Study Results
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View full resultsBasic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2014-09-30
2015-08-31
Brief Summary
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Detailed Description
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Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Group A
Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Enlite 3
Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen \& arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump
Group B
Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Enlite 3
Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen \& arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump
Interventions
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Enlite 3
Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen \& arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump
Eligibility Criteria
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Inclusion Criteria
2. A clinical diagnosis of type 1 or type 2 diabetes for a minimum of 12 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Adequate venous access as assessed by investigator or appropriate staff
4. Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.
Exclusion Criteria
2. Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) in the last 2 weeks
4. Subject is female and has a positive pregnancy screening test
5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by the investigator
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has had a hypoglycemic seizure within the past 6 months
8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
10. Subject has a history of a seizure disorder
11. Subject has central nervous system or cardiac disorder resulting in syncope
12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
13. Subject has a hematocrit (Hct) lower than the normal reference range
14. Subject has a history of adrenal insufficiency
14 Years
75 Years
ALL
No
Sponsors
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Medtronic Diabetes
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald Brazg, M.D
Role: PRINCIPAL_INVESTIGATOR
Rainier Clinical Research Center
Mark Christiansen, M.D
Role: PRINCIPAL_INVESTIGATOR
Diablo Clinical Research
Timothy Bailey, M.D
Role: PRINCIPAL_INVESTIGATOR
AMCR Institute
Satish Garg, M.D
Role: PRINCIPAL_INVESTIGATOR
Barbara Davis Center
Robert Slover, M.D
Role: PRINCIPAL_INVESTIGATOR
Barbara Davis Center
Bruce Bode, M.D
Role: PRINCIPAL_INVESTIGATOR
Atlanta Diabetes Associates
Locations
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AMCR Institute
Escondido, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Barbara Davis Center
Aurora, Colorado, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Countries
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References
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Christiansen MP, Garg SK, Brazg R, Bode BW, Bailey TS, Slover RH, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor. Diabetes Technol Ther. 2017 Aug;19(8):446-456. doi: 10.1089/dia.2017.0087. Epub 2017 Jul 12.
Other Identifiers
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CEP292
Identifier Type: -
Identifier Source: org_study_id