Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT)

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

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.

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.

The subjects will be telemonitored. All subject will use a CGM, a fit bit, and a smart pen during the entire trial period. Staff at the endocinology clinics will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject)

The subjects will wear a blinded CGM the first and final 20 days of the trial. The subjects will use a blinded smart pen throughout the trial period. Hence, the subjects are unable to see their measured data during the trial, and they will not be monitored.

Telemonitoring satisfaction and usability measured by the Telemonitoring Usability Questionnaire (TUQ). Minimum value =1, maximum value =7. A higher score = a better outcome

Diabetes-related quality of life measured by the DIDP Questionnaire. Ranges from "very negative" to "very positive"

Inclusion Criteria: ≥ 18 years T2D diagnosis for ≥ 12 months Residence in Region North Denmark or Region Zealand In treatment with insulin Being able to use a smartphone along with the other devices to be used in the trial Able to understand and read Danish. Exclusion Criteria: Pregnancy or breastfeeding, Major surgery planned during the trial period Participation in other trials Terms that, in the opinion of the investigator or subinvestigators, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate