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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
331
Telemonitoring of CGM and insulin pen data
Department of Endocrinology
Aalborg, Denmark
CGM time in range
Change in CGM time in range (3,9-10,0 mmol/L)
Time frame: At baseline to three months after randomization
Concentration of HbA1c
Change in HbA1c
Time frame: At baseline to three months after randomization
Total daily units of insulin
Change in total daily dose of insulin (units)
Time frame: At baseline to three months after randomization
Time below CGM range
Change in time below range (CGM)
Time frame: At baseline to three months after randomization
Time above CGM range
Change in time above range (CGM)
Time frame: At baseline to three months after randomization
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