A Randomized Trial of Intelligent Telemonitoring and Decision Support for Adults with Type 2 Diabetes on Insulin Therapy

What this Trial Is About

Researchers are evaluating telemonitoring methods to support insulin treatment in adults with type 2 diabetes T2D who are on insulin therapy. This open-label, randomized controlled trial compares an intelligent telemonitoring system that uses decision-support algorithms with regular telemonitoring and usual care. The study aims to understand how these technologies affect glucose control and treatment management over a three-month period. Participants will be randomly assigned to one of three groups the intelligent telemonitoring group, the telemonitoring group, or the usual care group. Both telemonitoring groups will use devices including a continuous glucose monitor CGM, an insulin pen, an activity tracker Fitbit, and a smartphone application during the trial. The intelligent telemonitoring group additionally benefits from decision-support algorithms accessible to both hospital staff and patients, including a risk assessment tool for nocturnal hypoglycemia. Hospital staff will monitor data and contact participants by telephone as needed. The usual care group will use blinded devices and will not have their data monitored during the trial. Participants will attend in-person visits at the trial site and have their glucose and insulin data closely monitored by hospital staff throughout the three-month trial. Assessments include continuous glucose monitoring metrics such as time in range, hypoglycemia and hyperglycemia episodes, HbA1c levels, insulin use, weight, quality of life measures, and treatment satisfaction. Researchers will track device usage and treatment adherence, while safety and overall health will be monitored during the study period ending in September 2026.

The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy