Continuous Glucose Monitoring in Youth With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

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 caloric and exercise related variation in blood glucose that is not identified by
      the subjects' current regimen of intermittent finger stick blood glucose measurements.
    

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 adolescents. Continuous glucose monitoring (CGM) has been successful in
      lifestyle modification in adults with T2D but use of CGM has not been studied in youth with
      T2D. Thus the feasibility of this technology should be evaluated in this patient population
      as it may prove to be an effective adjunct to treatment in the future.

      Youth with type 2 diabetes will be approached for enrollment in this study. The study will be
      explained to volunteers who meet eligibility criteria and informed consent/assent will be
      obtained. Demographic data will be recorded. A medical history will be performed. A urine
      pregnancy test (in women) will be measured to confirm eligibility. Height, weight, BMI,
      percent body fat, fat mass, and fat free mass will be measured. Hemoglobin A1c (HbA1c) will
      be measured. After enrollment a blinded CGM will be placed. CGM is a device inserted under
      the skin on the abdomen which monitors glucose levels every 5 minutes, recording this
      information. CGM is commonly worn by kids with type 1 diabetes. The study will allow
      collection of information on glucose variability in much greater detail than can be seen from
      intermittent fingerstick glucose values or from an oral glucose tolerance test. Subjects will
      meet with a nutritionist to learn how to keep a food record. They will be given empty food
      records to complete for each day. They will also be given an accelerometer and instructed in
      its use, however they will remain blinded to the data obtained. The study will be 5 days in
      length. Subjects will be urged to continue their normal eating and activity behaviors. During
      the study period blood sugar and CGM data will be recorded via glucometer and sensor
      downloads, dietary intake via food record, and activity via accelerometer. Glucometer testing
      of blood glucose is required at least every 12 hours to calibrate the CGM. To minimize the
      need for overnight tests to calibrate the CGM, subjects will be asked to check their blood
      sugar using a glucometer 3 times a day, preferably fasting in the morning before breakfast,
      before dinner, and at bedtime. To optimize the accuracy of dietary intake records, subjects
      will be contacted frequently and the food record information recorded by study personnel.
      Subjects will be given a "morning checklist" to keep in a visible area to improve compliance
      by reminding them to keep study devices with them all day. At the follow-up visit the CGM
      will be downloaded revealing blood glucose tracings for the study period. Additionally the
      completed food records will be collected and the accelerometer will be downloaded.
    

Intervention name(s): continuous glucose monitor
Intervention type(s): Device
Intervention description(s): In this study all subjects will wear a continuous glucose monitor for 5 days.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Youth with type 2 diabetes will be recruited from the type 2 diabetes clinic.