and for Youths With Type 1 Diabetes. Sullivan-Bolyai, S., Bova, C., Johnson, K.[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]

In a study involving 1,299 participants with type 2 diabetes, group peer support over 8-12 months led to a small but significant reduction in systolic blood pressure, particularly for those who attended at least one face-to-face session.

Despite the positive impact on blood pressure, there were no significant changes in HbA1c levels or other metabolic and psychological outcomes, suggesting that while peer support may help with blood pressure, its overall effectiveness on diabetes management needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of community based peer support in type 2 diabetes: a cluster randomised controlled trial of individual and/or group approaches. Simmons, D., Prevost, AT., Bunn, C., et al.[2022]

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]

Peer support significantly reduces HbA1c levels in patients with type 2 diabetes, with an average decrease of -0.57, based on a review of 13 randomized controlled trials.

Programs that provide moderate to high frequency of peer support contact are particularly effective, especially for patients with higher baseline HbA1c levels (≥ 8.5%), while low-frequency programs do not show significant benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of peer support for improving glycaemic control in patients with type 2 diabetes: a meta-analysis of randomized controlled trials. Qi, L., Liu, Q., Qi, X., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06296992/type-1-diabetes-exercise-and-mentoring-trial

Type 1 Diabetes, Exercise and Mentoring Trial The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06296992?term=AREA%5BConditionSearch%5D(Diabetes%20Mellitus,%20Type%201)%20AND%20AREA%5BBasicSearch%5D(pace)&rank=6

Type 1 Diabetes , Exercise and Mentoring Trial (TEAM) The peer mentors that complete the training will deliver a 12-week intervention to increase behavioural skills that foster autonomy for goal setting and ...

3. 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 ...

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

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

5. 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), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4305505/

Patient Perspectives on Peer Mentoring: Type 1 Diabetes ... A peer mentoring program is especially suitable for helping to overcome social barriers to diabetes control, which were recognized by both adolescent and YA ...

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

Peer mentor intervention for diabetes transition With this release, study staff collect information about completed appointments and clinical data from adult care. Measures. Diabetes Data.