Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System
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
1 other identifier
interventional
50
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
March 30, 2017
CompletedMarch 30, 2017
March 1, 2017
1.4 years
June 17, 2010
October 24, 2013
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Group A
OTHERGroup A will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature activated
Group B
OTHERGroup B will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature deactivated
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
AMCR Institute
Escondido, California, 92026, United States
Stanford University
Stanford, California, 94305, United States
Barbara Davis Center of Childhood Diabetes
Aurora, Colorado, 80045, United States
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80045, United States
Rainier Clinical Research Institute
Renton, Washington, 98057, United States
Related Publications (1)
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.
PMID: 22316089DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas P Troub
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Buckingham, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2010
First Posted
June 22, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
March 30, 2017
Results First Posted
March 30, 2017
Record last verified: 2017-03