Reduction in Hypoglycemia With the Predictive Low-Glucose Management System: A Long-term Randomized Controlled Trial in Adolescents With Type 1 Diabetes.

OBJECTIVE

Short-term studies with automated systems that suspend basal insulin when hypoglycemia is predicted have shown a reduction in hypoglycemia; however, efficacy and safety have not been established in long-term trials.

RESEARCH DESIGN AND METHODS

We conducted a 6-month, multicenter, randomized controlled trial in children and adolescents with type 1 diabetes using the Medtronic MiniMed 640G pump with Suspend before low (predictive low-glucose management [PLGM]) compared with sensor-augmented pump therapy (SAPT) alone. The primary outcome was percentage time in hypoglycemia with sensor glucose (SG) <3.5 mmol/L (63 mg/dL).

RESULTS

In an intent-to-treat analysis of 154 subjects, 74 subjects were randomized to SAPT and 80 subjects to PLGM. At baseline, the time with SG <3.5 mmol/L was 3.0% and 2.8% in the SAPT and PLGM groups, respectively. During the study, PLGM was associated with a reduction in hypoglycemia compared with SAPT (% time SG <3.5 mmol/L: SAPT vs. PLGM, 2.6 vs. 1.5, < 0.0001). A similar effect was also noted in time with SG <3 mmol/L ( < 0.0001). This reduction was seen both during day and night ( < 0.0001). Hypoglycemic events (SG <3.5 mmol/L for >20 min) also declined with PLGM (SAPT vs. PLGM: events/patient-year 227 vs. 139, < 0.001). There was no difference in glycated hemoglobin (HbA) at 6 months (SAPT 7.6 ± 1.0% vs. PLGM 7.8 ± 0.8%, = 0.35). No change in quality of life measures was reported by participants/parents in either group. There were no PLGM-related serious adverse events.

CONCLUSIONS

In children and adolescents with type 1 diabetes, PLGM reduced hypoglycemia without deterioration in glycemic control.