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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
AMCR Institute
Escondido, California, United States
Stanford University
Stanford, California, United States
Barbara Davis Center of Childhood Diabetes
Aurora, Colorado, United States
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States
The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.
Duration (minutes) of induced hypoglycemia (YSI \< 70 mg/dL)
Time frame: 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
Time frame: approximately 8 hours per induction experiment
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Rainier Clinical Research Institute
Renton, Washington, United States