Electronic Platform for Diabetic Patients Activation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoglycemia, Hypoglycemia Acute

Intervention / Treatment
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* Device: ti.care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |