Electronic Platform for Diabetic Patients Activation

Hypoglycemia Clinical Trial

— INSULINCOM  

Official title:

Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04595383
• Other study ID #: 2020/09
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2021
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: May 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoglycemia
• Hypoglycemia Acute

Intervention

Device:
• ti.care
Electronic platform for doctor-patient communication

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from HbA1c level at 3 months	Change from HbA1c level at 3 months	Baseline and at 3 months
Primary	Change from basal capillary blood glucose at 3 months	Change from basal capillary blood glucose at 3 months	Baseline and at 3 months
Primary	Change from postprandial blood glucose at 3 months	Change from postprandial blood glucose at 3 months	Baseline and at 3 months
Primary	Change from nocturnal blood glucose at 3 months	Change from nocturnal blood glucose at 3 months	Baseline and at 3 months
Primary	Total hypoglycemia	Number of total hypoglycemia events	At 3 months
Primary	Number of nocturnal hypoglycemia events	Number of nocturnal hypoglycemia events	At 3 months
Primary	Number of inadvertent hypoglycemia events	Number of inadvertent hypoglycemia events	At 3 months