assess the efficacy of the low glucose suspend (lgs) feature in the minimed paradigm® x54 system

Conditions: Type 1 Diabetes Mellitus

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. the study will consist of a total of 50 subjects, age 16 through 60 years with type 1 diabetes mellitus.

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 age 18-21 years, and 42 adult subjects age 22-60 years at time of enrollment. results for all subjects will be analyzed.

Eligibility criteria:
inclusion criteria: * 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 criteria: * 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

Keywords: aspire (automation to simulate pancreatic insulin response) x54 medtronic diabetes diabetes mellitus type 1