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Active, Not Recruiting

NCT Number: NCT05820477

FAMS-T1D Self-Regulation and Social Support for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FAMS-T1D

Behavioral

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

Digital resources for diabetes

Behavioral

Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.

Primary outcomes

  1. Change in HbA1c (Person with Diabetes)

    Time frame: Baseline and 6, 9, and 12 months post baseline

    Higher values indicate values more off target. Hemoglobin A1C assessed by mail-in kits from University of Minnesota ARDL

  2. Change in Self-Management (Person with Diabetes)

    Time frame: Baseline and 6, 9, and 12 months post baseline

    Self-care inventory revised, higher values indicate better self-management (values range from 1 to 5)

Secondary outcomes

  1. Diabetes Distress (Person with Diabetes)

    Time frame: Baseline and 6, 9, and 12 months post baseline

    The Diabetes Distress Scale for Adults with Type 1 Diabetes, higher values indicate greater distress (values range from X to X)

Other outcomes

  1. Change in Self-Regulation Failures (Person with Diabetes)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    Self-regulation failures (outcome and mediator) regarding failures in blood glucose checking ranging from 1 to 5 where higher values indicate greater failures.

  2. Change in Self-Efficacy (Person with Diabetes)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    Self-efficacy (outcomes and mediator), with scores ranging from 1 to 10 where higher numbers indicate greater self-efficacy.

  3. Change in Goal planning (Person with Diabetes)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    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.

  4. Change in Disclosure (Person with Diabetes)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    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

  5. Change in Helpful and Harmful Friend and Family Involvement (Person with Diabetes)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    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.

  6. Change in emotional support (Person with Diabetes)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    Emotional support (outcome and mediator). Scores range from 1 to 5, higher scores indicate greater emotional support.

  7. Time in range (Person with Diabetes)

    Time frame: Measured continuously from baseline through 12 months post baseline

    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.

  8. Change in solicitation of information from patient (support person)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    Solicitation of information from patient (outcome and mediator), with higher scores reflecting greater solicitation (range 1 to 5).

  9. Change in support burden (support person)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    Support burden (outcome and mediator), scores range from 0 to 4, higher scores indicate greater burden.

  10. Change in Diabetes Distress (support person)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    Support Person Diabetes Distress (outcome) with scores ranging from 0 to 4, higher scores indicate greater burden.

  11. Change in Helpful and Harmful Friend and Family Involvement (support person)

    Time frame: Baseline, and 6, 9, and 12 months post baseline.

    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

  12. Change in emotional support (support person)

    Time frame: Baseline, and 6, 9, and 12 months post baseline

    Emotional support (outcome and mediator). Scores range from 1 to 5, higher scores indicate greater emotional support.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FAMS-T1D

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2023
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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