Type 2 Diabetes Treated With InsulinDiaTRUSTNCT06185296
The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
A study testing Intelligent telemonitoring and Telemonitoring in people with Type 2 Diabetes Treated With Insulin, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Intelligent telemonitoring and Telemonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stine Hangaard, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Endocrinology
Aalborg, North Jutland, 9000
Katrine Vogensen, 004524794472, k.vogensen@rn.dk
Peter Vestergaard, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Intelligent telemonitoring, Telemonitoring
- Keywords
- Diabetes, Insulin, Telemedicine, Telehealth, Telemonitoring, CGM, Wearable devices, Adherence, Decision support, Algorithms
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent telemonitoringDevice
Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.
TelemonitoringDevice
Telemonitoring using CGM, insulin pen data, and Fitbit data
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM time in range
Change in CGM time in range (3,9-10,0 mmol/L)
Measured: At baseline to three months after randomization
Secondary outcomes (20)
Concentration of HbA1c
Change in HbA1c
Measured: At baseline to three months after randomization
CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L)
Change in CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L)
Measured: At baseline to three months after randomization
CGM time in level 2 hypoglycemia (<3.0 mmol/L)
Change in CGM time in level 2 hypoglycemia (<3.0 mmol/L)
Measured: At baseline to three months after randomization
CGM time in level 1 hyperglycemia (10.1-13.9 mmol/L)
Change in CGM time above range (10.1-13.9 mmol/L)
Measured: At baseline to three months after randomization
CGM time in level 2 hyperglycemia (>13.9 mmol/L)
Change in CGM time above range (>13.9 mmol/L)
Measured: At baseline to three months after randomization
Total daily units of insulin
Change in total daily dose of insulin (units)
Measured: At baseline to three months after randomization
Number of hypoglycemic episodes
Change in number of hypoglycemic episodes
Measured: At baseline to three months after randomization
Number of hyperglycemic episodes
Change in number of hyperglycemic episodes
Measured: At baseline to three months after randomization
Body weight
Change in body weight
Measured: At baseline to three months after randomization
Use of the telemonitoring equipment
The frequency of use of the telemonitoring equipment
Measured: Through study completion, an average of three months
Time-to-target
time until individualized treatment targets are reached
Measured: At baseline to three months after randomization
Time efficiency
Between-group difference in time spent on contact with subjects and on treatment evaluation and adjustment by hospital staff
Measured: At baseline to three months after randomization
Fear of hypoglycemia
Change in fear of hypoglycemia measured by Hypoglycemia Fear Survey-II short form (HFS-II short form) ranges from "never" to "almost always"
Measured: At baseline to three months after randomization
Diabetes-related quality of life
Diabetes-related quality of life measured by the DIDP Questionnaire. Ranges from "very negative" to "very positive"
Measured: From baseline to three months after randomization
Health-related quality of life
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).
Measured: From baseline to three months after randomization
Change in patient adherence
Patient adherence measured by the Insulin Adherence Questionnaire. Options are not numeric
Measured: From baseline to three months after randomization
Satisfaction with telemonitoring solution
Satisfaction with telemonitoring solution measured by Digital Health Solution Satisfaction questionnaire (DHSS)
Measured: At the three month assessment
Change in treatment satisfaction
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Measured: From baseline to three months after randomization
Change in perceived competence in Diabetes
Perceived competence in Diabetes measured by the Perceived competence in Diabetes questionnaire (PCD)
Measured: From baseline to three months after randomization
Change in CGM
Change from baseline in CGM time in level 2 hypoglycemia (<3.0 mmol/L)
Measured: Three months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start15 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, DexCom, Inc.
- Responsible party
- Principal investigator, Peter Vestergaard, Aalborg University Hospital
- Investigators
- Peter Vestergaard, MD, PhD, Principal investigator, Steno Diabetes Center North Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185296
- Sponsor's protocol ID
- DiaTRUST
- Acronym
- DiaTRUST
- Status last verified
- Feb 2026
- First submitted
- 6 Dec 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39511648
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06185296
- Acronym / sponsor ID
- DiaTRUST / DiaTRUST
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- Diabetes, Insulin, Telemedicine, Telehealth, Telemonitoring, CGM, Wearable devices, Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, DexCom, Inc.
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intelligent telemonitoring | Experimental | Device: Intelligent telemonitoringThe 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. |
| Telemonitoring | Active comparator | Device: TelemonitoringThe 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) |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent telemonitoringTelemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support. | Device | Intelligent telemonitoring |
| TelemonitoringTelemonitoring using CGM, insulin pen data, and Fitbit data | Device | Telemonitoring |
Primary outcome
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)
20 secondary outcomes
Concentration of HbA1c
Time frame: 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
CGM time in level 2 hypoglycemia (<3.0 mmol/L)
Time frame: 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
CGM time in level 2 hyperglycemia (>13.9 mmol/L)
Time frame: At baseline to three months after randomization
Total daily units of insulin
Time frame: At baseline to three months after randomization
Number of hypoglycemic episodes
Time frame: At baseline to three months after randomization
Number of hyperglycemic episodes
Time frame: At baseline to three months after randomization
Body weight
Time frame: At baseline to three months after randomization
Use of the telemonitoring equipment
Time frame: Through study completion, an average of three months
Time-to-target
Time frame: At baseline to three months after randomization
Time efficiency
Time frame: At baseline to three months after randomization
Fear of hypoglycemia
Time frame: At baseline to three months after randomization
Diabetes-related quality of life
Time frame: From baseline to three months after randomization
Health-related quality of life
Time frame: From baseline to three months after randomization
Change in patient adherence
Time frame: From baseline to three months after randomization
Satisfaction with telemonitoring solution
Time frame: At the three month assessment
Change in treatment satisfaction
Time frame: From baseline to three months after randomization
Change in perceived competence in Diabetes
Time frame: From baseline to three months after randomization
Change in CGM
Time frame: Three months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 39511648Thomsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stine Hangaard, PhD contact
Peter Vestergaard, MD, PhD principal investigator
Steno Diabetes Center North Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent telemonitoring and Telemonitoring in people with Type 2 Diabetes Treated With Insulin, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jannie Nørlev, PhD (004523676513, jadano@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGM time in range (time frame: At baseline to three months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06185296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.