Clinical trial NCT01148862: Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: ASPIRE (Automation to Simulate Pancreatic Insulin Response)
X54
Medtronic Diabetes
Diabetes Mellitus
Type 1
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.
timeFrame: approximately 8 hours per induction experiment
measure: The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia.
timeFrame: approximately 8 hours per induction experiment
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center of Childhood Diabetes
state: Colorado
city: Denver
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Renton
country: United States
facility: Rainier Clinical Research Institute
state: Washington
Study officials:
affiliation: Stanford University
name: Bruce Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garg S, Brazg RL, Bailey TS, Buckingham BA, Slover RH, Klonoff DC, Shin J, Welsh JB, Kaufman FR. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery: the in-clinic ASPIRE study. Diabetes Technol Ther. 2012 Mar;14(3):205-9. doi: 10.1089/dia.2011.0292. Epub 2012 Feb 8.