Electronic Platform for Diabetic Patients Activation

Not Applicable

• Conditions: Hypoglycemia Acute; Hypoglycemia

• 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

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