Status:
COMPLETED
Continuous Glucose Monitoring in Youth With Type 2 Diabetes
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
10-21 years
Brief Summary
The purpose of this study is to use a continuous glucose monitor (CGM) to describe the day to day blood glucose variability in youth with type 2 diabetes. The hypothesis is that CGM will identify calo...
Detailed Description
The TODAY study and other studies have reported disappointing results of intensive life-style programs alone or in combination with metformin in maintaining optimal control of type 2 diabetes (T2D) in...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 2 diabetes
- Duration of type 2 diabetes ≥ 3 months
- Naïve to continuous glucose monitoring
- Willing to wear a continuous glucose monitor for 5 days
- Willing to check blood sugar at least every 12 hours, preferably 3 times a day
- Willing to wear an accelerometer for 5 days
- Willing to keep a food record for 5 days, including frequent phone contact from the research staff
- Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
- Able to give informed consent (for children \<18 years, permission from parents and subject assent will be required)
- Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods
Exclusion
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of any medications (besides insulin and/or metformin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy
- Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- History of hypoglycemic seizure within last year or frequent hypoglycemia (≥2 time a month)
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02293577
Start Date
November 1 2014
End Date
November 1 2015
Last Update
March 6 2020
Active Locations (1)
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1
Yale Pediatric Diabetes Research Program
New Haven, Connecticut, United States, 06511