Clinical trial NCT04981808: Diabetes teleMonitoring of Patients in Insulin Therapy
Official title: The Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT) Trial: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: Diabetes
Insulin
Telemedicine
Telehealth
Telemonitoring
CGM
Adherence
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Sjaelland
name: Novo Nordisk A/S
name: Glooko
name: DexCom, Inc.
First posted: 2021-07-29
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: CGM time in range
timeFrame: At baseline to three months after randomization
Secondary outcomes:
measure: Concentration of HbA1c
timeFrame: At baseline to three months after randomization
measure: Total daily units of insulin
timeFrame: At baseline to three months after randomization
measure: Time below CGM range
timeFrame: At baseline to three months after randomization
measure: Time above CGM range
timeFrame: At baseline to three months after randomization
Other outcomes:
measure: Number of CGM days worn
timeFrame: During the intervention
measure: CGM percentage of time active
timeFrame: During the intervention
measure: Mean glucose
timeFrame: At baseline to three months after randomization
measure: Glycemic variability
timeFrame: At baseline to three months after randomization
measure: Time in hyperglycemia
timeFrame: At baseline to three months after randomization
measure: Time in hypoglycemia
timeFrame: At baseline to three months after randomization
measure: Episodes of hyperglycemia
timeFrame: At baseline to three months after randomization
measure: Episodes of hypoglycemia
timeFrame: At baseline to three months after randomization
measure: Use of the telemonitoring equipment
timeFrame: Through study completion, an average of 3 months
measure: Telemonitoring usability
timeFrame: Immediately after the intervention
measure: Diabetes-related quality of life
timeFrame: From baseline to three months after randomization
measure: Health-related quality of life
timeFrame: From baseline to three months after randomization
Locations:
city: Aalborg
country: Denmark
facility: Department of Endocrinology
Study officials:
References: