Continuous Glucose Monitoring in Youth With Type 2 Diabetes
Completed
Conditions studied: Type 2 Diabetes
In brief
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 caloric and exercise related variation in blood glucose that is not identified by the subjects' current regimen of intermittent finger stick blood glucose measurements.
Key facts
- Study ID
- NCT02293577
- Run by
- Yale University
- People needed
- 15
- Starts
- 2014-11-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2020-03-06
Who can join
Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yale Pediatric Diabetes Research Program — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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