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

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ClinicalTrials.gov Identifier: NCT05854069
Recruitment Status : Recruiting
First Posted : May 11, 2023
Last Update Posted : May 11, 2023
Sponsor:
Collaborators:
The Leona M. and Harry B. Helmsley Charitable Trust
University of Utah
University of California, Merced
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Lindsay Mayberry, Vanderbilt University Medical Center

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: FAMS-T1D Behavioral: Digital resources for diabetes Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Actual Study Start Date : April 4, 2023
Estimated Primary Completion Date : January 31, 2027
Estimated Study Completion Date : April 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: FAMS-T1D

Participants 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.

 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.

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

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

Behavioral: Digital resources for diabetes
Quality digital resources about diabetes management provided upon enrollment and during the study.
Placebo Comparator: Digital resources for 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: Digital resources for diabetes
Quality digital resources about diabetes management provided upon enrollment and during the study.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05854069


Contacts
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Contact: Lindsay S Mayberry, PhD, MS 615-875-5821 lindsay.mayberry@vumc.org
Contact: Erin M Bergner, PhD, MPH 615-936-7640 erin.m.bergner@vumc.org

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Cynthia A. Berg, PhD    801-581-8239    cynthia.berg@psych.utah.edu   
Contact: Jessica Mansfield, MS    801-585-1501    jessica.mansfield@psych.utah.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center
The Leona M. and Harry B. Helmsley Charitable Trust
University of Utah
University of California, Merced
Children's Hospital Los Angeles
More Information
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Responsible Party: Lindsay Mayberry, Principle Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05854069    
Other Study ID Numbers: 220847
G-2203-05822 ( Other Grant/Funding Number: The Leona M. and Harry B. Helmsley Charitable Trust )
First Posted: May 11, 2023    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
Access Criteria: Contact the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lindsay Mayberry, Vanderbilt University Medical Center:
Continuous glucose monitor
Social support
Goal setting
Diabetes distress
Hemoglobin A1c
 Time in range
Emerging adults
Family support
Text message
Mobile health
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases