Status:
COMPLETED
Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
International Diabetes Center at Park Nicollet
Abbott Diabetes Care
Conditions:
Type 2 Diabetes
Currently Taking Metformin
Eligibility:
All Genders
18+ years
Brief Summary
This study will look at the impact that meals have on blood glucose (sugar) levels. Subjects will be asked to use a Continuous Glucose Monitoring System (CGM), which monitors glucose levels continuous...
Eligibility Criteria
Inclusion
- Female or male
- 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
- Under 18 years of age
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00818077
Start Date
January 1 2008
End Date
September 1 2010
Last Update
December 2 2015
Active Locations (1)
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1
International Diabetes Center
Minneapolis, Minnesota, United States, 55416