NCT05820477

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Apr 2023Apr 2027

First Submitted

Initial submission to the registry

April 7, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

November 13, 2025

Status Verified

October 1, 2025

Enrollment Period

3.8 years

First QC Date

April 7, 2023

Last Update Submit

November 10, 2025

Conditions

Type 1 Diabetes

Keywords

emerging adultssocial supportgoal settingdiabetes distressHbA1cself-efficacy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Diabetes Distress (Person with Diabetes)

    Baseline and 6, 9, and 12 months post baseline

Other Outcomes (12)

  • Change in Self-Regulation Failures (Person with Diabetes)

    Baseline, and 6, 9, and 12 months post baseline

  • Change in Self-Efficacy (Person with Diabetes)

    Baseline, and 6, 9, and 12 months post baseline

  • Change in Goal planning (Person with Diabetes)

    Baseline, and 6, 9, and 12 months post baseline

  • +9 more other outcomes

Study Arms (2)

FAMS-T1D

EXPERIMENTAL

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-T1DBehavioral: Digital resources for diabetes

Digital resources for diabetes

PLACEBO COMPARATOR

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

Interventions

FAMS-T1DBEHAVIORAL

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.

Also known as: Family/friend Activation to Motivate Self-Care for those with Type 1 Diabetes
FAMS-T1D
Digital resources for diabetesBEHAVIORAL

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

Digital resources for diabetesFAMS-T1D

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Los Angeles

Los Angeles, California, 90027-6062, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The investigators use mail-in A1c kits for the primary outcome-hemoglobin A1c-and the lab analyzing these samples is masked to participants' assigned condition.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 19, 2023

Study Start

April 25, 2023

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

November 13, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigators

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After study results are posted on clinical trials and outcomes published in a peer-reviewed journal.
Access Criteria
Contact the principal investigator

Locations

US(2)