Status:
COMPLETED
Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
16-60 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy of the Low Glucose Suspend (LGS) feature in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction from exercise. ...
Detailed Description
50 subjects with previously diagnosed Type 1 Diabetes Mellitus will be studied. The subject population includes the following subsets: 4 pediatric subjects aged 16 -17 years, 4 young adult subjects ag...
Eligibility Criteria
Inclusion
- Subject is between the ages of 16 - 60 years old
- A clinical diagnosis of Type 1 Diabetes Mellitus, as determined by the Investigator, for a minimum of 12 months duration
- Subject has been on a Medtronic insulin pump for at least 3 months, which includes but is not limited to those on sensor augmented insulin pump therapy
- Subject has an A1C value between ≥ 7.0% and ≤ 10.0% at time of enrollment; as measured during the screening visit
- Subject must have a documented stress treadmill test within the last three years of enrollment if the subject had diabetes for \>20 years
- Subject willing to follow protocol and procedures for study.
Exclusion
- Systolic blood pressure on screening visit is \>140 Millimeters of Mercury
- Diastolic blood pressure on screening visit is \>90 Millimeters of Mercury
- Subject has a history of hypoglycemic seizure or hypoglycemic coma within the last two years
- Subject unable to tolerate tape adhesive in the area of sensor placement;
- Subject has any active adverse skin condition in the area of sensor placement (i.e. psoriasis, rash, staphylococcus infection) that is not resolved at the time of enrollment
- Subject is pregnant or plans to become pregnant during the course of the study
- Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Subject has active Graves disease
- Subject with renal impairment or creatinine above the normal reference range (of the laboratory that the clinical site is utilizing), as demonstrated by the screening laboratory value
- Subject is outside of the normal reference range (of the laboratory that the clinical site is utilizing) for hematocrit, as demonstrated by screening laboratory value
- Subject is outside of the normal reference range (of the laboratory that the clinical site is utilizing) for potassium, as demonstrated by screening laboratory value
- Subject is outside of the normal reference range (of the laboratory that the clinical site is utilizing) for Thyroid-Stimulating Hormone (TSH), as demonstrated by screening laboratory value
- Subject is outside of the normal reference range (of the laboratory that the clinical site is utilizing) for free Thyroxine (T4), as demonstrated by screening laboratory value
- Subject has history of smoking for \>5 years
- Electrocardiogram findings observed during the screening visit, which are deemed by the investigator to represent active ischemia or a condition that would compromise subject safety
- The stress treadmill (if subject met inclusion criteria #7) results are deemed by the investigator to represent active ischemia or a condition that would compromise subject safety
- Subject is currently participating in an investigational study (drug or device)
- Subject is currently on beta blocker medication
- Subject has taken oral or injectable steroids within the last 30 days
- Subject is deemed by the Investigator to be unwilling or unable to follow the protocol
- Subject has a history of diagnosed medical eating disorder
- Subject has a history of known illicit drug abuse
- Subject has a history of known abuse with prescription medication
- Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely per investigator discretion
- Subject has a history of current alcohol abuse
- Any other condition including abnormalities found on the screening tests which in the opinion of the Investigator, may preclude him/her from participating in the study
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01148862
Start Date
June 1 2010
End Date
November 1 2011
Last Update
March 30 2017
Active Locations (5)
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1
AMCR Institute
Escondido, California, United States, 92026
2
Stanford University
Stanford, California, United States, 94305
3
Barbara Davis Center of Childhood Diabetes
Aurora, Colorado, United States, 80045
4
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80045