1. Continuous insulin pumps were more effective than multiple daily insulin injections at lowering glycated hemoglobin (HbA1c), as well as 24-hour mean blood glucose concentrations levels in type II diabetes patients.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Many patients with advanced type II diabetes require insulin treatment, which may involve multiple daily injections of a combination of short and long-acting insulin to achieve sufficient glycemic control. However, in about 30% of patients, these intensified insulin treatment regimens may not meet glycemic control targets, and are associated with an increased risk of hypoglycemia and weight gain. The OpT2mise trial attempted to assess the efficacy of continuous insulin pump treatment versus multiple daily injections for glycemic control in type II diabetic patients.
Compared to multiple daily insulin injections, an insulin pump was better at reducing glycated hemoglobin (HbA1c). The baseline mean HbA1c was 9% in both groups, and at 6 months, decreased by 1.1% in the pump group vs. 0.4% in the injection group. Twice as many patients in the pump group reached a target range of HbA1c ≤8% compared to the injection group. Additionally, the pump group showed a significantly greater decrease in 24-hour mean glucose concentration group than the injection group. This study may be limited due to the open-label nature. Nevertheless, these results suggests that insulin pump treatment may help improve glycemic control in patients with difficult to control type II diabetes.
This study was funded by Medtronic.
In-Depth [randomized controlled trial]: The OpT2mise trial enrolled 495 patients aged 30-75 with poorly controlled type II diabetes to a 2 month run-in period to optimize daily insulin injection treatment. After the run-in period, 331 patients whose glycated hemoglobin (HbA1c) levels were ≥ 8.0% and ≤12% were randomly assigned to receive either insulin pump treatment (n=168) or multiple daily insulin injections (n=163).
At 6 months, the mean HbA1c had decreased to 7.9% in the insulin pump group (mean change -1.1%, Standard deviation [SD] 1.2) vs. 8.6% in the multiple daily injection group (-0.4%, SD 1.1), with between group difference of -0.7% (95% Confidence Interval [CI] -0.9 to -0.4; p<0.0001). The number of patients at 6 months with HbA1c levels of ≤8% was 85 (55%) in the pump group and 43 (28%) in the injection group (odds ratio [OR] 1.9, 95% CI 1.5 to 2.5, p<0.0001). 6-day masked continuous glucose monitoring data at baseline and 6 months showed a significantly greater decrease in 24-hour mean glucose concentration in the pump group (10.4 mmol/L, SD 2.0 at baseline; 9.3 mmol/L, SD 2.0 at 6 months) than in the injection group (10.1 mmol/L, 2.0 at baseline; 9.6 mmol/L, 2.1 at 6 months; p=0.0062). At the end of the study, the total daily dose of insulin was significantly lower in the pump group than in the injection group (mean 97 units [SD 56] vs. 122 units [SD 68], p<0.0001).
Two serious hyperglycemic adverse effects requiring hospital admission occurred in the pump group vs. one in the injection group. No ketoacidosis occurred in either group and one episode of severe hypoglycemia occurred in the injection group.
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