PUMP THERAPY SUPERIOR TO FURTHER INTENSIFICATION OF MULTIPLE DAILY INJECTION THERAPY IN TYPE 2 DIABETES
AACE ePoster Library. Lee S. 05/13/15; 97783; 231
Dr. Scott Lee
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Abstract
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Objective: Therapy intensification in poorly-controlled type 2 diabetes often involves insulin. A randomized controlled trial, OpT2mise (NCT01182493), was conducted to compare pump therapy (CSII) with multiple daily injections (MDI).
Methods: Subjects with poor glycemic control (N=495) on MDI were enrolled into a run-in period for dose optimization, after which those with A1Cs of 8-12% (N=331) either continued MDI (n=163) or switched to CSII (n=168) for 6 mo. Glycemia was evaluated with 2 blinded continuous glucose monitoring (CGM) studies and with periodic A1C measurements. Treatment satisfaction was assessed via questionnaires. Response dependence on autoimmune status and endogenous insulin were evaluated by stratification according to pre-randomization anti-GAD Ab concentrations (<1 or ≥1 U/mL) and C-peptide concentration quartiles (using cutoff values of 156, 310, and 569 pmol/L).
Results or Case Presentation: At baseline, mean A1C was 9% in both groups. By 6 mo, the change in A1C (ΔA1C) was -1.1±1.2% (CSII) and -0.4±1.1% (MDI), for a between-group difference of -0.7% in favor of CSII (95% CI, -0.9 to -0.4%, p<0.001). Patients in the CSII group were 1.9-fold more likely to achieve a 6-mo A1C <8% than those in the MDI group (p<0.001). Six-month total daily insulin doses were 97±56 U (CSII) and 122±68 U (MDI), p<0.0001. Compared to the first (pre-randomization) CGM study, 24-hour sensor glucose (SG) values at 6 months were significantly lower in CSII group than in the MDI group (between-group difference of -17.1 mg/dL, p<0.05); the CSII group also spent 169 fewer minutes per day in hyperglycemia >180 mg/dL (p<0.001) with no difference in exposure to SG <70 mg/dL. Greater A1C decreases at 6 months were significantly associated with improved treatment satisfaction in the CSII group (p<0.05) but not in the MDI group. There was no significant difference in ΔA1C between patients with (n=27) or without (n=135) anti-GAD antibodies in either group, and no association between ΔA1C and C-peptide concentration quartile in either group (p>0.1 for each).
Discussion: For the ~30% of patients with type 2 diabetes who are unable to reach A1C targets with MDI, CSII offers significant glycemic and treatment satisfaction benefits while allowing for decreased insulin use.
Conclusion: OpT2mise has demonstrated that switching to CSII from optimized MDI therapy allows many patients with poorly-controlled type 2 diabetes to decrease their A1C values and reach A1C goals. The benefits were achieved with no increased exposure to hypoglycemia, 20% less insulin usage, and improved treatment satisfaction. Benefits were independent of baseline C-peptide and anti-GAD antibody concentrations.
Methods: Subjects with poor glycemic control (N=495) on MDI were enrolled into a run-in period for dose optimization, after which those with A1Cs of 8-12% (N=331) either continued MDI (n=163) or switched to CSII (n=168) for 6 mo. Glycemia was evaluated with 2 blinded continuous glucose monitoring (CGM) studies and with periodic A1C measurements. Treatment satisfaction was assessed via questionnaires. Response dependence on autoimmune status and endogenous insulin were evaluated by stratification according to pre-randomization anti-GAD Ab concentrations (<1 or ≥1 U/mL) and C-peptide concentration quartiles (using cutoff values of 156, 310, and 569 pmol/L).
Results or Case Presentation: At baseline, mean A1C was 9% in both groups. By 6 mo, the change in A1C (ΔA1C) was -1.1±1.2% (CSII) and -0.4±1.1% (MDI), for a between-group difference of -0.7% in favor of CSII (95% CI, -0.9 to -0.4%, p<0.001). Patients in the CSII group were 1.9-fold more likely to achieve a 6-mo A1C <8% than those in the MDI group (p<0.001). Six-month total daily insulin doses were 97±56 U (CSII) and 122±68 U (MDI), p<0.0001. Compared to the first (pre-randomization) CGM study, 24-hour sensor glucose (SG) values at 6 months were significantly lower in CSII group than in the MDI group (between-group difference of -17.1 mg/dL, p<0.05); the CSII group also spent 169 fewer minutes per day in hyperglycemia >180 mg/dL (p<0.001) with no difference in exposure to SG <70 mg/dL. Greater A1C decreases at 6 months were significantly associated with improved treatment satisfaction in the CSII group (p<0.05) but not in the MDI group. There was no significant difference in ΔA1C between patients with (n=27) or without (n=135) anti-GAD antibodies in either group, and no association between ΔA1C and C-peptide concentration quartile in either group (p>0.1 for each).
Discussion: For the ~30% of patients with type 2 diabetes who are unable to reach A1C targets with MDI, CSII offers significant glycemic and treatment satisfaction benefits while allowing for decreased insulin use.
Conclusion: OpT2mise has demonstrated that switching to CSII from optimized MDI therapy allows many patients with poorly-controlled type 2 diabetes to decrease their A1C values and reach A1C goals. The benefits were achieved with no increased exposure to hypoglycemia, 20% less insulin usage, and improved treatment satisfaction. Benefits were independent of baseline C-peptide and anti-GAD antibody concentrations.
