The Impact of Insulin Pump Therapy on Glycemic Profiles in Patients with Type 2 Diabetes: Data from the OpT2mise Study

Abstract

Background: The OpT2mise randomized trial was designed to compare the effects of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) on glucose profiles in patients with type 2 diabetes.Research Design and Methods: Patients with glycated hemoglobin (HbA1c) levels of ≥8% (64 mmol/mol) and ≤12% (108 mmol/mol) despite insulin doses of 0.7–1.8 U/kg/day via MDI were randomized to CSII (n=168) or continued MDI (n=163). Changes in glucose profiles were evaluated using continuous glucose monitoring data collected over 6-day periods before and 6 months after randomization.Results: After 6 months, reductions in HbA1c levels were significantly greater with CSII (−1.1±1.2% [−12.0±13.1 mmol/mol]) than with MDI (−0.4±1.1% [−4.4±12.0 mmol/mol]) (P<0.001). Similarly, compared with patients receiving MDI, those receiving CSII showed significantly greater reductions in 24-h mean sensor glucose (SG) (treatment difference, −17.1 mg/dL; P=0.0023), less exposure to SG >180 mg/dL (−12.4%; P=0.0004) and SG >250 mg/dL (−5.5%; P=0.0153), and more time in the SG range of 70–180 mg/dL (12.3%; P=0.0002), with no differences in exposure to SG<70 mg/dL or in glucose variability. Changes in postprandial (4-h) glucose area under the curve >180 mg/dL were significantly greater with CSII than with MDI after breakfast (−775.9±1,441.2 mg/dL/min vs. −160.7±1,074.1 mg/dL/min; P=0.0015) and after dinner (−731.4±1,580.7 mg/dL/min vs. −71.1±1,083.5 mg/dL/min; P=0.0014).Conclusions: In patients with suboptimally controlled type 2 diabetes, CSII significantly improves selected glucometrics, compared with MDI, without increasing the risk of hypoglycemia.

The role of insulin pump therapy for type 2 diabetes mellitus

“…Important information was provided by data from the OpT2mise study; blinded CGM data were available for patients treated by CSII and MDI. Although a reduction in exposure to hyperglycemia in the CSII group was demonstrated, it was not associated with an increase in time spent in the hypoglycemic range (glucose levels < 70 mg/dL) . CSII treatment is not associated with elevated risk for hypoglycemic episodes.…”

Contribution of basal and postprandial hyperglycaemia in type 2 diabetes patients treated by an intensified insulin regimen: Impact of pump therapy in the OPT2mise trial

“…17 In the present work, we demonstrate that the BHG contribution predominates across a large range of HbA1c levels, from <8% 14 Their profiles were characterized by an elevated 24-hour mean glucose concentration, although the basal and postprandial hyperglycaemic components were not characterized.…”

“…[14][15][16][17] In this post hoc analysis, data from the OPT2mise study were used to perform different evaluations on BHG and PPHG ( Figure S1). Briefly, patients with poor glycaemic control while undergoing MDI therapy (n = 495) were enrolled in an 8-week run-in period for insulin dose optimization (≥0.7 and ≤1.8 U/kg/d).…”

“…The 24-hour CGM profiles among HbA1c subgroups are depicted in Figure S3 and suggest an incremental influence of basal hyperglycaemia from the lowest to the highest HbA1c subgroup. 17 3.2 | Relative contribution of basal and postprandial hyperglycaemia in MDI therapy Figure 2A shows AUC-B and AUC-P in the different HbA1c groups. 17 3.2 | Relative contribution of basal and postprandial hyperglycaemia in MDI therapy Figure 2A shows AUC-B and AUC-P in the different HbA1c groups.…”

Intensive insulin therapy combined with metformin is associated with reduction in both glucose variability and nocturnal hypoglycaemia in patients with type 2 diabetes

“…Although multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII) are 2 intensive insulin therapy methods in patients with type 2 diabetes, studies indicated an advantage in glycated haemoglobin (HbA1c) decrease and less daily insulin use in CSII when compared with MDI even though no difference was found between the 2 therapies in hypoglycaemic episode . Therefore, how to decrease the glucose fluctuation and hypoglycaemic episode at the same time of reducing HbA1c level becomes an essential part in intensive insulin therapy.…”