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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
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.
Quality digital resources about diabetes management provided upon enrollment and during the study.
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of Utah
Salt Lake City, Utah, United States
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
Time frame: Baseline and 6 months post-baseline
CGM frequency of use during the intervention period
Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better)
Time frame: Baseline and 6 months post-baseline
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)
Time frame: 6 months post-baseline
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)
Time frame: Baseline and 6 months post-baseline
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)
Time frame: Baseline and 6 months post-baseline
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)
Time frame: Baseline and 6 months post-baseline
CGM satisfaction during the intervention period
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Change in CGM satisfaction assessed by Benefits of CGM scale; higher scores indicate more perceived benefits of CGM use (better)
Time frame: Baseline and 6 months post-baseline