Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Continuous glucose monitor
Intervention description: Daily use of a continuous glucose monitor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 451.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No

Summary:

      Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0%
      in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring
      (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A
      parallel randomized trial is being conducted for a second cohort with HbA1c <7.0% that will
      follow an identical protocol to that of the first cohort with HbA1c >=7.0%.

      The >=7.0% trial was specifically designed and statistically powered to compare separately
      the impact of continuous versus standard intensive glucose monitoring in the three age
      groups. Both trials used standardized treatment algorithms and equivalent frequent contacts
      with subjects in both the CGM and control group.

      After completion of the 26-week trial, the CGM group continues to use CGM for another 26
      weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with
      longer-term use and less intensive contact and the control group initiates CGM use with less
      intensive contact after the first month than was provided at initiation of CGM use in the CGM
      group in the randomized trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one
             year

               -  The diagnosis of type 1 diabetes is based on the investigator's judgment; C
                  peptide level and antibody determinations are not needed.

          -  Age >8 years

          -  Glycated hemoglobin(HbA1c) 7.0%-10.0% for the primary cohort and <7.0% for the
             secondary cohort

               -  The DCA2000 or comparable point of care device will be used to assess
                  eligibility.

          -  Insulin regimen involves either use of an insulin pump or multiple daily injections of
             insulin (at least 3 shots per day) and has been stable for the last two months, with
             no plans to switch the modality of insulin administration during the next 6 months
             (e.g., injection user switching to a pump, pump user switching to injections, or the
             addition of Lantus (Glargine) insulin)

               -  Subjects using premixed fixed doses of insulin at the time of enrollment will not
                  be eligible

          -  Subject (and parent/guardian for children) understands the study protocol and agrees
             to comply with it

          -  Subjects >9 years old and primary care giver (i.e., parent or guardian if subject is a
             minor) comprehend written English or Spanish

               -  This requirement is due to the fact that the questionnaires to be used as outcome
                  measures do not have validated versions in other languages.

               -  Spanish-speaking subjects will be enrolled only if a RT-CGM device that functions
                  in Spanish and has a User Guide in Spanish is available.

          -  No expectation that subject will be moving out of the area of the clinical center
             during the next year, unless the move will be to an area served by another study
             center.

          -  Informed Consent Form signed by the subject (or parent/guardian if subject is a minor,
             with subject signing the Child Assent Form)

        Exclusion Criteria:

          -  The presence of a significant medical disorder or use of a medication such as
             oral/inhaled glucocorticoids that in the judgment of the investigator will affect the
             wearing of the sensors or the completion of any aspect of the protocol.

          -  The presence of any of the following diseases:

               -  Asthma if treated with systemic or inhaled corticosteroids in the last 6 months

               -  Cystic fibrosis

          -  Adequately treated thyroid disease and celiac disease do not exclude subjects from
             enrollment

          -  Inpatient psychiatric treatment in the past 6 months (if the subject is a minor, for
             either the subject or the subject's primary care giver).

          -  Home use of RT-CGM in past 6 months

               -  Use of a CGMS or GlucoWatch does not exclude subjects from enrollment

          -  Participation in an intervention study (including psychological studies) in past 6
             weeks.

          -  Another member of the same household is participating in this study.

          -  For females, pregnant or intending to become pregnant during the next year Pregnancy
             is an exclusion because of uncertainty about the lag between interstitial fluid
             glucose and blood glucose during pregnancy, which might affect the accuracy of the
             sensor. Subjects who become pregnant during the study will be discontinued from the
             study.