Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 2/8/2017 |
| Start Date: | July 2010 |
| End Date: | December 2017 |
The investigators are doing this research study to compare the pharmacokinetics (rate of
absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine
(Apidra) within individual subjects.
Additionally, the investigators will perform a preliminary feasibility evaluation of a
minimally invasive continuous insulin monitoring (CIM) device and its use to derive PK
parameters in human subjects.
absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine
(Apidra) within individual subjects.
Additionally, the investigators will perform a preliminary feasibility evaluation of a
minimally invasive continuous insulin monitoring (CIM) device and its use to derive PK
parameters in human subjects.
Inclusion Criteria:
- Age 12 years or older with clinical type 1 diabetes for at least five years
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting
insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin
glulisine (Apidra).
- Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 9
units of rapid acting insulin
Exclusion Criteria:
- Unable to provide informed consent
- Unable to comply with study procedures
- Inadequate venous access as determined by study nurse or physician at time of
screening.
- Pregnancy
- History of gastric banding, gastric bypass, or other gastrointestinal condition that
may prevent a subject from consuming a normal sized meal
- Hemoglobin <13.5 for men, < 12 for women
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