Type 1 Diabetes
Conditions
Keywords
Type I diabetes, Insulin pump, Continuous glucose monitoring, Insulin to carbohydrate ratio, Correction factor, Pramlintide
Brief summary
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
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.
Interventions
DRUGpramlintide
PROCEDUREcontinuous glucose monitoring
Sponsors
Amylin Pharmaceuticals, LLC.
Diabetes Care Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed