Electronic Platform for Diabetic Patients Activation (INSULINCOM)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypoglycemia; Hypoglycemia Acute
• Intervention / Treatment: Device: ti.care

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 Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care and usual communication with health professional
Experimental: Intervention; 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; Electronic platform for doctor-patient communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: 2020/09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No