Continuous glucose monitoring and intensive treatment of type 1 diabetes.
BACKGROUND
The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined.


METHODS
In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks.


RESULTS
The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P=0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P=0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference.


CONCLUSIONS
Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.)
Tamborlane
William V
WV
Beck
Roy W
RW
Bode
Bruce W
BW
Buckingham
Bruce
B
Chase
H Peter
HP
Clemons
Robert
R
Fiallo-Scharer
Rosanna
R
Fox
Larry A
LA
Gilliam
Lisa K
LK
Hirsch
Irl B
IB
Huang
Elbert S
ES
Kollman
Craig
C
Kowalski
Aaron J
AJ
Laffel
Lori
L
Lawrence
Jean M
JM
Lee
Joyce
J
Mauras
Nelly
N
O'Grady
Michael
M
Ruedy
Katrina J
KJ
Tansey
Michael
M
Tsalikian
Eva
E
Weinzimer
Stuart
S
Wilson
Darrell M
DM
Wolpert
Howard
H
Wysocki
Tim
T
Xing
Dongyuan
D
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D018670:Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods*
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin