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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00760526 |
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Date of registration:
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25/09/2008 |
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Primary sponsor: |
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Public title:
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Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM
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Scientific title:
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A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds) |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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140 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00760526 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Roy W Beck, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jaeb Center for Health Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least
twelve months
2. Age >4.0 to <10.0 years
3. HbA1c > 7.5%
4. Current insulin regimen involves either use of an insulin pump or multiple daily
injections of insulin (at least 3 shots per day) for the last three 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)
Exclusion Criteria:
1. Diabetes diagnosed <6 months of age
2. 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.
3. The presence of any of the following diseases or another disease that the
investigator believes to be a contraindication to participation in the protocol:
- Asthma if treated with systemic or daily inhaled corticosteroids in the last 6
months (Intermittent treatment with inhaled corticosteroids does not exclude
subjects from enrollment)
- Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not
exclude subjects from enrollment)
4. Home use of CGM in past 6 months.
5. Participation in an intervention study (including psychological studies) in past 6
weeks.
6. Another member of the same household is participating in this study.
Age minimum:
4 Years
Age maximum:
9 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 1
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Intervention(s)
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Device: Continuous glucose monitor
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Device: Home blood glucose monitor
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Primary Outcome(s)
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HbA1c
[Time Frame: 26 weeks]
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Secondary Outcome(s)
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Biochemical hypoglycemia (percentage of sensor values
[Time Frame: 26 weeks]
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Measures of variability: mean amplitude of glycemic excursions (MAGE), SD, mean absolute rate of changes
[Time Frame: 26 weeks]
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Parental quality of life measures
[Time Frame: 26 weeks]
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Percentage of sensors values in range (71 mg/dL to 180 mg/dL)
[Time Frame: 26 weeks]
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Severe hypoglycemia
[Time Frame: 26 weeks]
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Secondary ID(s)
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DirecNet 011
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HD041890,
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HD041906-01,
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HD041908-01,
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HD041915-01,
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HD041918-01,
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HD041919-01,
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M01 RR00069,
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RR 06022,
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RR00059,
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RR00070-41
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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