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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05854069
• Other study ID #: 220847
• Secondary ID: G-2203-05822
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: June 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: April 30, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Utah	Salt Lake City	Utah

Sponsors (5)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Children's Hospital Los Angeles, The Leona M. and Harry B. Helmsley Charitable Trust, University of California, Merced, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Data sharing during the intervention period	Number of data sharing relationships, between groups; more is better	6 months post-baseline
Other	Satisfaction with data-sharing relationships	Satisfaction with data-sharing relationships assessed by CGM-Satisfaction Scale; higher scores are better	6 months post-baseline
Primary	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	Baseline and 6 months post-baseline
Primary	CGM frequency of use during the intervention period	Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better)	Baseline and 6 months post-baseline
Primary	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)	6 months post-baseline
Secondary	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)	Baseline and 6 months post-baseline
Secondary	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)	Baseline and 6 months post-baseline
Secondary	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)	Baseline and 6 months post-baseline
Secondary	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)	Baseline and 6 months post-baseline