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The effect of continuous glucose monitoring in well-controlled type 1 diabetes.

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study GroupBeck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D - Diabetes Care (2009)

Bottom Line: 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).CONCLUSIONS Most outcomes, including those combining A1C and hypoglycemia, favored the CGM group.

View Article: PubMed Central - PubMed

ABSTRACT
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%.

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Combined A1C and hypoglycemia outcomes. Four outcomes are shown: A, combined outcome of A1C improved by ≥0.3% from baseline to 26 weeks and no severe hypoglycemic events; B, combined outcome of A1C improved by ≥0.3% from baseline to 26 weeks and CGM-measured hypoglycemia (≤70 mg/dl) not increased from baseline to 26 weeks by ≥43 min/day (3% of the day); C, combined outcome of A1C not worse by ≥0.3% and CGM-measured hypoglycemia (≤70 mg/dl) decreased from baseline to 26 weeks by ≥43 min/day (3% of the day); D, combined outcome of either B or C.
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Figure 1: Combined A1C and hypoglycemia outcomes. Four outcomes are shown: A, combined outcome of A1C improved by ≥0.3% from baseline to 26 weeks and no severe hypoglycemic events; B, combined outcome of A1C improved by ≥0.3% from baseline to 26 weeks and CGM-measured hypoglycemia (≤70 mg/dl) not increased from baseline to 26 weeks by ≥43 min/day (3% of the day); C, combined outcome of A1C not worse by ≥0.3% and CGM-measured hypoglycemia (≤70 mg/dl) decreased from baseline to 26 weeks by ≥43 min/day (3% of the day); D, combined outcome of either B or C.

Mentions: On a subject level, a reduction in time ≤70 mg/dl was defined as a decrease from baseline of ≥43 min/day (3% of the day), and an increase likewise was defined as an increase from baseline of ≥43 min/day (representing an ∼50% change from the average baseline level). Four outcome measures were created by combining A1C and hypoglycemia data (as defined in the legend to Fig. 1) and compared between treatment groups, using a logistic regression model adjusting for baseline A1C.


The effect of continuous glucose monitoring in well-controlled type 1 diabetes.

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study GroupBeck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D - Diabetes Care (2009)

Combined A1C and hypoglycemia outcomes. Four outcomes are shown: A, combined outcome of A1C improved by ≥0.3% from baseline to 26 weeks and no severe hypoglycemic events; B, combined outcome of A1C improved by ≥0.3% from baseline to 26 weeks and CGM-measured hypoglycemia (≤70 mg/dl) not increased from baseline to 26 weeks by ≥43 min/day (3% of the day); C, combined outcome of A1C not worse by ≥0.3% and CGM-measured hypoglycemia (≤70 mg/dl) decreased from baseline to 26 weeks by ≥43 min/day (3% of the day); D, combined outcome of either B or C.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2713649&req=5

Figure 1: Combined A1C and hypoglycemia outcomes. Four outcomes are shown: A, combined outcome of A1C improved by ≥0.3% from baseline to 26 weeks and no severe hypoglycemic events; B, combined outcome of A1C improved by ≥0.3% from baseline to 26 weeks and CGM-measured hypoglycemia (≤70 mg/dl) not increased from baseline to 26 weeks by ≥43 min/day (3% of the day); C, combined outcome of A1C not worse by ≥0.3% and CGM-measured hypoglycemia (≤70 mg/dl) decreased from baseline to 26 weeks by ≥43 min/day (3% of the day); D, combined outcome of either B or C.
Mentions: On a subject level, a reduction in time ≤70 mg/dl was defined as a decrease from baseline of ≥43 min/day (3% of the day), and an increase likewise was defined as an increase from baseline of ≥43 min/day (representing an ∼50% change from the average baseline level). Four outcome measures were created by combining A1C and hypoglycemia data (as defined in the legend to Fig. 1) and compared between treatment groups, using a logistic regression model adjusting for baseline A1C.

Bottom Line: 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).CONCLUSIONS Most outcomes, including those combining A1C and hypoglycemia, favored the CGM group.

View Article: PubMed Central - PubMed

ABSTRACT
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%.

Show MeSH
Related in: MedlinePlus