Type 1 DiabetesFAMS-T1DNCT05820477
FAMS-T1D Self-Regulation and Social Support for T1D
A study testing FAMS-T1D and Digital resources for diabetes in people with Type 1 Diabetes, run by University of Utah at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- FAMS-T1D and Digital resources for diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- SUPPORT PERSON
- Can speak, read, and write in either English or Spanish
- Comfortable sending and receiving texts
- Ages 18 and older
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Los Angeles
Los Angeles, California, 90027-6062
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- FAMS-T1D, Digital resources for diabetes
- Keywords
- emerging adults, social support, goal setting, diabetes distress, HbA1c, self-efficacy
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAMS-T1DBehavioural
Also called Family/friend Activation to Motivate Self-Care for those with Type 1 Diabetes
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.
Digital resources for diabetesBehavioural
Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: FAMS-T1D; Behavioral: 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. Receives: Behavioral: Digital resources for diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline and 6, 9, and 12 months post baseline
Secondary outcomes (1)
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)
Measured: Baseline and 6, 9, and 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start25 Apr 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, University of California, Merced, Children's Hospital Los Angeles, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Cynthia Berg, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820477
- Sponsor's protocol ID
- 00148660
- Other IDs
- 1R01DK124719
- Acronym
- FAMS-T1D
- Status last verified
- Oct 2025
- First submitted
- 7 Apr 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigators
Publications
Berg CA, Wiebe DJ, Mansfield JH, Raymond JK, Sandoval MV, LeStourgeon LM, Roddy MK, Ellis EB, Darow EL, Gonzalez F, Boyd SA, Spieker AJ, Butner JE, Greevy RA, Mayberry LS. Randomized controlled trial evaluating a mHealth intervention to optimize self- and social-regulation for emerging adults with type 1 diabetes (FAMS-T1D): protocol and lessons learned. Contemp Clin Trials. 2026 Oct 25:108508. doi: 10.1016/j.cct.2026.108508. Online ahead of print.
PubMed 42927777
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-Regulation and Social Support for Type 1 Diabetes During Emerging Adulthood (FAMS-T1D)
- ClinicalTrials.gov ID
- NCT05820477
- Acronym / sponsor ID
- FAMS-T1D / 00148660
- Conditions
- Type 1 Diabetes
- Keywords
- emerging adults, social support, goal setting, diabetes distress, HbA1c, self-efficacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, University of California, Merced, Children's Hospital Los Angeles, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAMS-T1D | Experimental | Behavioral: FAMS-T1D, Behavioral: Digital resources for diabetesParticipants 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. |
| Digital resources for diabetes | Placebo comparator | Behavioral: Digital resources for diabetesPersons 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 may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAMS-T1DAlso: Family/friend Activation to Motivate Self-Care for those with Type 1 DiabetesBehavioral 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. | Behavioural | FAMS-T1D |
| Digital resources for diabetesBehavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly. | Behavioural | Digital resources for diabetes, FAMS-T1D |
Primary outcome
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
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)
1 secondary outcome
Diabetes Distress (Person with Diabetes)
Time frame: Baseline and 6, 9, and 12 months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Derived from this study: PubMed 42927777Berg CA, Wiebe DJ, Mansfield JH, Raymond JK, Sandoval MV, LeStourgeon LM, Roddy MK, Ellis EB, Darow EL, Gonzalez F, Boyd SA, Spieker AJ, Butner JE, Greevy RA, Mayberry LS. Randomized controlled trial evaluating a mHealth intervention to optimize self- and social-regulation for emerging adults with type 1 diabetes (FAMS-T1D): protocol and lessons learned. Contemp Clin Trials. 2026 Oct 25:108508. doi: 10.1016/j.cct.2026.108508. Online ahead of print.
- Individual participant dataSharing planned: Yes. After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAMS-T1D and Digital resources for diabetes in people with Type 1 Diabetes, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (Person with Diabetes) (time frame: Baseline and 6, 9, and 12 months post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.