The study, funded by Medtronic, follows an earlier study that compared pump users to those using daily injections to manage type 2 diabetes.
While insulin is typically associated with type 1 diabetes, a small share of those with type 2 disease—about 4.7% of the 422 million worldwide—use the hormone to manage their diabetes.
In raw numbers, however, that’s a lot of people: roughly 20 million. Poorly managed type 2 diabetes (T2D) can lead to complications that result in a visit to the emergency department (ED) or hospitalization. A key study in The American Journal of Managed Care in 2011 found that the average cost of a hypoglycemia visit was $17,564 for an inpatient admission, $1387 for an ED visit, and $394 for an outpatient visit.1
Today, the insulin pump maker Medtronic announced data published in the journal Diabetes, Obesity and Metabolism,2 which followed up on an earlier study in the journal Lancet. That phase of the study found T2D patients who used its MiniMed pump to deliver insulin had superior glycemic control and needed less insulin than a similar group of patients who received insulin through injections over a 6-month period.3
New results show that when the group injecting insulin was able to switch to a pump, these patients’ glycated hemoglobin (A1C) caught up to the original pump users by the 12-month mark, even though the first group had a lower average A1C at 6 months, and 55% of the pump users achieved 8.0% or lower, compared with 28% of those using injections.2,3 During the second phase, the original pump users achieved an additional 0.1% A1C reduction, for a final average of 7.8%.
The study, known as OpT2mise, was described by Medtronic as the largest randomized controlled trial to compare the efficacy and safety of insulin pump therapy with multiple daily injections in patients with poorly controlled T2D. Medtronic funded the study.
Insulin pumps, said lead author Ronnie Aronson, MD, FRCPC, FACE, “helped participants with insulin-requiring type 2 diabetes safely achieve better glucose control, with lower insulin doses, than (multiple daily injections).”
“Given that many patients with type 2 diabetes have difficulty achieving glycemic control, these additional data demonstrate that insulin pumps provide a significant advantage over (injections) with a safe and consistent effect.”
Results published in the current study involved 331 patients with T2D, whose A1C was at least 8.0% and not more than 12.0%. Patients were randomized to start with pump therapy (n= 168) or injections (n= 163), and the mean A1C at baseline was 9.0% for both groups. The mean decline in A1C at 6 months was 1.2% for the pump group and 0.4% for the injection group.
At the midpoint of the study, the injection group switched to pump therapy. The pump group maintained a mean decline of 1.2% in A1C, but the second group now declined 0.8%, to achieve the same decline as the first group. Researchers reported no differences in weight gain or ketoacidosis between the groups. During the first phase of the trial, 1 patient in each group experienced severe hypoglycemia.
Also noteworthy were the amounts of insulin needed to maintain control. In the first 6 months, the average total daily dose among the pump users was 97 units, compared with 122 units for those using injections for a difference of 20.4%. The total daily insulin dose dropped 19% for the group that switched from injections to pump therapy, and the 2 groups pulled even in insulin use.
Data presented with the study show that approximately the same percentage of patients in both groups were able to achieve A1C levels of less than 8.0% (57%) and less than 7.5% (36%) at 12 months; a slightly higher share of the original injection group (20%) achieved A1C of less than 7.0% than the group on the pump for the entire study (18%).
Medtronic spokesman Pamela Reese said in an email the cost savings of using less insulin over time on pump therapy compared with daily injections had not been calculated, but these studies are planned.
1. Quilliam BJ, Simeone JC, Ozbay B, Kogut SJ. The incidence and cost of hypoglycemia in type 2 diabetes. Am J Manag Care. 2011;17(10):673-680.
2. Aronson R, Reznik Y, Conget I, et al. Sustained efficacy of insulin pump therapy compared with multiple daily injections in type 2 diabetes: 12-month data from the OpT2mise randomized trial. Diab Obes Metab. 2016;18(5):500-507.
3. Reznik Y, Cohen O, Aronson A, et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomized open-label controlled trial. Lancet. 2014; 384(9950):1265-1272.