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Background
  • Insulin Glargine is:
    • A long acting, and “peakless” insulin.
    • Cannot be mixed with other insulin analogs.
    • Widely used in insulin intensive management (IIM).

  • Major drawbacks to its use in pediatric patients are:
    • Duration of effect < 24h.
    • Requirement for multiple injections.
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Background
  • Mixing insulin Glargine with Regular insulin in healthy dogs did not affect the glucose lowering activity1.


  • The effect of mixing insulin Glargine with short acting insulin analogs has not been evaluated in humans.
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Objective
  • Evaluate the effect of mixing insulin Glargine with short acting insulin analogs on glycemic control in adolescents with type 1 diabetes (T1D).


  • Compare the glycemic control of insulin Glargine given twice a day versus once daily.
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HYPOTHESIS
  • In adolescents with T1D, mixing insulin Glargine with short acting insulin analogs, or dividing the dose to twice a day does not worsen glycemic control
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Inclusion Criteria:
  • 10-17 yr.
  • Type I diabetes > 1yr.
  • A1C < 9.0%
  • Already on IIM therapy.
  • No other chronic illnesses.
  • No other medications.
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Study Design
  • Subjects were studied
    • 1.  At baseline, on their current insulin regimen (once a day Glargine).
    • 2.  Then in random order on:
      • Mixing injection: insulin Glargine dose was divided into two halves and given before breakfast and before dinner, mixed in the same syringe with the short acting insulin.
      • Separate injections: same as the mixing, except that Glargine and short acting insulin were administered separately.
  • Glucose concentrations measured for 72h using the CGMS Medtronic MiniMed®.
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STUDY DESIGN
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DATA ANALYSIS
  • Repeated measures ANOVA was used to determine the effects of
    • treatment
    • order of treatment
    • and their interaction
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Results: Subjects characteristics
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Percentage of Hypoglycemic Episodes

  • Baseline - 5%
  • Mixing- 9%
  • Separate injections-2%



    • (p<0.8)
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SUMMARY
  • There was no difference among the three studies regarding:
    • 24h or 72h average glucose concentrations.
    • Number of hypoglycemic episodes.
    • Pre-prandial or post-prandial glucose concentrations.
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CONCLUSION
  • Mixing insulin Glargine with short acting insulin analogs in adolescents with T1D:
    • Does no compromise glycemic control
    • Does not increase hypoglycemic episodes.
    • Simplifies IIM therapy, which could result in improve compliance and control.
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Reference
  • 1: Werner U, Gerlach M, Hofmann M, et al. Mixture of regular human insulin and insulin glargine injected subcutaneously in healthy dogs does not increase risk of hypoglycemia. Diabetes 2002; 51(suppl 2):A296