Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
NCT ID: NCT01684943
Last Updated: 2019-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2010-07-31
2017-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Multiplex pharmacokinetic profiling
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.
Multiplex pharmacokinetic profiling
Continuous insulin monitoring
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.
Continuous insulin monitoring
Interventions
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Multiplex pharmacokinetic profiling
Continuous insulin monitoring
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Steven J. Russell, MD, PhD
Associate Professor
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2010P001005
Identifier Type: -
Identifier Source: org_study_id
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