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

Not Applicable

Completed

Conditions: Type 1 Diabetes Mellitus

Interventions: Device: The MiniMed Paradigm® X54 System

Registration Number: NCT01148862

Lead Sponsor: Medtronic Diabetes

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.

The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1 Diabetes Mellitus.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	The MiniMed Paradigm® X54 System	Group A will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature activated
Group B	The MiniMed Paradigm® X54 System	Group B will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature deactivated

Primary Outcome Measures

Name	Time	Method
The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.	approximately 8 hours per induction experiment	Duration (minutes) of induced hypoglycemia (YSI \< 70 mg/dL)
The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia.	approximately 8 hours per induction experiment	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (5): AMCR Institute
🇺🇸
Escondido, California, United States
Stanford University
🇺🇸
Stanford, California, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸
Denver, Colorado, United States
Rainier Clinical Research Institute
🇺🇸
Renton, Washington, United States
Barbara Davis Center of Childhood Diabetes
🇺🇸
Aurora, Colorado, United States