JMIR Publications

ABSTRACT

Background:

The adherence in people with type 2 diabetes (T2D) is overall suboptimal, which can hinder glycemic control. Multiple adherence barriers have been identified, e.g. dislike and fear of injections. Several of the recommended antidiabetic drugs are available in oral formulations and may be a good alternative to injection therapy when possible. However, strict dosing instruction, e.g. those of oral semaglutide (pre- and post-dose fasting and restricted water intake at dosing time) could be adherence barriers. Currently, oral semaglutide is the only oral glucagon-like peptide-1 receptor agonist and have only been available for a few years, therefore limited knowledge exists on adherence to it.

Objective:

The aim of this study is to investigate the effect of adherence to oral semaglutide dosing instructions on glycemic control in people with T2D, who are dysregulated on metformin and optionally an SGLT2i and naïve to oral semaglutide.

Methods:

This prospective, non-interventional, open-label, clinical trial with a duration of 12 weeks will be conducted in Denmark and had first participant first visit in April 2024. Eligible participants are adults (≥18 years) with dysregulated T2D (HbA1c of 53-75 mmol/mol) in treatment with metfor-min and optionally SGLT2i for whom the next natural step in the treatment is to add an antidiabet-ic drug to the treatment regimen. Potential participants are recruited through announcements e.g., on social media and digital mails send to the official digital mailbox (e-boks). During the trial, the 20 participants will be initiated on oral semaglutide and escalated in dosage in accordance with the label. Information on the participants’ behavior related to the dosing instructions will be collected using the following devices: a smart watch to track activity and sleep time, a smart pill bottle to track dosing time, a smart bottle to track time and volume of water intake at dosing time, and a smart phone to take a photo of the breakfast to log time of breakfast. The glycemic control will be assessed using an unblinded continuous glucose monitoring (CGM) sensor that the participants will wear. Participants are asked to report any cases of nausea or vomiting in terms of time of occurrence, duration, and severity. The primary endpoint is change from baseline to end-of-study in time-in-range (TIR) derived from CGM data.

Results:

Three months of high frequency temporal data on adherence behavior will be collected, despite the relatively few expected participants included.

Conclusions:

Participants may change their behavior due to awareness of being observed. Regardless, the knowledge gained from this trial might be integrated in a decision support system, providing people with diabetes with guidance on how to increase adherence and thereby potentially increase glycemic control. Clinical Trial: ClinicalTrials.gov identifier: NCT06333080. Registered on 27 March 2024, https://clinicaltrials.gov/study/NCT06333080.