FAMS-T1D Self-Regulation and Social Support for T1D (FAMS-T1D)

Improving Self-Regulation and Social Support for Type 1 Diabetes During Emerging Adulthood (FAMS-T1D)

The goal of this clinical trial is to evaluate how effective the FAMS-T1D intervention is for improving self-regulation (e.g., setting and meeting goals for type 1 diabetes) and social support for meeting those goals for young adults. The main questions that are examined include 1) whether the intervention improves blood glucose, self-management and diabetes distress across time, 2) whether these improvements occur through better self-regulation and social-regulation, 3) whether the intervention improves outcomes for support persons (a friend or family member invited to participate by the person with diabetes) without increasing support burden and 4) whether the intervention improves for persons with diabetes who are on continuous blood glucose monitor their time in range.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: FAMS-T1D; Behavioral: Digital resources for diabetes

Detailed Description

This 12-month intervention is an adaptation and expansion of an intervention originally developed for adults with type 2 diabetes (FAMS; NCT02481596) for young adults with type 1 diabetes. FAMS-T1D includes multiple components:

• Monthly coaching sessions (20-30 minutes each) with young adults with type 1 diabetes by phone. The coaching focuses on how to set specific and achievable diabetes goals and to increase helpful and decrease unhelpful family and friend behaviors related to those goals.
• Daily text messages to the person with diabetes to support meeting diabetes goals and engage support that is helpful in meeting those goals.
• Weekly text messages where the person with diabetes responds to how well they have met their goals followed by personalized feedback from the coach.
• The option to invite an adult support person to also receive text messages that assist the support person in providing support that assists the person with diabetes in meeting their goals set in the coaching sessions.

Participants will be randomized to either the intervention or an active control where individuals receive materials relevant to their type 1 diabetes. We plan to enroll 280 persons with diabetes and support persons (optional for persons with diabetes). Persons with type 1 diabetes and their support person (when enrolled) will be randomized together. The study is powered to detect a .5% reduction in hemoglobin A1c. Analyses will examine effects at 6 months (post intervention) and at 12 months (maintenance of effects). The investigators will impute missing data and individuals will be analyzed as randomized irrespective of whether they withdraw or remain in the study following intention-to-treat principals.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027-6062
      • Children's Hospital of Los Angeles
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

PERSONS WITH DIABETES

• Ages 18-24
• Have a diagnosis of T1D and has been taking insulin for at least one year
• Comfortable sending texts
• Can speak, read, and write in English
• Meets one of the following two criteria: 1) has a most recent A1c value in of 7.5% or higher (prioritizing EHR, next self-report) or missing in EHR) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2).

SUPPORT PERSON

• Can speak, read, and write in either English or Spanish
• Comfortable sending and receiving texts
• Ages 18 and older

Exclusion Criteria:

PERSONS WITH DIABETES:

• Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
• Plans to live outside of the country during study period.

SUPPORT PERSON

• Shares a phone with the patient participant.
• Plans to live outside of the country during study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAMS-T1D; 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.	Behavioral: FAMS-T1D; Behavioral FAMS-T1D FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled.; Other Names: Family/friend Activation to Motivate Self-Care for those with Type 1 Diabetes; Behavioral: Digital resources for diabetes; Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.
Placebo Comparator: Digital resources for diabetes; 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.	Behavioral: Digital resources for diabetes; Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c (Person with Diabetes)	Higher values indicate values more off target. Hemoglobin A1C assessed by mail-in kits from University of Minnesota ARDL	Baseline and 6, 9, and 12 months post baseline
Change in Self-Management (Person with Diabetes)	Self-care inventory revised, higher values indicate better self-management (values range from 1 to 5)	Baseline and 6, 9, and 12 months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Distress (Person with Diabetes)	The Diabetes Distress Scale for Adults with Type 1 Diabetes, higher values indicate greater distress (values range from X to X)	Baseline and 6, 9, and 12 months post baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Regulation Failures (Person with Diabetes)	Self-regulation failures (outcome and mediator) regarding failures in blood glucose checking ranging from 1 to 5 where higher values indicate greater failures.	Baseline, and 6, 9, and 12 months post baseline
Change in Self-Efficacy (Person with Diabetes)	Self-efficacy (outcomes and mediator), with scores ranging from 1 to 10 where higher numbers indicate greater self-efficacy.	Baseline, and 6, 9, and 12 months post baseline
Change in Goal planning (Person with Diabetes)	Goal Planning (outcome and mediator) subscale from the Goal Systems Assessment Battery with scores ranging from 1 to 5 where higher values indicate greater planning.	Baseline, and 6, 9, and 12 months post baseline
Change in Disclosure (Person with Diabetes)	Disclosure (outcome and mediator) as measured by disclosure subscale with scores ranging from 1 to 5 where higher values indicate greater disclosure to family and friends	Baseline, and 6, 9, and 12 months post baseline
Change in Helpful and Harmful Friend and Family Involvement (Person with Diabetes)	Change in Helpful (range 1 to 5, higher scores indicate more helpful involvement) and Harmful friend and family involvement (range 1 to 5, higher scores indicate more harmful involvement) (outcome and mediator) as measured by modified FIAD (Mayberry et al., 2019) for type 1 diabetes management.	Baseline, and 6, 9, and 12 months post baseline
Change in emotional support (Person with Diabetes)	Emotional support (outcome and mediator). Scores range from 1 to 5, higher scores indicate greater emotional support.	Baseline, and 6, 9, and 12 months post baseline
Time in range (Person with Diabetes)	Time in range (outcome). For individuals on a continuous blood glucose monitor (CGM) we collect time in range from their monitor. Higher scores indicate greater time spent with blood glucose values in the target range of 70-180 mg/dL.	Measured continuously from baseline through 12 months post baseline
Change in solicitation of information from patient (support person)	Solicitation of information from patient (outcome and mediator), with higher scores reflecting greater solicitation (range 1 to 5).	Baseline, and 6, 9, and 12 months post baseline
Change in support burden (support person)	Support burden (outcome and mediator), scores range from 0 to 4, higher scores indicate greater burden.	Baseline, and 6, 9, and 12 months post baseline
Change in Diabetes Distress (support person)	Support Person Diabetes Distress (outcome) with scores ranging from 0 to 4, higher scores indicate greater burden.	Baseline, and 6, 9, and 12 months post baseline
Change in Helpful and Harmful Friend and Family Involvement (support person)	Change in helpful (range 1 to 5, higher scores indicate more helpful involvement) and Harmful friend and family involvement (range 1 to 5, higher scores indicate more harmful involvement) (outcome and mediator) as measured by modified FIAD for type 1 diabetes management	Baseline, and 6, 9, and 12 months post baseline.
Change in emotional support (support person)	Emotional support (outcome and mediator). Scores range from 1 to 5, higher scores indicate greater emotional support.	Baseline, and 6, 9, and 12 months post baseline

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Vanderbilt University Medical Center; Children's Hospital Los Angeles; University of California, Merced

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: HbA1c; social support; self-efficacy; emerging adults; diabetes distress; goal setting
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 00148660; 1R01DK124719 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigators
• IPD Sharing Time Frame: After study results are posted on clinical trials and outcomes published in a peer-reviewed journal.
• IPD Sharing Access Criteria: Contact the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No