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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ti.care | Device | Electronic platform for doctor-patient communication |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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