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

Vanderbilt University Medical Center

Status: Active, not recruiting

Conditions: Type 1 Diabetes

Treatments: Behavioral: FAMS-T1D; Behavioral: Digital resources for diabetes

Study type: Interventional

Funder types: Other

Identifiers

NCT05854069

220847

G-2203-05822 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups, including a placebo group

FAMS-T1D

Experimental group

Description:

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.

Treatment:

Behavioral: Digital resources for diabetes

Behavioral: FAMS-T1D

Digital resources for diabetes

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Digital resources for diabetes