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Trial record 1 of 1 for:    NCT01148862
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Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01148862
First received: June 17, 2010
Last updated: March 2, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus Device: The MiniMed Paradigm® X54 System

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

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia. [ Time Frame: 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. [ Time Frame: 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


Enrollment: 50
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Group A will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature activated
Device: The MiniMed Paradigm® X54 System
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.
Other Name: MiniMed Paradigm® X54 Pump (X54 Pump)
Group B
Group B will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature deactivated
Device: The MiniMed Paradigm® X54 System
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.
Other Name: MiniMed Paradigm® X54 Pump (X54 Pump)

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

Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148862

Locations
United States, California
AMCR Institute
Escondido, California, United States, 92026
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center of Childhood Diabetes
Aurora, Colorado, United States, 80045
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80045
United States, Washington
Rainier Clinical Research Institute
Renton, Washington, United States, 98057
Sponsors and Collaborators
Medtronic Diabetes
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01148862     History of Changes
Other Study ID Numbers: CEP235/Z25
Study First Received: June 17, 2010
Results First Received: October 24, 2013
Last Updated: March 2, 2017

Keywords provided by Medtronic Diabetes:
ASPIRE (Automation to Simulate Pancreatic Insulin Response)
X54
Medtronic Diabetes
Diabetes Mellitus
Type 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 19, 2017