Status:
COMPLETED
Feasibility Study of a Modular Control to Range System in Type 1 Diabetes Mellitus
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Abbott Diabetes Care
Insulet Corporation
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
In this protocol the investigators plan to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic ...
Eligibility Criteria
Inclusion
- 21 years of age and up to and including 65 years of age.
- 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 2 months 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
- Willingness to stop using any dietary supplements for two weeks prior to admission and for the duration of their participation.
Exclusion
- Age \<21or \>65
- Pregnancy
- Hematocrit \<36% (females); \<38% (males)
- HemoglobinA1c \> 10.0
- 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%).
- Use of a medication that significantly lowers heart rate (beta blockers, reserpine, guanethidine, methyldopa, clonidine, cimetidine, digitalis, calcium channel blockers, amiodarone, antiarrythmic drugs, or lithium)
- 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 by patient history, substance abuse by patient history, 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 :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01418703
Start Date
October 1 2009
End Date
December 1 2010
Last Update
November 13 2014
Active Locations (1)
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1
University of Virginia Health System
Charlottesville, Virginia, United States, 22904