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A virtual clinic for the management of diabetes-type 1: study protocol for a randomised wait-list controlled clinical trialElisabet Nerpin1,2,3* , Eva Toft4,5, Johan Fischier5, Anna Lindholm-Olinder6,7 and Janeth Leksell3,6
From the article Discussion
The aim of this study is to evaluate the effect of a virtual diabetes clinic on treatment satisfaction, quality of life and glycaemic control in young adults (aged 18–25 years) with type-1 diabetes. We chose to include young adults because we want to see if participants using vir- tual diabetes care show improved: HbA1c levels; time in ranges for continuous subcutaneous glucose monitoring; quality of life; physical, mental and social health; and general treatment diabetes satisfaction.
Time in range is the percentage of time that glucose levels are in low, target and high ranges. We will use Check Your Health Scale and treatment satisfaction assessed with the DTSQ, to detect changes in perceived health and general quality of life. The evaluation points for the intervention will be at baseline, and 6 and 12 months (virtual care) to allow comparisons and determine any changes.
In Sweden, all Patients with type 1 diabetes are treated at specialist centres, which means that all patients at the clinic who fulfil the inclusion criteria can be enrolled, re- gardless of race and ethnicity.
Data from national register in Sweden, include almost 90% of all diabetes patients. Data indicate that more than 70% of young patients with type 1 diabetes have a HbA1c level above the target level of 52 mmol/mol. For this reason, it is important to take actions to support patients to attain optimal glycaemic control and at the same time maintain a good quality of life and to post- pones diabetes-related complications.
The potential reduction of unsatisfactory glycaemic control and burden of diabetes using virtual diabetes care would be of benefit, and potentially even more clinically significant, in comparison with usual care (i.e. face-to face care meeting).
Background: Diabetes is a serious chronic disease. Medical treatment and good psychosocial support are needed to cope with acute and long-term effects of diabetes. Self-management is a large part of diabetes management, with healthcare providers playing a supportive role.
Young adults with type 1 diabetes are of special interest as they tend to have higher mean glycosylated haemoglobin values than other patients with type 1 diabetes, and they often miss visits in traditional diabetes care.
A well-designed virtual solution may improve a range of measures (e.g. glycaemic control and perceived health) and reduce hospitalisations.
Method: This randomised controlled trial with a control group using a wait list design will recruit 100 young adults from a hospital in Sweden. All participants will receive usual diabetes care besides the virtual clinic. The primary objective is to evaluate the effect of a virtual diabetes clinic on glycaemic control, treatment satisfaction and quality of life in young adults (aged 18–25 years) with type-1 diabetes. The secondary objective is to determine the effects of virtual care on the patient experience.
Discussion: Virtual tools are becoming increasingly common in healthcare; however, it remains unclear if these tools improve diabetes self-management. The results of this study will build understanding of how healthcare providers can use a virtual clinic to improve diabetes self-management.
Trial registration: Current controlled trials: ISRCTN, number: 73435627, registered 23 October 2019. https://doi.org/ 10.1186/ISRCTN73435627
Hälsa och Samhäller Högskolan Dalarna
Medicinska Vetenskaper, Uppsala Universitet
Vetenskaplig sekreterare SFSD