Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoglycemia
- Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Enrollment
- 106
- Primary Endpoint
- Change from HbA1c level at 3 months
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Domingo Orozco
Principal investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from HbA1c level at 3 months
Time Frame: Baseline and at 3 months
Change from HbA1c level at 3 months
Change from postprandial blood glucose at 3 months
Time Frame: Baseline and at 3 months
Change from postprandial blood glucose at 3 months
Number of inadvertent hypoglycemia events
Time Frame: At 3 months
Number of inadvertent hypoglycemia events
Change from basal capillary blood glucose at 3 months
Time Frame: Baseline and at 3 months
Change from basal capillary blood glucose at 3 months
Change from nocturnal blood glucose at 3 months
Time Frame: Baseline and at 3 months
Change from nocturnal blood glucose at 3 months
Number of nocturnal hypoglycemia events
Time Frame: At 3 months
Number of nocturnal hypoglycemia events
Total hypoglycemia
Time Frame: At 3 months
Number of total hypoglycemia events