NCT04981808

Diabetes teleMonitoring of Patients in Insulin Therapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type 2 Diabetes Treated With Insulin

Interventions

Type	Name	Description
DEVICE	Telemonitoring	Telemonitoring of CGM and insulin pen data

Timeline

• Start date: 2021-08-18
• Primary completion: 2023-11-24
• Completion: 2023-11-24
• First posted: 2021-07-29
• Last updated: 2024-01-31

Locations

1 site across 1 country: Denmark