Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study

Abstract

BackgroundProper training and follow-up for patients new to continuous glucose monitor (CGM) use are required to maintain adherence and achieve diabetes-related outcomes. However, CGM training is hampered by the lack of evidence-based standards and poor reimbursement. We hypothesized that web-based CGM training and education would be effective and could be provided with minimal burden to the health care team. ObjectiveThe aim of this study was to perform a pilot feasibility study testing a theory-driven, web-based intervention designed to provide extended training and follow-up support to adolescents and young adults newly implementing CGM and to describe CGM adherence, glycemic control, and CGM-specific psychosocial measures before and after the intervention. MethodsThe “Intervention Designed to Educate and improve Adherence through Learning to use CGM (IDEAL CGM)” web-based training intervention was based on supporting literature and theoretical concepts adapted from the health belief model and social cognitive theory. Patients new to CGM, who were aged 15-24 years with type 1 diabetes for more than 6 months were recruited from within a public university’s endocrinology clinic. Participants were randomized to enhanced standard care or enhanced standard care plus the IDEAL CGM intervention using a 1:3 randomization scheme. Hemoglobin A1c levels and psychosocial measures were assessed at baseline and 3 months after start of the intervention. ResultsTen eligible subjects were approached for recruitment and 8 were randomized. Within the IDEAL CGM group, 4 of the 6 participants received exposure to the web-based training. Half of the participants completed at least 5 of the 7 modules; however, dosage of the intervention and level of engagement varied widely among the participants. This study provided proof of concept for use of a web-based intervention to deliver follow-up CGM training and support. However, revisions to the intervention are needed in order to improve engagement and determine feasibility. ConclusionsThis pilot study underscores the importance of continued research efforts to optimize the use of web-based intervention tools for their potential to improve adherence and glycemic control and the psychosocial impact of the use of diabetes technologies without adding significant burden to the health care team. Enhancements should be made to the intervention to increase engagement, maximize responsiveness, and ensure attainment of the skills necessary to achieve consistent use and improvements in glycemic control prior to the design of a larger well-powered clinical trial to establish feasibility. Trial RegistrationClinicalTrials.gov NCT03367351, https://clinicaltrials.gov/ct2/show/NCT03367351.