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Feasibility of The Web-Based IDEAL CGM Training and Follow-Up Support Intervention: A Randomized Control Pilot Study
ABSTRACT
Background:
Proper training and follow-up for patients new to continuous glucose monitor (CGM) use is required to maintain adherence and achieve diabetes-related outcomes. However, CGM training is hampered by a lack of evidence-based standards and poor reimbursement for training. We hypothesized that web-based CGM training and education, targeting patient adherence, glycemic control and acceptance of the technology, would be effective and could be provided with minimal burden to the healthcare team.
Objective:
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 pre- and post-intervention.
Methods:
The “Intervention Designed to Educate and improve Adherence through Learning to use CGM”, (IDEAL CGM) web-based training intervention and evaluation of related outcome measures were determined using supporting literature and theoretical concepts adapted from the Health Belief Model and Social Cognitive Theory. Patients new to CGM ages 15-24 with type 1 diabetes for >6 months were recruited from within a public university’s endocrinology clinics. Participants were randomized to enhanced standard care or enhanced standard care plus the IDEAL CGM intervention using a 3:1 randomization scheme. Baseline HbA1c and psychosocial measures were assessed again within 3 months of CGM use.
Results:
In total, 10 eligible subjects were approached for recruitment and eight were randomized. Within the IDEAL CGM group 4/6 participants received exposure to the web-based training. This feasibility study demonstrated proof of concept and indicated that some components of the intervention may be effective despite insufficient evidence to determine the feasibility of the IDEAL CGM intervention and its described impact on diabetes-related outcomes.
Conclusions:
This research underscores the importance of continued research efforts to 1) establish evidence-based standards for training patients using CGM, 2) determine the dosage and/or level of educational exposure associated with improved outcomes and 3) determine key design elements of the web-based intervention necessary to increase engagement, dissuade attrition, and ensure attainment of the skills necessary to achieve consistent use and improvements in glycemic control. Findings from this pilot will be used to design future clinical interventions seeking to optimize CGM training. Clinical Trial: Registration: ClinicalTrials.gov NCT03367351, https://clinicaltrials.gov/ct2/show/NCT03367351.
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