NCT06134934

TeleCare North Diabetes

TeleCare North Diabetes: A Feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Telemonitoring 1	This telemonitoring intervention design include self-monitoring of blood glucose (SMBG) together with monitoring of sleep, mental health, blood pressure and activity.
OTHER	Telemonitoring 2	This telemonitoring intervention design include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health.

Timeline

• Start date: 2024-01-09
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2023-11-18
• Last updated: 2025-10-01

Locations

1 site across 1 country: Denmark