Continuous Glucose Monitor in Children With Poorly Controlled Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to determine if the use of continuous glucose monitoring in a
      practical outpatient clinic setting in children with poorly controlled diabetes will lead to
      improved blood sugar control.
    

Detailed description: 
      The trial was designed as a six month, randomized, prospective, interventional pilot study of
      children with uncontrolled (HgbA1c > 8.5%) diabetes who were between the ages of 7-17 years
      of age. The purpose of the study was to determine the effect in glycemic control as measured
      by HgbA1c with use of iPro™ CGM at regularly scheduled clinic appointments. Recruitment for
      this study was limited to patients at the University of Texas Health Science Center in San
      Antonio Pediatric Diabetes Clinic from May 2011 to March 2013. Subjects were randomized into
      Group1 or Group 2 using sequentially numbered, opaque sealed envelopes (SNOSE).

      All subjects had point-of-care HgbA1c (standard of care) and CGM data collected at time
      points 0, 3 months, and 6 months. After a regularly scheduled clinic appointment, all
      subjects and families at time 0 were counseled by a registered dietician regarding
      carbohydrate counting with a focus on minimizing errors in carbohydrate estimation, as is
      standard of care for patients with poorly controlled diabetes in our clinic. At time 0,
      subjects in both Group 1 and 2 had CGM placement after meeting with the dietician. Group 1
      subjects were blinded to the first CGM data, meaning that they did not review the CGM
      download data. Group 2 was scheduled to return to clinic within 2 weeks of placement to meet
      with a pediatric endocrinologist involved in the study to interpret the CGM results and make
      adjustments to insulin regimen if appropriate. Both Groups 1 and 2 were not blinded to CGM
      data at 3 months and 6 months. Again, the CGM was placed after their regularly scheduled
      diabetes clinic appointments and all families returned within 2 weeks of these visits to meet
      with the pediatric endocrinologist to interpret the data and adjust the insulin regimen if
      necessary.

      The iPro™ CGM was worn for a minimum of 48 hours (2 days), maximum 96 hours (4 days).
      Participants were instructed to complete a minimum of 4 SMBG records daily while wearing the
      iPro™ CGM for system calibration purposes. Subjects documented SMBGs, meal times,
      carbohydrate intake, insulin doses, exercise, and any hypoglycemic symptoms in a log book for
      correlation to CGM data.
    

Intervention name(s): continuous glucose monitoring (CGM)
Intervention type(s): Device
Intervention description(s): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
Other intervention name(s): iPRO
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are pediatric, with a clinical diagnosis of diabetes for at least 6 months, who
        have been treated in the diabetic clinic for at least 3 months previously.
      
Keywords: children; poor adherence; continuous glucose monitoring