Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy, tolerability, safety, and effect on
      quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.
    

Detailed description: 
      On the day of enrollment, a hemoglobin A1c level will be obtained, and potential subjects
      will be evaluated for study eligibility through the elicitation of a medical history and
      performance of a physical examination by a study investigator.

      The subject will return for a second visit about 6 weeks after the enrollment visit. At this
      visit, quality of life questionnaires will be completed and a CGM sensor will be inserted.
      The monitor will be blinded so that the glucose values cannot be seen. The parent will be
      instructed on insertion, calibration, and care of the CGM.

      The subject will return for a randomization visit 14 to 28 days after the blinded CGM was
      initiated.

        -  Subjects who have been compliant with use of the CGM and HGM will be randomized to one
           of two treatment groups: CGM Group or Control Group

        -  For the CGM Group, the CGM, HGM, and pump data (if applicable) will be reviewed and
           changes will be made to diabetes management as needed. Parents will be taught to use the
           protocol-developed instructions for changes to diabetes management to be used in real
           time based on CGM and HGM data. Instructions for downloading the CGM and HGM will be
           provided to subjects with a home computer.

        -  For the Control Group, a HGM and test strips will be provided. The HGM and pump data (if
           applicable) will be reviewed and changes will be made in diabetes management as needed.
           The blinded CGM data will be downloaded but will not be reviewed by study personnel
           until the end of the first 6 months of the study. Parents will be taught to use the
           protocol-developed instructions for how to make changes to diabetes management based on
           HGM data.

      Both groups will have follow-up visits at 1,4,8,13,19, and 26 weeks (+/- 1 week) plus one
      contact between each visit (including one phone contact between the second visit and the one
      week visit) to review their diabetes management.

        -  Both groups will download device data on a weekly basis (if the subject has a computer).
           Subjects with email access will be instructed to email the downloaded data to the
           clinical center prior to each phone contact.

        -  For both groups, at each visit, the HGM and pump (if applicable) will be downloaded and
           for the CGM group, the CGM will be downloaded.

      In the 13th and 26th weeks, the Control Group will use a blinded CGM for one week. The CGM
      Group will continue to use the blinded CGM. The Control Group will return the blinded CGM to
      the clinic after a week. The data will be reviewed by personnel who are not involved in the
      care of the subject to determine if additional blinded sensor data are needed. The blinded
      data will not be reviewed by the study personnel for management decisions until the end of
      the first 6 months of the study.

      Following the 26-week visit:

        -  Subjects in the RT-CGM Group will continue to use the CGM.

        -  Subjects in the Control Group will be provided with a CGM and sensors after the week of
           blinded use and will have visits after 1 week and 4 weeks, with a phone contact during
           the first and second weeks.

        -  Both groups will have visits after 13 weeks and 26 weeks
    

Intervention name(s): Continuous glucose monitor; Home blood glucose monitor
Intervention type(s): Device; Device
Intervention description(s): Daily use of a continuous glucose monitor; Home monitoring 3 or more times a day
Other intervention name(s): FreeStyle Navigator; Medtronic Paradigm System; FreeStyle meter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Continuous Glucose Monitor