Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
Completed · Not applicable
Conditions studied: Type 1 Diabetes Mellitus, Type2 Diabetes Mellitus
In brief
The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
Key facts
- Study ID
- NCT03966911
- Run by
- Medtronic MiniMed, Inc.
- People needed
- 335
- Starts
- 2019-06-14
- Expected to finish
- 2020-05-13
- Last updated by the study team
- 2021-06-07
Who can join
Age: 2 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Individual is 2 - 80 years of age at time of enrollment
- A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Adequate venous access as assessed by investigator or appropriate staff
- Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity ratio. Subjects without ratios may participate under observation only
You may not qualify if…
- Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- Subject is female and has a positive pregnancy screening test
- Female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator
- Subject is female and plans to become pregnant during the course of the study
- Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment
- Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
- Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
- Subject has a history of a seizure disorder
- Subject has central nervous system or cardiac disorder resulting in syncope
- 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
- Subject has a hematocrit (Hct) lower than the normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents)
- Subject has a history of adrenal insufficiency
- Subject is a member of the research staff involved with the study.
Where it is running
- AMCR Institue — Escondido, California, United States
- Sansum Diabetes Research Institute — Santa Barbara, California, United States
- SoCal Diabetes — Torrance, California, United States
- Diablo Clinical Research — Walnut Creek, California, United States
- Diablo Clinical Research — Walnut Creek, California, United States
- Barbara Davis Center - Adults — Aurora, Colorado, United States
- Barbara Davis Center for Childhood Diabetes (Pediatric) — Aurora, Colorado, United States
- University of South Florida — Tampa, Florida, United States
- Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
- IDERC — Des Moines, Iowa, United States
- Mayo Clinic (Rochester MN) — Rochester, Minnesota, United States
- AM Diabetes & Endocrinology Center — Bartlett, Tennessee, United States
- Texas Diabetes and Endocrinology — Austin, Texas, United States
- University of Virgina — Charlottesville, Virginia, United States
- Rainer Clinical Research Center — Renton, Washington, United States
Full record on ClinicalTrials.gov
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