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

Mass General Brigham

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Continuous insulin monitoring; Other: Multiplex pharmacokinetic profiling

Study type: Interventional

Funder types: Other

Identifiers

NCT01684943

2010P001005

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Multiplex pharmacokinetic profiling

Experimental group

Description:

Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin. All subjects participated in the single study arm and received injections of each type of insulin. Blood samples were drawn at intervals for pharmacokinetic profiling.

Treatment:

Other: Multiplex pharmacokinetic profiling

Continuous insulin monitoring

Experimental group

Description:

Continuous insulin monitoring (CIM) of insulin lispro. Some subjects participated in the CIM sub-study, which is distinct from the Multiplex Pharmacokinetic Profiling study. This intervention involved administering insulin lispro and monitoring pharmacokinetic profile of the drug using blood samples and an investigational continuous insulin monitoring system.

Treatment:

Other: Continuous insulin monitoring