Electronic Platform for Diabetic Patients Activation

Not Applicable

• Conditions: Hypoglycemia Acute; Hypoglycemia
• Interventions: Device: ti.care

• Registration Number: NCT04595383
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19
• Study Start: 2021-10-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	ti.care	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.

Primary Outcome Measures

Name	Time	Method
Change from HbA1c level at 3 months	Baseline and at 3 months	Change from HbA1c level at 3 months
Change from postprandial blood glucose at 3 months	Baseline and at 3 months	Change from postprandial blood glucose at 3 months
Number of inadvertent hypoglycemia events	At 3 months	Number of inadvertent hypoglycemia events
Change from basal capillary blood glucose at 3 months	Baseline and at 3 months	Change from basal capillary blood glucose at 3 months
Change from nocturnal blood glucose at 3 months	Baseline and at 3 months	Change from nocturnal blood glucose at 3 months
Number of nocturnal hypoglycemia events	At 3 months	Number of nocturnal hypoglycemia events
Total hypoglycemia	At 3 months	Number of total hypoglycemia events