NCT06134934

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 9, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

November 1, 2023

Last Update Submit

September 26, 2025

Conditions

Diabetes Mellitus, Type 2

Keywords

Blood glucoseDiabetes mellitusType 2TelemedicineTelehealthTelemonitoringFeasibility

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (17)

  • Feasibility of the recruitment assessment 1

    1 month

  • Feasibility of the recruitment assessment 2

    1 month

  • Feasibility of the recruitment assessment 3

    1 month

  • Feasibility of the recruitment assessment 4

    1 month

  • Feasibility of the recruitment assessment 5

    1 month

  • +12 more secondary outcomes

Study Arms (2)

Telemonitoring design 1

EXPERIMENTAL

* Self-Monitoring of Blood Glucose (SMBG) * Sleep * Mental health * Blood pressure * Activity

Other: Telemonitoring 1

Telemonitoring design 2

EXPERIMENTAL

* Self-Monitoring of Blood Glucose (SMBG) * Sleep * Mental health

Other: Telemonitoring 2

Interventions

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 design 1
Telemonitoring 2OTHER

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

Telemonitoring design 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center North Denmark

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 38778345DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Peter Vestergaard, PhD (and MD)

    Aalborg University Hospital and Steno Diabetes Center North Denmark

    PRINCIPAL INVESTIGATOR

  • Sisse H Laursen, PhD

    Aalborg University and Aalborg University Hospital

    STUDY CHAIR

  • Stine Hangaard, PhD

    Aalborg University and Steno Diabetes Center North Denmark

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 18, 2023

Study Start

January 9, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

DK(1)