Diabetes teleMonitoring of Patients in Insulin Therapy — DiaMonT  

Type 2 Diabetes Treated With Insulin Clinical Trial

Official title: The Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT) Trial: Study Protocol for a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

The trial is an open-label randomized controlled trial. Patients with T2D on insulin therapy will be randomized to a telemonitoring group (intervention) and a usual care group (control). The telemonitoring group will use various devices at home. Hospital staff will monitor their data for a period of three months.

Clinical Trial Description

The DiaMonT trial is an open-label randomized controlled trial with a trial period of three months conducted. The trial will be conducted in two sites in Denmark: Steno Diabetes Center North Jutland and Steno Diabetes Center Zealand. Patients with T2D on insulin therapy will be randomized (1:1) to a telemonitoring group (intervention) or a usual care group (control). The telemonitoring group will use an insulin pen, an activity tracker, a CGM, and a smartphone application throughout the trial period. Hospital staff (lab technicians and nurses) will monitor the telemonitoring groups' data and contact the subjects by telephone repeatedly throughout the trial period. The usual care group will use a blinded CGM the first and last 20 days of the trial and will use a blinded insulin pen for the entire period. The usual care groups' data will not be monitored during the trial. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes Treated With Insulin

• NCT number: NCT04981808
• Study type: Interventional
• Source: Aalborg University Hospital
• Status: Completed
• Phase: N/A
• Start date: August 18, 2021
• Completion date: November 24, 2023