Type 1 Diabetes Clinical Trial
Official title:
Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes(BPK004)
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | Juvenile Diabetes Research Foundation |
United States,
Kovatchev B, Cobelli C, Renard E, Anderson S, Breton M, Patek S, Clarke W, Bruttomesso D, Maran A, Costa S, Avogaro A, Dalla Man C, Facchinetti A, Magni L, De Nicolao G, Place J, Farret A. Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: summary of the results. J Diabetes Sci Technol. 2010 Nov 1;4(6):1374-81. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of Hypoglycemic Episodes | Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer). | Overnight (21:30 until 08:00) | No |
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