Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | December 2015 |
Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Volunteers With Type 1 Diabetes
The investigators are doing this research study to find out if the type of needle used to
administer them affects the speed with which insulin and glucagon get into the blood. The
investigators will compare a traditional insulin needle to an injection device, called the
MicronJet, that uses microneedles to deliver medication into the top layer of your skin.
administer them affects the speed with which insulin and glucagon get into the blood. The
investigators will compare a traditional insulin needle to an injection device, called the
MicronJet, that uses microneedles to deliver medication into the top layer of your skin.
Inclusion Criteria:
- Age 18 years or older with clinical type 1 diabetes for at least one year
- 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 5
units of rapid acting insulin
- Stimulated C-peptide <0.1 nmol/L at 90 minutes after liquid mixed meal tolerance
test.
Exclusion Criteria:
- Unable to provide informed consent
- Unable to comply with study procedures
- Current participation in another diabetes-related clinical trial other than one that
is primarily observational in nature. Potential subjects enrolled in trails of
passive monitoring equipment, such as continuous glucose monitors (CGMs), are not
excluded
- Inadequate venous access as determined by study nurse or physician at time of
screening
- Pregnancy
- Hemoglobin less than 13.5 for men and less than 12 for women
- History of pheochromocytoma (fractionated metanephrines will be tested in patients
with history increasing the risk for a catecholamine secreting tumor to include
episodic or treatment refractory hypertension defined as requiring 4 or more
medications to achieve normotension, paroxysms of tachycardia, pallor, or headache,
or personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von
Hippel-Lindau disease)
- History of adverse reaction to glucagon (including allergy) besides nausea and
vomiting
- History of adrenal disease or tumor
- Hypertension (blood pressure > 160/100 mm/Hg at screening or day of study visit
- History of allergy to aspirin or any history of aspirin intolerance, including Reye's
syndrome, or gastric ulcer or bleeding associated with salicylates.
- Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrand's disorder,
and idiopathic thrombocytopenic purpura (ITP)
- Peptic Ulcer
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