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NCT Number: NCT05854069

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

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.

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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

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.

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 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)
  • 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

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 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

Treatment and study plan

FAMS-T1D

Behavioral

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.

Other names: Family/friend Activation to Motivate Self-Care for those with Type 1 Diabetes

Digital resources for diabetes

Behavioral

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

Primary outcomes

  1. CGM frequency of use during the intervention period

    Time frame: Baseline and 6 months post-baseline

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

  2. CGM frequency of use during the intervention period

    Time frame: Baseline and 6 months post-baseline

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

  3. Gaps in CGM use

    Time frame: 6 months post-baseline

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

Secondary outcomes

  1. CGM behavioral responses during the intervention period

    Time frame: Baseline and 6 months post-baseline

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

  2. Barriers to CGM use during the intervention period

    Time frame: Baseline and 6 months post-baseline

    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)

  3. Barriers to CGM use during the intervention period

    Time frame: Baseline and 6 months post-baseline

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

  4. CGM satisfaction during the intervention period

    Time frame: Baseline and 6 months post-baseline

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

Other outcomes

  1. Data sharing during the intervention period

    Time frame: 6 months post-baseline

    Number of data sharing relationships, between groups; more is better

  2. Satisfaction with data-sharing relationships

    Time frame: 6 months post-baseline

    Satisfaction with data-sharing relationships assessed by CGM-Satisfaction Scale; higher scores are better

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Children's Hospital Los Angeles
  • The Leona M. and Harry B. Helmsley Charitable Trust
  • University of California, Merced
  • University of Utah

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 11, 2023
Registry last updated
Oct 29, 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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