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

February 5, 2026 updated by: Peter Vestergaard, Aalborg University Hospital

The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The DiaTRUST trial is an open-label randomized controlled trial with a three-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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • North Jutland
      • Aalborg, North Jutland, Denmark, 9000
        • Recruiting
        • Department of Endocrinology
        • Contact:
        • Principal Investigator:
          • Peter Vestergaard, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: Intelligent telemonitoring
Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.
Active Comparator: 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)
Device: Telemonitoring
Telemonitoring using CGM, insulin pen data, and Fitbit data
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CGM time in range
Time Frame: At baseline to three months after randomization
Change in CGM time in range (3,9-10,0 mmol/L)
At baseline to three months after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentration of HbA1c
Time Frame: At baseline to three months after randomization
Change in HbA1c
At baseline to three months after randomization
Total daily units of insulin
Time Frame: At baseline to three months after randomization
Change in total daily dose of insulin (units)
At baseline to three months after randomization
Diabetes-related quality of life
Time Frame: From baseline to three months after randomization
Diabetes-related quality of life measured by the DIDP Questionnaire. Ranges from "very negative" to "very positive"
From baseline to three months after randomization
Number of hypoglycemic episodes
Time Frame: At baseline to three months after randomization
Change in number of hypoglycemic episodes
At baseline to three months after randomization
Number of hyperglycemic episodes
Time Frame: At baseline to three months after randomization
Change in number of hyperglycemic episodes
At baseline to three months after randomization
Body weight
Time Frame: At baseline to three months after randomization
Change in body weight
At baseline to three months after randomization
CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L)
Time Frame: At baseline to three months after randomization
Change in 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)
Time Frame: At baseline to three months after randomization
Change in 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)
Time Frame: At baseline to three months after randomization
Change in CGM time above range (10.1-13.9 mmol/L)
At baseline to three months after randomization
CGM time in level 2 hyperglycemia (>13.9 mmol/L)
Time Frame: At baseline to three months after randomization
Change in CGM time above range (>13.9 mmol/L)
At baseline to three months after randomization
Use of the telemonitoring equipment
Time Frame: Through study completion, an average of three months
The frequency of use of the telemonitoring equipment
Through study completion, an average of three months
Time-to-target
Time Frame: At baseline to three months after randomization
time until individualized treatment targets are reached
At baseline to three months after randomization
Time efficiency
Time Frame: At baseline to three months after randomization
Between-group difference in time spent on contact with subjects and on treatment evaluation and adjustment by hospital staff
At baseline to three months after randomization
Fear of hypoglycemia
Time Frame: At baseline to three months after randomization
Change in fear of hypoglycemia measured by Hypoglycemia Fear Survey-II short form (HFS-II short form) ranges from "never" to "almost always"
At baseline to three months after randomization
Health-related quality of life
Time Frame: From baseline to three months after randomization
Health-related quality of life measured by the European Quality of Life Five Dimension Questionnaire (EQ-5D-5L). Options are not numeric in the descriptive part and follow the VAS scale in the second rating part ranging from 0 (The worst health you can image) to 100 (The best health you can image).
From baseline to three months after randomization
Change in patient adherence
Time Frame: From baseline to three months after randomization
Patient adherence measured by the Insulin Adherence Questionnaire. Options are not numeric
From baseline to three months after randomization
Satisfaction with telemonitoring solution
Time Frame: At the three month assessment
Satisfaction with telemonitoring solution measured by Digital Health Solution Satisfaction questionnaire (DHSS)
At the three month assessment
Change in treatment satisfaction
Time Frame: From baseline to three months after randomization
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
From baseline to three months after randomization
Change in perceived competence in Diabetes
Time Frame: From baseline to three months after randomization
Perceived competence in Diabetes measured by the Perceived competence in Diabetes questionnaire (PCD)
From baseline to three months after randomization
Change in CGM
Time Frame: Three months after randomization
Change from baseline in CGM time in level 2 hypoglycemia (<3.0 mmol/L)
Three months after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean glucose
Time Frame: At baseline to three months after randomization
Mean glucose levels (mmol/l) measured by CGM
At baseline to three months after randomization
Number of CGM days worn
Time Frame: During the intervention and active comparator
Number of days that the subjects wear the CGM
During the intervention and active comparator
CGM percentage of time active
Time Frame: During the intervention and active comparator
Percentage of time that the CGM is active
During the intervention and active comparator
Glycemic variability
Time Frame: At baseline to three months after randomization
Glycemic variability - percentage of coefficient of variation
At baseline to three months after randomization
Glucose management indicator
Time Frame: At baseline to three months after randomization
Change in estimated A1c (%) derived from CGM
At baseline to three months after randomization
Self-reported adherence
Time Frame: Through study completion, an average of 6 months
Self-reported adherence insights from contacts between hospital staff and patients during the trial in the telemonitoring groups. Topics of conversation related to self-reported adherence will be collected based on predefined themes (e.g., missing basal dose due to forgetfulness, varying basal insulin dose during a week due to error on smartpen).
Through study completion, an average of 6 months
Insulin doses
Time Frame: Through study completion, an average of 6 months
Any differences in the use of insulin in terms of dosing between the three groups are examined based on data from the insulin pens, e.g., differences in the amount of insulin taken per patient (measured by units per insulin type), and differences in change in insulin dose during the trial period (measured by units).
Through study completion, an average of 6 months
Insulin dosing time
Time Frame: Through study completion, an average of 6 months
Any differences in the use of insulin in terms of timing of the dosing between the three groups are examined based on data from the insulin pens, e.g., differences in injection patterns.
Through study completion, an average of 6 months
Dietary habits
Time Frame: At baseline to three months after randomization
Change in diet habits collected by predefined questions. Options are not numeric.
At baseline to three months after randomization
Exercise habits
Time Frame: At baseline to three months after randomization
Change in exercise habits collected by predefined questions. Options are not numeric.
At baseline to three months after randomization
Self-reported information on diet and exercise habits
Time Frame: Through study completion, an average of 3 months
Self-reported information on diet and exercise habits collected from the contacts between hospital staff and patients throughout the trial period. Notes will be collected based on these conservations on e.g., the patient's realising impact of certain foods in blood glucose variations, patient and hospital staff agree to try reach a higher number of steps per day.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novo Nordisk A/S
DexCom, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Vestergaard, MD, PhD, Steno Diabetes Center North Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DiaTRUST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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