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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred between January 2009 and December 2010 at the 5 participating DirecNet clinical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, enrolled participants had a run-in period of 6 weeks to optimize glycemic control prior to CGM use. A blinded CGM was then used for 2-4 weeks prior to randomization to familiarize participants and parents with the device and to collect data for assessment of baseline glycemic control.

Reporting Groups
  Description
Continuous Glucose Montoring Participants randomized to the CGM (treatment) group were provided with an unblinded CGM device, sensors, and a FreeStyle Flash blood glucose meter and test strips. A Free- Style Navigator was provided unless the participant was already using a Medtronic Paradigm insulin pump, in which case a MiniMed MiniLink REAL-Time Transmitter could be used. Parents were instructed on device use and daily sensor use was encouraged. They were instructed to continue testing with the home blood glucose meter >=4 times/day and to verify the accuracy of the CGM glucose measurement with the meter before making management decisions. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
Standard Glucose Monitoring With Home Glucose Meter Participants in the control group were given a FreeStyle Flash blood glucose meter and test strips and asked to perform blood glucose monitoring at least four times daily. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.

Participant Flow:   Overall Study
    Continuous Glucose Montoring     Standard Glucose Monitoring With Home Glucose Meter  
STARTED     74     72  
COMPLETED     69     68  
NOT COMPLETED     5     4  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

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
  Show All Outcome Measures

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 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Number of Severe Hypoglycemic Events Experienced by Participants
Measure Description No text entered.
Time Frame 26 weeks  
Safety Issue Yes  

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.
Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization.

Reporting Groups
  Description
Continuous Glucose Montoring Treatment group
Standard Glucose Monitoring With a Home Glucose Meter Control Group

Measured Values
    Continuous Glucose Montoring     Standard Glucose Monitoring With a Home Glucose Meter  
Number of Participants Analyzed  
[units: participants]
  73     71  
Number of Severe Hypoglycemic Events Experienced by Participants  
[units: events]
  3     6  

No statistical analysis provided for Number of Severe Hypoglycemic Events Experienced by Participants



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
  Hide Limitations and Caveats

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
No text entered.


  More Information