FAMS-T1D Support Program for Type 1 Diabetes

(FAMS-T1D Trial)

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

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

What data supports the effectiveness of the FAMS-T1D treatment for Type 1 Diabetes?

The FAMS-T1D treatment, which uses mobile phone support to help manage diabetes, has been effective in adults with type 2 diabetes by improving self-care skills. Additionally, similar family-based interventions have shown promise in improving diabetes management and reducing stress in families dealing with type 1 diabetes. ^{1 2 3 4 5}

How is the FAMS-T1D treatment different from other treatments for type 1 diabetes?

FAMS-T1D is unique because it is a mobile phone-delivered program that focuses on improving self-care and social support for young adults with type 1 diabetes, involving family and friends to enhance self-regulation and reduce diabetes distress. ^{4 6 7 8 9}

What is the purpose of this trial?

This trial tests a program called FAMS-T1D that helps young adults with type 1 diabetes manage their condition. The program includes regular coaching calls, frequent text messages, and optional support from a friend or family member. The goal is to improve blood sugar control and reduce diabetes-related stress by providing consistent advice and encouragement.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Family-based psychoeducation and Care Ambassador intervention to improve glycemic control in youth with type 1 diabetes: a randomized trial. [2022]

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

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

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

Design and development of a stepped-care behavioral intervention to support parents of young children newly diagnosed with type 1 diabetes. [2023]

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

Acceptability and Feasibility of FAMS-T1D mHealth intervention to optimize self- & social regulation for emerging adults with type 1 diabetes. [2023]

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

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Mixed-Methods Randomized Evaluation of FAMS: A Mobile Phone-Delivered Intervention to Improve Family/Friend Involvement in Adults' Type 2 Diabetes Self-Care. [2021]

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

Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons. [2023]

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

Developing and Testing an Intervention to Reduce Distress in Mothers of Adolescents with Type 1 Diabetes. [2022]

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

Using an Expert Panel to Develop Social Support Program Sequencing for Young Adults With Type 1 Diabetes. [2018]