Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
NCT ID: NCT00818077
Last Updated: 2015-12-02
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
15 participants
OBSERVATIONAL
2008-01-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Metformin, Type 2 Diabetes
Continuous Glucose Monitoring of Carbohydrate Intake
Subjects eat standard breakfast and lunch and keep food records.
Interventions
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Continuous Glucose Monitoring of Carbohydrate Intake
Subjects eat standard breakfast and lunch and keep food records.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 and older
* Diagnosed with type 2 diabetes for a minimum of 6 months
* Is taking metformin for diabetes management; no other diabetes medications
* Has been on a stable dose of metformin for at least 3 months
* HbA1c is 7% or greater and less than 9%; \>7% or \<9%
* BMI \<30kg/m2
* Willing to give informed consent
* No evidence of acute illness, fever, undue stress
* 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
* Has not been diagnosed with type 2 diabetes for a minimum of 6 months
* Is currently taking other diabetes medications in addition to metformin
* Has taken other diabetes medications within the past 3 months
* HbA1c \<7% or \>9%
* BMI \> 30kg/m2
* Unable to follow the study protocol
* No access to telephone communications
* Unable to read and write in English
* Unable to maintain their health, or have undue stress
* Skin abnormalities at the insertion sites that would confound assessment of the effect of the device on the skin
* Allergy to adhesives
* Any concomitant medical condition that would likely affect the evaluation of device performance
* Taken oral or inhaled prednisone or cortisone medications in the previous 30 days
18 Years
ALL
No
Sponsors
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International Diabetes Center at Park Nicollet
OTHER
Abbott Diabetes Care
INDUSTRY
HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Margaret Powers, PhD, RD, CDE
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center at Park Nicollet
Locations
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International Diabetes Center
Minneapolis, Minnesota, United States
Countries
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References
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American Diabetes Association. Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007 Jan;30 Suppl 1:S48-65. doi: 10.2337/dc07-S048. No abstract available.
Franz MJ, Boucher JL, Green-Pastors J, Powers MA. Evidence-based nutrition practice guidelines for diabetes and scope and standards of practice. J Am Diet Assoc. 2008 Apr;108(4 Suppl 1):S52-8. doi: 10.1016/j.jada.2008.01.021.
Crapo PA, Reaven G, Olefsky J. Postprandial plasma-glucose and -insulin responses to different complex carbohydrates. Diabetes. 1977 Dec;26(12):1178-83. doi: 10.2337/diab.26.12.1178.
Other Identifiers
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03654-07-A
Identifier Type: -
Identifier Source: org_study_id