Diabetes teleMonitoring of Patients in Insulin Therapy

NCT ID: NCT04981808

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 331 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2023-11-24

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.

Conditions

Type 2 Diabetes Treated With Insulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Telemonitoring

Intervention Type: DEVICE

Telemonitoring of CGM and insulin pen data

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telemonitoring

Telemonitoring of CGM and insulin pen data

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Sjaelland

OTHER_GOV

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Glooko

INDUSTRY

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Vestergaard

MD, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Endocrinology

Aalborg, , Denmark

Countries

Denmark

References

Hangaard S, Kronborg T, Hejlesen O, Aradottir TB, Kaas A, Bengtsson H, Vestergaard P, Jensen MH. The Diabetes teleMonitoring of patients in insulin Therapy (DiaMonT) trial: study protocol for a randomized controlled trial. Trials. 2022 Dec 7;23(1):985. doi: 10.1186/s13063-022-06921-6.

Reference Type: DERIVED

PMID: 36476605 (View on PubMed)

Other Identifiers

N-20200068

Identifier Type: -

Identifier Source: org_study_id