Hypoglycemia, Hypoglycemia Acute
Conditions
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.
Interventions
DEVICEti.care
Electronic platform for doctor-patient communication
Sponsors
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from HbA1c level at 3 months | Baseline and at 3 months | Change from HbA1c level at 3 months |
| Change from basal capillary blood glucose at 3 months | Baseline and at 3 months | Change from basal capillary blood glucose at 3 months |
| Change from postprandial blood glucose at 3 months | Baseline and at 3 months | Change from postprandial blood glucose at 3 months |
| Change from nocturnal blood glucose at 3 months | Baseline and at 3 months | Change from nocturnal blood glucose at 3 months |
| Total hypoglycemia | At 3 months | Number of total hypoglycemia events |
| Number of nocturnal hypoglycemia events | At 3 months | Number of nocturnal hypoglycemia events |
| Number of inadvertent hypoglycemia events | At 3 months | Number of inadvertent hypoglycemia events |
Outcome results
None listed