Surprising CONCEPTT findings on insulin pumps versus injections in pregnant women
medwireNews: A prespecified analysis of the CONCEPTT trial shows that pregnant women with type 1 diabetes who were using pumps at baseline did not achieve as good glycemic control as those using multiple daily injections (MDI).
Moreover, they had higher rates of gestational hypertension (14.4 vs 5.2%), neonatal hypoglycemia (31.8 vs 19.1%), and neonatal intensive care unit admission for more than 24 hours (44.5 vs 29.6%).
Commenting on the research for medwireNews, Rebecca Reynolds (University of Edinburgh, UK) described the findings as “very surprising,” saying that diabetologists would generally assume that pump use would be associated with improved glycemic control in pregnancy, which would in turn improve pregnancy outcomes. “Certainly in our hospital if you’ve got poor control and you’re pregnant you would go up the waiting list to be put on a pump.”
She feels that the study as it stands is unlikely to change clinical practice, but said: “It alerts us – both patients and healthcare professionals – that being on a pump during pregnancy means that there’s going to need to be continual assessment to ensure it’s being used in the most appropriate way.”
At baseline, 125 of the CONCEPTT participants were using insulin pumps and 123 were on MDI, and the two groups had similar glycated hemoglobin (HbA1c) levels, at 6.84% (51 mmol/mol) and 6.95% (52 mmol/mol), respectively.
But between randomization (to continuous glucose monitoring or self-monitored blood glucose, after stratification for insulin delivery method) and week 34 of follow-up, pump users had a significantly smaller HbA1c decrease than MDI users, at 0.32% versus 0.55% (3 vs 6 mmol/mol), and a significantly smaller 52.0% versus 65.1% were at or below their HbA1c target of 6.5% (48 mmol/mol).
These differences remained significant after accounting for duration of diabetes, education level, cigarette smoking, and gestational age, report Denice Feig (Mount Sinai Hospital, Toronto, Ontario, Canada) and co-researchers in Diabetes Care.
Reynolds said that “there’s no doubt that pump therapy does work, but there’s a lot more subtleties that we need to be aware of, and so you can’t just assume that putting someone on a pump is going to be the end product.”
The fact that the CONCEPTT participants were not randomly assigned to pumps versus MDI may partly underlie the unexpected finding, but she stressed that “there’s almost certainly a need for better understanding of how to use these technologies in pregnancy, both from the patient point of view and the healthcare professional point of view.”
She noted a need for larger studies, but also for qualitative studies, investigating women’s experiences with pump use during pregnancy. “As healthcare professionals, we assume the reason is to do with something that we think we know about, but when you go and actually speak to patients it’s often something completely different, and that’s why I think it’s important to do that kind of work as well.”
Reynolds also pointed out that “the goalposts have shifted” since CONCEPTT was performed, with the wider availability of flash glucose monitoring likely to impact diabetes management in pregnancy irrespective of whether patients are on pumps or MDI.
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