Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

The investigators are doing this research study to compare the pharmacokinetics (PK) (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.

Key facts

Study ID

NCT01684943

Run by

Massachusetts General Hospital

People needed

33

Starts

2010-07-01

Expected to finish

2017-12-01

Last updated by the study team

2019-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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