Diabetes teleMonitoring of Patients in Insulin Therapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Treated With Insulin

Intervention / Treatment
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* Device: Telemonitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br>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) | Device: Telemonitoring<br>* Telemonitoring of CGM and insulin pen data<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM time in range | Change in CGM time in range (3,9-10,0 mmol/L) | At baseline to three months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of HbA1c | Change in HbA1c | At baseline to three months after randomization | 
| Total daily units of insulin | Change in total daily dose of insulin (units) | At baseline to three months after randomization | 
| Time below CGM range | Change in time below range (CGM) | At baseline to three months after randomization | 
| Time above CGM range | Change in time above range (CGM) | At baseline to three months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin, Telemedicine, Telehealth, Telemonitoring, CGM, Adherence