Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An In-clinic, Randomized, Cross-Over Study to Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System With Hypoglycemic Induction From Exercise

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: The MiniMed Paradigm® X54 System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Group A will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature activated | Device: The MiniMed Paradigm® X54 System<br>* The MiniMed Paradigm® X54 System: A insulin pump equipped with a number of features to actively manage the user's glucose levels. One example is the Low Glucose Suspend (LGS) feature. The LGS feature is only available when the pump is used with the subcutaneous glucose sensor for continuous glucose monitoring. To use this feature, the user will be required to select a sensor low suspend limit, or threshold, at which the LGS feature will be triggered. When this feature is selected, if the sensor glucose reading reaches the level that is equal to or less than the programmed threshold, the user receives an alert and the pump suspends.<br>* Other names: MiniMed Paradigm® X54 Pump (X54 Pump);|
| Other: Group B<br>Group B will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature deactivated | Device: The MiniMed Paradigm® X54 System<br>* The MiniMed Paradigm® X54 System: A insulin pump equipped with a number of features to actively manage the user's glucose levels. One example is the Low Glucose Suspend (LGS) feature. The LGS feature is only available when the pump is used with the subcutaneous glucose sensor for continuous glucose monitoring. To use this feature, the user will be required to select a sensor low suspend limit, or threshold, at which the LGS feature will be triggered. When this feature is selected, if the sensor glucose reading reaches the level that is equal to or less than the programmed threshold, the user receives an alert and the pump suspends.<br>* Other names: MiniMed Paradigm® X54 Pump (X54 Pump);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia. | Duration (minutes) of induced hypoglycemia (YSI < 70 mg/dL) | approximately 8 hours per induction experiment | 
| The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia. | Severity (Milligrams per Deciliter) of induced hypoglycemia (YSI < 70 Milligrams per Deciliter) is defined as 70 Milligrams per Deciliter minus absolute lowest blood sugar level | approximately 8 hours per induction experiment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASPIRE (Automation to Simulate Pancreatic Insulin Response), X54, Medtronic Diabetes, Diabetes Mellitus, Type 1