Timothy W. Jones
Children and adolescents with type 1 diabetes using a predictive low-glucose management system experienced greater reductions in time spent in hypoglycemia than those who used sensor-augmented pump therapy, according to study results published in Diabetes Care.
Timothy W. Jones, MD, FRACP, of the Children’s Diabetes Centre, Kids Institute at The University of Western Australia, and colleagues conducted a 6-month randomized controlled trial on 154 children and adolescents (mean age, 13.2 years; 53% boys) with type 1 diabetes (mean duration of diabetes, 7.1 years; mean HbA1c, 7.5%; mean duration of pump therapy, 4.6 years) using the Medtronic MiniMed 640G pump with suspend before low (predictive low-glucose management [PLGM]) compared with sensor-augmented pump therapy alone to determine the effect of each on rates of hypoglycemia.
Percentage time in hypoglycemia with sensor glucose less than 3.5 mmol/L served as the primary outcome.
Pump start and sensor training were performed at the first and second study visits and confidence in using the system was confirmed through a minimum of a 2-week run-in period. Researchers randomly assigned participants to PLGM (n = 80) or sensor-augmented pump (n = 74) at the third visit. Follow-up was conducted at 3 and 6 months after randomization.
Both groups demonstrated a reduction in time spent in hypoglycemia from the beginning of the study to 6 months; the reduction was greater with PLGM (2.8% to 1.4%) compared with sensor-augmented pump therapy (3% to 2.6%; P < .0001). Reduction in time spent in hypoglycemia during the day was not significant with the sensor-augmented pump; however, there was a small reduction in time spent in hypoglycemia at night (3.8% to 3.3%; P = .04). PLGM demonstrated reductions in day (2.4% to 1.3%; P < .001) and night (3.4% to 1.6%; P < .0001) time spent in hypoglycemia.
During the run-in period, both groups demonstrated similar numbers of sensor-defined hypoglycemic events. The PLGM group had fewer hypoglycemic events compared with the sensor-augmented pump group at the end of the study (139 vs. 227; P < .001). No episodes of severe hypoglycemia occurred during the study period in either group.
Among 90 participants aged at least 12 years at baseline, 17% had impaired awareness of hypoglycemia (PLGM, 18%; sensor-augmented pump, 16%) and impaired awareness decreased in both groups at 6 months; however, fewer participants in the PLGM group had impaired awareness at the end of the study compared with the sensor-augmented pump group (4% vs. 13%).
HbA1c remained unchanged in both groups at the end of the study. No difference in the rate of ketosis events was observed between the two groups, and no severe adverse events were reported during the study period.
“New diabetes technologies are showing potential to improve diabetes care,” Jones told Endocrine Today. “The use of continuous glucose sensing linked to a pump and an automated insulin suspension algorithm is an effective and safe means to reduce hypoglycemia exposure. Intensive management of diabetes with insulin can be made safer with this technology.” – by Amber Cox
For more information:
Timothy W. Jones, MD, FRACP, can be reached at email@example.com.
Disclosures: The authors report no relevant financial disclosures.