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

NCT06185296 | Recruiting

• 1 other identifier: DiaTRUST
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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 three months. In the intelligent telemonitoring group, hospital staff and participants will be supported by decision-support algorithms in the management of insulin treatment.

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Diabetes; Insulin; Telemedicine; Telehealth; Telemonitoring; CGM; Wearable devices; Adherence; Decision support; Algorithms

Outcome Measures

Primary Outcomes (1)

• CGM time in range

  Change in CGM time in range (3,9-10,0 mmol/L)

  At baseline to three months after randomization

Secondary Outcomes (20)

• Concentration of HbA1c

  At baseline to three months after randomization

• CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L)

  At baseline to three months after randomization

• CGM time in level 2 hypoglycemia (<3.0 mmol/L)

  At baseline to three months after randomization

• CGM time in level 1 hyperglycemia (10.1-13.9 mmol/L)

  At baseline to three months after randomization

• CGM time in level 2 hyperglycemia (>13.9 mmol/L)

  At baseline to three months after randomization

Other Outcomes (11)

• Self-reported adherence

  Through study completion, an average of 6 months

• Insulin doses

  Through study completion, an average of 6 months

• Insulin dosing time

  Through study completion, an average of 6 months

Study Arms (3)

Intelligent telemonitoring

EXPERIMENTAL

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.

Device: Intelligent telemonitoring

Telemonitoring

ACTIVE COMPARATOR

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)

Device: Telemonitoring

Usual care

NO INTERVENTION

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.

Interventions

Intelligent telemonitoring DEVICE

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

Intelligent telemonitoring

Telemonitoring DEVICE

Telemonitoring using CGM, insulin pen data, and Fitbit data

Telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or breastfeeding.
• Major surgery is planned during the trial period.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: collaborator
• DexCom, Inc.: collaborator
• Aalborg University Hospital: lead

Study Sites (1)

Department of Endocrinology

Aalborg, North Jutland, 9000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 39511648 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Peter Vestergaard, MD, PhD

  Steno Diabetes Center North Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannie Nørlev, PhD

CONTACT

004523676513; jadano@hst.aau.dk

Stine Hangaard, PhD

CONTACT

svh@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, professor

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 29, 2023
• Study Start: November 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)