Objective: Therapy intensification in poorly-controlled type 2 diabetes often involves insulin. A randomized controlled trial, OpT2mise (NCT01182493), was conducted to compare pump therapy (CSII) with multiple daily injections (MDI).
Methods: Subjects with poor glycemic control (N=495) on MDI were enrolled into a run-in period for dose optimization, after which those with A1Cs of 8-12% (N=331) either continued MDI (n=163) or switched to CSII (n=168) for 6 mo. Glycemia was evaluated with 2 blinded continuous glucose monitoring (CGM) studies and with periodic A1C measurements. Treatment satisfaction was assessed via questionnaires. Response dependence on autoimmune status and endogenous insulin were evaluated by stratification according to pre-randomization anti-GAD Ab concentrations (<1 or ≥1 U/mL) and C-peptide concentration quartiles (using cutoff values of 156, 310, and 569 pmol/L).
Results or Case Presentation: At baseline, mean A1C was 9% in both groups. By 6 mo, the change in A1C (ΔA1C) was -1.1±1.2% (CSII) and -0.4±1.1% (MDI), for a between-group difference of -0.7% in favor of CSII (95% CI, -0.9 to -0.4%, p<0.001). Patients in the CSII group were 1.9-fold more likely to achieve a 6-mo A1C <8% than those in the MDI group (p<0.001). Six-month total daily insulin doses were 97±56 U (CSII) and 122±68 U (MDI), p<0.0001. Compared to the first (pre-randomization) CGM study, 24-hour sensor glucose (SG) values at 6 months were significantly lower in CSII group than in the MDI group (between-group difference of -17.1 mg/dL, p<0.05); the CSII group also spent 169 fewer minutes per day in hyperglycemia >180 mg/dL (p<0.001) with no difference in exposure to SG <70 mg/dL. Greater A1C decreases at 6 months were significantly associated with improved treatment satisfaction in the CSII group (p<0.05) but not in the MDI group. There was no significant difference in ΔA1C between patients with (n=27) or without (n=135) anti-GAD antibodies in either group, and no association between ΔA1C and C-peptide concentration quartile in either group (p>0.1 for each).
Discussion: For the ~30% of patients with type 2 diabetes who are unable to reach A1C targets with MDI, CSII offers significant glycemic and treatment satisfaction benefits while allowing for decreased insulin use.
Conclusion: OpT2mise has demonstrated that switching to CSII from optimized MDI therapy allows many patients with poorly-controlled type 2 diabetes to decrease their A1C values and reach A1C goals. The benefits were achieved with no increased exposure to hypoglycemia, 20% less insulin usage, and improved treatment satisfaction. Benefits were independent of baseline C-peptide and anti-GAD antibody concentrations.
Methods: Subjects with poor glycemic control (N=495) on MDI were enrolled into a run-in period for dose optimization, after which those with A1Cs of 8-12% (N=331) either continued MDI (n=163) or switched to CSII (n=168) for 6 mo. Glycemia was evaluated with 2 blinded continuous glucose monitoring (CGM) studies and with periodic A1C measurements. Treatment satisfaction was assessed via questionnaires. Response dependence on autoimmune status and endogenous insulin were evaluated by stratification according to pre-randomization anti-GAD Ab concentrations (<1 or ≥1 U/mL) and C-peptide concentration quartiles (using cutoff values of 156, 310, and 569 pmol/L).
Results or Case Presentation: At baseline, mean A1C was 9% in both groups. By 6 mo, the change in A1C (ΔA1C) was -1.1±1.2% (CSII) and -0.4±1.1% (MDI), for a between-group difference of -0.7% in favor of CSII (95% CI, -0.9 to -0.4%, p<0.001). Patients in the CSII group were 1.9-fold more likely to achieve a 6-mo A1C <8% than those in the MDI group (p<0.001). Six-month total daily insulin doses were 97±56 U (CSII) and 122±68 U (MDI), p<0.0001. Compared to the first (pre-randomization) CGM study, 24-hour sensor glucose (SG) values at 6 months were significantly lower in CSII group than in the MDI group (between-group difference of -17.1 mg/dL, p<0.05); the CSII group also spent 169 fewer minutes per day in hyperglycemia >180 mg/dL (p<0.001) with no difference in exposure to SG <70 mg/dL. Greater A1C decreases at 6 months were significantly associated with improved treatment satisfaction in the CSII group (p<0.05) but not in the MDI group. There was no significant difference in ΔA1C between patients with (n=27) or without (n=135) anti-GAD antibodies in either group, and no association between ΔA1C and C-peptide concentration quartile in either group (p>0.1 for each).
Discussion: For the ~30% of patients with type 2 diabetes who are unable to reach A1C targets with MDI, CSII offers significant glycemic and treatment satisfaction benefits while allowing for decreased insulin use.
Conclusion: OpT2mise has demonstrated that switching to CSII from optimized MDI therapy allows many patients with poorly-controlled type 2 diabetes to decrease their A1C values and reach A1C goals. The benefits were achieved with no increased exposure to hypoglycemia, 20% less insulin usage, and improved treatment satisfaction. Benefits were independent of baseline C-peptide and anti-GAD antibody concentrations.
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