A telemonitoring intervention design for patients with poorly controlled type 2 diabetes: protocol for a feasibility study

TL;DR

This study will test two telemonitoring designs for people with poorly controlled type 2 diabetes to determine which is more feasible for future large trials.

Contribution

The study introduces a feasibility evaluation of two telemonitoring intervention designs for type 2 diabetes.

Findings

The study will assess feasibility of telemonitoring designs including blood glucose, sleep, mental health, and additional metrics.

Qualitative insights from participants and clinicians will inform the acceptability and cost differences of the interventions.

Results will guide the design of future large-scale trials on telemonitoring for diabetes management.

Abstract

Maintaining optimal glycemic control in type 2 diabetes (T2D) is difficult. Telemedicine has the potential to support people with poorly regulated T2D in the achievement of glycemic control, especially if the telemedicine solution includes a telemonitoring component. However, the ideal telemonitoring design for people with T2D remains unclear. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring designs for people with non-insulin-dependent T2D with a goal of identifying the optimal telemonitoring intervention for a planned future large-scale randomized controlled trial.

This 3-month randomized feasibility study will be conducted in four municipalities in North Denmark starting in January 2024. There will be 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) combined with sleep and mental health monitoring. 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, sources of differences in direct intervention costs between the two alternative interventions will be investigated.

Telemonitoring has the potential to support people with diabetes in achieving glycemic control, but the existing evidence is inconsistent, and thus, the optimal design of interventions remains unclear. The results of this feasibility study are expected to produce relevant information about telemonitoring designs for people with T2D and help guide the design of future studies. A well-tested telemonitoring design is essential to ensure the quality of telemedicine initiatives, with goals of user acceptance and improved patient outcomes.

ClinicalTrials.gov, ID: NCT06134934. Registered November 1, 2023. The feasibility trial has been approved (N-20230026) by the North Denmark Region Committee on Health Research Ethics (June 5, 2023).

The online version contains supplementary material available at 10.1186/s40814-024-01509-0.

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