Clinical trial NCT05854069: Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Official title: Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Continuous glucose monitor
Social support
Goal setting
Diabetes distress
Hemoglobin A1c
Time in range
Emerging adults
Family support
Text message
Mobile health
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
name: University of Utah
name: University of California, Merced
name: Children's Hospital Los Angeles
First posted: 2023-05-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: CGM frequency of use during the intervention period
timeFrame: Baseline and 6 months post-baseline
measure: CGM frequency of use during the intervention period
timeFrame: Baseline and 6 months post-baseline
measure: Gaps in CGM use
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: CGM behavioral responses during the intervention period
timeFrame: Baseline and 6 months post-baseline
measure: Barriers to CGM use during the intervention period
timeFrame: Baseline and 6 months post-baseline
measure: Barriers to CGM use during the intervention period
timeFrame: Baseline and 6 months post-baseline
measure: CGM satisfaction during the intervention period
timeFrame: Baseline and 6 months post-baseline
Other outcomes:
measure: Data sharing during the intervention period
timeFrame: 6 months post-baseline
measure: Satisfaction with data-sharing relationships
timeFrame: 6 months post-baseline
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: