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

Measure Type Primary
Measure Title Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events
Measure Description No text entered.
Time Frame 26 weeks  
Safety Issue No  

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 five subjects in the CGM group and four in the control group who dropped out prior to the 26-week visit; for one subject who was missing central laboratory HbA1c values at randomization and one at 26 weeks, the DCA value measured at the site was used to impute values using repeated-measures regression models

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]
  69     68  
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events  
[units: participants]
  13     19  

No statistical analysis provided for Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events



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

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 ]

Measure Type Secondary
Measure Title CGM Glucose Values (mg/dL)
Measure Description Percentage of sensors values in range (71 mg/dL to 180 mg/dL)
Time Frame 26 weeks  
Safety Issue No  

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.
CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data

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]
  62     67  
CGM Glucose Values (mg/dL)  
[units: percentage of sensor readings]
Median ( Inter-Quartile Range )
  48  
  ( 37 to 59 )  
  49  
  ( 38 to 59 )  

No statistical analysis provided for CGM Glucose Values (mg/dL)



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

Measure Type Secondary
Measure Title Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)
Measure Description CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.
Time Frame 26 weeks  
Safety Issue No  

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

Measured Values
    Continuous Glucose Montoring     Standard Glucose Monitoring With a Home Glucose Meter  
Number of Participants Analyzed  
[units: participants]
  62     67  
Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)  
[units: percentage of sensor readings]
Median ( Inter-Quartile Range )
  1.5  
  ( .6 to 3.5 )  
  2.1  
  ( .6 to 5.9 )  

No statistical analysis provided for Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)



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

Measure Type Secondary
Measure Title Measures of Variability: Standard Deviation (SD)
Measure Description standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.
Time Frame 26 weeks  
Safety Issue No  

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.
CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.

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]
  74     72  
Measures of Variability: Standard Deviation (SD)  
[units: mg/dL]
Median ( Inter-Quartile Range )
  73  
  ( 65 to 87 )  
  81  
  ( 68 to 92 )  

No statistical analysis provided for Measures of Variability: Standard Deviation (SD)



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

Measure Type Secondary
Measure Title Measures of Variability: Mean Absolute Rate of Change
Measure Description mean absolute rate of change
Time Frame 26 weeks  
Safety Issue No  

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.
CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data

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]
  74     72  
Measures of Variability: Mean Absolute Rate of Change  
[units: mg/dL per minute]
Median ( Inter-Quartile Range )
  0.91  
  ( 0.80 to 1.00 )  
  0.90  
  ( 0.77 to 1.00 )  

No statistical analysis provided for Measures of Variability: Mean Absolute Rate of Change



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

Measure Type Secondary
Measure Title Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)
Measure Description Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55
Time Frame 26 weeks  
Safety Issue No  

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.
CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data

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]
  74     72  
Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)  
[units: percentage of median]
Median ( Inter-Quartile Range )
  144  
  ( 125 to 168 )  
  145  
  ( 127 to 173 )  

No statistical analysis provided for Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)



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

Measure Type Secondary
Measure Title Parental Quality of Life Measures: Hypoglycemia Fear Survey
Measure Description The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0–100 with higher score denoting more fear. The results reported below are the values at 26 weeks.
Time Frame 26 weeks  
Safety Issue No  

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: Hypoglycemia Fear Survey
Standard Glucose Monitoring With a Home Glucose Meter Control Group: Hypoglycemia Fear Survey

Measured Values
    Continuous Glucose Montoring     Standard Glucose Monitoring With a Home Glucose Meter  
Number of Participants Analyzed  
[units: participants]
  69     68  
Parental Quality of Life Measures: Hypoglycemia Fear Survey  
[units: units on a scale]
Mean ± Standard Deviation
  38  ± 17     42  ± 19  

No statistical analysis provided for Parental Quality of Life Measures: Hypoglycemia Fear Survey



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

Measure Type Secondary
Measure Title Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)
Measure Description The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.
Time Frame 26 weeks  
Safety Issue No  

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: PAID
Standard Glucose Monitoring With a Home Glucose Meter Control Group: PAID

Measured Values
    Continuous Glucose Montoring     Standard Glucose Monitoring With a Home Glucose Meter  
Number of Participants Analyzed  
[units: participants]
  69     68  
Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)  
[units: units on a scale]
Mean ± Standard Deviation
  44  ± 17     49  ± 16  

No statistical analysis provided for Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)



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

Measure Type Secondary
Measure Title Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale
Measure Description The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1–4. Higher score denotes fewer problems in the past month.
Time Frame 26 weeks  
Safety Issue No  

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: Blood Glucose Monitoring System Rating Scale
Standard Glucose Monitoring With a Home Glucose Meter Control Group: Blood Glucose Monitoring System Rating Scale

Measured Values
    Continuous Glucose Montoring     Standard Glucose Monitoring With a Home Glucose Meter  
Number of Participants Analyzed  
[units: participants]
  69     68  
Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale  
[units: units on a scale]
Mean ± Standard Deviation
  2.7  ± 0.5     2.4  ± 0.5  

No statistical analysis provided for Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale



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

Measure Type Secondary
Measure Title Parental Quality of Life Measures: CGM Satisfaction Scale
Measure Description

Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)

JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679–684

Time Frame 26 weeks  
Safety Issue No  

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: CGM Satisfaction

Measured Values
    Continuous Glucose Montoring  
Number of Participants Analyzed  
[units: participants]
  69  
Parental Quality of Life Measures: CGM Satisfaction Scale  
[units: units on a scale]
Mean ± Standard Deviation
  3.9  ± 0.5  

No statistical analysis provided for Parental Quality of Life Measures: CGM Satisfaction Scale




  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
No text entered.


  More Information