Electronic Platform for Diabetic Patients Activation (INSULINCOM)

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status: Unknown

Conditions: Hypoglycemia; Hypoglycemia Acute

Treatments: Device: ti.care

Study type: Interventional

Funder types: Other

Identifiers

NCT04595383

2020/09

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of an electronic platform for doctor-patient communication in order to reduce severe and non-severe hypoglycemia events as well as inadvertent hypoglycemia events.

Full description

This is an open randomized clinical trial without drugs. Patients with type 2 diabetes and treated with insulin will be included. Patients allocated in the intervention group will use the electronic platform as a communication channel with their health provider during the time between visits.

The name of the platform is ti.care (https://ti.care/es) and it will be a complement of the control visits to resolve doubts through chats, email or video call. Health providers will answer the patient requests.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged over 17 years
• Patients with type 2 diabetes diagnosis
• Patients who start insulin treatment or with intensification of treatment
• Patients who sign informed consent

Exclusion criteria

• Patients with type 1 diabetes diagnosis
• Life expectancy less than one year
• Pregnancy
• Patients with dementia
• Patients with treatment different to insulin
• Patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Control

No Intervention group

Description:

Usual care and usual communication with health professional

Intervention

Experimental group

Description:

They will be trained to use the ti.care platform and will be able to use it as a communication channel for any questions or clarification they require during the time elapsed between routine control visits. This platform will be a complement to the visits, but in no case will it replace them or be used as a diagnostic or therapeutic method. The platform does not have any treatment algorithm and only aims to facilitate communication between the patient at home and the health professional, both the doctor and the nurse educator. It will be used in a preventive and advisory manner for the patient for follow-up. In no case it will be used for emergencies. Daily during working hours from Monday to Friday, health professionals will review patient requests and respond to them.

Treatment:

Device: ti.care