The intelligent diabetes telemonitoring using decision support to treat patients on insulin therapy (DiaTRUST) trial: study protocol for a randomized controlled trial.

Background: Diabetes affects 10.5% of adults globally, with type 2 diabetes accounting for 90-95% of cases. Achieving optimal glycemic control is crucial yet challenging, particularly with insulin therapy, where 30-50% of patients fail to meet treatment targets. Telemedicine can improve diabetes management but generates vast amounts of data, burdening healthcare professionals. Integrating clinical decision support tools into telemonitoring systems may enhance care efficiency and glycemic control.

Methods: The trial is a multicenter 3-month, three-arm, open-label, randomized controlled trial. The trial aims to enroll 51 participants with type 2 diabetes on insulin therapy. Participants will be divided with a 3:1:1 ratio into telemonitoring with decision support, telemonitoring without decision support, and usual care groups. The study employs connected insulin pens, continuous glucose monitors (CGMs), and activity trackers to enable telemonitoring. Outcomes measured include CGM time in range, HbA1c, hypo- and hyperglycemia incidents, total daily insulin dose, body weight, treatment satisfaction, and adherence.

Discussion: Telemonitoring with decision support has the potential to revolutionize diabetes management by offering personalized treatment suggestions, thereby reducing the burden on healthcare professionals, and improving patient outcomes. This study will provide valuable insights into the effectiveness of such an approach in achieving glycemic control in people with type 2 diabetes on insulin therapy. By evaluating both clinical outcomes and patient and healthcare professionals' satisfaction, the study aims to contribute to the development of efficient, scalable telehealth solutions for diabetes care.

Trial registration: ClinicalTrials.gov NCT06185296. Registered on December 14, 2023.