RESUMO
GlucoTab@MobileCare, a digital workflow and decision support system with integrated basal and basal-plus insulin algorithm was investigated for user acceptance, safety and efficacy in persons with type 2 diabetes receiving home health care by nurses. During a three months study nine participants (five female, age 77 ± 10 years, HbA1c 60 ± 13 mmol/mol (study start) vs. 57 ± 12 mmol/mol (study end) received basal or basal-plus insulin therapy as suggested by the digital system. In total 95% of all suggested tasks (blood glucose (BG) measurements, insulin dose calculations, insulin injections) were performed according to the digital system. Mean morning BG was 171 ± 68 mg/dL in the first study month vs. 145 ± 35 mg/dL in the last study month, indicating a reduced glycemic variability of 33 mg/dL (standard deviation). No hypoglycemic episode < 54 mg/dL occurred. User's adherence was high and the digital system supported a safe and effective treatment. Larger scale studies are needed to confirm findings under routine care. German Clinical Trials Register ID: DRKS00015059.
RESUMO
The aim of this study was to develop a novel nanoparticulate formulation and test its potential for oral peptide drug delivery. Chitosan-6-mercaptonicotinic acid is a novel thiolated chitosan with strong mucoadhesive properties. Nanoparticles were developed by an ionic gellation method. The obtained particles were characterized in terms of mucoadhesion, stability, toxicity, and in vitro release. Human insulin (HI) was chosen as a model peptide drug, incorporated in the particles and orally administered to rats. Human insulin was quantified in the blood by means of ELISA. The size of the obtained particles was in the range of 200-300 nm and the zeta potential was determined to be +8-+23 depending on the amount of thiol groups attached on the polymer. After 3 h of incubation up to 60% of the thiolated chitosan nanoparticles remained attached to the mucosa in contrast to 20% of unmodified chitosan particles. The AUC of HI after oral administration of thiolated chitosan nanoparticles was 4-fold improved compared to unmodified chitosan nanoparticles. Due to these improvements, chitosan-6-mercaptonicotinic acid nanoparticles are promising vehicles for oral delivery of peptide drugs.