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

BACKGROUND: 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. METHOD: 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. DISCUSSION: 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. TRIAL REGISTRATION: 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).

Discordance Between Mealtimes Reported by Trial Participants with Type 2 Diabetes and Healthcare Professionals.

Healthy lifestyle behaviors are essential in the treatment of type 2 diabetes, and meal registration is therefore important. Manual meal registration is cumbersome and could be automated using continuous glucose monitoring (CGM). If such an algorithm is based on patient-reported meals, potential errors might be induced. Thus, the aim was to investigate potential errors in patient-reported mealtimes and the effect on automatic meal detection. Two healthcare professionals (HCPs) reported the mealtimes of the 18 included patients based on the patients' CGM data to assess the agreement between HCP- and patient-reported mealtimes. A developed meal detection algorithm based on detecting the post-prandial glucose response using cross-correlation was used to assess the impact of errors in patient-reported meals. The results showed poor disagreement between HCP- and patient-reported meals and that the meal detection algorithm had a moderately better performance on the HCP-reported meals. Therefore, the possibility of errors in patient-reported mealtimes should be considered in the development of meal detection algorithms. However, more research is needed to confirm the results of this study.

A study of the discriminative properties of the Six-Spot Step Test in people with Parkinson's disease at risk of falling.

BACKGROUND: Clinical tests that can discriminate between people at risk of falling and those not at risk are warranted. The discriminative properties of the Six-Spot Step Test was investigated in people with Parkinson's disease at risk of falling. METHODS: Eighty-one participants with a median age of 69 years (Q1-Q3:63-74) and a median Hoehn and Yahr score of 2.5 (Q1-Q3:2-3) completed the Six-Spot Step Test and the Timed "Up and Go" test. A mini-BESTest score of 19 or below was used as a cut-off for defining risk of falling, and a receiver operating characteristics curve was generated to determine clinical relevant cut-off scores. RESULTS: A cut-off score of 7.0 and 6.8 seconds identified people not at risk of falling, while 11.1 and 9.4 seconds identified people at risk of falling for the Six-Spot Step Test and the Timed "Up and Go" test, respectively. When maximizing the sensitivity and specificity a cut-off score of 9.2 (accuracy of 84%) and 8.1 seconds (accuracy of 70%) was found for the Six-Spot Step Test and the Timed "Up and Go" test, respectively. CONCLUSION: The Six-Spot Step Test discriminates accurately between people with Parkinson's disease at risk of falling and people not at risk.