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Diabetes Mellitus, Type 2NCT06134934

TeleCare North Diabetes

A study testing Telemonitoring 1 and Telemonitoring 2 in people with Diabetes Mellitus, Type 2, run by Aalborg University Hospital at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This feasibility study will evaluate the feasibility of two telemonitoring designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Telemonitoring 1 and Telemonitoring 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteDenmark
Study dates
9 Jan 2024to 1 May 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

  • Women and men ≥ 18 years
  • Poorly controlled T2D, i.e. HbA1c > 58 mmol/mol
  • Diagnosis of T2D for at least 12 months
  • General Practitioner responsible for diabetes treatment
  • Residence in Hjørring, Morsø, Jammerbugt, or Rebild municipality
  • Ability and willingness to use a smartphone/tablet along with the other devices to be used in the trial
  • Signed informed consent
  • Ability to understand and read Danish

Who cannot join

  • Pregnancy or breastfeeding
  • Insulin treatment
  • Prednisolone treatment
  • Severe diabetes complications such as severe neuropathy or nephropathy (dialysis treatment)
  • Participation in diabetes rehabilitation courses
  • Participation in other intervention trials
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center North Denmark

    Aalborg, 9000

Other trials in Denmark

About this study

Official title: TeleCare North Diabetes: A Feasibility Study

This feasibility study will evaluate the feasibility of two telemonitoring designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.

Read the detailed description

Background: Maintaining optimal glycaemic control in type 2 diabetes (T2D) is difficult. Telemedicine has potential to support poorly controlled people with T2D in the achievement of glycaemic control if the telemedicine solution includes a telemonitoring component. However, only few telemonitoring solutions for non-insulin treated T2D exist. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring intervention designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.

Method: The trial will be conducted as a three-month randomized feasibility study in four municipalities in North Denmark with 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, differences in direct intervention costs between the two alternative interventions will be evaluated.

Being tested
Telemonitoring 1, Telemonitoring 2
Keywords
Blood glucose, Diabetes mellitus, Type 2, Telemedicine, Telehealth, Telemonitoring, Feasibility
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemonitoring 1Other

    This telemonitoring intervention design include self-monitoring of blood glucose (SMBG) together with monitoring of sleep, mental health, blood pressure and activity.

  • Telemonitoring 2Other

    This telemonitoring intervention design include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health.

Study groups in NCT06134934
Study groupRoleWhat they receive
Telemonitoring design 1Experimental* Self-Monitoring of Blood Glucose (SMBG) * Sleep * Mental health * Blood pressure * Activity
Receives: Other: Telemonitoring 1
Telemonitoring design 2Experimental* Self-Monitoring of Blood Glucose (SMBG) * Sleep * Mental health
Receives: Other: Telemonitoring 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Experiences with and acceptability of intervention design(s)

    Qualitative interviews will be conducted with selected participants and HCPs to gain deeper insight into the participants and HCPs' experiences and acceptability with the two different telemonitoring intervention designs and the trial procedures.

    Measured: 3 months

Secondary outcomes (17)

  1. Feasibility of the recruitment assessment 1

    Number (whole) of people agreeing to receive participant information letter about the study.

    Measured: 1 month

  2. Feasibility of the recruitment assessment 2

    Proportion (percentage) of people agreeing to receive participant information letter about the study.

    Measured: 1 month

  3. Feasibility of the recruitment assessment 3

    Number (whole) of eligible participants who agree to participate.

    Measured: 1 month

  4. Feasibility of the recruitment assessment 4

    Proportion (percentage) of eligible participants who agree to participate.

    Measured: 1 month

  5. Feasibility of the recruitment assessment 5

    Potential inequalities regarding recruitment feasibility assessed by comparing those who accepted participation to those who declined with respect to demographic data on age (years), sex (m/f/other), ethnicity (danish/other western/not western), municipality, setting (health care center versus home health care setting), and HbA1c levels (mmol/L).

    Measured: 1 month

  6. Retention assessment 1

    Number (whole) of participants withdrawing from the trial.

    Measured: 3 months

  7. Retention assessment 2

    Proportion (percentage) of participants withdrawing from the trial.

    Measured: 3 months

  8. Retention assessment 3

    Timepoint(s) for withdrawal.

    Measured: 3 months

  9. Retention assessment 4

    Reasons of discontinuation of the trial.

    Measured: 3 months

  10. Retention assessment 5

    Potential inequalities regarding retention feasibility assessed by comparing those who retented participation to those who withdrawal with respect to demographic data on age (years), sex (m/f/other), ethnicity (danish/other western/not western), municipality, setting (health care center versus home health care setting), and HbA1c levels (mmol/L).

    Measured: 3 months

  11. Adherence to answering the questionnaire: Diabetes-related quality of life: The Problem Areas in Diabetes Questionnaire (PAID-5)

    The respons rate for PAID-5 at baseline and at 3 months, respectively.

    Measured: At baseline (T0) and 3 months (T1)

  12. Adherence to answering the questionnaire: Quality of Life: The Short Form 12 Questionnaire (SF-12v2)

    The respons rate for SF-12v2 at baseline and at 3 months, respectively.

    Measured: At baseline (T0) and 3 months (T1)

  13. Adherence to answering the questionnaire: Well-being: The World Health Organization Five Well-being Index (WHO-5)

    The respons rate for WHO-5 at baseline and at 3 months, respectively.

    Measured: At baseline (T0) and 3 months (T1)

  14. Adherence to answering the questionnaire: The Patient Activation Measure questionnaire (PAM)

    The respons rate for PAM at baseline and at 3 months, respectively.

    Measured: At baseline (T0) and 3 months (T1)

  15. Challenges in the blood sampling schedule

    Explore through qualitative interviews whether there are any analysis challenges or uncertainties in the clinical workflow with regard to the blood sampling schedule.

    Measured: At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3)

  16. Adherence to the blood sampling schedule

    Number and proportion of the participants who completes the blood sampling at baseline, 3 months, 6 months, and 12 months, respectively.

    Measured: At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3)

  17. Costs

    Differences in direct intervention costs between the two alternatives. Resource categories are comprised of equipment and time spent on monitoring, time spent training patients in using the equipment, and potential additional training for community nurses. Resources will be evaluated as prices paid and hourly wages and represented as equivalent annual costs in 2023 prices.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start9 Jan 2024
  3. Primary completion1 May 2025
  4. Study completion1 May 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134934
Sponsor's protocol ID
N-20230026
Status last verified
Sep 2025
First submitted
1 Nov 2023
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Laursen SH, Giese IE, Udsen FW, Hejlesen OK, Barington PF, Ohrt M, Vestergaard P, Hangaard S. A telemonitoring intervention design for patients with poorly controlled type 2 diabetes: protocol for a feasibility study. Pilot Feasibility Stud. 2024 May 22;10(1):83. doi: 10.1186/s40814-024-01509-0.

    PubMed 38778345

Questions about this trial

What is this clinical trial studying?

A study testing Telemonitoring 1 and Telemonitoring 2 in people with Diabetes Mellitus, Type 2, 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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Experiences with and acceptability of intervention design(s) (time frame: 3 months). 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 NCT06134934, 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 1 Oct 2025.

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