Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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. The Closed-Loop control algorithm will: 1. Suggest adequate insulin delivery for blood glucose control in steady state (overnight); 2. Cover adequately with an insulin bolus the pre-set carbohydrate content of a breakfast. If successful, this study will conceptually prove the feasibility of automated model-predictive closed-loop glucose control in T1DM.

Key facts

Study ID

NCT00977808

Run by

University of Virginia

People needed

12

Starts

2008-05-01

Expected to finish

2009-02-01

Last updated by the study team

2014-09-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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