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NCT Number: NCT06185296

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

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.

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Key information

Conditions

Type 2 Diabetes Treated With Insulin Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology

Aalborg, North Jutland, 9000, Denmark

Location status: Recruiting

Location contact

Katrine Vogensen

CONTACT

[email protected]

004524794472

Peter Vestergaard, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intelligent telemonitoring

Device

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

Telemonitoring

Device

Telemonitoring using CGM, insulin pen data, and Fitbit data

Primary outcomes

  1. 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)

Secondary outcomes

  1. Concentration of HbA1c

    Time frame: At baseline to three months after randomization

    Change in HbA1c

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Total daily units of insulin

    Time frame: At baseline to three months after randomization

    Change in total daily dose of insulin (units)

  7. Number of hypoglycemic episodes

    Time frame: At baseline to three months after randomization

    Change in number of hypoglycemic episodes

  8. Number of hyperglycemic episodes

    Time frame: At baseline to three months after randomization

    Change in number of hyperglycemic episodes

  9. Body weight

    Time frame: At baseline to three months after randomization

    Change in body weight

  10. Use of the telemonitoring equipment

    Time frame: Through study completion, an average of three months

    The frequency of use of the telemonitoring equipment

  11. Time-to-target

    Time frame: At baseline to three months after randomization

    time until individualized treatment targets are reached

  12. 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

  13. 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"

  14. 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"

  15. 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).

  16. 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

  17. Satisfaction with telemonitoring solution

    Time frame: At the three month assessment

    Satisfaction with telemonitoring solution measured by Digital Health Solution Satisfaction questionnaire (DHSS)

  18. Change in treatment satisfaction

    Time frame: From baseline to three months after randomization

    Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

  19. 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)

  20. Change in CGM

    Time frame: Three months after randomization

    Change from baseline in CGM time in level 2 hypoglycemia (<3.0 mmol/L)

Other outcomes

  1. 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).

  2. 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).

  3. 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.

  4. Number of CGM days worn

    Time frame: During the intervention and active comparator

    Number of days that the subjects wear the CGM

  5. CGM percentage of time active

    Time frame: During the intervention and active comparator

    Percentage of time that the CGM is active

  6. Mean glucose

    Time frame: At baseline to three months after randomization

    Mean glucose levels (mmol/l) measured by CGM

  7. Glycemic variability

    Time frame: At baseline to three months after randomization

    Glycemic variability - percentage of coefficient of variation

  8. Glucose management indicator

    Time frame: At baseline to three months after randomization

    Change in estimated A1c (%) derived from CGM

  9. Dietary habits

    Time frame: At baseline to three months after randomization

    Change in diet habits collected by predefined questions. Options are not numeric.

  10. Exercise habits

    Time frame: At baseline to three months after randomization

    Change in exercise habits collected by predefined questions. Options are not numeric.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jannie Nørlev, PhD

CONTACT

[email protected]

004523676513

Stine Hangaard, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • DexCom, Inc.
  • Novo Nordisk A/S

Registry information

Official study title

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

Acronym: DiaTRUST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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