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| Sponsor: | Medtronic Diabetes |
|---|---|
| Information provided by (Responsible Party): | Medtronic Diabetes |
| ClinicalTrials.gov Identifier: | NCT01464346 |
Purpose
The purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.
| Condition |
|---|
|
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Type 1 or type 2 diabetes mellitus adult subjects 18-75 years of age
Inclusion Criteria:
A clinical diagnosis of type 1 or 2 diabetes as determined by the
Investigator, for a minimum of 12 months duration:
Criteria for type 1 diabetes:
Criteria for type 2 diabetes:
Required: History of being overweight at time of diagnosis.
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Profil Institute for Clinical Research | Recruiting |
| Chula Vista, California, United States, 91911 | |
| Contact: Elaine Watkins 866-308-7427 volunteer@profilinstitute.com | |
| Contact: Heidi Guthrie | |
| Principal Investigator: Elaine Watkins, DO, MSPH | |
| AMCR Institue | Recruiting |
| Escondido, California, United States, 92026 | |
| Contact: Timothy Bailey, MD 760-466-1530 tbailey@amcrinstitute.com | |
| Contact: Jane Joaquin 760-466-1526 jjoaquin@amcrinstitute.com | |
| Principal Investigator: Timothy Bailey, MD | |
| Diablo Clinical Research | Recruiting |
| Walnut Creek, California, United States, 94598 | |
| Contact: Mark Christiansen mchristiansen@diabloclinical.com | |
| Principal Investigator: Richard Weinstein | |
| United States, Washington | |
| Rainier Clinical Research Center | Recruiting |
| Renton, Washington, United States, 98057 | |
| Contact: Ronald Brazg, MD 425-271-1720 rbrazg@rainier-research.com | |
| Contact: Kristin Hughes 425-271-1720 ext 15 | |
| Principal Investigator: Ronald Brazg, MD | |
| Study Director: | Scott Lee, MD | Medtronic Diabetes |
More Information
| Responsible Party: | Medtronic Diabetes |
| ClinicalTrials.gov Identifier: | NCT01464346 History of Changes |
| Other Study ID Numbers: | CEP247 |
| Study First Received: | November 1, 2011 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
diabetes glucose sensor CGM |
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |