• Hyperglycemia/Hypoglycemia
• Diabetes Mellitus
• Diabetes & Endocrinology Clinical Trials

The use of sensor-augmented pump (SAP) therapy resulted in significant decreases in HbA1C compared with multiple daily injection (MDI) therapy across age groups. Richard M. Bergenstal, MD, International Diabetes Center at Park Nicollet, Minneapolis, MN, presented findings from the Sensor-Augmented Pump Therapy for A1C Reduction 3 (STAR 3; NCT00406133).

STAR 3 was a 1-year, multicenter, randomized, controlled trial that included 485 patients aged 7 to 70 years (329 adults and 156 children) with inadequately controlled type 1 diabetes mellitus (T1DM) on MDI (≥3 injections, including a long-acting analog, for at least 3 months). Patients were randomized to receive either SAP (n=244) or MDI (n=241), and all patients utilized diabetes management software (CareLink Therapy Management Systems for Diabetes-Clinical, Medtronic) throughout the duration of the study. The groups were well matched at baseline with the exception of weight and student status among adult patients in both treatment groups. The baseline mean glycated hemoglobin for all treatment groups, regardless of age, was 8.3%. The glycated hemoglobin target throughout the duration of STAR 3 was <7.0%.

Follow-up visits took place at 3, 6, 9, and 12 months. The primary endpoint was the difference in HbA1C from baseline to 1 year. The secondary endpoints included the frequency of severe hypoglycemia (defined as an episode that required assistance and documented blood glucose value <50 mg/dL or recovery with restoration of plasma glucose), percentage of patients with A1C ≤7%, and area under the curve (AUC) from continuous glucose monitoring >180 mg/dL and <70 mg/dL.

The baseline mean glycated hemoglobin in the SAP group had decreased to 7.5% at 1 year compared with 8.1% in the MDI group (absolute reduction of 0.8±0.8% for SAP vs 0.2±0.9% for MDI; p<0.001). When stratified according to age group, the between-group differences favored SAP among children (aged 7 to 18 years) and adults (aged ≥19 years; p<0.001 for both). At 1 year, 27% of patients in the SAP group (n=67) achieved the target glycated hemoglobin of ≤7% versus 10% in the MDI group (n=23; p<0.001). Of those who reached glycated hemoglobin of ≤7%, children accounted for 13% in the SAP group and 5% in the MDI group. Of note, increased frequency of sensor use in the SAP group was associated with greater reductions in glycated hemoglobin levels at 1 year (p=0.003 after adjustment for baseline levels).

Rates of severe hypoglycemia and diabetic ketoacidosis were similar among the two treatment groups at 1 year (Table 1). Three serious adverse events occurred during the study. One death from sudden cardiac arrest occurred in a patient with a history of cardiovascular disease in the MDI group, and there were 2 hospitalizations due to cellulites that resulted from insertion-site infections in the SAP group. At 1 year, no severe hypoglycemic events were observed among children with glycated hemoglobin ≤7%, regardless of the treatment regimen.

SAP significantly decreased HbA1C concentrations regardless of age. This decrease was observed within the first 3 months of treatment and was sustained through the first year. This benefit was not associated with increased incidence of severe hypoglycemia, diabetic ketoacidosis, or weight gain. Patients who were treated with SAP are more likely to reach the target HbA1C (≤7%) than those on MDI therapy, and age does not appear to be a factor. An integrated approach that includes sensors, pumps, and diabetes management software may be appropriate for patients with inadequately controlled T1DM.

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