Conventional forms of insulin therapies often fail to provide the needed ‘almost’ daily guidance for therapy safety. This can lead to inadequate metabolic control, non-achievement of target values, and even blood glucose derailments. In order to support patients in their blood glucose management at home, the GlucoTab® system, which has been tried and tested in clinical inpatient use, has been adapted for patient self-management. It supports in the continuous adjustment of short- and long-acting insulins, dosage suggestions for meal and correction insulin, and provides intelligent, immediate protective measures.
The necessary adaptations to the current GlucoTab® Basal Bolus insulin dosing algorithm were identified using a detailed requirements analysis within the framework of a co-creation process. This included user surveys, a structured literature review, and analysis of existing data. The specification, prototypical development and technical documentation were carried out according to the standards of IEC 62304 within the ISO EN 13485 quality management system.
The new care concept potentially results in the following benefits for patients:
- More frequent therapy feedback
- Increased sense of safety
- Lowering of the HbA1c value
- Reduction of blood glucose variability
- Avoidance of hypoglycemia
- Avoidance of medication errors