Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00977808
First received: September 15, 2009
Last updated: October 20, 2009
Last verified: October 2009
  Purpose

This study plans to link two existing technologies, the insulin pump and the continuous glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop. This will be done using two continuous glucose monitors (CGMs), a computer containing an investigational control algorithm that uses glucose information from the CGM to recommend insulin dosing, and an insulin pump. The purpose of this study is to test the ability of continuous glucose monitors together with an insulin pump and a mathematical formula to control blood sugar levels of people with type 1 diabetes.


Condition Intervention
Type 1 Diabetes
Device: Closed-loop control

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Enrollment: 12
Study Start Date: May 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closed-loop control Device: Closed-loop control
Artificial Pancreas, testing mathematical formulas testing the closed-loop control. Continuous glucose monitors linked to an insulin pump via the computer with the math formulas being tested.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21 years of age or older
  • Have Type 1 Diabetes Mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 2 years (including those who may also be treated with metformin, thiazolidinedione, exenatide, or pramlintide).
  • Use of an insulin pump
  • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 1 month prior to enrollment in the study
  • Willingness to use lispro (Humalog) insulin for the duration of the inpatient study
  • Demonstration of proper mental status and cognition for the study

Exclusion Criteria:

  • Age <21
  • Pregnancy
  • Hematocrit <36% (females); <38% (males)
  • Symptomatic coronary artery disease (e.g. history of myocardial infarction, history of acute coronary syndrome, history of therapeutic coronary intervention, history of coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, positive stress test or catheterization with coronary blockages >50%).
  • Congestive heart failure
  • History of a cerebrovascular event
  • Use of a medication that significantly impacts glucose metabolism (oral steroids)
  • Atrial fibrillation
  • Uncontrolled hypertension (resting blood pressure >140/90)
  • History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
  • Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the FreeStyle NavigatorTM CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
  • Active enrollment in another clinical trial
  • Allergy or adverse reaction to lispro insulin
  • Known adrenal gland problem, pancreatic tumor, or insulinoma
  • Current alcohol abuse, substance abuse, or severe mental illness
  • Retinopathy and renal failure
  • Uncontrolled anxiety or panic disorder
  • Known bleeding diathesis or dyscrasia
  • Renal insufficiency (creatinine >1.5)
  • Any comorbid condition affecting glucose metabolism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977808

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22904
Sponsors and Collaborators
University of Virginia
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Boris P Kovatchev, Ph.D. University of Virginia
  More Information

No publications provided

Responsible Party: Boris Kovatchev, Ph.D., University of Virginia
ClinicalTrials.gov Identifier: NCT00977808     History of Changes
Other Study ID Numbers: 12998, BPK004
Study First Received: September 15, 2009
Last Updated: October 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
Artificial pancreas
Closed-Loop control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014