The Effect of Pramlintide on Meal Time Insulin Bolus

Pramlintide. an amylinomimetic, is effective in reducing post-meal glucose by non-insulin means. As such, when patients requiring insulin treatment are treated with pramlintide, the bolus insulin does must be reduced. Current recommendations suggest a 50% reduction but in our experience and that of a recent study this appears excessive. By using continuous glucose monitoring(CGM) to guide pre-meal insulin treatment, we will determine the percentage reduction in meal time insulin bolus comparing pre-pramlintide to maximum pramlintide treatment. We anticipate that the reduction in bolus dosage will be about 25%. In addition, the secondary aim of this study is to determine which bolus pattern, standard, square or dual wave, provides the best post-meal glucose control with pramlintide therapy.

Inclusion criteria

• Age: >17
• Type I diabetes
• Onset of diabetes >3 months
• Use of insulin pump >3 months
• Hb A1C <8.9%
• Demonstrated compliance to clinic visits
• Demonstrated knowledge and use of bolus dosing calculations, carbohydrate counting, use of insulin pump and blood glucose meter
• Monitor blood glucose >4/day

Exclusion criteria

• Pregnancy or nursing
• Recent (within last 3 months) factor that may cause change in insulin sensitivity, e.g. severe emotional or physical stress, recent significant infection or surgery. etc.
• Renal failure (creatinine >1.5 mg/dl
• Symptomatic gastroparesis
• Using a medication that would interfere with insulin sensitivity
• Treatment with extenatide or DPP IV inhibitor within the last 4 weeks
• HbA1C change >0.9 % within the last 3 months
• Significant change in eating or activity pattern
• Weight change of >1.9 kg within the last 3 months
• ALT >3 times upper limits of normal