The Effect of Pramlintide on Meal Time Insulin Bolus

Study Overview
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Brief Summary
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The primary objective is to establish the mean percentage of change in the insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6 mcg before each meal is reached. The secondary objective is to establish which insulin bolus wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated with maximum pramlintide dosage.

Detailed Description
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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.

Official Title
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The Effect of Pramlintide on Meal Time Insulin Bolus

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: pramlintide
* Procedure: continuous glucose monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pramlintide|nan|
|Procedure: continuous glucose monitoring|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean ICR from Vist 3a-e and 4a-e will be compared. Percentage reduction of ICR will be calculated. From these the mean ICR will be calculated. |  | 12-10-07 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean post-meal glucose from the four hour period after beginning a meal will be averaged for each bolus wave form. Then the three wave form mean glucose results will be compared. |  | 12-10-07 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type I diabetes, Insulin pump, Continuous glucose monitoring, Insulin to carbohydrate ratio, Correction factor, Pramlintide