Use of insulin pumps is associated with better glycemic control and lower rates of severe hypoglycemia and diabetic ketoacidosis compared with multiple daily injections among youth with type 1 diabetes, new research shows.
The findings, from a large European database, were published in the October 10 issue of the Journal of the American Medical Association by Beate Karges, MD, of the division of endocrinology and diabetes, medical faculty, RWTH Aachen University, Aachen, Germany, and colleagues.
Previous studies have suggested that insulin-pump use improves glycemic control and reduces severe hypoglycemia compared with multiple daily injections of insulin, but some data also have raised concern that pump use might increase the risk for diabetic ketoacidosis (DKA). However, few prior studies have been large enough to assess the true rates of these relatively infrequent complications.
Dr Karges and colleagues note that use of insulin pumps for the treatment of type 1 diabetes has increased substantially in recent years, with almost half of all patients worldwide (47%) using them by 2016. However, there has been an issue with access, and, in some countries, use in children and adolescents in particular is still quite low.
The new findings, based on data for nearly 20,000 patients with type 1 diabetes under 20 years of age from four European countries, "provide evidence for improved clinical outcomes associated with insulin-pump therapy compared with injection therapy in children, adolescents, and young adults with type 1 diabetes," Dr Karges and colleagues write.
Demonstrating that insulin pumps are safe and effective is also important because they are one of the core components of "artificial-pancreas" technology, the authors point out.
Ronald Tamler, MD, medical director of the Mount Sinai Clinical Diabetes Institute, New York, who was not involved in the study, said the study "highlights the great progress the technology has made….We at Mount Sinai use insulin-pump therapy — with or without continuous glucose monitoring — for many of our patients with type 1 diabetes."
However, he also cautioned, "It's not for everyone."
Several Improvements Over Multiple Daily Injections
The study population came from 350 diabetes centers in Germany, Austria, Luxembourg, and Switzerland, all participating in the Diabetes Prospective Follow-up (DPV) Initiative database. Overall, there were 14,119 patients with type 1 diabetes younger than 20 years of age using insulin pumps and 16,460 using multiple (four or more) daily insulin injections.
Because baseline characteristics of patients who choose to use insulin pumps may differ from those who opt for injections, propensity-score matching was used to pair 9814 patients from each treatment group on the basis of age, sex, diabetes duration, migration background, body mass index, and HbA1c.
Primary outcomes were rates of severe hypoglycemia — defined as requiring treatment assistance from another person (via carbohydrates, glucagon, or intravenous glucose) — and diabetic ketoacidosis, defined as pH less than 7.3 or bicarbonate below 15 mmol/L, during the most recent treatment year.
Hypoglycemic coma was defined as loss of consciousness or occurrence of seizures, and severe ketoacidosis as pH less than 7.1 or bicarbonate concentration below 5 mmol/L.
Rates of severe hypoglycemia were significantly lower among the pump users compared with those taking multiple daily injections (9.55 vs 13.97 per 100 patient-years; incidence rate ratio [IRR], 0.68), as were rates of hypoglycemic coma (2.30 vs. 2.96 per 100 patient-years; IRR, 0.78).
The differences remained significant after adjustment for multiple comparisons (P < .001 for severe hypoglycemia, P = .03 for hypoglycemic coma).
Pump therapy was also associated with significantly lower overall DKA rates compared with injections (3.64 vs 4.26 per 100 patient-years; IRR, 0.85), and severe DKA rates (2.29 vs 2.80 per 100 patient-years; IRR, 0.82).
Results Favor Pump Therapy
Secondary outcomes included HbA1c and insulin dose.
Overall HbA1c levels were significantly lower with pump therapy (8.04% vs 8.22%), although the difference wasn't significant among the matched pairs of children aged 1.5 to 5 years.
"The average HbA1c of over 8% for both groups highlights the challenges at hand," Dr Tamler noted.
Total daily insulin doses were lower in the pump patients, and they also took a higher proportion of their daily doses as premeal rather than basal insulin (P < .001 overall).
The smaller but more frequent insulin doses in the pump group allow for more flexible dosing with lower glycemic variability and fewer severe hypoglycemia episodes, Dr Karges and colleagues explain.
They note that pump therapy seemed to be particularly effective compared with multiple daily injections in preventing severe hypoglycemia and hypoglycemic coma among school-age children.
And mean daily frequency of self-monitoring of blood glucose level was significantly higher among the pump patients in all age groups (P < .001) and was associated with the lower DKA risk, they stress.
Results were similarly significant for the entire cohort as in the matched pairs.
Overall "these results favor pump therapy with lower rates of acute complications and, at the same time, lower HbA1c levels, reflecting improved metabolic control," Dr Karges and colleagues conclude.
Dr Tamler said, "It remains to be seen if these encouraging results can be extrapolated to an adult population or to the diverse population in the US."
This study was supported by the Competence Network Diabetes Mellitus and the German Center for Diabetes Research, both funded by the Federal Ministry of Education and Research, Berlin, Germany; and by the European Foundation for the Study of Diabetes. Dr Karges has no relevant financial relationships; disclosures for the coauthors are listed in the paper. Dr Tamler has no relevant financial relationships.
JAMA. 2017; 318:1358-1366. Abstract
Medscape Medical News © 2017
Cite this: Insulin-Pump Use Benefits Young People With Type 1 Diabetes - Medscape - Oct 10, 2017.