Assessing the clinical impact of socialdiabetes medical device in patients with type 1 diabetes mellitus

Abstract

Diabetes mellitus is a chronic and prevalent disease that requires almost constant attention from the patient and regular evaluation by the clinician. However, in health care systems, physicians have some difficulties to provide optimal care for patients with diabetes due to the lack of patient involvement and poor communication. The rapid development of a variety of new technologies is making a huge impact on healthcare field because these new tools are helping to deal with those obstacles. The chance to automatically transfer data to clinicians and receive timely guidance in therapy adjustments through remote consults, can lead to an improvement of patients' diabetes self-management ability, which is directly related to an enhancement of blood glucose control, minor risk of long-term complications and better perception of quality of life and treatment satisfaction.

Purpose

The aim of this study is to determine the safety and the efficacy of SocialDiabetes mobile phone application in the management of the intensive insulin therapy of patients with type 1 diabetes mellitus in comparison to the management with current model of medical assistance.

Design

An open-label, controlled, randomized cluster sampling, non-inferiority clinical trial that will be executed at Hospital Universitari Doctor Josep Trueta of Girona with a follow-up period of 6 months.

Participants

The study will evaluate a total of 192 subjects. The sample will be composed by men and women (≥18-≤55 years old) who had been diagnosed of T1DM at least 1 year before the beginning of this study and at this moment are in treatment with intensive insulin therapy.

Intervention

SocialDiabetes intervention, involving the use of mobile devices and applications

for remote patient monitoring and delivery of clinical feedback for self- management of diabetes, versus the current model of assistance through in-person

hospital visits.

Outcomes

The main outcome will be changes in HbA1c and secondary outcomes will be perception of treatment satisfaction and quality of life