Diabetes teleMonitoring of Patients in Insulin Therapy

Not Applicable

Completed

• Conditions: Type 2 Diabetes Treated With Insulin
• Interventions: Device: Telemonitoring

• Registration Number: NCT04981808
• Lead Sponsor: Aalborg University Hospital

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.

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-29
• Study Start: 2021-08-18
• Primary Completion: 2023-11-24
• Study Completion: 2023-11-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring	Telemonitoring	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)

Primary Outcome Measures

Name	Time	Method
CGM time in range	At baseline to three months after randomization	Change in CGM time in range (3,9-10,0 mmol/L)

Secondary Outcome Measures

Name	Time	Method
Time below CGM range	At baseline to three months after randomization	Change in time below range (CGM)
Total daily units of insulin	At baseline to three months after randomization	Change in total daily dose of insulin (units)
Concentration of HbA1c	At baseline to three months after randomization	Change in HbA1c
Time above CGM range	At baseline to three months after randomization	Change in time above range (CGM)

Trial Locations

Locations (1)

Department of Endocrinology; 🇩🇰 Aalborg, Denmark