AzTrials
AzTrials

Type 1 DiabetesNCT05854069

Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes

A study testing FAMS-T1D and Digital resources for diabetes in people with Type 1 Diabetes, run by Vanderbilt University Medical Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
2 sitesUnited States
Study dates
30 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 and receiving texts
  • Can speak, read, and write in English
  • Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)
Show all 11Show fewer
  • Using a continuous glucose monitor (CGM)
  • SUPPORT PERSONS
  • Age 18 or older
  • Can speak, read, and write in English or Spanish
  • Comfortable sending and receiving texts

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 the country during the study period
  • SUPPORT PERSONS
  • Shares a phone with the person with diabetes
  • Plans to live outside of the country during the study period

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.

Read the detailed description

FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication).

Within the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.

Conditions
Type 1 Diabetes
Being tested
FAMS-T1D, Digital resources for diabetes
Keywords
Continuous glucose monitor, Social support, Goal setting, Diabetes distress, Hemoglobin A1c, Time in range, Emerging adults, Family support, Text message, Mobile health
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

    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.

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

  • Digital resources for diabetesBehavioural

    Quality digital resources about diabetes management provided upon enrollment and during the study.

Study groups in NCT05854069
Study groupRoleWhat they receive
FAMS-T1DExperimentalParticipants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons 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 diabetesPlacebo comparatorAll 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: Digital resources for diabetes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CGM frequency of use during the intervention period

    Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better

    Measured: Baseline and 6 months post-baseline

  2. CGM frequency of use during the intervention period

    Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better)

    Measured: Baseline and 6 months post-baseline

  3. Gaps in CGM use

    Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse)

    Measured: 6 months post-baseline

Secondary outcomes (4)

  1. CGM behavioral responses during the intervention period

    Change in frequency of making behavioral changes in response to CGM data assessed by self-report; higher scores indicate more frequent response (better)

    Measured: Baseline and 6 months post-baseline

  2. Barriers to CGM use during the intervention period

    Change in perceived influence of CGM on glycemic control scale assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse)

    Measured: Baseline and 6 months post-baseline

  3. Barriers to CGM use during the intervention period

    Change in perceived influence of CGM on social complications assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse)

    Measured: Baseline and 6 months post-baseline

  4. CGM satisfaction during the intervention period

    Change in CGM satisfaction assessed by Benefits of CGM scale; higher scores indicate more perceived benefits of CGM use (better)

    Measured: Baseline and 6 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start30 Apr 2023
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854069
Sponsor's protocol ID
220847
Other IDs
G-2203-05822
Status last verified
Oct 2026
First submitted
24 Apr 2023
Last updated
3 Nov 2026
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 investigator.

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

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 Vanderbilt University Medical Center 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 11 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 3 Nov 2026. 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?

CGM frequency of use during the intervention period (time frame: Baseline and 6 months post-baseline). The study lists 3 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 NCT05854069, 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 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in