TeleCare North Diabetes

NCT ID: NCT06134934

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2026-05-01

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.

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telemonitoring design 1

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

Group Type: EXPERIMENTAL

Telemonitoring 1

Intervention Type: OTHER

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

Telemonitoring design 2

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

Group Type: EXPERIMENTAL

Telemonitoring 2

Intervention Type: OTHER

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

Interventions

Telemonitoring 1

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

Intervention Type: OTHER

Telemonitoring 2

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Nordjylland

OTHER

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Vestergaard

MD, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Vestergaard, PhD (and MD)

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital and Steno Diabetes Center North Denmark

Sisse H Laursen, PhD

Role: STUDY_CHAIR

Aalborg University and Aalborg University Hospital

Stine Hangaard, PhD

Role: STUDY_CHAIR

Aalborg University and Steno Diabetes Center North Denmark

Locations

Steno Diabetes Center North Denmark

Aalborg, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 38778345 (View on PubMed)

Other Identifiers

N-20230026

Identifier Type: -

Identifier Source: org_study_id