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Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00760526
First received: September 25, 2008
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: October 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Diabetes Mellitus, Type 1
Interventions: Device: Continuous glucose monitor
Device: Home blood glucose monitor

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Continuous Glucose Montoring Treatment group
Standard Glucose Monitoring With a Home Glucose Meter Control Group
Total Total of all reporting groups

Baseline Measures
    Continuous Glucose Montoring     Standard Glucose Monitoring With a Home Glucose Meter     Total  
Number of Participants  
[units: participants]
  74     72     146  
Age  
[units: participants]
     
<=18 years     74     72     146  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.5  ± 1.8     7.5  ± 1.7     7.5  ± 1.7  
Gender  
[units: participants]
     
Female     34     33     67  
Male     40     39     79  
Region of Enrollment  
[units: participants]
     
United States     74     72     146  



  Outcome Measures
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1.  Primary:   Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events   [ Time Frame: 26 weeks ]

2.  Secondary:   Number of Severe Hypoglycemic Events Experienced by Participants   [ Time Frame: 26 weeks ]

3.  Secondary:   CGM Glucose Values (mg/dL)   [ Time Frame: 26 weeks ]

4.  Secondary:   Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)   [ Time Frame: 26 weeks ]

5.  Secondary:   Measures of Variability: Standard Deviation (SD)   [ Time Frame: 26 weeks ]

6.  Secondary:   Measures of Variability: Mean Absolute Rate of Change   [ Time Frame: 26 weeks ]

7.  Secondary:   Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)   [ Time Frame: 26 weeks ]

8.  Secondary:   Parental Quality of Life Measures: Hypoglycemia Fear Survey   [ Time Frame: 26 weeks ]

9.  Secondary:   Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)   [ Time Frame: 26 weeks ]

10.  Secondary:   Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale   [ Time Frame: 26 weeks ]

11.  Secondary:   Parental Quality of Life Measures: CGM Satisfaction Scale   [ Time Frame: 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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