Diabetes Mellitus
Conditions
Brief summary
Diabetes mellitus is one of the most prevalent disease in the western world. The control of glucose levels has a big impact in the prevention of diabetes complications. The measure of glucose levels in capillary blood with glucometers is the gold standard to measure and control the glucose levels. Nowadays the glucometers become to more precise and sophisticated devices. One of the most notables advance is the inclusion of software that cam predicts glucose trends. This software has not be tested in routine clinical practice.
Interventions
DEVICEVerio Pattern Alert® activated
DEVICEVerio Pattern Alert® deactivated
Sponsors
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient diagnosed with diabetes mellitus 1 or 2 * Treatment with insulin regimen during at least 12 months * Capability of performed 3 glucose measurement per day * Levels of glycated hemoglobin (A1C) less than 10%
Exclusion criteria
* Patients diagnosed of mental disorders * Patients included in structured therapeutic health 6 months before the inclusion * Patients included in any clinical trial in the 4 months before the inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of hypoglycemic events | 20 months | Glucose levels under 70 mg/dL with or without clinical manifestation |
Countries
Spain
Outcome results
None listed