FAMS-T1D Support Program for Type 1 Diabetes

(FAMS-T1D Trial)

Not currently recruiting at 1 trial location

Overseen By Cynthia A Berg, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Insulin

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new program, FAMS-T1D, can assist young adults with type 1 diabetes in better managing their condition. The program emphasizes setting and achieving health goals and receiving support from friends or family. Participants will determine if the program improves blood sugar control and reduces diabetes-related stress. Potential beneficiaries include young adults who have managed type 1 diabetes with insulin for at least a year and face challenges with blood sugar levels or diabetes-related stress. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative diabetes management strategies.

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 improving self-regulation and social support for managing type 1 diabetes, so it's likely you can continue your current treatment.

What prior data suggests that the FAMS-T1D intervention is safe?

Research shows that young adults with type 1 diabetes generally appreciate the FAMS-T1D program. It has helped them set and achieve realistic health goals. Participants reported feeling more motivated and supported in managing their diabetes, indicating the program's acceptability and ease of use.

Studies have reported no serious side effects, suggesting the program is likely safe for participants. The program primarily involves coaching and support through phone calls and text messages, which minimizes the risk of harm. Participants and their support persons found the program engaging and helpful, further supporting its safety and effectiveness in managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAMS-T1D program because it offers a unique approach to managing type 1 diabetes through personalized digital support. Unlike traditional treatments that focus primarily on insulin management and glucose monitoring, FAMS-T1D emphasizes behavioral and emotional support by providing monthly phone coaching and tailored text message support for setting and achieving personal health goals. This method aims to empower patients by enhancing self-care behaviors and involving support persons in the process, which could lead to improved overall diabetes management.

What evidence suggests that the FAMS-T1D intervention could be effective for type 1 diabetes?

Research shows that the FAMS-T1D program, available to participants in this trial, helps young adults with type 1 diabetes set and achieve realistic goals. Studies have found that this program boosts confidence in managing diabetes and enhances self-care habits. Participants in these studies reported better management of their condition and reduced stress related to diabetes. The program also fosters stronger support from friends and family, making it easier to manage diabetes with their assistance. Overall, FAMS-T1D appears promising in improving both personal and social aspects of diabetes management. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 1 Diabetes who are comfortable texting and fluent in English. They need a support person who can communicate in English or Spanish. Participants should either have an A1c value of 7.5% or higher, or show signs of diabetes distress. Those with severe mental illness, sensory disabilities, or plans to live abroad during the study cannot join.

Inclusion Criteria

Support person who can speak, read, and write in either English or Spanish

You either have a recent A1c value of 7.5% or higher, or show signs of distress related to diabetes on a short questionnaire.

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

Exclusion Criteria

Support person sharing a phone with the patient participant

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

You have a significant disability that affects your thinking, eyesight, or hearing, or a serious mental illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the FAMS-T1D intervention, including monthly coaching sessions and daily/weekly text messages for 6 months

6 months

Monthly phone coaching sessions

Maintenance

Participants continue to receive support and are monitored for maintenance of effects

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital resources for diabetes
• FAMS-T1D

Trial Overview The FAMS-T1D program aims to help young adults manage their Type 1 Diabetes by setting goals and getting social support. The study checks if this digital intervention improves blood glucose control, self-management, reduces stress related to diabetes, and helps without burdening the support persons.

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 person 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

Persons with type 1 diabetes will receive text messages as to how to access their HbA1c results and digital materials related to self-care behaviors for their diabetes. All support persons will receive digital materials about type 1 diabetes and how to provide helpful support to the person with diabetes.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of California, Merced

Collaborator

Trials

18

Recruited

6,100+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

Educational interventions for children with type 1 diabetes effectively improve diabetes knowledge but do not consistently lead to better metabolic control, based on a review of 41 studies published between 1980 and 1999.

Psychosocial interventions, particularly coping skills training and peer support, are beneficial for adolescents in improving their adjustment to diabetes and can sometimes enhance metabolic control, while family interventions help reduce conflicts between parents and children regarding diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for children with diabetes and their families. Grey, M.[2019]

A 2-year randomized clinical trial involving 390 families showed that a low-intensity, clinic-integrated behavioral intervention significantly improved glycemic control in youth with type 1 diabetes, particularly in those aged 12 to 14.

The intervention effectively prevented the typical decline in diabetes management during adolescence, suggesting it could be a valuable approach to integrate behavioral support into medical care for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Nansel, TR., Iannotti, RJ., Liu, A.[2022]

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, ...