Study Design: This is a non-pivotal, randomized, parallel group, two-arm, prospective study. This 60-day pilot study will evaluate the effect of a Nutrition-Focused Approach (NFA) versus a Self-Directed Approach (SDA) during CGM initiation in people with T2D. It is hypothesized that the NFA arm will see greater improvement in TIR than the SDA arm, due to the potential for dietary improvements that come from the NFA. To test this hypothesis, participants will be randomized 1:1 to either the NFA or the SDA arm. Participants in each arm complete baseline assessments, an in-person CGM initiation appointment, a remote follow-up appointment, and post-intervention assessments. Difference in changes between baseline and post-intervention periods will be assessed.
Arms: In brief, the NFA arm participants will receive introduction to CGM with emphasis placed on using the CGM data to adjust food choices. The NFA will encourage food choices that align with evidence-based nutrition recommendations for people with diabetes (PWD), and that achieve internationally recognized glucose targets (e.g. glucose 70-180 mg/dL, and TIR > 70%). The SDA arm participants will receive introduction to CGM using manufacturer-provided manuals and resources. The SDA will encourage participants to use the device and apps in the way they feel is most useful to them. The SDA is intended to reflect current CGM initiation practices, which focus on technical use of the CGM and a general review of CGM data.
Intervention: Prior to the intervention, there is an approximately 10-day baseline assessment period, which includes blinded baseline CGM data assessment. The intervention begins on Day 0, which is the day the CGM sensor is paired with apps on the participant’s personal cell phone. The intervention follows participants for approximately 50 days, which includes up to 10-days of post-intervention CGM data assessment (approximately Days 40 to 50). During the final 10 days, the participant is instructed to continue using the CGM device in accordance with the guidance provided based on randomization arm.
Sample Size: This study expects to enroll at least N=132 participants with the expectation for an analytic sample size of N=120. This sample size is based on the N needed to adequately power the primary hypothesis with a realistic and clinically meaningful effect size for % TIR.
Source: View full study details on ClinicalTrials.gov
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