期刊
DIABETES CARE
卷 40, 期 6, 页码 764-770出版社
AMER DIABETES ASSOC
DOI: 10.2337/dc16-2584
关键词
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资金
- Faculty of Medicine, University of Ljubljana
- Slovene National Research Agency [J3-6798, V3-1505, P3-0343]
- Abbott
- Medtronic
- Novo Nordisk
- GluSense
- Sanofi
- Sandoz
- Diamyd Medical
- Abbott Diabetes Care
- Dexcom
- Insulet Corporation
- Animas
- Andromeda Biotech
- MacroGenics
- Medtronic International Trading Sarl
- Eli Lilly
- Roche
- Pfizer
- DreamMed Diabetes
OBJECTIVE To investigate whether predictive low glucose management (PLGM) of the MiniMed 640G system significantly reduces the rate of hypoglycemia compared with the sensor-augmented insulin pump in children with type 1 diabetes. RESEARCH DESIGN AND METHODS This randomized, two-arm, parallel, controlled, two-center open-label study included 100 children and adolescents with type 1 diabetes and glycated hemoglobin A(1c) 10% (<= 86 mmol/mol) and using continuous subcutaneous insulin infusion. Patients were randomly assigned to either an intervention group with PLGM features enabled (PLGM ON) or a control group (PLGM OFF), in a 1:1 ratio, all using the same type of sensor-augmented insulin pump. The primary end point was the number of hypoglycemic events below 65 mg/dL (3.6 mmol/L), based on sensor glucose readings, during a 14-day study treatment. The analysis was performed by intention to treat for all randomized patients. RESULTS The number of hypoglycemic events below 65 mg/dL (3.6 mmol/L) was significantly smaller in the PLGM ON compared with the PLGM OFF group (mean SD 4.4 +/- 4.5 and 7.4 +/- 6.3, respectively; P = 0.008). This was also true when calculated separately for night (P = 0.025) and day (P = 0.022). No severe hypoglycemic events occurred; however, there was a significant increase in time spent above 140 mg/dL (7.8 mmol/L) in the PLGM ON group (P = 0.0165). CONCLUSIONS The PLGM insulin suspension was associated with a significantly reduced number of hypoglycemic events. Although this was achieved at the expense of increased time in moderate hyperglycemia, there were no serious adverse effects in young patients with type 1 diabetes.
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