Status:
COMPLETED
Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Each patient had an outpatient screening evaluation, and two 22 h overnight hospital admissions separated by a 2- to 4-week waiting period. Each inpatient admission began at 15:00 and ended at 13:00 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00977808
Start Date
May 1 2008
End Date
February 1 2009
Last Update
September 4 2014
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22904