Improved glycemic control in a patient group performing 7-point profile self-monitoring of blood glucose and intensive data documentation: An open-label, multicenter, observational study
Diabetes Therapy Sep 18, 2017
Sieber J, et al. - An open-label, multicenter, observational study was designed to evaluate the impacts on glycemic control of taking 7-point self-monitoring of blood glucose (SMBG) profiles and applying a diabetes management system (DMA) on a smartphone. They demonstrated that glycemic control can be enhanced, without receiving any recommendations or advice on insulin dose, by conducting daily 7-point SMBG profiles and using electronic documentation with a smartphone app. These results must be confirmed in a larger controlled trial, but they already strengthen the importance of structured SMBG in diabetes therapy. Methods
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- Researchers designed a 12-week, open-label, multicenter, observational study
- In this study, 51 patients [26 with type 1 diabetes mellitus (T1DM) and 25 with type 2 diabetes mellitus (T2DM)] were instructed to perform SMBG at least seven times a day applying DMA combined with the iBGStar SMBG system.
- They assessed HbA1c at regular visits to the study sites.
- Thereafter, patients reviewed and managed their data as well as their treatment on their own and there were no further assistance or treatment recommendations.
- They recorded adverse events (AEs).
- The data indicated that overall, mean (SD) change from baseline in HbA1c at week 12 was -0.46 (0.57)% [-5 (6) mmol/mol (p < 0.0001)].
- It was showed that alteration in HbA1c was observed in patients with T1DM [-0.27 (0.45)% (-3 [5] mmol/mol; p = 0.0063)] and T2DM [-0.65 (0.62)% (-7 [7] mmol/mol; p < 0.0001)].
- The alteration in HbA1c was not associated with an increased number of hypoglycemic events (blood glucose less than 55 mg/dL).
- Remarkably, the majority of AEs were symptomatic hypoglycemic events (42 events; nine patients).
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