The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy

NCT ID: NCT06185296

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-06-30

Brief Summary

The trial is an open-label, randomized controlled trial. Patients with T2D on insulin therapy will be randomized to an intelligent telemonitoring group (intervention), a telemonitoring group (control), and a usual care group (control). Both the intelligent telemonitoring group and the telemonitoring group will use various devices at home. Hospital staff will monitor their data for six months. In the intelligent telemonitoring group, hospital staff and participants will be supported by decision-support algorithms in the management of insulin treatment.

Detailed Description

The DiaTRUST trial is an open-label randomized controlled trial with a six-month trial period. The trial will be conducted at Steno Diabetes Center North Jutland. Patients with T2D on insulin therapy will be randomized (3:1:1) to an intelligent telemonitoring group (intervention), telemonitoring alone (control), or a usual care group (control). Both telemonitoring groups 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. For patients assigned to the intelligent telemonitoring group, decision support algorithms will provide hospital staff with insight and data overviews to support treatment evaluation and adjustment throughout the trial. Furthermore, patients in the intelligent telemonitoring group will have access to algorithms through a smartphone application that can provide a risk assessment before bed of nocturnal hypoglycemia. The usual care group will use a blinded CGM for the first 20 days after inclusion, 20 days before the second visit to the trial site, and 20 days before the end of 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

Intelligent telemonitoring

The subjects will be telemonitored using the intelligent telemonitoring system. All subjects will use a CGM, a Fitbit, and a smart pen during the trial period. Staff at the endocrinology clinic will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject) using the intelligent telemonitoring system with embedded decision support to facilitate treatment evaluation and adjustments. The subjects will have access to a smartphone app that is able to provide a risk for nocturnal hypoglycemia before bed.

Group Type: EXPERIMENTAL

Intelligent telemonitoring

Intervention Type: DEVICE

Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.

Telemonitoring

The subjects will be telemonitored. All subjects will use a CGM, a Fitbit, and a smart pen during the entire trial period. Staff at the endocrinology clinic will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject)

Group Type: ACTIVE_COMPARATOR

Telemonitoring

Intervention Type: DEVICE

Telemonitoring using CGM, insulin pen data, and Fitbit data

Usual care

The subjects will wear a blinded CGM the first 20 days after inclusion, 20 days before the second visit to the trial site, and the final 20 days of the trial. The subjects will use a blinded smart pen throughout the trial period. Hence, the subjects cannot see their measured data during the trial and will not be monitored.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intelligent telemonitoring

Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.

Intervention Type: DEVICE

Telemonitoring

Telemonitoring using CGM, insulin pen data, and Fitbit data

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults ≥ 18 years.
• Diagnosis of T2D for at least 12 months prior to the day of screening.
• Patients who are being treated with insulin or about to start insulin treatment (insulin naïve) willing to travel to trial site in North Denmark to attend in-person visits.
• Have internet at home, have MitID, and willingness to use a smartphone and the other devices used in the trial
• Signed informed consent.
• Ability to understand and read Danish.

Exclusion Criteria

• Pregnancy or breastfeeding.
• Major surgery is planned during the trial period.
• Cancer diagnosis within five years prior to inclusion.
• Participation in other interventional trials.
• Limited literacy affecting the use of trial devices.
• Patient who has worn a CGM monitor less than 6 months prior to the trial.
• Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate.
• Patients treated with mixed insulin.

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

Sponsors

Novo Nordisk A/S

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

Principal Investigators

Peter Vestergaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center North Denmark

Locations

Department of Endocrinology

Aalborg, North Jutland, Denmark

Countries

Denmark

Central Contacts

Camilla Thomsen

Role: CONTACT

chnt@hst.aau.dk

004530646241

Thomas Larsen

Role: CONTACT

tkl@hst.aau.dk

004525617380

Facility Contacts

Katrine Vogensen

Role: primary

k.vogensen@rn.dk

004524794472

References

Thomsen CHN, Norlev JTD, Hangaard S, Jensen MH, Hejlesen O, Cohen SR, Kofoed-Enevoldsen A, Kristensen SNS, Aradottir TB, Kaas A, Vestergaard P, Kronborg T. The intelligent diabetes telemonitoring using decision support to treat patients on insulin therapy (DiaTRUST) trial: study protocol for a randomized controlled trial. Trials. 2024 Nov 8;25(1):744. doi: 10.1186/s13063-024-08588-7.

Reference Type: DERIVED

PMID: 39511648 (View on PubMed)

Other Identifiers

DiaTRUST

Identifier Type: -

Identifier Source: org_study_id