FAMS-T1D + Digital Resources for Type 1 Diabetes

Recruiting at 1 trial location

Overseen By Erin M Bergner, PhD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: Insulin

Disqualifiers: Intellectual disability, Blindness, Severe mental illness, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a special program, FAMS-T1D, assists people with Type 1 Diabetes (T1D) in better utilizing their continuous glucose monitors (CGMs). Participants receive phone coaching and text support for diabetes management, while their friends or family receive text messages to learn supportive strategies. Suitable candidates have T1D, use a CGM, and either have high A1c levels (a measure of blood sugar over time) or experience stress about managing their diabetes. As an unphased trial, this study provides a unique opportunity for participants to enhance their diabetes management skills 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. However, since the trial involves people with Type 1 Diabetes who are already using insulin and continuous glucose monitors, it seems likely that you will continue your current diabetes management.

What prior data suggests that the FAMS-T1D intervention and digital resources for diabetes are safe?

Research shows that people generally have a positive experience with FAMS-T1D. Young adults report that the program helps them set practical goals for managing their diabetes and boosts their motivation to maintain their health. These findings suggest that FAMS-T1D is both helpful and supportive, indicating its safety.

No reports of harmful effects from FAMS-T1D have emerged. The program includes monthly phone coaching and text message support, both non-invasive methods. These methods do not physically affect the body, so the risk remains low. Overall, based on available information, FAMS-T1D appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAMS-T1D approach because it offers a personalized support system through a combination of monthly phone coaching and tailored text message support for individuals with Type 1 Diabetes. Unlike standard treatments that focus primarily on medication and insulin management, FAMS-T1D emphasizes behavioral support and self-care education. This method not only aims to empower patients by providing them with easy access to their health data, like HbA1c results, but also involves their support network, ensuring they receive comprehensive, goal-oriented care.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

Research has shown that FAMS-T1D, a treatment in this trial, can greatly benefit people with type 1 diabetes. Participants have improved in setting and reaching realistic diabetes management goals. This goal-setting correlates with better self-care and increased confidence in managing their condition. FAMS-T1D also involves both the individual with diabetes and their support network, enhancing the support they receive. Young adults have found the program useful for managing their diabetes. Overall, FAMS-T1D appears promising in helping people with type 1 diabetes manage their condition more effectively. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-24 with Type 1 Diabetes who have been on insulin for at least a year and either have high A1c levels or experience diabetes distress. They must use a CGM, be comfortable with texting, and speak English (or Spanish for support persons). Support persons must be over 18. Those with conditions like severe mental illness or plans to live abroad during the study cannot join.

Inclusion Criteria

I have Type 1 Diabetes and have been on insulin for over a year.

I can speak, read, and write in English or Spanish.

Can speak, read, and write in English

Exclusion Criteria

I have diabetes but no severe mental illness, blindness, or hearing problems that would stop me from completing the study.

Support persons planning to live outside of the country during the study period

You have diabetes and plan to live in another country during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FAMS-T1D intervention, including monthly phone coaching and text message support for 6 months

6 months

Monthly phone coaching sessions

Follow-up

Participants are monitored for changes in CGM use and satisfaction with data-sharing relationships

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Digital resources for diabetes
• FAMS-T1D

Trial Overview The trial is testing an adapted FAMS intervention designed to improve the use of Continuous Glucose Monitors (CGMs) in young adults with Type 1 Diabetes. It's part of a larger study where participants are given digital resources to help manage their condition.

How Is the Trial Designed?

Group I: FAMS-T1D Experimental Treatment 2 Interventions

Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.

Group II: Digital resources for diabetes Placebo Group 1 Intervention

All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

University of California, Merced

Collaborator

Trials

18

Recruited

6,100+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

The New-Onset Diabetes Educator (NODE) web application significantly improved diabetes knowledge among child/caregiver dyads, with post-intervention scores showing a medium effect size (Δ=0.56) compared to standard education methods.

NODE was found to be user-friendly and feasible, suggesting it could be an effective tool for enhancing diabetes self-management education at the time of diagnosis, potentially leading to better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. Bernier, A., Fedele, D., Guo, Y., et al.[2023]

In a study of 92 youth with type 1 diabetes using the Minimed 670G hybrid closed loop (HCL) system, 30% discontinued use within 6 months, with higher baseline HbA1c levels significantly predicting discontinuation.

The main barriers to continued use of HCL included difficulties with calibrations, frequent alarms, and the overall workload required to manage the system, indicating a need for interventions to support users, especially those with higher HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Messer, LH., Berget, C., Vigers, T., et al.[2021]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690330/

social regulation for emerging adults with type 1 diabetes Emerging adults said FAMS-T1D helped with setting realistic goals, motivated them to prioritize diabetes goals, and increased support, indicating acceptability ...

2. frontiersin.org frontiersin.org/journals/clinical-diabetes-and-healthcare/articles/10.3389/fcdhc.2024.1297422/full

Goal change and goal achievement for emerging adults ... In the feasibility study with EAs, FAMS-T1D was acceptable, feasible, and pre-post improvements were found in self-efficacy, self-management, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38045417/

social regulation for emerging adults with type 1 diabetes Conclusions: Findings suggest potential for FAMS-T1D to engage emerging adults and their support persons and feasibility for evaluation of ...

4. ajmc.com ajmc.com/view/goal-achievement-in-t1d-management-boosts-self-efficacy-self-care-among-emerging-adults

Goal Achievement in T1D Management Boosts Self ... Findings from the FAMS-T1D study demonstrate that structured goal-setting and achievement significantly enhance self-efficacy and self-care in emerging adults.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05854069

Adapting FAMS to Optimize CGM Use Among Emerging ... The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000651

Design of the type 1 diabetes and life (T1DAL) pilot ... This pilot study will generate preliminary data about a brief intervention targeting HRQOL for youth and adult PWDs and family members.

7. researchgate.net researchgate.net/publication/380205904_Goal_change_and_goal_achievement_for_emerging_adults_across_the_pilot_FAMS-T1D_intervention_for_type_1_diabetes

Goal change and goal achievement for emerging adults ... Emerging adults said FAMS-T1D helped with setting realistic goals, motivated them to prioritize diabetes goals, and increased support, ...