BACKGROUND: There is a need for patients to be able to adjust their insulin doses accurately and independently during continuous subcutaneous insulin infusion (CSII) therapy in order to avoid glycemic excursions and improve glycemic control. Use of new technology has the potential to aid patients in visualizing their circadian patterns and improving their understanding of data provided by self-monitored blood glucose (SMBG) measurements. METHODS: A 24-week crossover study was performed in 25 patients with type 1 diabetes mellitus using CSII and SMBG. Patients were randomized either to entering blood glucose data into handwritten logbooks or to using the Accu-Chek SmartPix information management system (IMS) coupled with instructions from a training manual to aid interpretation of the IMS readings. Patients analyzed these chart readings every 2 weeks, and outpatient visits were scheduled for both arms every 6 weeks. RESULTS: There was a significantly lower mean overall blood glucose level with the IMS compared with use of a logbook (139 ± 16.2 versus 150 ± 19.8 mg/dl; Δ = 10.8 mg/dl; p < .01), and a significantly higher proportion of blood glucose values was in the target range compared with use of a logbook (43.6% versus 38.5%; p < .001). Hypoglycemic events were also significantly lower with the IMS compared with logbooks (3.7 fewer events/6 weeks; p < .05). There was no significant difference between groups in the daily frequency of SMBG measurements. CONCLUSIONS: The use of an IMS, coupled with an easily understood training manual, enables patients to improve glycemic control by performing accurate and timely self-adjustments to their insulin regimens.
RCT Entities:
BACKGROUND: There is a need for patients to be able to adjust their insulin doses accurately and independently during continuous subcutaneous insulin infusion (CSII) therapy in order to avoid glycemic excursions and improve glycemic control. Use of new technology has the potential to aid patients in visualizing their circadian patterns and improving their understanding of data provided by self-monitored blood glucose (SMBG) measurements. METHODS: A 24-week crossover study was performed in 25 patients with type 1 diabetes mellitus using CSII and SMBG. Patients were randomized either to entering blood glucose data into handwritten logbooks or to using the Accu-Chek SmartPix information management system (IMS) coupled with instructions from a training manual to aid interpretation of the IMS readings. Patients analyzed these chart readings every 2 weeks, and outpatient visits were scheduled for both arms every 6 weeks. RESULTS: There was a significantly lower mean overall blood glucose level with the IMS compared with use of a logbook (139 ± 16.2 versus 150 ± 19.8 mg/dl; Δ = 10.8 mg/dl; p < .01), and a significantly higher proportion of blood glucose values was in the target range compared with use of a logbook (43.6% versus 38.5%; p < .001). Hypoglycemic events were also significantly lower with the IMS compared with logbooks (3.7 fewer events/6 weeks; p < .05). There was no significant difference between groups in the daily frequency of SMBG measurements. CONCLUSIONS: The use of an IMS, coupled with an easily understood training manual, enables patients to improve glycemic control by performing accurate and timely self-adjustments to their insulin regimens.
Authors: David M Nathan; Patricia A Cleary; Jye-Yu C Backlund; Saul M Genuth; John M Lachin; Trevor J Orchard; Philip Raskin; Bernard Zinman Journal: N Engl J Med Date: 2005-12-22 Impact factor: 91.245
Authors: Elizabeth Russell-Minda; Jeffrey Jutai; Mark Speechley; Kaitlin Bradley; Anna Chudyk; Robert Petrella Journal: J Diabetes Sci Technol Date: 2009-11-01
Authors: Irl B Hirsch; Bruce W Bode; Belinda P Childs; Kelly L Close; William A Fisher; James R Gavin; Barry H Ginsberg; Charles H Raine; Carol A Verderese Journal: Diabetes Technol Ther Date: 2008-12 Impact factor: 6.118