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Sponsors and Collaborators: |
Park Nicollet Institute Eli Lilly and Company |
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Information provided by: | Park Nicollet Institute |
ClinicalTrials.gov Identifier: | NCT00569907 |
Approximately 30 adults will participate in this study at the International Diabetes Center (IDC). The IDC is the only site conducting this study.
Length of participation can range from two to three months which will include four to seven clinic visits.
The purpose of this study is to use a Continuous Glucose Monitoring (CGM) system to determine the characteristics of glucose control and patterns of food intake before exenatide is started, during the start and adjustment of exenatide and during exenatide treatment.
The long-term purpose of this study is to determine to what extent continuous glucose monitoring improves or alters clinical decision making for patients treated with exenatide. And, the study will also compare CGM to conventional self-monitored blood glucose methods.
The study will also compare subjects' changes, if any, in nutrient intake such as energy, protein, fat and carbohydrate during the course of the study through interpretation/analysis of self-reported food intake.
Condition |
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Diabetes Mellitus Type 2 |
Study Type: | Observational |
Study Design: | Case-Crossover, Prospective |
Official Title: | Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Community sample.
Inclusion Criteria:
Exclusion Criteria:
Contact: Nathan Tessum | 952-993-3267 | nathan.tessum@parknicollet.com |
Contact: Kimberly Gunyou | 952-993-3640 | kimberly.gunyou@parknicollet.com |
United States, Minnesota | |
International Diabetes Center - Park Nicollet Health Services | Recruiting |
Minneapolis, Minnesota, United States, 55416 | |
Principal Investigator: Roger Mazze, PhD | |
Principal Investigator: Robert M. Cuddihy, MD | |
Principal Investigator: Ellie Strock, ANP |
Principal Investigator: | Roger Mazze, PhD | International Diabetes Center - Park Nicollet Institute |
Principal Investigator: | Robert M. Cuddihy, MD | International Diabetes Center - Park Nicollet Institute |
Principal Investigator: | Ellie Strock, ANP | International Diabetes Center - Park Nicollet Institute |
Responsible Party: | Park Nicollet Institute dba International Diabetes Center ( Roger S. Mazze, PhD - Chief Academic Officer ) |
Study ID Numbers: | 03520-06-C |
Study First Received: | December 6, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00569907 |
Health Authority: | United States: Institutional Review Board |
type 2 diabetes continuous glucose monitoring exenatide exenatide use |
Metabolic Diseases Exenatide Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |