OBJECTIVE To investigate whether predictive low-glucose management (PLGM) of the MiniMed 640G system significantly reduces the rate of hypoglycemia compared with 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 A1c ≤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 <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 <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 >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.
This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2584/-/DC1.
- Received December 3, 2016.
- Accepted March 7, 2017.
- © 2017 by the American Diabetes Association.