medwireNews: Research suggests that a predictive low-glucose management (PLGM) system significantly reduces hypoglycemic events in children and adolescents with type 1 diabetes.
But the study authors point out that “this was achieved at the expense of increased time in moderate hyperglycemia.”
The randomized, open-label study, conducted at two clinical sites, in Slovenia and Israel, involved 96 children and adolescents with type 1 diabetes. Of these, 47 used the MiniMed 640G system (Medtronic Diabetes UK) with PLGM turned ON, while 49 used it with PLGM turned OFF, meaning the system was acting as a regular sensor-augmented pump.
The patients, aged between 8 and 18 years, had been diagnosed with type 1 diabetes at least 12 months before the study and had received continuous subcutaneous insulin infusion, with or without continuous glucose monitoring (CGM), for at least 3 months before inclusion.
They all had glycated hemoglobin (HbA1c) levels at or below 10% (86 mmol/mol), and were not allowed to use the low glucose suspend feature of the CGM during the last 2 weeks before the study.
During 2 weeks of continuous use of the MiniMed 640G system, glucose sensor readings, taken at 07:00 hours each morning and at least a further seven times during the day, showed that patients in the PLGM ON group experienced significantly fewer hypoglycemic events (<65 mg/dL; 3.6 mmol/L) than the patients in the PLGM OFF group, at an average of 4.4 versus 7.4.
A significant difference was also evident when hypoglycemic events during the night and day were calculated separately.
“Our study demonstrated that PLGM might further improve metabolic control by reducing hypoglycemia burden,” say Tadej Battelino (University Medical Centre–University Children’s Hospital, Ljubljana, Slovenia) and study co-authors in Diabetes Care.
No severe hypoglycemic or other adverse events occurred, but there was a significant increase in time spent in hyperglycemia (>140 mg/dL; 7.8 mmol/L) in the PLGM ON group relative to the PLGM OFF group, at an average 936.3 versus 860.7 min/day.
While none of the participants experienced severe hyperglycemic events and there were no increases in ketone levels, the researchers stress that the increased time the PLGM ON group spent in hyperglycemia should not be ignored, particularly in the younger children.
“Hyperglycemia in young children is associated with smaller gray matter volume, among other changes, and chronic hyperglycemia and glucose variability are suspected to be detrimental to the white matter structures,” they say.
By Tony Kirby
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