Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes.
BACKGROUND
Recently developed technologies for the treatment of type 1 diabetes mellitus include a variety of pumps and pumps with glucose sensors.


METHODS
In this 1-year, multicenter, randomized, controlled trial, we compared the efficacy of sensor-augmented pump therapy (pump therapy) with that of a regimen of multiple daily insulin injections (injection therapy) in 485 patients (329 adults and 156 children) with inadequately controlled type 1 diabetes. Patients received recombinant insulin analogues and were supervised by expert clinical teams. The primary end point was the change from the baseline glycated hemoglobin level.


RESULTS
At 1 year, the baseline mean glycated hemoglobin level (8.3% in the two study groups) had decreased to 7.5% in the pump-therapy group, as compared with 8.1% in the injection-therapy group (P<0.001). The proportion of patients who reached the glycated hemoglobin target (<7%) was greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycemia in the pump-therapy group (13.31 cases per 100 person-years) did not differ significantly from that in the injection-therapy group (13.48 per 100 person-years, P=0.58). There was no significant weight gain in either group.


CONCLUSIONS
In both adults and children with inadequately controlled type 1 diabetes, sensor-augmented pump therapy resulted in significant improvement in glycated hemoglobin levels, as compared with injection therapy. A significantly greater proportion of both adults and children in the pump-therapy group than in the injection-therapy group reached the target glycated hemoglobin level. (Funded by Medtronic and others; ClinicalTrials.gov number, NCT00417989.)
Bergenstal
Richard M
RM
International Diabetes Center at Park Nicollet, Minneapolis, MN 55416, USA. richard.bergenstal@parknicollet.com
Tamborlane
William V
WV
Ahmann
Andrew
A
Buse
John B
JB
Dailey
George
G
Davis
Stephen N
SN
Joyce
Carol
C
Peoples
Tim
T
Perkins
Bruce A
BA
Welsh
John B
JB
Willi
Steven M
SM
Wood
Michael A
MA
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D016883:Diabetic Ketoacidosis / Q000209:etiology; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D016896:Treatment Outcome; D055815:Young Adult
D006442:Glycated Hemoglobin; D007328:Insulin