Electronic Platform for Diabetic Patients Activation

NCT04595383 | Unknown

• 1 other identifier: 2020/09
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoglycemia; Hypoglycemia Acute

Outcome Measures

Primary Outcomes (7)

• Change from HbA1c level at 3 months

  Change from HbA1c level at 3 months

  Baseline and at 3 months

• Change from basal capillary blood glucose at 3 months

  Change from basal capillary blood glucose at 3 months

  Baseline and at 3 months

• Change from postprandial blood glucose at 3 months

  Change from postprandial blood glucose at 3 months

  Baseline and at 3 months

• Change from nocturnal blood glucose at 3 months

  Change from nocturnal blood glucose at 3 months

  Baseline and at 3 months

• Total hypoglycemia

  Number of total hypoglycemia events

  At 3 months

• Number of nocturnal hypoglycemia events

  Number of nocturnal hypoglycemia events

  At 3 months

• Number of inadvertent hypoglycemia events

  Number of inadvertent hypoglycemia events

  At 3 months

Study Arms (2)

Control

NO INTERVENTION

Usual care and usual communication with health professional

Intervention

EXPERIMENTAL

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.

Device: ti.care

Interventions

ti.care DEVICE

Electronic platform for doctor-patient communication

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 20, 2020
• Study Start: October 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: May 31, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03