Completed
Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
What is being tested
Multiplex pharmacokinetic profiling
+ Continuous insulin monitoring
Other
Who is being recruted
Autoimmune Diseases+5
+ Diabetes Mellitus
+ Endocrine System Diseases
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: July 2010
Summary
Principal SponsorMassachusetts General Hospital
Last updated: December 12, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2010
Actual date on which the first participant was enrolled.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.
Principal SponsorMassachusetts General Hospital
Last updated: December 12, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Autoimmune DiseasesDiabetes MellitusEndocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 1
Criteria
3 inclusion criteria required to participate
Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 9 units of rapid acting insulin
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)
6 exclusion criteria prevent from participating
Hemoglobin < 13.5 for men, < 12 for women
History of gastric banding, gastric bypass, or other gastrointestinal condition that may prevent a subject from consuming a normal sized meal
Inadequate venous access as determined by study nurse or physician at time of screening
Pregnancy
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalMultiplex 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.
Group II
ExperimentalContinuous 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Massachusetts General Hospital
Boston, United StatesOpen Massachusetts General Hospital in Google MapsCompletedOne Study Center