Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide
NCT ID: NCT00569907
Last Updated: 2015-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
18 participants
OBSERVATIONAL
2007-01-31
2009-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Previously diagnosed with type 2 diabetes
* Age 21 and older
* Treated with metformin, a sulfonylurea, a thiazolidinedione, a combination or metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione (approved FDA indications)
* HbA1c 7.1-11%, unless subject has been using exenatide prior to study; in that case, there is no restriction on HbA1c level.
* Willing to give informed consent
* Motivated and capable of following the protocol and instructions provided by the healthcare professional
* Available for the study on the scheduled visit days
* Access to telephone communications
Exclusion Criteria
* Pregnancy
* Creatinine clearance \<30 ml/min (using MDRD formula)
* Known gastrointestinal disease
* Without diabetes or known type 1 diabetes
* Unable to follow the study protocol
* Unable to read and write in English
* Allergy to adhesives
* Any concomitant medical condition that would likely affect the evaluation of CGM device performance as determined by the investigator such as dermatological conditions or myxedema.
21 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
HealthPartners Institute
OTHER
Responsible Party
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Park Nicollet Institute dba International Diabetes Center
Principal Investigators
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Roger Mazze, PhD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center - Park Nicollet Institute
Robert M. Cuddihy, MD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center - Park Nicollet Institute
Ellie Strock, ANP
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center - Park Nicollet Institute
Locations
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International Diabetes Center - Park Nicollet Health Services
Minneapolis, Minnesota, United States
Countries
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References
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Mazze RS, Lucido D, Langer O, Hartmann K, Rodbard D. Ambulatory glucose profile: representation of verified self-monitored blood glucose data. Diabetes Care. 1987 Jan-Feb;10(1):111-7. doi: 10.2337/diacare.10.1.111.
Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD; Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004 Nov;27(11):2628-35. doi: 10.2337/diacare.27.11.2628.
DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005 May;28(5):1092-100. doi: 10.2337/diacare.28.5.1092.
Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006 Jan;29(1):44-50. doi: 10.2337/diacare.29.01.06.dc05-1686.
Other Identifiers
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03520-06-C
Identifier Type: -
Identifier Source: org_study_id