Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
12 participants
INTERVENTIONAL
2013-03-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes
NCT04230694
Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus
NCT04653454
CGM/Clarity Use, Glycemic Control and Clinical Outcomes
NCT03827434
Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS
NCT03445377
Continuous Glucose Monitoring in the Intensive Care Unit
NCT06190808
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Closed-loop blood glucose control
Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is \> 1 u/kg or \> 2 u/kg.
Closed-loop blood glucose control
The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose \> 2 u/kg).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Closed-loop blood glucose control
The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose \> 2 u/kg).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 21 to 75 with clinical type 1 diabetes for at least one year
* Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
* Total daily dose (TDD) of insulin that is \< 1 u/kg
Subjects with type 2 diabetes
* Age 21 to 75 with clinical type 2 diabetes for at least one year
* Diabetes managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin
* Total daily dose (TDD) of insulin that is \> 1 u/kg/day but \< 2 u/kg/day or \> 2 u/kg/day
Exclusion Criteria
* Renal insufficiency
* Cancer
* Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
* Acute illness or exacerbation of chronic illness at the time of the study procedure
* Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin
* History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders
* Known history of coronary artery disease, TIA or stroke
* History of seizures
* Transaminitis
* Stage 2 hypertension at the time of screening
21 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston University
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Steven J. Russell, MD, PhD
Assistant Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven J Russell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MGH Diabetes Research Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011P000993
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.