The effect of continuous glucose monitoring in well-controlled type 1 diabetes.
OBJECTIVE The potential benefits of continuous glucose monitoring (CGM) in the management of adults and children with well-controlled type 1 diabetes have not been examined. RESEARCH DESIGN AND METHODS A total of 129 adults and children with intensively treated type 1 diabetes (age range 8-69 years) and A1C <7.0% were randomly assigned to either continuous or standard glucose monitoring for 26 weeks. The main study outcomes were time with glucose level < or =70 mg/dl, A1C level, and severe hypoglycemic events. RESULTS At 26 weeks, biochemical hypoglycemia (< or =70 mg/dl) was less frequent in the CGM group than in the control group (median 54 vs. 91 min/day), but the difference was not statistically significant (P = 0.16). Median time with a glucose level < or =60 mg/dl was 18 versus 35 min/day, respectively (P = 0.05). Time out of range (< or =70 or >180 mg/dl) was significantly lower in the CGM group than in the control group (377 vs. 491 min/day, P = 0.003). There was a significant treatment group difference favoring the CGM group in mean A1C at 26 weeks adjusted for baseline (P < 0.001). One or more severe hypoglycemic events occurred in 10 and 11% of the two groups, respectively (P = 1.0). Four outcome measures combining A1C and hypoglycemia data favored the CGM group in comparison with the control group (P < 0.001, 0.007, 0.005, and 0.003). CONCLUSIONS Most outcomes, including those combining A1C and hypoglycemia, favored the CGM group. The weight of evidence suggests that CGM is beneficial for individuals with type 1 diabetes who have already achieved excellent control with A1C <7.0%.
Roy W
RW
Beck
Irl B
IB
Hirsch
Lori
L
Laffel
William V
WV
Tamborlane
Bruce W
BW
Bode
Bruce
B
Buckingham
Peter
P
Chase
Robert
R
Clemons
Rosanna
R
Fiallo-Scharer
Larry A
LA
Fox
Lisa K
LK
Gilliam
Elbert S
ES
Huang
Craig
C
Kollman
Aaron J
AJ
Kowalski
Jean M
JM
Lawrence
Joyce
J
Lee
Nelly
N
Mauras
Michael
M
O'Grady
Katrina J
KJ
Ruedy
Michael
M
Tansey
Eva
E
Tsalikian
Stuart A
SA
Weinzimer
Darrell M
DM
Wilson
Howard
H
Wolpert
Tim
T
Wysocki
Dongyuan
D
Xing
D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000379:methods*; D055815:Young Adult
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin