Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes

Completed · Phase 3

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT00406133

Run by

Jaeb Center for Health Research

People needed

451

Starts

2006-12-01

Expected to finish

2009-02-01

Last updated by the study team

2017-04-14

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Southern California — Beverly Hills, California, United States
• Kaiser Permanente — San Diego, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Children's Hospital of Iowa — Iowa City, Iowa, United States
• Joslin Diabetes Center - Adults — Boston, Massachusetts, United States
• Joslin Diabetes Center - Children — Boston, Massachusetts, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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